How to reduce risk As Far As Possible

In 1987 Chuck D, frontman of the hip-hop group Public Enemy, asked: “How low can you go?”
In 2017 Europe responded: “As Far As Possible.”

The new European Union Medical Device Regulation entered into effect in 2017 and will require devices to reduce risk As Far As Possible by 2020. Noncomplying devices will be removed from the market by 2024. The penalty is strong because improving risk management is critical for global healthcare: 85,000 to 250,000 people die each year due to healthcare errors in America, and recently 400,000 Europeans received toxic medical implants. Learn more in my article about the MDR Big Picture.

Reducing risk As Far As Possible (AFAP) has been one of the most confusing parts of the European Union Medical Device Regulation (EUMDR). Officials have tried to offer guidance. First, they modified the international standard for risk management, ISO 14971:2007, to include AFAP in the European version, EN ISO 17971:2012. Unfortunately, this introduced the term but did not explain the concepts, adding to confusion. In 2014 officials tried to clarify the concept in a consensus paper for the interpretation and application of EN ISO 14971:2012, where they state that they’ve clarified AFAP in a way that’s “clear, easy to understand, and unambiguous.”

I offer possible explanations of why we’re confused in Why reducing risk as far as possible seems confusing; I believe it has to do with psychological concepts of anchor bias and a modern corporate culture that doesn’t allow employees to see the big picture of their work.
Regardless of the reasons, it’s important to understand reducing risk to patients As Far As Possible. Here’s my attempt to describe the concept in a way that’s clear, easy to understand, and unambiguous.
AFAP
A company must demonstrate for each product or family of products, depending on the device classification that:
All risks were reduced as far as possible compared to the “state of the art,” including risks deemed negligible under the practice of As Far As Reasonably Practicable. This does not mean the latest, unproven technology; in European law, “state of the art” means “generally accepted state of the art,” which implies general acceptance of best-practices based on current medical knowledge and competitive products.Cost wasn’t a factor in reducing risk. In other words, you can not justify stoping at a level of risk control because the next level is state of the art is more expensive.Additional risk control won’t lower risk levels.Benefits of the medical device outweigh all remaining risks.
These are concepts, not simple definitions, that I’ll try to illuminate below.
State of the Art

Think of “state of the art” in terms of an automobile: you wouldn’t buy a car without state of the art safety such as seatbelts, anti-lock brakes, or child-safety seat attachments. Conversely, there’s not enough evidence to make self-driving cars the “generally accepted state of the art.” Learn how to make state of the art medical devices in my article that demonstrates the concept using David Hasselhoff’s 1982 self-driving car.
“Cost can not be a factor” means you can’t choose not to make state of the art medical devices because your management thinks it costs too much or would reduce profits. Sate of the art means other companies have figured out how to control risks therefore you should too.
Risk Controls & Risk/Benefit Analysis
You will still have some risks even after you’ve applied state of the art risk controls, which is why reducing risk As Far As Possible requires a risk/benefit analysis for all remaining risks.
There will always be remaining risks in medical devices. For example, hospital workers were at risk of being stuck by used needles that carried viruses such as HIV and hepatitis until state of the art risk controls included caps for needles and designated disposal containers. But, there’s still a needle that must be able to penetrate skin, so there’s still risk. Risk/benefit analysis documents that you followed state of the risk controls and that benefits to patients outweigh your remaining risks.

That’s the “point” of my article on risk controls and risk-benefit analysis by applying the method to Harry Anderson’s magic trick of apparently sticking a needle through his arm.
At this “point” you will have a risk/benefit analysis documenting that you reduced risk as far as possible by applying risk controls that are state of the art, and that any remaining risk is outweighed by benefits to the patient population on your marketing literature. This risk/benefit analysis will be linked to other MDR requirements such as clinical data and post-market surveillance.
Continuous learning
To reduce risk as far as possible for MDR regulations requires linking to other processes in your quality system, especially clinical data and post-market surveillance. That’s beyond the scope of this article but you can learn more.
I provide more information on the transition to the new regulations in MDR: the medical device regulation formerly known as MDD.

You can hire consultants to help you prepare or train your teams.
I encourage all companies to discuss original phrasing in the MDR and consensus paper as a team until concepts are clear, easy to understand, and unambiguous. That’s why my workshops focus on teamwork, learning-by-doing, and the bigger picture of how our work impacts the lives of other people.
To help, I share a few steps you could take starting today that will help you comply with the MDR and reduce risk As Far As Possible. Taking small, measurable steps is the basis of Kaizen approach to management. See Take these steps to comply with the EU MDR, with an application to reducing risk As Far As Possible.

Thank you
Please share this article if you think others could benefit.
For what it’s worth
I first heard Public Enemy’s album “It’ll take a nation of millions to hold us back” in the 1980’s when they collaborated with diverse styles of music to bridge gaps in our society, such as the heavy metal band Anthrax, and the folk singer Stephen Stills from the band Buffalo Springfield while collaborating with filmmaker Spike Lee to remake their classic 1967 song “For What it’s Worth.”
Though not everyone appreciates all of Public Enemy’s political messages, I respect that they collaborated with seemingly different people. I hope the medical device community can do this too; it’ll take an industry of millions to provide healthcare for billions, and innovation will depend on diversity in boardrooms that begins as equitable education in classrooms.
To do my part, I waive consulting fees for companies that contribute to programs supporting equitable education. Contact me to discuss more.
Now, let’s have fun with the 1987 hit “Bring the Noise” that was ranked #160 in Rolling Stone magazine’s 500 best songs of all time. It begins with the phrase “Bass! How low can you go?”

And the original 1967 “For What it’s Worth,” a message that’s still relevant today and emphasizes that seemingly different people share common beliefs.

And with their grammy-nominated collaboration with Heavy Metal band Anthrax.

Hiking over the Himalayas helped me…

I hiked over one of the world’s highest mountain passes in a four-week journey, offline, without plans. This blog describes people I met, life in the Himalayas, altitude sickness (and rescues), and methods I used to develop mindfulness that allowed me to overcome a decade of suffering from chronic pain. It began in the town of Besisahar and ended in Beni Bazar 28 days later.
The hike was part of a longer backpacking trip through Nepal and India, where I arrived in Kathmandu, learned basic Nepali phrases, then traveled through both countries without plans, adapting each day based on people I met and lessons I learned.
I’ve traveled this way for 30 years, flying into one country and out of another. This trip was different because I had a goal to hike without pain medications. Doctors at the Veterans Health Administration had prescribed pain medications to me for over nine years to postpone surgeries that have low probabilities of relieving pain. The meds treated symptoms, but my mind became sluggish and it was difficult to make wise choices for long-term health. And, as I would later realize, something had been going wrong with my mind that reminded me of when I first started noticing symptoms of physical diseases, mistaking symptoms for being sore from exercising or stiff from sitting at a desk. Similarly, I was now noticing slips in my mental capabilities, especially with simple math and remembering details even when I made a conscious effort to do so.
I share a few techniques I used to develop mindfulness throughout blogs about this trip, hopefully helping others.
The trail

I took a bus from Kathmandu to the village of Besisahar, being dropped where the dirt road ended and a hiking trail began. I had a backpack with two months worth of clothes. I carried a day’s worth of food and water, a few books, a camera, and a Frisbee.
The trail cut into the sides of mountains, crossing rivers with suspension bridges swinging hundreds of feet in the air. Two people could not pass on the narrow bridges, so we’d coordinate who went first. Goats, cows, and buffalo used the bridges; I gave right-of-way to anything with horns, and played with anything that was cute.

Sleeping & eating
I carried a day’s worth of food an water, knowing I’d find more on the trail. The trail goes through villages, passing people’s front doors. Most families offer simple beds and dinners to travelers. Their ancestors had done the same thing to Tibetan traders for generations.

Most villages don’t have schools. Some do, and nearby villagers walk the trail for hours to reach them. There are not medical services. Poverty is common, and the area was recovering from a recent civil war that killed 19,000 people and displaced 200,000. Foreign aid doesn’t reach them. Despite these challenges, the Himalayan people are kind, industrious, hard-working, and peaceful. Himalayan people say, “what is there to do?” as a way to be present in the moment and only worry about what is within their control.

Part of what’s in everyone’s control is our kindness towards others. Nepali culture encourages compassion, shown by how kids would run into the street to greet me when I approached a village. They’d clasp their hands, bow, and say “Namaste,” the Hindu word for “I see the divine in you.” I’d clasp my hands, bow, and wait to feel the sentiment before returning the word, “Namaste.”
Feeling compassion and speaking truthfully makes everyone happier. Imagine if our culture encouraged pausing to seek compassion for a person before saying, truthfully, “I hope you’re well.”
The poorest backpacker is wealthier than these kids can imagine, and many share treats. A consequence is a that kids start seeing backpackers, most of whom are caucasian (white), as sources of things rather than as people. They don’t say Namaste, they shout, “Money! Chocolate! Sweet!” You can’t see the divine in each other with a hierarchical relationship, so I gave the most valuable thing I have, time.

Many Himalayan families had been in travelers’ photos, but had never used a camera or seen their own picture. I lent my camera to kids, letting them learn by playing with it. They’d take photos of their parents, show them, and try again with new button combinations. In return, they’d teach me Nepali words for what they saw. This is co-learning, a powerful tool for connecting with students.
Kids took many of these photos, letting us see the world through their eyes.

People

I was hiking uphill each day, gaining 400-500 meters of elevation. Each night got colder; before going to bed, I’d huddle around kitchen fires, learning to cook Himalayan food while talking with families.

Most guest houses were people’s homes, and they juggled family duties while preparing our dinners. One host, Narme Llama, was a third-generation Tibetan with newborn twins. He had a warm smile, had learned four languages, and helped take care of his new daughters while running his business.
I arrived at the end of season without tourists, so a bed was free. A meal cooked over their wood stove was 200 Rupees ($2 U.S.). Ginger tea was 60 Rupees. They saved money to send their older daughter to boarding school in the nearest city, two-days away, for $15/month. They were lucky to save $2 per month, which would have to support them in old age. There were no schools nearby, and all jobs were physical labor that didn’t need an education, but Narme-Llama valued education. He realized their government wouldn’t build roads, schools, or hospitals in rural areas, but was grateful for his family and the values installed by his grandfather that helped make their exile from Tibet and independence in the Himalayas peaceful, despite being viewed as unwelcome refugees. Images of Buddha were on the walls; the Buddha taught how to seek your own happiness, because no one else can do that for you.

Sometimes a guesthouse would have other backpackers, or travelers with a guide, and we’d share time around a fire learning different perspectives on the world.
Some travelers had smart-phones with translation apps and solar-chargers, allowing us to communicate with almost anyone. Even tiny villages had WiFi; people couldn’t get toilet paper, but could browse the internet. Our world could be moving towards a global democracy, where people solve problems rather than politicians, or we could could be moving towards replacing democracy with “dataism.” (Read “Homo Deus.”) Wherever we’re going, 7.6 billion people using smart-phones will get us there faster.

Elevation
I hiked uphill 4 to 8 hours per day. Trees became rare, and snow-capped mountains became common. Tibetan prayer-flags highlighted mountains I’d eventually cross.

At higher elevations, people from poor castes walk downhill to collect firewood each day, walking back uphill to sell it. Tourists use more firewood than the local ecosystem can resupply; to balance this, the government agency overseeing this area has encouraged gas stoves. The alternative was burning yak-dung, which isn’t as smelly as you’d imagine, but I wouldn’t try it at home.
Mules resupply villages with gas tanks and food that can’t be grown in high elevations.

Democracy
Every few days I’d walk into a town, which is larger than a village and serves as a trading center. Towns had comfortable guest houses and supplies for backpackers, such as Snickers candy bars.

In the town of Manang, we had to wait four days because all guest-houses in the region were full of people from Kathmandu, who had traveled to vote in the national election. In Nepal, people must vote in the town they’re registered, usually where their ancestors were born. This was Nepal’s second election; their democracy was new, and followed a ten-year civil war that had divided the people between the poor and wealthy.
Nepali soldiers patrolled the streets, enforcing a curfew with guns rather than logic. Nepal uses their soldiers as defense, police, and national park protection. Until the civil war, they were the only people with guns, and without checks-and-balances they abuse their power in rural areas. I believe this will change now that Nepal has a democracy; I’ve never had a gun pointed at me in a country with a functional democracy.

The curfew didn’t affect our stay in Manang because there was nothing to do at night, especially when temperatures were below freezing. We’d walk up and down the street then return to our guesthouse to get warm around a yak-dung fire.
The guesthouse where we stayed was decorated for what the owners imagined a typical traveler would enjoy. Their home look like a rustic version of a 1970’s television sitcom; for some reason, they assumed that a typical traveler expected a Tiki bar. We’d sit under the Tiki bar, heating our tea in steel mugs on the yak-dung burning stove.
Frisbees are surprisingly useful for meeting people. One of our group used my Frisbee to prepare wild herbs he had found hiking in the lowlands earlier on the trip.

We spoke with local families about the election. Most people didn’t understand the differences between political ideologies, they simply hoped for a better life. The communist party overwhelmingly won elections in rural areas. In cities, the status-quo remained. Their new democracy would share government decisions between parties. Regardless of this year’s outcome, it’s a step towards more people having a voice in their future. They celebrated with parties in the street.

Silence
After the elections, I started hiking through remote areas. My head hurt from spinal injuries, my hips hurt from arthritis and inflammation, and the screws in my ankle caused the bones to throb with pain. But I did not experience worry, anxiety, stress, or suffering. I walked silently, concentrating on being mindful.

You see more wildlife when walking silently. Some, like this yak, are not subtle. Others are easily missed; there are at least four mountain goats in this photo:

And at least two in this photo:

Altitude
Many people do not get altitude sickness. I’m not one of them.
This photo was taken from the window of a shelter, where I stayed for three nights to recover.

For almost a week, I had been hiking at over 3,400 meters (~11,000 feet), gaining 300-500 meters each day. I had a headache and craved oxygen. My body fought two needs: deep breaths to get oxygen vs. tightening my windpipe to keep out the cold, dry air. I have asthma, and my breath “wheezed” on steep sections of the trail.
When you’re emotionally detached from discomfort, you’re able to differentiate between transient discomfort and symptoms of altitude sickness. At 4,880 metres (16,010 ft, ~ 3 miles) I realized that my headaches and dizziness were signs of trouble, so I descended to a shelter at 4,540 meters.

I stayed in a small room with one window that allowed cold wind into the room. I laid awake for hours, trying to stay warm as ice formed in my water bottle. It was -17 degrees by 2am. My heart was pounding at 124 beats per minute, more than twice my normal resting rate. Every muscle in my body was tense, sending blood to vital organs. I couldn’t descend; in daylight, it was six hours down a narrow and dangerous trail to the next shelter. I concentrated on relaxing until my jaw unclenched, which led to my teeth chattering at 124 beats per minute. I had preferred a clenched jaw.
By sunrise, my pulse was down to 80 beats per minute. I didn’t move that day, and by that evening my pulse was ~ 60 beats per minute, still more than my normal resting rate, but reasonable considering I was 3 miles high.

I acclimated by hiking to higher elevations during the day, descending to sleep at night. On one of these hikes, I found an emergency satellite phone. Three years prior, almost 400 people were trapped at this location by a surprise snowstorm; 42 died, and 175 suffered frostbite. I was not reassured by the satellite phone, which was made from a coffee can and something that looked like the dish-drying rack by my sink at home.
I’ve sumitted mountains all over the world, and frequently rock-climb in the Sierra Nevada mountains, where the amount of focus for each motion makes you not notice almost all other thoughts or feelings. This requires concentration; your mind is sluggish from high altitudes, low oxygen, and physical exertion, and it wants to be anywhere other than the present moment. Hiking above 17,000 feet can require 10 to 15 seconds of focus per step, requiring 6-8 hours of unbroken concentration. For me, I also must remain aware of the nature of pain in my body. For example, the metal screws in my ankle can wear into the bone, leading to a risky situation if I can’t walk effectively, and my normal headaches must be continuously evaluated to ensure it’s not progression to severe altitude sickness.
If you think about how difficult it is to concentrate on something unpleasant, you have an idea of the real challenge of high-altitude hiking, which is maintaining that level of focus for 6-8 hours per day for several weeks.
Here’s my metaphor for being mindful while hiking, which applies to anything in life. You’re the pilot of a bus, a driver with passengers, navigating a road with other drivers. You are the pilot, and the bus is your body and the passengers are your thoughts. The road and other drivers are external situations often out of your control. In other words, you’re in control of piloting your bus and maintaining it’s well-being, and sometimes you must pilot your bus on and rough and bumpy road despite deflated tires, weak shock absorbers, pain from screws in your ankle, pain from spinal disease. Your passengers are loud and all talk at once, like kids on a school bus shouting things that may or may not help you. They constantly tell your about your deflated tires, weak shock absorbers, pain in your ankle, pain in your neck; they warn you to look out for other buses even when the risk is negligible; they worry about where you’re going or question where you’ve been; they ask about work project you need to finish, wonder what other people in your life are doing, and talk about other aspects of your life not relevant to the immediate situation of piloting your bus over a rough road with weak shock absorbers and the potential to get a flat tire. But, some of those voices are telling you when to rest, ensuring your headache is not a symptom of life-threatening altitude sickness, notifying you of potential risks to avoid such as slippery ice or a possible avalanche or another driver on the road out of control, and other things critical to your safety at the moment. Your challenge is to acknowledge the voices of all passengers while maintaining focus on piloting the bus; you acknowledge pain, worry, anxiety, fear, and even joy or elation while concentrating on being in control of your bus.
When you pilot your bus 6-8 hours per day for several weeks you begin to recognize that you can listen to passengers while being detached from them, to acknowledge without judgement, and to make choices based on what’s important for your safety and peace of mind regardless of the condition of the road, your tires, or other passengers sharing the road.

I had been focused on piloting my bus, which required ten seconds for each step, for six hours when I saw a tea shop.
Seriously. I shook my head to ensure I wasn’t mistaken.
A cheerful entrepreneur had brought gas stoves and tea to a shelter at 17,900 feet. I paid $1.50 for a cup of hot tea; I would have paid a hundred.
Over the next few hours, his hut saved someone’s life.

I reached the summit, sat down, then got up as I realized something was wrong with one of the four other people. She was suffering severe altitude sickness. Her eyes were rolled back into her head, her breathing was in brief gasps, and her pulse was more than 150 beats per minute. She was in shock, and it was likely that pressure was building insider her brain.
None of us spoke the same language; we carried her into the tea hut while her guide was trying a satellite phone to call help. Over the next few hours, we kept her warm in the tea shop while preparing a helicopter landing zone. We carried her and her bags onto the helicopter, which would prioritize getting her to a lower elevation, and then to a hospital.

The helicopter cost $10,000. It was a private service, and the patient’s guide received a commission for calling it. The tea shop entrepreneur made $1.50. Three years ago, when the storm trapped 500 people here, local people dug through snow without concern for how they would get paid. There’s no right or wrong, just facts. Mindfulness is being aware of facts, but differing judgement until those facts are necessary to make a decision.
When the helicopter left, I was alone again. I started walking down the other side of the pass.
Mindfulness & a transformational moment
I had been so focused on the rescue that I hadn’t felt pain or symptoms of altitude sickness. I started to notice the pain again. Descending steep trails is harder on your joints than hiking uphill, and my head and joints screamed with pain. People become addicted to temporary relief from pain, either from medications or by pouring themselves into their work, so more doctors are recommending mindfulness, which can allow someone to become detached from discomfort while maintaining mental clarity.
When I had descended enough to reduce the effects of altitude sickness, I stopped to eat a Snickers candy bar. It was the first food I could hold down in 24 hours; at that moment was the most delicious thing I had ever eaten. In the time it took for my teeth to break through a peanut, all discomfort faded. I had no thoughts, just awareness. The sky was brighter, the air cleaner, rocks more beautiful than before I began taking that bite. This experience lasted for a month, and, to a lesser extent, remains now that I’m home. I’ve tried to share the continued experience throughout my blogs; this one remains the most challenging to describe because few people have that experience therefore it’s difficult to relate.
I had read writings from the historic Buddha who described the feeling of Nirvana, complete peace, as “all that needs to be done is done.” That’s apt, but only for people who have experienced that before. For me, it applies because I’m a person who takes several months off at a time to backpack or travel without anything else to do. But it was more than that; I truly and deeply understand many things now that became clear in that brief moment that lasted the time it takes to bite through a peanut.
First, a little background on me: I’ve taught physics, among other topics. But, I don’t have a physics degree, I enjoy physics as a hobby, and have had the opportunity to apply my understanding in medical research and aerospace engineering, and a lot of my free time is spent trying to deepen my understanding of the overlap between theories of relativity, quantum mechanics, gravity, and time. I can pass any exam, test, or conversation about physics because the people who write exams or test or have conversations about physics are simply repeating the words, not understanding the concepts, and definitely unable to apply them. But I did not truly understand what it would feel like to ride a beam of light in the eight minutes it takes to reach Earth from the sun; what it would be like to ride the gravitation wave that recently passed through Earth and originated 130 million light-years away; why my body disintegrates as the laws of Entropy ensure will happen to all of us.
The Buddha said that there are only four truths, and that Nirvana is seeing them. One of the truths is that we all will grow old, get sick, and die. That’s entropy, which is also the foundation for surprisingly recent explanation of life on earth beginning and, possibly, the arrow of time. I wouldn’t realize that part until reading books by Carlos Revelli. But, sometime between the moment I started biting through the peanut and before the peanut broke apart in my mouth, I gained a deeper level of understanding about the works of Einstein, Hawking, and many other physicists. I also gained a deeper understanding of what the Buddha taught, and how it applies to mindfulness and wisdom. I wrote about the books I read on this trip that contributed to that understanding in another blog.
I eventually learned that mindfulness can be permanent, but takes as much concentration as hiking at high altitude. The same concentration that allowed me to hike over the Himalayas without suffering from pain, the same focus that allowed me to assist in a helicopter rescue without noticing pain or worry, is possible in our daily lives without external motivation. As the Buddha said, peace comes from within. Over the next two months in Nepal and India, and the following six months back in the United States, I’d learn that, for me, being mindful while piloting a bus on a challenging road is easy compared to piloting a bus in daily life. The moment I transformed while eating a Snickers bar allowed me to feel mindfulness for many weeks, so I had evidence that it was possible, which gave me the conviction that I could learn to make it permanent.
It happens that Buddhist philosophy on meditation and mindfulness are useful tools in a deeper understanding of what these words mean. Just like memorizing physics words or formulas doesn’t ensure understanding, using words or citing philosophers doesn’t ensure understanding, and hearing words does not mean you’ll understand what you don’t practice, just like hearing someone describe riding a bicycle doesn’t mean you’ll be able to ride a bicycle without practicing yourself.
I decided to practice the methods with an open-minded approach (ha!) to see if I could understand mindfulness on the same level I understand physics. I had an advantage, I had experienced it. The focus and concentration on my body and mind’s reactions for a couple of weeks, combined with my attempts to practice yoga and meditate for the year before, had led to me experiencing what could not be denied: I could become detached from physical discomfort and mental worry, I could understand things on a deeper level at a rate faster than words allow, and that these feelings could be maintained over weeks if not longer, including a lifetime.
This is explained by how our brain connects neuron cells to other neuron cells to form complex patterns of association, creating present experiences based on a combination of past experiences and expectations for the future. This was famously seen in the experiment with Pavlov’s dogs. Does that name ring a bell? (Ha!) Pavlov was a psychologist who noticed that his dogs began to salivate when he conditioned them by ringing a bell before serving food; over time, they would salivate with only the bell, without smelling food or being near dinner time. Mind and body, perceptions and situations, thoughts and feelings, are inseparably linked and those connections are difficult to distinguish. Our discomfort or worry in a moment are almost indistinguishable from a complex network of past experiences and expectations that combine to make us salivate at the sound of a bell. Almost. I learned to distinguish the two on a daily bases, just as I learned to acknowledge all voices on the bus in a way that was detached and allowed me to pilot the bus despite bad tires and an icy road. What could be conditioned could be unconditioned through practice.
Einstein would often talk about detaching himself from conditioned thoughts that were obstacles to seeing reality. The Buddha’s final words were, “All conditioned things are impermanent. Practice diligently.” We don’t understand physics or our minds by reading about them, we must concentrate and practice diligently until we can ride our bicycle or pilot our bus effortlessly.
I walked downhill for a few more hours, found a guest house, and enjoyed the sunset. The sunset was beautiful because of ice crystals forming in the air; the lenticular clouds coming from mountain peaks indicated pressure was building and snow would arrive. Two days later, it began snowing on the mountain pass I had just summited, and it was raining in the areas of where I would spend the next two weeks. I started hiking through the rain, going off-the-beaten-path and into the Kingdom of Mustang.

Other blogs share key experiences during this trip through Nepal and India. Too much happened to list every detail, but many come out at appropriate times with friends. One’s worth mentioning here: On the hike down the other side of the Himalayas I stumbled across a small house that advertised itself as a bed-and-breakfast and Dutch bakery. It had American wild-west photos on the walls, and images of galaxies and quotes on astrophysics. The owners were a Dutch physicist and Nepali Buddhist; the physicists had hiked this route 20+ years before, fell in love with a Nepali woman, and lived with her in this remote town. He loved American western films, and decorated the home to look like a saloon from the California Gold Rush, which was near my home in San Diego, California. Of course, I stayed there. We spoke all day and night about physics and what the Buddha taught, realizing that insights of Einstein and Buddha were simply applications of geniuses applied to the tools they had available, physics and the mind.
Many of my side-stories are interesting in the context of main stories in these blogs. If you and I meet, I hope we spend enough quality time together to share stories.
Continue to:
Or, jump forward two weeks:

You get what you give in Varanasi India

7 minute read if you skip the bad stuff.
Varanasi tested my patience, humor, and immune system more than anywhere in the world. The Lonely Planet guide to India, the gold-standard of travel guides, a bible for budget backpackers, and usually a kind voice encouraging you to travel without judgement, said:
Brace yourself. You’re about to enter one of the most blindingly colorful, unrelentingly chaotic and unapologetically indiscreet places on earth. Varanasi takes no prisoners.
Varanasi sits on the banks of the Ganges River. The World Health Organization found that Ganga water is polluted from:
* Domestic and industrial wastes.
* Animal carcasses and half-burned and unburned human corpses thrown into the river.
* Defecation on the banks by the low-income people.
* Mass bathing and ritualistic practices.
The protagonist of the novel White Tiger said this about the Ganga:
I urge you not to dip in the Ganga, unless you want your mouth full of feces, straw, soggy parts of human bodies, buffalo carrion, and seven different kinds of industrial acids.
I’m about to describe my experiences of poverty, death, and cow diarrhea in Varanasi. You may want to skip it, or at least scroll through the next few “bad” paragraphs to the “good” ones.
Judging something as bad or good is the opposite of my blog about nonjudgemental mindfulness in Kushinagar, but I wanted to paint a picture with words so that you’d understand the experience. I’m glad I went. I met wonderful people and experienced things few people in the western world do. But there’s no denying the harsh realities of Varanasi, which concentrates the poverty of India into 1.4 million people and a lot of cows with diarrhea.
Thousands of years ago people in India realized that if you kill a cow you eat for a week but if allow a cow to live you continue receiving milk. Cows became sacred and are protected by laws; if you kill a cow you can go to jail. Today, cities have grown to have more concrete than grass and cows eat by rummaging through trash.
The cows develop diarrhea from eating trash. In Varanasi, they squirted streams of brown liquid, and that brown liquid would slowly and continuously drip down their legs and tails. When they swatted flies with their tails drops of diarrhea would sling through the air and land on anyone nearby. They seemed to swat flies every time I walked by.

Thousands of shop owners cleaned their steps by splashing water on the cow diarrhea, spreading it in a thin layer across streets. Over the next few days I would slip in that viscous brown water several times and watch brown footprints get tracked through cleaner streets where children sat to eat. The water made thick, brown waterfalls on steps leading to the river where people bathed.
Cows are more prevalent in Varanasi than other Indian cities, probably because of its history as a holy city. Poor people from all over India travel to Varanasi, partially because elderly rich people travel to Varanasi to have a peaceful transition to death and a more auspicious rebirth by becoming detached from money and material possessions. I oversimplified that for the sake of time; understand that there are many poor people in Varanasi competing with cows and dogs for scraps of food or attention from people.

Many of the beggars were left there by their families who believe this is how “the system” works; rich give to the poor in order to be born in a higher role, and everyone does their duty. This was especially true for disabled or mentally troubled people. Crippled beggars crawled towards me through streets covered in feces from cows, dogs, and people. Try to empathize with them, not with me.
Human feces is a major health concern in India, especially in Varanasi. Train toilets are simply holes leading to the train tracks, and 25 million people ride the trains each day. In cities, the few public toilets require a small amount of money. Many poor people defecate in the streets or alleys. Human poop contains bacteria and viruses that make us sick if ingested.

Poop isn’t restricted to trains. Defecation in open spaces is a challenge for 1.2 billion people. 300,000 children die from sanitation-related illness, and an untold number are held back from their full potential. UNICEF tracks this health hazard internationally and there’s a TED talk about the reasons why it’s so predominate in India.

I received food poisoning in Varanasi, which is a euphemism eating human poop, or at least bacteria from human poop carried by flies, water, or hands. I spent several days unable to leave my hotel room because any food or water ejected my body with extreme haste and what seemed like malicious intent. I didn’t always reach the toilet in time. I became dehydrated, which added to physical pain that I had been experiencing. But, I could come home. In poor countries, 525,000 children under five die each year from diarrhea; we know this and we choose to focus on other things that are often trivial in perspective.
But the worse part for me was the noise. I can’t describe the amount of noise that distracted me from feeling calm or focusing on positive things. It wasn’t necessarily loud, but it was constant and often directed at me. I tried to measure the longest time between when someone was in my face or on my arm demanding my attention; it never exceeded three minutes, and even that break was rare. I experienced a nonstop series of questions and pitches as I walked, often by multiple people simultaneously with one set of hands on my arms transitioning to the next set of hands while I processed whether or not their open sores were contagious. Since then I’ve heard a constant ringing, known as tinnitus. But, I was able to return home to my doctor; the poor of India are surrounded by health concerns that perpetuates poverty.
There’s a correlation between noise and poverty even in the United States. Kids are unable to change their situations, which perpetuates the problem. There aren’t enough education reformers reaching the right areas.

I stayed in Varanasi several times because planes were full and trains were delayed due to fog. On one train ride into Varanasi I saw someone pushed from a moving train, probably dying. I contributed to this. None of us did it intentionally, it was the result of an overloaded train in the cheaper general-admission section with few seats and broken doors. People crammed in after several days of trains being delayed by thick fog, which had hardship for people earning less than $2.50/day and relying on public transportation to get between work and home; they couldn’t afford to eat while waiting, and their families were loosing income each day.

When a train came we boarded the general admission boxcar, which was standing-only. At first I enjoyed getting to know people in tight quarters. There was a young couple and their three month old daughter, returning from a state-ran hospital because of her cleft palate. The parents were diminutive in size, with features of dwarfism, but were smiling and kind while sharing their story with us before the train became crowded. They could not afford corrective surgery and would spend the next few years adjusting how she ate, but they only spoke of the joy of having a daughter to love. At each train stop we became more and more cramped as people pushed onboard.
Soon I wasn’t able move my arms, much less take photos to convey how tightly were were packed. A few of us huddled around the baby and her parents to protect them as crowds packed us so tightly that people started standing above us, placing their feet on our shoulders or hunched backs, unable to go anywhere else.
I’m 7 inches taller than an average Indian and probably stronger, and I decided to give us more room by forcing myself upright. From my perspective I saw deep inside the train as people shouted for more elbow room while people near us shouted to stop people from stepping on them. I saw people outside of the train clutching the door with fear in their eyes as people near them shouted and pushed crowds inward. Everyone pushed. I saw the man lose his grip and disappear out of my reach and into the fog. I processed that while continuing to prevent people from stepping on the diminutive couple and their daughter for the next two hours.
I was in more pain than I had been in years due to physical exertion on the train and my weakened immune system from food poisoning. For more than two weeks in Varanasi my spinal chord reacted to inflammation, and I was nauseous from headaches. Pain would radiate into my arm, and my back muscles would spasm all day and night, reducing sleep and aggravating my mental reactions to the pain.
My mental reaction to pain impacted my perception of Varanasi, but something more important was bothering me. I saw the train ride was a metaphor for our planet; some of us are wanting what’s best for ourselves without realizing the impact is has on others. I unknowingly contributed to this on the train, pushing to stand up as other people pushed to help the man clinging to the door. I was pushing for more comfort, he was pushing for survival. Some people were pushing for more elbow room, and in the higher-class cars people were probably pushing for more space to stretch their feet. Everyone was pushing, and we only helped the people we could see or with whom we could empathize, like the baby with a clef palate and her frightened parents.
Every day I’m unknowingly pushing people on our planet with my choices, such as when I choose to buy cheaper food or products rather than paying more for products that are regulated to encourage sustainability. There are 7.6 Billion people on Earth and there will be 10 billion by the year 2050. More than half of us will be poor, and all of us will be pushing for more comfort.
When I returned from India I started waiving my consulting fees for companies that contribute to equitable education and healthcare. I also started this blog as a marketing effort to reach executives with corporate social responsibility programs and philanthropists with compassion or religious convictions to serve the poor.
To clarify, I’ve always been socially-minded. All of my clothing and most gear for this trip was bought in thrift stores. An exception was my underwear, socks, and a lightweight down jacket I used for at the beginning of this trip when I hiked over the Himalaya mountains. I bought the jacket from Patagonia, a benefit-corporation with products that cost more because they push less.
This isn’t about individual choices, it’s about global sustainability built into all products. I would like to live in a world where we’re all comfortable, no product pushed anyone, and some products pull people onto the train. In other words, I would like a world of abundance. To do this will require innovation, empathy, sustainable businesses, and possibly new forms of currency. Contact me to discuss more, or share this with people who could be interested.
Now let’s get to the good.
Welome to Varanasi.

This blog is a compilation of several trips to Varanasi over two weeks. The first time was with a friend, Iris, whom I met in a shared guest-house in Sarnath when we were practicing yoga one morning. Iris and I were in Sarnath for similar reasons, one of which was to see where Siddhartha Gautama gave his first sermon 2,600 years ago, after which he became known as the Buddha. Siddhartha went there because even 2,600 years ago the region around Varanasi was an ancient holy site where the wisest men taught and became ascetics, people who forgo worldly pleasures to focus on spiritual development. This tradition continues today, and the ghats were lined with elderly men in simple clothes and a small bucket, sitting quietly and hoping for enough food to sustain their body as their minds prepare for death in a state of contemplative peace. The sooner we realize we’re dying the sooner we stop worrying about things that aren’t important and can be at peace with the world as it is.

Iris and I rented a motorcycle for the nine-mile trip to Varanasi and explored the Ganges River together. One of my fondest memories came after walking her back to her hotel then returning to the river to meditate in quiet, near an ascetic who was also meditating. We quietly sat cross-legged for about 30 minutes before he got up to leave. He did not seem to notice me as he dipped his hand into the Ganga before gesturing towards the cardinal directions, dripping holy water as he quietly spoke. I felt that he was expressing gratitude and wishing others well. I offered one of the two mangos in my backpack. He accepted it, smiled, bowed, and held it towards the cardinal directions while expressing gratitude and wishing others well before sitting beside me. We sat silently for ten minutes then he made the same symbol towards me that he had made towards the cardinal directions and walked into the fog.

Not all people in Varanasi are ascetics. Most are families no different than in the western world, performing rituals similar to Catholics gathering on Sunday for communion or to baptize a baby in water. Families would bathe in the Ganges river in a combination of devotion and playfulness, taking photos that they probably posted on Facebook. During the daytime the ghats are covered in tourists, pilgrims, touts, people praying while bathing, and, surprisingly, people simply enjoying the river view or playing games with friends. River cruises are popular with families, and I met the sweetest groups of people who were able to see the good Varanasi, which is why they were happy in an area where it would be easy to focus on the bad.

I learned to visit ghats late at night or early in the morning, whenI could walk in peace while people collected trash or sat quietly gazing over the river. I took photos subtly, by pushing a button on my small camera without framing the photo or disrupting people’s moments.

When I zoomed in on one of the photos it became one of my favorite photos from India; they’re sharing a pipe of wild-grown marijuana, something many Hindus associate with the god Shiva and use for relaxation and meditation. But, it’s more than that. According to 3,000+ year old Hindu texts, the qualities of a good person are self-restraint, compassion, and charity.
(Bhagavad Gita 16:01-03 and the Upanishads) An ascetic has no possessions but can still be compassionate to others by sharing what they have.

Sharing and charity are not unique to Hinduism. In Christianity, Jesus said that the faithful will be “given enough to share,” and “it’s better to give than to receive,” instructing a wealthy man to give his money to the poor, saying “It’s easier for a camel to pass through the eye of a needle than for a rich man to enter heaven.” (Mark 10:17-31) Similarly, one of the five pillars of Islam is charity, and the Koran specifically states giving to your family, orphans, and the poor, keeping enough for yourself to remain financially sound. (Quran 2:271, 2:276, 2:277) Jewish Tzedakah includes charity.
We seek the same things in different ways, including two guys getting high on the banks of the Ganges River.
Local artists decorate ghats with symbolism. I’ve always appreciated well-done street art, especially as you realize the layers of thought put into it. I’ll share some of the more obvious, but trust me that this graffiti has more depth than much of the art people pay to see in museums.

You can sense the respect the artist has for the spiritual practice of asceticism, renouncing what was once enjoyed for the sake of a spiritual path. In one hand the mystic is holding a lotus flower, which I described in my blog on Kushinagar as a symbol for becoming detached that pre-dates written words. A symbol for death’s inevitably floats above the lotus. The ascetic is holding a joint in one hand, emphasizing the association between Shiva, marijuana, and detached charity. The peacock feather represents many things including compassion, tolerance, and wisdom. Above the feather is the trident of Shiva, the destroyer of evil and god of transformation; when you die you are transformed. The red paint near his head is from an adjacent work of art, which was a personification of fire consuming a funeral pyre and the perfect segue to the burning ghats of Varanasi.

People are cremated on the burning ghats and their ashes are poured into the Ganges. No photos of the ceremonies are allowed. I took photos of temporarily unused pyres or wood burning late at night with Shiva’s iron trident glowing red-hot while the caste workers kept warm.
The lower castes in Varanasi earn their living cutting wood, explaining the ritual to tourists, or catering to the needs of the dying. I spoke with many of them and learned their perspectives. One day I’ll find the words to convey it to others, which is simplified as “death is inevitable for everyone.”
Not all of my trip was on the Ganga river. I also explored modern Varanasi, including staying in a luxury hotel converted from a Nepali king’s palace for his visits to the Ganges River. I stayed there after the man was pushed off our train. I wanted a break and did something I rarely do while traveling: I used money to solve a problem.
Usually I try to empathize with people by living close to their means. In India I lived off of approximately $10 per day for rooms, food, and travel, but after the train ride my headache was more than I wanted to handle and my mind cringed at the idea of more food poisoning and noise from street vendors and honking horns. I relaxed in a hotel literally built for a king; the former palace for the King of Nepal to visit Varanasi. I can not express the bliss I felt from a hot shower and soft bed, nor can I convey how joyful I felt after my first solid bowel movement in weeks. Everything’s relative!
Like most cities, Varanasi has wealthy suburbs with western comforts. I was near a shopping mall with American icons like Starbucks and MacDonalds, where wealthy Indians usually found ways to eat Big Macs while checking their smart phones.

I investigated chartering an airplane to skip the fog and fly to a warmer region. I could afford it, and thought it could be an entrepreneurial opportunity. Richard Branson, the billionaire founder of Virgin Records, formed Virgin Airlines after he responded to a canceled flight by chartering an airplane, asking people complaining about the cancelation if they’d like to buy space on his charter to the next airport. My luxury hotel was full of wealthy tourists complaining about being stuck because of train delays, pushing hotel staff to solve their problems. I declined chartering a plan and chose to solve my problem using the same resources available to a working-class Indian rather than a relatively wealthy tourists. But first I had an amazing meal, guilt-free, and cooked in the same kitchen that had fed the king of Nepal. A waiter brought me his favorite foods of northern India, including a brand of local beer called Kingfisher. I smiled and reflected on the kingfishers I saw flying in the jungles of Nepal and the Buddha ghat in Kushinagar. and the humility I was experiencing after thinking I had reached a level of wisdom to never focus on bad things again.

My favorite part of Varanasi was seeing Iris’s impact on people who met her as we explored the old city together. At night we’d walk along the ghats, where one night she lit a floating prayer candle made with flowers and released them into the Ganges, a ritual many people followed that created miniature parades of floating lights drifting down the dark Ganga waters. After I took this photo I walked her home for the last time. I returned to the spot where she launched her flowered candle into the Ganga, which is when I met the Hindu ascetic and shared a mango. At that time I was reflecting on Iris and processing what would become my blog on meditating in Kushinagar, realizing that I had a lot more to learn and could learn it from Iris, who saw kingfishers where I saw turds.
It was her first time in India. She had been volunteering with a school in Sarnath after departing from her mom in a small town called Pushgar. Her mom had volunteered in Pushgar in her youth and traveled there with Iris before letting her develop her own experiences by traveling alone for the first time.

Pushgar is known for music, and Iris was a musician and artist. She brought small, locally made and inexpensive instruments from Pushgar and practiced whenever we paused, spreading her joy to me and everyone around us. We sought out an oasis in the old city, The Brown Bread Cafe, which caters to tourists but and uses proceeds to children education programs that promote hygiene and best-business practices. The cafe supports local artists and musicians who can supplement their income playing traditional Indian music. Plus, their food is wonderful! It’s everything I support in a sustainable social business.
Iris smiled constantly. It was hard not to smile with her when she was playing her music or seeking Indian sweet deserts. Store owners would stop me when she wasn’t around to inquire when she’d be back. Iris created joy among all with whom she interacted and she did not take this for granted. We discussed her thoughts on whether or not to follow a traditional path of marriage and a family or to share a positive influence with people who could use more joy, such as children in India. These were thoughts I had at her age, and it makes me happy every time I see people receive joy from helping others.
Varanasi represented the lowest part of my trip, not because of anything in the city but because I went from seeing both beauty and turds, to only seeing turds, to ruminating about past or future turds that weren’t there at the moment. I created what I experienced, just like Iris created her experiences. A Buddhist parable expresses this more eloquently; my paraphrasing is:
A wise man and his sons worked alongside a road when a traveler approached and asked what it was like in the next town. The wise man asked what is was like where the traveler was coming from, to which the traveler replied,”It’s horrible! The people are selfish and unkind, and the food is bland and expensive.” The wise man said, “You won’t like the next town, it’s the same as from whence you came.”
Later that day another traveler walked by and asked what it was like in the next town. The wise man asked what it was like where the traveler was coming from, to which the second traveler replied, “It’s wonderful! The people were generous and kind, and I discovered wonderful sites and foods.” The wise man said, “You’ll like the next town, it’s the same as from whence you came.”
The wise mans sons were confused because their father taught them to always be truthful, so they asked how we could tell two travelers two different things. Wouldn’t the wise man by lying once? The man replied, “I told both of them the truth; what they saw in one town would be what they saw in the next” At this revelation the sons became wiser.

Iris’s perception of Varanasi is an example of seeing what you believe and receiving what you give. One could argue that she was young and new to traveling, and that my 20+ more years of traveling reduced the novelty of Varanasi to me therefore I didn’t see wonder in each day. Or, that my pain led to an irritated mind that focused on the negative. Both excuses are the point of my blog on meditating in Kushinagar, that our mind’s attachments to what we want leads to our own suffering. It’s not easy to remove those attachments but it’s worth trying, if only to continue seeing beauty in any situation as our minds and bodies age.

Seeing beauty requires effort but it’s better than the alternative. Kurt Vonnegut was a prisoner in Germany during WWII when the allies bombed Dresden, killing 135,000 people overnight. German guards held him at gunpoint while he cleared rubble and buried bodies, yet he became famous for writing novels filled with humor. He said,
Laughter and tears are both responses to frustration and exhaustion. I myself prefer to laugh, since there is less cleaning up to do afterward.
I believe he would have found something funny to say about cows in Varanasi instead of focusing on bullshit.
Varanasi gave me a final lesson in humility when I left; I bought a bus ticket and showed up to find that the bus company had moved but not told the ticket agencies. As a last resort I caught an overnight bus ride in a modified cargo hold, cramming my 5’11” body into a 5’6″ box for a 14-hour overnight bumpy ride to the next destination. After Varanasi I was going wherever that bus was going. And, no bull, I was smiling about it.

My next travel blog will probably be Sarnath or Radjasthan. Subscribe for updates every few months, or follow on Linkedin for professional blogs in medical device healthcare and equitable education.

How to apply ISO 14971 risk-management (it’s easier than you think)

6 minute read.
In 1986 the space shuttle Challenger exploded, killing the crew and a high-school teacher that had trained with the astronauts.

The explosion originated near an O-ring gasket that sealed rocket fuel. The gasket protected a known design flaw that could expose fuel to fire. NASA’s purchasing department had bought the O-ring based on expectations of warm conditions at the launch-site in Florida. The launch was delayed until January. A rare cold day lowered temperatures below the specified rating of the O-ring, decreasing its ability to seal the design flaw. The incomplete seal led to leaking fuel, which led to an explosion at takeoff.
The explosion is shown in this video. An important aspect of Risk Management is alluded to at 1:30; NASA had been under pressure to launch on that day.

I’ve simplified the situation because I wanted to focus on the need for risk management standards and transparent communication. Engineers had warned of the risk, but NASA didn’t have processes linking risk analysis with purchasing and launch-team decisions. In fairness, it would be hard to see the significance of an O-ring, which emphasizes that Risk isn’t just about the part, it’s about what happens if that part fails, and the hazardous situations that would have to align for that failure to occur.
The international standard for risk management is ISO 14971, which was updated in 2007. If it had been available in 1986 the Challenger probably would not have exploded and the astronauts and first teacher in space would be alive. If we could travel back in time, this is how modern risk management would have looked for NASA and the space shuttle team, with ISO 14971 sections (in parentheses)
Plan
A risk management plan would have been created by before doing any work, when the team is not under pressure (3.4). The team would document what other risk management documents are required and who’s responsible, acceptable levels of risk, priorities for how to reduce risk, how to monitor assumptions, and how to update and improve the plan based on new information.
Brainstorm hazardous situations
A diverse team would have ensured understanding of intended use of the space shuttle and it’s parts, including the o-ring (4.2). They would have listed high-level hazards, including “The space shuttle could explode if fire reached the fuel tank” (4.3). The team would brainstorm sequences of events that could lead to hazardous situations (4.4). For example:
The launch date could be postponed from a warm month to a colder monthThe weather in Florida, where launch occurs, could have an unusually cold day where the temperature drops below o-ring specificationsThe o-ring could “shrink” due to the cold weather, becoming unable to seal the pathwayThe launch team could not know the risk of cold weatherAfter takeoff fuel could be exposed to fire, causing an explosion
The hazardous situations would be documented and updated based on new information (4.4). I believe it’s advantageous to document the sequence of events, too.
Estimate risk levels
Risk would be quantified for each hazardous situation (5). Risk is the combination of the severity of an event and the probability of that event occurring (2.16).
Risk = Severity X Probability
Teams would assign numbers to severity and probability, multiply them together, and the result would be compared to pre-determined acceptable risk levels in the plan (3.4). In this example the severity of an explosion is so high that risk control would have been required.
Risk levels would be documented and continuously improved based on new information.
Control risks
The team would have prioritized risk control (6.2):
Improve the designAdd protective measuresAdd warning labels, instructions, or procedures
For this example, options could have included:
Improve the space shuttle design, such as eliminating the path to rocket fuel.Add safeguards to reduce risk, such as changing the o-ring specifications to be resistant to cold weather.Create procedures to reduce risk, such as a policy for the launch team to delay a launch if the temperature is below 40 degrees.
Risk controls would be verified and documented (6.3), and the hazards document would be revisited to ensure all hazards were addressed (6.7) and new hazards were not introduced. Any residual risks would be evaluated to ensure the benefits outweigh risks (6.4, 6.6).
Monitor for effectiveness
The risk management plan would be continuously improved using real-world data to adjust risk assumptions. For example, current, real-world information about probability assumptions would have been adjusted. There are two probabilities in risk analysis:
P1 = the probability that a sequence of events will occur
P2 = the probability that the sequence of events will result in harm
P1 must be proactively researched and documented because hazardous situations are rarely recognized or reported. For example, it’s possible that other space shuttle launches had the same sequence of events but had not exploded because of slight differences in temperatures or air currents between the leaking fuel and fire. Many other teams of astronauts may have unknowingly come close to a similar explosion, but this wouldn’t be known if we weren’t monitoring P1 assumptions. P1 is proactive risk management that reduces P2.
P2 is reactionary, resulting from deaths or catastrophes.
Please focus on P1.
Link risk management to all department policies
All departments would fall under risk management, and the risk plan would be referenced for all decisions. In the space shuttle example, information from design engineers would be fed into a risk management policy used by purchasing, manufacturing, and the launch-team.
Links within an organization and monitoring and improving a plan are known as the “process approach” to risk management. Modern quality system standards require risk-based decisions in a process of continuous improvement.
Documents
All risk management work would have been documented (3.5). The final document would have been be a trace-matrix ensuring all hazards are addressed by risk control, and that work was carried out according to a plan. This would have allowed subsequent teams to continuously reduce risk by adjusting probabilities based on new information, adding newly identified hazardous situations, and using state-of-the-art risk analysis methods.
Standards
Lessons from the Challenger explosion are part of current, international standards for quality control and risk management. The most common international standard for quality management is ISO 9001, and the standard specific to medical devices quality systems is ISO 13485, which is the foundation of a new audit method, the Medical Device Single Audit Program (MDSAP). They require that quality systems function as a risk-driven process of continuous improvement, which is also emphasized by the FDA quality system requirements and the European Union medical device requirements (EU MDR). All use the concepts prescribed by ISO 14971:2007, Risk Management. and the supplemental version for Europe, EN ISO 14971:2012.
Regulatory requirements are emphasized by a MDSAP diagram showing Risk Management as the highest level of guidance for companies.

Practical application
In the case of the case of Challenger explosion, it’s obvious in hindsight how a series of disconnected processes led to harm. What’s less obvious is how to apply risk-based decisions into your existing quality systems. I give an examples of how to apply risk management to decisions in purchasing, vendors, and supply chains in another blog, That’s not a knife! How to make risk-based decisions, which uses another phenomenon from 1986, the film Crocodile Dundee, about an Australian crocodile hunter in New York City, as a fun way to learn risk management techniques.

Risk management requires a corporate that culture understands and applies the concepts. These consulting companies can help your organization continuously improve.
Oriel STAT-A-MATRIX (I consult with Oriel)

MaetricsLNE G-MedMDI Consultants

Me(Jason 🙂
Summary
Plan

Pre-determined acceptable risk levelsHow to monitor risk assumptionsHow to update plan
Hazards analysis

Sequence of eventsHazardous situations
Risk analysisRisk = Severity X Probabilty
Risk control

Improve the designAdd safeguardsCreate warning, labels, instructions, or procedures

Continuously improve

Europe has additional risk requirements in .

Consulting companies can help you continuously improve.

Please share
Risk affects all of society, and the more people who think in big-picture concepts the safer our world becomes for everyone. Please share this article if you think others would benefit.
Parting thoughts
The space shuttle Challenger explosion was a rare event that in hindsight had preventable sequences of events. History has many similar examples, such as the , the , and every . These events are often referred to as “” because of the book “,” which emphasizes that we can’t predict outlier events but we can build robust systems resistant to their impact and able to adapt to changes.
But, no amount of quality-control and mathematical modeling can replace humans working together and communicating effectively. In the case of the space shuttle example, individuals struggled to have their voices heard. To improve your company, focus on culture, communication, and transparency.

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Meditation on the Buddha’s final words

This article shares what I learned while meditating on the Buddha’s final words, while backpacking the route of his life from birth to death, from Nepal to India.
Read more

How to be efficient with “internet searches” OR find information in documents

8 minute read (4 if you ignore one part).
This article is to help anyone who would like to improve their electronic search skills. Over the past couple of years, I’ve noticed a wider range of people unsure of, or unaware of, search techniques I take for granted. To cut to the chase, read these two articles from Lifehack.org and Lifehacker.com
LifeHack for internet searchesLifeHacker for keyboard searches (any document)
Or this list of search operators from Google’s support site.
Or, Scroll down to the video tutorials below, because before I give search tips I’ll write why I’m doing this. I won’t put much time into editing it; as Mark Twain said, “I’m sorry I didn’t write a shorter letter, but I didn’t have time,” so scroll down to the techniques if you’re not interested in my ramblings. I’ll indent my missive. so you can more easily scroll down to my tutorial.
I used to be surprised how few people new how to efficiently find information on the internet, or within long documents, until I read an article that 90% of people don’t, according to research by Google employees. (I’m not making that up. To verify that statistic, JFGI.)
All joking aside, these techniques are important. But surprisingly few people are good at it. I have, unfortunately and regrettably, been sarcastic to the point of being cruel when joking about internet search skills when people, including clients, have asked how I “know so much” (their words, not mine).
I realized I was being hurtful after helping a local nonprofit with a wide range of things, helping them help at-risk kids in our community find free and fun resources for education. When they asked how I “knew so much,” I replied, “The internet, just like we’re trying to help the kids learn how to do!” I thought I was attributing my knowledge to publicly-available sources of learning, for which I’m grateful, but the looks on their faces indicated that they felt stupid. Ouch! That’s especially cruel considering that they were trying to help under-served kids in my community, which is a euphemism for kids living in poor neighborhoods, often from multiple generations of poverty, obtain an equitable education.
That story is a primary reason why digital search skills is important; when the majority of teachers in under-served aren’t efficient at using the internet or searching electronic documents for information, they are perpetuating an archaic education system where the teacher gives “facts” for kids to memorize and regurgitate on tests, missing the point that the future of education, and the future for these kids to change their situations, depends less on “facts” and more on what they’d like to accomplish, how to access, critically analyze, create, and use information that helps your team obtain their goals.
This approach to education is part of “Project-Based Learning,” where kids are coached rather than taught, starting with a common goal that teams try to achieve, similar to how the real-world works when a project-manager leads a team, or an inventor starts a new company and hires people who haven’t learned the new invention yet, or a civic leader wants to coordinate community action. In other words, we start with a goal, and learning occurs along the way, sometimes guided by a person who doesn’t know all of the information but is good at embracing ambiguity and adhering to a general process rather than a rigid formula.
This is also key to the Next Generation Science Standards, NGSS, which are new science standards for over 20 states that focus on observing phenomena and learning through observation, research, and experimentation. Again, information is no longer valuable; what you can do with existing information, and the process for discovering new information, is education for the future.
It’s worth noting that NGSS introduces “engineering” as a core science, which, like internet searches will be challenging to teach if the teachers don’t understand it themselves, or aren’t comfortable embracing ambiguity and being a “co-learner” with students.
If you’re interested in helping provide equitable education, find schools in your community that could use your help helping kids, especially under-served communities. To find them, JFGI.
Finally, to the point of the bad joke earlier (“which one?” you ask), if you doubt anything, or would like to confirm something before repeating to to others, it’ critical to have effective internet search skills. If more people had these skills our society wouldn’t be plagued with “fake news,” and we’d all be happier and at peace, discussing what we’d like to accomplish and how we obtained information rather than arguing over what to do about inaccurate information.
For me, it continues to surprise me how, as a consultant, I end up answering questions available, for free, on the internet in less time than it takes to review my consulting contract. I started subtly incorporating search-skills into my workshops, mixing teams for group-work to distribute skills, and noticed that people seem to learn quickly without realizing they’re learning, but only when starting with a team-centered goal, similar to project-based learning.
As your first goal, what does JFGI mean? As a hint, one answer is the Jewish Federation of Greater Indianapolis. Neither is it the Jacob’s Financial Group, Inc. Neither are what JFGI means in the context of this article, though several of my friends refer to the Jewish Federation of Greater Indianapolis when someone asks an easily-answered question. The point is, words are weaker than context, so use the context of what you’re looking for, and why you’re looking for it, to help you phrase searches or navigate results.
Search any document or web page
Please, please, please learn to use cntrl+F on a personal computer (PC), or cmd+F on an Apple computer. When a document or web page is open on your computer, simultaneously press the “control” button and the letter F on a PC, or the “command” button and “F” on an Apple computer. This will open a small window to Find any word, symbol, or combination of words or symbols. You type what you’d like to find, our computer will list them, or highlight them, and take you to them. Smart phones have similar features.
Personal Computer:

Apple Computer:

Practice:
use cntl+F to find every time I wrote “JFGI” in this articlefind every time I wrote the phrase, “search for phrases”
For more keyboard tips, read LifeHack for keyboard tricks.
Search the Internet
Don’t rely on Google. Try Bing,Yahoo, or DuckDuckGo. As a society, if we all use the same source of information we may become biased towards incomplete or inaccurate information, more so than we already are.
How to choose words or phrases to search
This is a genuine and useful skill that will become better with practice. There’s no “shortcut key” for rewiring your brain to think like a computer search engine, but it happens so subtly that you’ll eventually take it for granted. In other words, it’s not like a golf score or bowling handicap where you can track progress, you simply get faster at it, with results closer to what you really need. To get started, watch this video, or read the text below it, or both.

Here are basics:
Use quotation marks to “search for phrases.” In this example, typing search for phrases would return search results for all combinations of those words, but typing “search for phrases” would return results for the one phrase you needed.
Conversely, if you want random combinations of words, not just the sequence in which you type them, don’t use quotation marks. In the previous example, search for phrases would be similar to for phrases search, and would show results from Yoda (just kidding, I am).
Use an asterisk (*) when you don’t know a word in a phrase, and Google will replace your * with probable words. For example, “Jewish * of Greater Indianapolis”
Use a hyphen (-) to omit words. For example, type JFGI -jewish to omit the word “Jewish.” (Whether or not you use capital letters is irrelevant to most searches.)
Use the word “site” and a colon (:) to search specific sites. For example, search for colon cancer in the government’s national cancer institute by typing colon cancer site:cancer.gov.
Combine techniques. For example, “colon cancer” site:cancer.gov
Use Google’s tips for refining web searches in Google, which, unsurprisingly, was the #1 ranked result from Google. They may seem obscure, but can be useful. For example, when I was designing medical implants by researching competitive products, used “cache:” to find files from sites that no longer available, perhaps because the owners had deleted them but didn’t know that Google ‘caches’ search results. I believe this is ethical (it was originally public information), and am sharing that information so you’re reminded that the internet is public, even for “secure” sites, and even after you delete something, so don’t upload anything if you’d be uncomfortable if someone saw it.
Practice
A great way to practice is using the internet to play Jeopardy! or any trivia game for random information, especially if it’s drastically different than your most common sources of information, which will exercise your search-engine skills more than doing what you already know. For example, Who was the childhood actor famous from the 1980’s television show “Different Strokes” and running for governor of California?
If you’d like to try a trivia game I wrote, try this game of Celebrity Jeopardy that I created to teach medical device regulations. I created it for a similar reason as the blog you’re reading now, to help people focus less on “facts” and more on the process of asking the right questions to find information, and using that information to achieve goals. If you used the internet, you could become an expert in almost any law or regulation, especially if you cross-reference that information with things you already know, called “lateral transfer,” which is a technique for, and indication of, deeper understanding.
Learn more techniques by, you guessed it, searching the internet. But, nothing beats practice, so I’ll reiterate that you’ll get faster and faster without noticing it. One day, people will ask you “how do you know so much?” and you can reply, “JFGI.”
Advanced Tips
Sometimes searching for images, even when you want text, can be more effective.The second tip is the reason for the first tip: understand Search Engine Optimization, or SEO.
Many web pages are great at Search Engine Optimization, SEO, which is a fancy word for they know how to show up in your searches more than they know how to answer your question. But, for some reason, they aren’t as careful with their images, so finding an image that matches your search and then going to that web site may help find information, especially specific information that is swamped with SEO-driven sites trying to sell you something rather than help you.
Watch this video to understand SEA, or read the following text, or both.

SEO is a reason most articles you find using text-based searches are written with the same words being repeated again and again, like:
So you are a Jewish person in Indianapolis, who wants to learn more about what a Jewish person can do in our city of Indianapolis? Or, you’d like to find greater knowledge about the Jewish faith, and perhaps you live in Indianapolis, or are a Jewish person who knows there’s no greater place to visit than the city of Indianapolis. Well, you’ve come to the right place, home of the Jewish Federation of Greater Indianapolis, a federation in the Indianapolis greater region, for Jewish people, in Indianapolis.
The first clue that this not a useful page, but is a page designed to rank high in SEO for a wide range of search styles, using any combination of Jewish Federation of Greater Indianapolis, including people who didn’t type quotation marks when searching for the “Jewish Federation of Greater Indianapolis,” or for someone who typed “Jewish Federation of * Indianapolis,” is that it assumed someone wanted to visit Indianapolis. I mean, come on.
The second is the phrasing. Legitimate sites don’t need all of that. In fact, many fake web site are generated by computer programs that mix up keywords from legitimate sites to gain viewers, which, unfortunately, increases their rank in search engines to get viewer “hits,” not to solve your problem.
For more advanced tips, JFGI.
Finally
Now, you’re ready for nerd humor, like this video where a guy looks up information asked as if people were typing on Google. Warning: it’s PG-13, which doesn’t mean to omit the number 13. If you’d like to know more, JFGI.

MDR: the Medical Device Regulation formerly known as MDD

In 1993, the rock musician Prince changed his name to an unpronounceable symbol, confusing record companies, concert venues, and even fans. It turned out to be one of the most productive times of Prince’s esteemed career, releasing two albums each year during this transition.
In 2020, the European Union is changing their Medical Device Directive (MDD) to the Medical Device Regulation (MDR). It’s confusing companies, distributers, and even auditors.
Yes, they’re related. Well… they’re related a little bit. This article is trying to help people understand the MDR by making it less daunting. The MDR is a 175 page document, with almost 191,000 words that include terms and concepts from other quality and regulatory standards. The best short summary I’ve been able to develop is:
Why:The former directive, MDD, allowed risky products to reach hundreds of thousands of European citizens; the MDR protects people
When:

May 2020, only MDR can be used for new products and “significant changes” to existing productsMay 2024, only MDR certified products can be sold in the European Union
What are some minor requirements

a qualified person must be dedicated to MDR compliance for each companyadditional and more strict pre-market classification; for example, some Class IIa devices will become Class IIb
What are some major changes:

Unique Device Identifiers (UDI) for all products throughout distributionComprehensive post-market surveillance and reporting according to strict methodsExtensive clinical data for each device or device class, depending on its risk categoryTechnical documentation replaces technical files; technical documentation includes all information from initial product requirements to post-market surveillance for each device or device class, depending on its risk categoryAll device risks must be reduced As Far As Possible (AFAP)
Let’s get back to Prince and the MDR.
In 1993, there was confusion about The Artist Formerly Known As Prince: How did you use a symbol to alphabetize his albums? How did you write his name on a contract? Why is he doing this? Despite that confusion he produced two albums per year, the record industry made millions of dollars, and everything turned out okay.
The transition from MDD to MDR will be the same. The companies that embrace change will become more effective and gain more market share. It will take 8-14 months for your transition, so I suggest starting as soon as possible. Don’t expect to understand every detail just yet; a first step could simply be appointing a qualified person who has existing knowledge, a desire to learn, and an ability to lead from within. Give them the time and resources to help your company while maintaining their work/life harmony.
This article digs deeper to help you prepare for the next steps.
BACKGROUND
Prince
In 1993, Prince, the rock musician, changed his name to a symbol.

At the time, The Artist Formerly Known as Prince (TAFKAP) was one of the world’s most famous musicians. But, Warner Brothers Records owned his music and, practically, the name “Prince.” But, they did not own the new symbol, which he created and copyrighted it. Warner Brothers had to scramble to create fonts for the symbol, change contracts, explain the changes to record stores, vendors, etc. Concert venues didn’t know how to advertise his shows, Record stores were confused about how to alphabetize his albums, and lawyers didn’t know how to type his name on contracts.
From 1993-1996, TAFKAP released two albums per yer, accelerating the end of his contract with Warner Brothers Records, then signed to a different record company. In 2000, he changed his name back to Prince, after demonstrating that innovation and creativity can come from confusion.
Prince was one of the most creative musicians of our time, releasing 39 albums before he passed away in 2016. He died from an overdose of opioid-based pain medications. He suffered from epilepsy, and several sources reported that he had hip-replacement surgery due to pain. I wish him Peace.
Medical Devices in Europe

Formerly, the European Commission provided guidelines for selling medical devices in Europe through the Medical Device Directive (MDD) and the Active Implantable Medical Devices Directive (AMIDD); these have been combined to for them new Medical Device Regulation (MDR). The MDR is only for medical devices, not for in vitro diagnostic equipment such lab tests for blood or genetics. In vitro diagnostic equipment is covered by the new In Vitro Diagnostic Regulation (IVDR); this article only applies to the MDR.
Why change?
Medical device scandals in the European Union increased public awareness of faults in the previous MDD that allow risk to citizens. People demanded more protection from their public officials, which led to the MDR.

An examples of patient risk under the former MDD are breast implants manufactured by a French company, Poly Implant Prothèse (PIP). PIP used industrial silicone instead of medical-grade silicone; the industrial silicone was 7X cheaper than medical silicone, but was more prone to bursting, resulting in harm and suffering for patients and lawsuits against the manufacturer and regulators. 400,000 women were affected, many of whom continue to suffer.
The MDR provides more safety regulations, re-classifies some devices to emphasize potential risk to patients, and creates a way to track each device through importers and distributors.
Time-Lines
2017: The MDR “entered into effect” already, which means that parts of it can be applied. This is nuanced, and beyond the scope of an overview article
May 2020: MDR is your only option for new products or “significant changes” to existing products; this is left ambiguous and it will be difficult to justify what’s not a “significant change”
May 2024: No product without MDR certification can be sold in European Union, even products that have been on the market for many years without changes; in other words, there’s no “grandfathering” and all products must comply with the MDR or they will be removed from sale
Minor Changes
Many requirements are the same as or not very different than previous directives.
Each manufacturer must designate at least one “qualified person” in their company who ensures compliance with MDR, and that person’s qualifications must be documented for review.Each distributor and importer must be trained and able to use the Unique Device Identifier system. These entities can be inspected by auditors, just like the manufacturer.”Technical documentation” replaces “technical files” as a more extensive list of documents that include pre-market planning, device design, manufacturing, and post-market surveillance; most of these documents should already exist for companies with ISO 13485 certified quality systemsMore products will be regulated. This won’t impact most companies, but products not previously considered medical devices, such as colored contact lenses and cosmetic implants, will require MDR compliance.Regulatory authorities and notified bodies can inspect any product at any stage of manufacturing or distribution to ensure it conforms to quality-system requirements for that stage.

The European Union is creating more agencies and programs to coordinate between countries and assist manufacturers with clarifications of requirements. This won’t significantly affect companies, but are useful to know because they’re for your benefit. For example:

The Medical Device Coordination Group (MDCG) advises the European Commission, coordinates activities between national agencies, and other high-level duties
Expert Panels provide technical and scientific expertise, and will be developing common specifications for some products to ensure uniformity between manufacturers.
Technical Working Groups are more focused than expert panels, offering classification of novel devices and detailing common specifications
EUDAMED database for Unique Device Identifiers (UDI), allowing full traceability of every medical device
Medium-Level Changes
There are several new regulations or additional requirements that may require more effort on your part, depending on your products and existing quality system.
More pre-market classification rules, and more strict risk classificationsUnique device indicators (UDI’s) for each product throughout its distribution chainAdditional post-market surveillance for for each device or device family that must be provided to the EU in Periodic Safety Update Report (PSUR)Additional clinical data requirements for each device or device group, depending on its classification
I’ll share details of these changes; skip to the next section if you’d rather not read them.
Pre-market classification
There will be a few changes to pre-market classifications. Don’t underestimate this step: the extent of your technical documentation and other time-consuming requirements all start with the device class, so ensure you’re on the right path before beginning any plan.
Class I products, which are the lowest-risk, such as bandages and thermometers, has these sub-categories:
Class I, generalClass IS, sterileClass IR, reusableClass IM, measure
Class IIa, IIb, and III categories haven’t changed, but they have additional rules and may be more strict than before; for example, some Class IIa devices are now Class Ib. Classifications are based on situations such as:
Duration of contact with the patient, such as a short procedure vs. a one-week implant vs. a permanent implantHow it’s introduced into the body, such as through a surgical procedure or natural oraficeIf the device is disposable or reusableWhere it’s used, such as on the skin vs. near the spinal chord.
Rather than list all of the situations, I created a “MDR Game and Quiz“so that you can learn-by-doing. Classifications aren’t challenging, they just require going through the process a few times. My strongest advice is to do this step with a diverse team. Most mistakes I’ve seen were miscommunications from using medical terminology or interpreting the MDR, but a team would know more than any individual therefore teams should collaborate on this important step.
Unique Device Identifier (UDI)
A UDI will be required for all classes of medical devices, and must be on each device or the device’s label. UDI’s will be scanned and tracked, creating a record of each medical device throughout its distribution chain. Each UDI will be a combination of two parts:
A Device Identifier (DI), with the company’s identification and the device version or model

The Production Information (PI), unique to each, single device, which includes information such as:

Expiration dateManufacture dateManufacturing siteDistributors of each device, storage of each device, etc.
As I write this article, the European Union doesn’t have software in place to handle UDI’s, but it will eventually be hosted by the European Databank on Medical Devices, EUDAMED. Further guidance is expected to unfold over the next year. European Union UDI’s will probably look like FDA recommendations for UDI’s. In the example below, the UDI is given in a bar code, in addition to other information required.

The barcode uses a standard format, allowing automated scanning by all distributors, hospitals, etc., and can be read by a people without needing scanners.

In this example, the numbers in the parentheses indicate the different parts of the UDI.
Device Identifier (DI) – 12345678901234

Production Identifiers (PI):

Expiration Date: 140102Manufacturing Date: 100102Lot Number: A1234Serial Number: 1234
It’s important to re-emphasize that a UDI will be scanned by distributors, allowing complete traceability of medical devices. Currently, it won’t be required on external packaging, which seems to go against guidelines for traceability, so UDI requirements may evolve.
One difference between the European Union’s planned UDI process and the existing FDA process is that the FDA doesn’t require UDI’s for low-risk devices, but the EU will require them for all device classifications.
Post-market surveillance
Post-market surveillance means that a company proactively monitors real-world data of their products and similar, competitive products, reports adverse events to regulatory agencies, and uses all information to continuously improve products and company quality system processes, especially risk-management methods.
The MDR requires more diligent post-market surveillance than previous regulations, and prescribes how to to perform the surveillance. First, MDR requires a plan. This seemingly simple step is often overlooked by companies; specifically, it’s overlooked by project-planners and senior management in those companies. In my experience, companies that don’t focus on effective planning, which is different than extensive planning, have inefficient projects that are chaotic and introduce risk to patients.
More time sharpening an axe means less time chopping wood.
Good planning practices are a separate topic, but, generally speaking, a plan will describe be an exact, detailed, proactive process, including how to monitor adherence to the plan. That last step is often overlooked despite being critical for a process of continuous improvement: plan when and how to update and improve your plan based on real-world data and new regulations. The MDR gives specific, detailed requirements for what must be in your post-market plan in Annex III of the official regulation.
Each manufacturer must provide periodic reports for high-risk devices, which are Class III and implantable Class II devices, Classes IIa and IIb. This is through a Periodic Safety Update Report, or PSUR, which requires updates for Class III and IIb devices annually and to IIa devices at least every two years, or when there’s a “significant” change to the device risk through adverse event notifications or design changes.
Post-market surveillance also protects public safety: Each manufacturer must notify regulatory agencies of any serious incident within 15 days, and deaths within 10 days. If there’s a chance of public risk, this must be within 2 days.
The format and details of PSURs are out of scope for this article, but are easily found through your EU representative or an online search. What’s important is to know they will require more planning than previously, will be updated more frequently, and will be used with clinical data for technical documentation of each product or group of products, depending on the device classification.
Clinical data
Clinical data is a combination of medical literature review, current competitor information, and each product or product group’s unique information. The extent of clinical data depends on the device classification, and is ambiguous in the MDR. To help plan how much you need, consider that your clinical data will be submitted along with your post-market surveillance to justify if your product is “state of the art” and has reduced risk “As Far As Possible.”
Major Changes

In 1989 Chuck D, frontman of the hiphop band Public Enemy, asked the question: How low can you go?
In 2017 Europe replied: As Far As Possible.
I believe that most companies will struggle with the requirement that all medical devices must reduce risk As Far As Possible (AFAP). This is based on my experience consulting; your company may be an exception. I wrote an article explaining AFAP based around the 80’s hiphop group Public Enemy, giving examples of where confusion may originate and steps you could take to gradually work towards complying, a technique from the Kaizen approach to continuous improvement.
The phrasing of AFAP guidelines in the MDR is almost identical to EN ISO 14971:2012, the European Union version of the international standard for risk management, ISO 14971:2007. In short, the MDR requires that for each product a company demonstrates:
All risks are reduced AFAP compared to state of the art, which is a combination of clinical data and post-market surveillanceCost can not be a factor in not reducing risk; if someone has found a solution to reduce risk you must, tooBenefit to the patient outweighs any residual risks

Reducing risk As Far As Possible requires understanding what is “state of the art.” In European law, this doesn’t mean the latest technology, it means the “generally accepted state of the art.” I demonstrate how to make state of the art medical devices using a 1980’s television show about a self-driving, talking car. In 2018 we have self-driving cars, but that’s not “generally accepted state of the art” because there’s not enough history of driver safety yet. But safety features such as seatbelts, child safety seat connections, and anti-lock breaks are state of the art. Medical device state of the art is more complex than car safety features and I demonstrate this using case-studies from medical device failures that impacted society.
I consider reducing risk As Far As Possible a major change because it will impact all functions in a quality system. You can’t demonstrate AFAP if you don’t have a strong post-market surveillance system, clinical data process, or risk management policy that complies with EN ISO 14971. Also, and perhaps most importantly, many companies will not be able to comply with MDR risk requirements because they haven’t reduced risk As Far As Possible and will need to make design changes that require more time and resources than expected.
Challenges and Solutions
The MDR creates several challenges, not just in the work companies must perform, but in getting started. For example, the UDI database in EUDAMED doesn’t exist yet, which can be intimidating for anyone preparing for UDI’s. Also, “Common Standards” are still works-in-progress, “Notified Bodies” are over-scheduled and overwhelmed, and this is a new process for everyone, including consultants. But, just like everyone that adjusted to Prince’s new symbol, we’ll be fine.
The first few steps on your journey may look like this:
Designate a person in your company to be responsible for MDR complianceEnsure all of your distributors and importers are able to use the UDI bar-code system.

Create a list of your company’s internal documents that reference MDD by name, or by specific paragraphs, that will need to be updated as you re-certify your products

Create a list of your productsWrite their current MDD classificationWrite their new MDR classificationGive links to existing Technical Files (CE mark files)Give links to existing clinical data”Check off” things that haven’t changedMark things that have changed, such as a Class IIb becoming a Class IIICreate a Y/N column for “yes,” we may need more clinical data, or “no,” we definitely won’t need more clinical data.

Use the resources in this article to answer specific questions as they arise, or to find further training or consultants.Schedule internal audits as soon as possible.

My strongest advice is to start today, declare your intention, and put on earphones and listen to Prince on Spotify while you maintain a positive attitude, focus on patient safety, and create work/life harmony for yourself and coworkers. If you do that, everything will be fine, and you’ll look back and realize you didn’t have to understand every detail if you have the right intention and the right method, which is a philosophical way to describe a quality system that continuously improves with the goal of reducing risk to patients.
Resources

We can’t all be Chuck Norris. I suggest reading the official regulations and online help guides, and hiring consultants who can help with concepts.
OFFICIAL REGULATIONS
PRIVATE-COMPANY SUMMARIES
PRIVATE-COMPANY TOOLS & FAQ’S
EU MDR “Readiness review” to prepare for the transition, by BSI.
“Table of contents” for the EU MDR, which is, surprisingly, missing from the official document. This one includes a copy of the 175-page MDR, provided by Oriel STAT-A-MATRIX.
CONSULTING & TRAINING
Oriel STAT-A-MATRIX(I consult with Oriel)

MaetricsLNE G-MedMDI Consultants

Me(Jason 🙂
AUDITING ORGANIZATIONS
IntertekBSI GroupTUV SUDUL
MY BLOG

Example: Play Celebrity Jeopardy! to learn the MDR: I grouped celebrities that share common medical treatments and created a game where I give hints and you guess their treatment then classify the medical device under MDR rules.
If you found this useful, please “like” and share it so that others benefit.

How Harry “The Hat” Anderson helped me learn Design, Risk, & Entrepreneurship

Harry Anderson passed away last month; my thoughts are with his wife, son, daughter, and family.
The following is unusual, but truthful. It’s how Harry “The Hat” Anderson helped me learn, and teach, design, entrepreneurship, and risk management.
7 minute read.

Harry Anderson was a television star on Cheers, Night Court, Dave’s World, It, and other shows for almost 30 years. He was most known as Judge Harry Stone on television’s Night Court, where his character was a kind-hearted prankster, magician, and fan of jazz music.
Judge Harry Stone was an iteration of Harry “The Hat” Gittes from television’s Cheers, where Harry was a good-natured con-artist and magician.

Harry’s career jump-started in 1983 when he appeared on the famous comedy show Saturday Night Live, apparently shoving a needle through his arm.

Today, I use Harry’s Needle Through the Arm routine in workshops for medical device companies, teaching them how to comply with Risk Management and European Union Medical Device Regulations in ways that balance patient safety with innovative products.
Risk (this may get “Hairy” 🙂
I use Harry’s needle-through-the-arm routine in corporate training for medical device development on Reducing Risk As Far As Possible and applying Risk-Benefit Analysis, concepts that are often confusing. I believe the needle example explains the “point.” (ha!)
During the Saturday Night Live performance Harry fumbled while looking for the instructions to his trick while he had a needle stuck through is bleeding arm. This “stuck” in my mind (ha!) as a way to illustrate the concept of designing products that don’t require written warnings to protect people. The international standard for medical device risk management, ISO 14971, requires three priorities for reducing risk to patients:
Make the design inherently safeAdd safeguardsProvide written instructions or warnings

New regulations in Europe require that each medical device prove that the highest level of risk reduction were applied. Harry’s needle-through-the-arm represents a real-world challenge in healthcare, accidental needle sticks, that helps explain why these priorities are enforced.
Healthcare workers would get stuck by needles that had been in contact with patient blood, which resulted in transmission of diseases. Some of those diseases included life-threatening viruses such as HIV. Written instructions were ineffective at protecting healthcare workers, and it was difficult to make needles inherently safe because it must be sharp to penetrate patient skin. Innovative companies found cost-effective ways to add safeguards to needle after government regulations for needles required more safety, and those companies excelled in the market. Companies that didn’t innovate lost in the market. In all cases the reduced risks benefited society.

If an innovative company improves needle designs to be inherently safe, which is priority level #1, then that would become state of the art and society would once again benefit. Similarly, all medical devices are now required to “reduce risk as far as possible,” but companies struggle balancing cost effectiveness, innovation, and applying risk control. I provide guidance in a full article on risk management that uses more analogies from Harry and other 1980’s pop-culture.

Design & Education
I saw Harry perform his Needle Through the Arm on television’s Saturday Night Live in 1983. I wanted to replicate it so I started brainstorming how it could be done, prototyping ideas, and testing them in front of audiences. I’d repeat this process until audiences enjoyed the trick and my presentation.

Over the next few years, Harry performed a total of eight times on Saturday Night live, including when he opened the show by saying the

famous words, “Live! From New York! It’s Saturday Night!” with his mouth full of a guinea pig he apparently ate live because it wouldn’t jump through hoops on television.
I would repeat the same process with each Harry Anderson skit: brainstorm, prototype, test, improve, repeat. This process is how I teach design, and is the basis of engineering design and the method of Next Generation Science Standards, NGSS, which include Engineering Design as a core science, the same as Physics or Biology.
Engineering Design is now a requirement for kids from Kindergarten to 12th grade in 22 states, but that doesn’t mean we know how to teach it yet. I’ve used Harry’s magic to help students learn design and innovation at two universities, a public high school, and in several countries; teaching teachers how to lead project-based learning where kids learn-by-designing, where the teacher is a coach, encouraging iteration and providing hints to overcome obstacles. I’ve also started incorporating the design process into my consulting on how to apply government regulations in ways that create more innovative designs.
Many of Harry’s magic effects were mechanical innovations, and even later in life, famous and wealthy enough to retire, he maintained a workshop to prototype ideas for the joy of observing a product evolve. Imagine that instead of reading text books to learn the mathematics behind mechanical engineering mechanisms students prototyped ways to swap cards or dollar bills when you activate the mechanism arm by dropping your pants on national television and moving the trigger connected through your pants, coat, and sleeve.

We loose some of our most creative students because they don’t fit traditional education models. New education standards like the NGSS are trying to improve education for all students, moving away from memorization, job training, and competitiveness towards critical thinking, design, and teamwork.
In hindsight, it makes sense that minds Harry Anderson was dyslexic, and had to find non-traditional ways to earn a living after high school.
“My high school teachers were always asking me what I was going to do. Cheers’ was my first acting job, but it was basically the character I had developed on the street,” he said. “That’s now I made my living, hustling drinks in bars and quarters on the street.”

Harry published a book sharing his good-natured con-games, “Games you can’t lose, a guide for suckers.” His”cons” were usually plays on words, but were often based on mathematics and probability, which is a more engaging way to learn the concepts than traditional teaching methods. I use those concepts in both high school classrooms and corporate workshops to help students learn math by practicing applications rather than reading concepts.
Harry wrote Games You Can’t Lose with Turk Pipkin, a writer for Night Court and other shows and movies. They co-founded The Nobelity Project for “bridging gaps in education at home and abroad.” It turns out that a many celebrities, athletes, and entrepreneurs are dyslexic, and also had to find non-traditional ways to earn a living that didn’t depend on written words.

Entrepreneurship
Entrepreneurship uses a similar process as designing: brainstorm, prototype, test, improve, repeat. Like design, entrepreneurship can’t be taught but it can be experienced. Almost every successful entrepreneur or inventor has more stories of failure than of success.
Magic and designing magic tricks is an ideal way to make iterative design fun, remove the fear of failure, and enforce the public speaking skills necessary to communicate with diverse people. Performing for real people develops skills that lead to other opportunities, like Harry discussed on television’s Late Night with Johny Carson, who was also a magician.

All of my classes incorporate some form of entrepreneurship, even if only how to communicate complex topics confidently. Innovators benefit from the iterative design process, getting a product closer to what is useful to a larger market, and everyone benefits from the hands-on skills and mathematical concepts that result from prototyping. I incorporate how to patent ideas and ways to build a business, which, like design, comes more from practice than lectures. As an example, rather than taking tests one of my Design Engineering classes created an online company that sold products they designed and continuously improved throughout the course using the process of brainstorm, prototype, test, repeat.
Combining all of Harry’s influences on me
My first medical device job had been with a start-up company founded by the original inventor of needle safety features, a serial entrepreneur who continues to invent products and start companies. In our interview he wanted to see how I brainstormed new ideas; by then I had designed or invented dozen of magic effects, starting with Harry Anderson’s 1983 Needle Through the Arm. I got the job, learned from mentors, invented medical devices, co-founded companies, retired, taught, and now consult on all of these things while incorporating my childhood love of magic.
In lieu of payment, I will exchange my service for corporate donations to non-profits or benefit-corporations that provide equitable education. Some of the work funded hands-on engineering laboratories in inner-city middle schools, and programs that incorporate community service into design engineering courses. I also perform magic shows for corporate events and private parties under the same arrangement.
I enjoy the work I do and feel gratitude for the good luck and influences that helped get here.
This is leading to my point.

A common theme in regulations I teach is “linked processes,” a concept that’s complex and difficult to apply in large organizations or government policies; I use Harry as a metaphor for linked processes, that we’re all connected by our words and actions in small but measurable ways. A lot of my luck and opportunities can be tracked back to seeing a guy in a hat apparently shove a needle through his arm on Saturday Night Live in 1983. Harry’s influence had ripple-effects that continue to help me help others.
I was fortunate to share a few drinks with Harry and his wife in their magic shop in New Orleans. We performed magic and discussed our love of the city and people who live there. I wasn’t consulting then, and I probably wasn’t self-aware enough to piece together the series of events that led to my career, so I didn’t share the positive ripples he created.

I don’t have the writing skills to convey what I’d like to say or to summarize my thoughts in one point. Maybe it’s that I was happy to see him doing what he loved, performing magic, 35 years after I first saw him on Saturday Night Live.
Or, maybe the point is that everything we do influences others in ways we may never know.
There are probably many points I could make from this article, and maybe one day I’ll have the skills to express them. If I do, it’ll unlikely to happen from luck, it would probably happen from the process of brainstorming, prototyping, testing, and improving.
Maybe that was the point.
For now, there’s no point, but I’m enjoying practicing writing while reflecting on influences in my life that have brought me joy.
Rest in peace, Harry Anderson, aka Harry “The Hat” Gittes, aka Harry Masters, aka Judge Harry Stone.

Play Celebrity Jeopardy! to learn the European Medical Device Regulation

I grouped celebrities who share a common medical treatment and ask you to classify the device using the new European Union Medical Device Regulation rules. I give the answers, you respond in the form of a question. If you need to see it in action, watch the video of Saturday Night Live’s Celebrity Jeopardy spoof. (warning: it’s rated PG-13)

Use these resources
If you’re unfamiliar with the EU-MDR, please see this article on the MDR “Big Picture.”otherwise use these resources to play Celebrity Jeopardy using MDR rules
The official MDRthe classification rules for this game are in Annex VIII
Use the internet for pop-culture references, and don’t take anything too seriously. Give the movie role or rock band if you don’t know a name. The point is to learn the MDR while having fun, and part of learning is embracing ambiguity and using the internet.
MDR Device Classifications

category: HAVE A HEART
Hints are given in each category.
$100: They are known as:
the host of television’s “Late Night” throughout the 80’s and 90’s
the 42nd presidentof the USA
the 43rd president of the USA
$200: This medical device has been implanted in the three celebrities shown.
$300: This MDR classification and rule apply to the device.
$400: This presidential candidate played the saxophone on a late-night comedy show in 1992, which is credited as changing all subsequent political strategies to reach out to younger voters.

KEEP UP THE PACE
$100: They are known as:
a singer, knighted by the Queen of England
a clown on television’s The Simpsons
$200: This medical device, which was first prototyped in 1899, is implanted in the celebrities shown, and controls their heart rhythms.
$300: This MDR classification and rule apply to the device.
$400: This celebrity, one of the four shown in the photo above, had their heart stop when they overdosed on drugs, but doctors revived them with a shot of adrenaline into their chest.
$500: This MDR classification and rule apply to “Automated External Defibrillators,” or AED’s, which are publicly available devices that can revive someone without the need to shoot adrenaline into their chest.

IT’S HIP TO BE SQUARE
$100: They are known as:
$200: This medical device, which is implanted in more than 300,000 Americans each year, is implanted in all four celebrities shown.
$300: This MDR classification and rule apply to the device.
$400: This 1987 science-fiction film, about an alien that hunts humans, stared two of the celebrities, before they both were elected as state governors.

BEAUTY AND THE BEAST
$100: They are known as:
$200: Both celebrities became deaf as children but obtained limited hearing thanks to this medical implant that converts sound to electrical signals sent to their nervous system.
$300: This MDR classification and rule apply to the device.
$400: This 1977 documentary film profiled one of these celebrities and the future governor of California as they trained for “Mr. Olympia,” and led to both of them starting in action films in the 1980’s.

HELLO. YOUR DONATION SAVED MY LIFE.
$100: They are known as:
$200: All received this general type of medical treatment, using a donation from another person.
$300: This MDR classification and rule apply to the device that transported the donations to the operating rooms of the celebrities shown.
$400: This celebrity, pictured above, lost the election for governor of California to Arnold Schwarzenegger in 2003.

BABY GOT BACK
$100: They are known as:
an Oscar-winning actor and star of the films Ocean’s 11, Batman, and Syriana who was 1997’s People Magazine “Sexiest Man Alive”
$200: Both celebrities had chronic pain for this part of the human body (see the hint).
$300: This MDR classification and rule apply to the dancer’s implant, a total disc replacement.
$400: This MDR classification and rule apply to the actors implants, permanent fusion devices
Please consider this: Classification is a first step for the MDR and will impact the amount of work you need to do over the subsequent years. These two devices seem similar but have different classifications based on a nuance in terminology that could easily be overlooked by a single person or department. In this case they call a fusion device a “wedge,” which is unclear because not all fusion devices are shaped like wedges. Nuances like this are why I encourage using diverse teams to make decisions throughout the MDR.
$600: This 1978 science-fiction film about tomatoes that become sentient and revolt against humanity was the first movie role for the academy-award winning star of Syriana, Batman, and Ocean’s Eleven.

FINAL JEOPARDY
bet as much as you’d like
This company used industrial-grade silicone instead of medical-grade silicone for breast implants, creating pain and suffering for thousands of patients and a lifetime of health risks for the 400,000 people who received the implants, and was a major reason for the new medical device regulations.

There’s a lot more to MDR. If you’d like to learn more, or work with a training company or consultant, please consider the resources below.
Resources
OFFICIAL REGULATIONS
PRIVATE COMPANY SUMMARIES
CONSULTING & TRAINING
Oriel STAT-A-MATRIX(an International company; I consult with Oriel)

MaetricsLNE G-MedMDI Consultants

Qunique (based in Switzerland)
Me(Jason 🙂
My Opinion

As a society we’re learning that healthcare should improve. You can help.
For example, consider the spine implants and cardiovascular implants of the celebrities shown. They have access to the any healthcare money can buy, yet are still subject to the same risks as billions of people on the planet who hope our healthcare companies and providers are informed and ethical.
But, spine implant companies are often the subject of lawsuits and federal investigations for conflicts of interests when doctors advise patients but are paid by medical device companies that receive revenue from the procedures.
Similarly, For example, Cardiovascular stents are implanted in millions of people each year, including David Letterman, Bill Clinton, and George Bush, but have been criticized as often being an unnecessary procedure, even for the president, and by the president’s surgeon who implanted the stent.
This is a problem globally. 400,000 people received toxic implants from Europe, and in the United States 80,000 – 240,000 people die from healthcare errors each year, and globally 5 million people die each year from low-quality healthcare. The MDR is a step towards data-driven decisions in healthcare that’s less influenced by marketing and false views. Learn more in my MDR blogs about reducing risk as far as possible.
As professionals, we can help society by understanding regulations like the MDR that intended to protect people, practicing leadership skills that let us influence our organizations, and letting our elected officials know that healthcare safety and cost-effectiveness is important to us.
Rock on
Please share this game if you think other people could benefit.
Keep in Touch
I post a few articles through my Linkedin page but most articles are in my website’s blog. I update subscribers once or twice a year with big-picture summaries of different disciplines.
My work is focused on equitable healthcare and education globally, and combines my experiences as a medical device developer, teacher, and traveler in ways that I hop provide immediate benefit to each reader. It’s part of my work-life harmony, a concept I integrate into corporate consulting and teacher training.

Understand the ISO process approach by using 1980’s pop-culture

Three of my skills in this world include medical device development, teaching, and 1980’s pop culture. This article combines all three, using pop culture to illustrate concepts behind medical device quality system regulations that require a “process-based approach.” It’s starts with this, which will either confuse you or make you chuckle:
Was that a process?
Before I give my answer I’ll share the background of MC Hammer, Vanilla Ice, and the Process Approach to quality control so that everyone can make an informed decision.
Background
1990’s?
MC Hammer was famous in the 80’s, especially for the lyrics, “Stop! Hammer Time!” His video for “Can’t Touch This” has been viewed 500 million times.

Vanilla Ice was famous in the 80’s, especially for the lyrics, “Stop! Collaborate & Listen!” His video for “Ice Ice Baby” has been viewed 250 million times.

If you knew hip-hop music from the late 1980’s and 1990’s, answering questions on the first diagram would make you either Stop! and Hammertime; or Stop! Collaborate, and listen.
International Standards Organization (ISO)
Medical device companies must have an approved quality system to sell their products. The international standards for quality systems is ISO 13485, which was updated to emphasize risk-driven processes. ISO 13485 training videos have, collectively, been viewed a few thousand times, but impact the lives of billions of people.

500,000 million people know about MC Hammer, but only a few understand the process approach to quality control of medical devices, which affects billions of people. 44% of medical device recalls could have been prevented by process controls, and healthcare mistakes lead to 250,000 deaths in the United States each year. The process approach could save more lives and make the world a healthier place.
The process approach
The international standard for quality management, ISO 9001, defines a process in clause 3.4.1 as:
“… a set of interrelated or interacting activities that transforms inputs into outputs.”
Inputs and outputs could be things, such as drawings or parts, or information, such as documents or test results.ISO 13485:2016, which is based on ISO 9001 but focused on medical devices, defines a process as:
“Any activity that receives input and converts it to output can be considered as a process. Often the output from one process directly forms the input to the next process.”
and the process approach as:
“…the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach.”
with a goal of:
“…improving processes based on objective measurement.”
Clause 8.2.5 of the standards adds that all processes:
“…should be monitored and improved for effectiveness.”
In other words, all processes should be controlled by an overall process of continuous improvement. But, that still doesn’t tell us what is and what is not a process.
Is this a process?
The first example leads you through a series of choices that result in a a decision, either to “Hammertime” or “Collaborate – Listen.”

Is this a process as defined by the ISO process approach? Why or why not?
I’ll provide space before my answer with lyrics from MC Hammer’s 1989 hit song, “U Can’t Touch This”:
Every time you see me that Hammer’s just so hype I’m dope on the floor and I’m magic on the mic Now why would I ever stop doing this With others makin’ records that just don’t hit I toured around the world from London to the bank It’s Hammer go Hammer It’s a Hammer yo Hammer and the rest go and play
You can’t touch this (oh-oh oh oh-oh-oh) You can’t touch this (oh-oh oh oh-oh-oh) Can’t touch this (oh-oh oh-oh-oh) Yeah u can’t touch this I told you u can’t touch this (oh-oh oh-oh-oh) Too hype can’t touch this Get me outta here u can’t touch this (Oh-oh-oh-oh-oh-oh-oh-oh-oh-oh-oh-oh)

Here’s my answer: The example is not an ISO process according to the process approach.
It’s a flow chart, and useful way to choose “Hammertime” or “Collaborate and Listen”that could be used within a process to help visualize written instructions, but it’s not a process in the context of ISO 13485 because it doesn’t use inputs to produce outputs.
Someone may perceive that it has implied inputs and outputs, but it’s unclear how implied outputs could be used as inputs for other processes that would be linked in a cycle of continuous improvement.
Let’s look at another example from Devo’s 1980 song, “Whip It.” I encourage you to listen to the video while reading the example. Crank up the volume so that everyone in your office can jam with you.

Is this an ISO process-approach? Why or why not?
I’ll provide space before my answer with lyrics from Devo’s 1980 hit song, “Whip It!”
When a good time turns around You must whip it You will never live it down Unless you whip it No one gets away Until they whip it
I say whip it Whip it good I say whip it Whip it good
Crack that whip
Give the past the slip Step on a crack Break your momma’s back
When a problem comes along You must whip it Before the cream sits out too long You must whip it When something’s going wrong You must whip it

The “Whip It!” chart is not the process approach. It’s elaborate and a lot of work went into it, but it’s not monitored for effectiveness. In other words, the song remains the same.
Another way to view this could be to use a term from Systems Engineering, “closed-loop process.” A closed-loop process is also called a “feedback” process because outputs are fed back into the process so that the process improves. Conversely, an open-loop process does not improve.

The Whip It flow chart would always result in the same song, and The MC Hammer flow chart would continue giving two choices but would not improve, would not stay relevant, and would not maintain effectiveness over time. In other words, neither example was a process in the ISO definition of process approach.
This is a process
Let’s look at what ISO considers a process using the

which is based on the process approach.

In the diagram, arrows show the flow of information between departments, which means that each departments processes are linked, and that “Risk Management” is the basis all processes.

“Purchasing”

is shown to link to all departments, because to monitor and control supply-chains so that things external to our quality system don’t become a weak link in our processes.

The diagram doesn’t show inputs from the external world that are described in the text of ISO standards, which includes inputs for “Design and Development” that come from real-world feedback based on the needs of customers, users, and patients; and international regulatory requirements. These regulatory requirements are continuously improved based on outputs of all medical device companies, such as products and patient outcomes, creating a closed-loop system of continuous improvement for global healthcare.
As an example of a process within a company linked to other processes within that company, consider “Design and Development” and the FDA design-control guidance:

The written descriptions state that Design Input includes:
user needs (shown in the flow-chart)regulatory requirements

post-market surveillance of existing productsfrom outputs of linked processes in Measurement, Analysis, & Improvement
risk management policiesfrom outputs of linked processes overseen by Management.
The work of your design team converts design inputs into Design Output, which can include:
part drawingssoftware codesservices to customers

risk analysis documentsbecome input to Purchasing through linked processes
After verification and validation, Design Output becomes input for other departments, such as manufacturing and purchasing. In this way, each company functions as a process of continuous improvement.

A company’s quality system should monitor effectiveness of it’s products and feed that information back into product design in a process of continuous improvement. ISO summarizes the process approach as:
For an organization to function effectively, it needs to identify and manage numerous linked processes. The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach.”
Processes should be linked to form a closed-loop system of inputs and outputs. If an output isn’t used by other processes it could be an unnecessary use of resources. In the words of MC Hammer and Vanilla ice, it’s time to Stop! that process, then Collaborate and Listen! to make team-based decisions on prioritizing value-added steps in a process of continuous improvement.
Process symbols
Process maps aren’t required, but they can help you and your team analyze any part of your quality system to ensure it’s a risk-driven process, or to look for gaps to close. They don’t have to be elaborate; simple process maps can be more effective because a diverse group of people can use them without formal training. Common flowchart symbols are shown here:

Resources
CONSULTING & TRAINING
Oriel STAT-A-MATRIX (I consult with Oriel)

MaetricsLNE G-MedMDI Consultants

Me (Jason 🙂
AUDITING ORGANIZATIONS
Summary
Processes receive inputs and creates outputs that become inputs for other processes, creating a continuous flow of information and actions.A company’s quality system coordinates these processes

The FDA and the EU-MDR require processes that reduce risk and continuously improve.
Please share
If you think this has been entertaining and useful, please link to it or forward it for others who could benefit.
Parting words
Vanilla Ice wrote at age 16.

I listened to “Ice Ice Baby” at my high school prom. It’s a fun song, but my taste and choices have evolved, especially with haircuts.

Today, I help corporation improve by becoming more efficient and innovative while reducing risk to people. I focus on life-work harmony for employees, and keep the perspective that we can help >7.6 Billion people have healthier, happier lives.
Life, like a quality system, is process of continuous improvement. I wish you well with both.

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