This article gives two steps your company can quickly take to prepare for the most confusing requirement of the new European Union Medical Device Regulation, reducing risk As Far As Possible. I use the Kaizen approach to continuous improvement of applying small steps that are likely to be understood rather than drastically new procedures that cause confusion.

If you’re not familiar with the MDR please see my article on the MDR big picture.

If you’re not familiar with the concept of reducing risk to patients “As Far As Possible” please see How to reduce risk As Far As Possible.

All of those concepts can become daunting, which is why I suggest the Kaizen approach of taking small steps even in learning through each of those articles. Now I assume you’re ready to get two Kaizen steps to start complying with the ED MDR:

Assign a qualified person to be your MDR representative. This is required in the MDR, which states that person’s qualifications should be a combination of education and experience and documented in your quality system.Schedule consultants or trainers. Their schedules may be filled as other companies wait until closer to MDR deadlines. Of course this is optional, but I recommend it and list consultants at the end of this article.Modify existing risk/benefit procedures to gradually incorporate the concept of As Far As Possible for products sold in Europe; this may not involve a complete change of your system and will vary for each company.

The last step is difficult to describe in writing because it will be unique to your company. Kaizen is a concept that you must understand then apply to your unique situation; no one can help you determine a Kaizen step without understanding where you are currently. To give examples, I assume your company has an established risk/benefit table and uses Failure Modes Effects and Analysis for risk analysis.

Example of new Risk/Benefit tables

Most of the western world uses Failure Mode Effects and Analysis (FMEA) to quantify risk. The calculated residual risk, RPN, is often based on the severity of harm if a part fails (S) times the probability of that failure happening compared to the acceptable risk table to determine if further work is needed.

Those companies probably document acceptable risk levels in a Risk/Benefit matrix that uses the concept of “As Far As Reasonably Practicable,” which allows companies to decide not to reduce risk because it’s too costly and also allows them to ignore low risks.

A Kaizen step would be changing your risk/benefit table that does not have multiple risk categories but is binary, either unacceptable or reduced as far as possible, eliminating any category that could be justified as “negligible” risk or deemed an acceptable acceptable risk because of business needs instead of patient needs.

The risk analysis method would not have to be changed at first, nor would many other procedures. After implementing this first step you’d continuously improve your quality system with additional Kaizen steps.

But, the Kaizen step I just showed is just one step, it’s not the final goal. I ask attendees in my workshops to think about the concept of reducing risk as far as possible, discuss their understanding in small groups, and to brainstorm the limitations of what I suggested and what a final policy could look like.

For this blog, think about the limitations of a binary risk table before scrolling down to my answer, which I’ll share after copying the lyrics to Weird Al Yankovic‘s song “Yoda,” which is sang to the rhythm of “Lola” by the Kinks.

I met him in a swamp down in Dagoba Where it bubbles all the time like a giant carbonated soda S-O-D-A, soda

I saw the little runt sitting there on a log I asked him his name and in a raspy voice he said “yoda” Y-O-D-A, Yoda Yo-yo-yo-yo Yoda

Well, I’ve been around, but I ain’t never seen A guy who looks like a muppet, but he’s wrinkled and green Oh, my Yoda Yo-yo-yo-yo Yoda

Well, I’m not dumb, but I can’t understand How he can lift me in the air just by raising his hand Oh, my Yoda Yo-yo-yo-yo Yoda yo-yo-yo-yo Yoda

Well, I left home just a week before And I’ve never ever been a Jedi before But Obi Wan, he set me straight, of course He said, “Go to Yoda and he’ll show you the Force”

The limitation of a binary risk matrix is that it isn’t truly reducing risk as far as possible according to a closed-loop process of continuous improvement. To truly understand the concept there wouldn’t be a matrix, all risk would be lowered as far as possible.

In the context of the European Union Medical Device Regulation, reducing risk as far as possible a continuous process and that even “negligible” risks in former risk management tables must be continuously improved reduced until products are state of the art, additional risk reduction wouldn’t lower risk (severity X probability), products are state of the art, and that benefits outweigh residual risks when compared against competitive products and alternative treatments.

In other words, reducing risk as far as possible can’t be quantified in a table because it’s a continuous process that improves based on evolving real-world comparisons every 1-2 years or “as needed.” Reducing risk as far as possible is a concept that must be emphasized by senior management, the core job of every employee, and part of a company’s daily culture.

“The farther you go along the path the more you realize there’s no path.” – Buddhist wisdom

Continuous learning

The FMEA table is commonly used but is not state of the art risk analysis because it focuses on parts and misses unforeseen situations that could lead to hazardous situations. Simply adding this step to existing risk analysis processes would bring your company closer to the international standard for risk management, ISO 14971. I cover ISO 14971 in detail throughout my blog and demonstrate it in How to apply ISO 14971 (it’s easier than you think). by re-analyzing the 1986 space shuttle explosion using state of the art risk management.

Learn more independently by using the 2014 consensus paper for EN ISO 14971:2012and theEuropean Union Medical Device Regulation.

Learn more in my article the MDR: the medical device regulation formerly known as MDD.

Or learn more by hiring consultants to work with your teams or train them.

MaetricsThe Weinberg GroupGreenlightJason (me)

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.

Thank you

Please share this article if you think others could benefit.

Parting Thoughts

I share this information because I believe reducing risk As Far As Possible will benefit society. This does not mean healthcare will become more expensive, it means that innovative companies now how an advantage over companies that previously had more risky products locked in contracts through business interests rather than patient safety.

Many government regulations can seem burdensome but are simply trying to make companies function as a process of continuous improvement that reduces risks to patients. I discuss my bigger-picture approach to continuous improvement using religions and philosophies from around the world, including lessons from the Buddha, who was an inspiration for Yoda in 1979’s film Star Wars. The Buddha summarized continuous improvement more in a sentence that is clear, easy to understand, and unambiguous:

Each day do more of what you know to be right and less of what you know to not be right – The Buddha

I wish you happiness.

7 minute read.

The new European Medical Device Regulation will be required for all medical devices sold in the EU. This was motivated by European citizens demanding safer healthcare; the United States is considering similar changes.

This article is the EU-MDR big picture with links to learn more.

WHY

Almost 400,000 people received toxic implants from one company under the former European medical device directives (MDD). A French company used industrial silicone instead of medical-grade silicone for breast implants, resulting in harm and suffering for patients and lawsuits against the manufacturer and lawmakers.

WHEN

May 2017: the MDR “entered into effect,” meaning that auditors can selectively apply portions of it.

May 2020: only MDR can be used for new products and “significant changes” to existing products.

May 2024: only MDR certified products can be sold in the European Union.

HOW

The EU-MDR enforces methods for reducing risk to patients, re-classifies some devices, and creates a way to track each device throughout it’s distribution system.

Devices must be re-designed to be as safe as competitive options. This will be proven for each device by submitting clinical data, which includes competitive products, and reports of your products compared to the competitive products.

Follow the steps below, where I broke the MDR into manageable topics.

1) Assign an MDR representative for your company.

The MDR requires at least one person in your company be responsible for all regulatory compliance (Article 15). The MDR also requires that a management shall ensure a strategy for regulatory compliance (Article 10).

Give your team time to plan. More time sharpening an axe means less time chopping wood.

New classification rules for your devices are given in Annex 8.

Consider playing this game to learn the rules: I grouped celebrities who share the same medical devices and ask you to practice identifying the celebrities and classifying their medical devices. The game is structured like “Celebrity Jeopardy” from Saturday Night Live.

The space shuttle Challenger exploded in 1986. It became one of the most famous case-studies for risk management. I reanalyzed the events leading to the explosion using modern methods from international standard for risk management, ISO 14971

The MDR describes risk management methods in Annex 1, which is almost identical to ISO 14971.

ISO 14971 allows companies to accept some risks to patients based on business needs. The MDR requires that all risks to patients be reduced As Far As Possible.

In 1988 Chuck D, frontman of the hiphop group Public Enemy, asked “How low can you go?” In 2017 the European Union replied “As Far As Possible.”

This may be the biggest challenge for companies complying with the EU MDR. Reducing risk to patients As Far As Possible (AFAP) is a concept, not a definition. I try to demonstrate the concept through examples for people willing to follow links to deeper levels.

For the big picture, the MDR requires:

All risks must be reduced As Far As PossibleCost can not be a factor in risk controlBenefits to patients must outweigh remaining risks

Reducing risk as far as possible must be demonstrated for each product or family of products.

I can’t emphasize this enough: please read the article and understand the concepts rather than memorizing rules and applying them without seeing their impact on society.

In the 1980’s David Hasselhoff starred in television’s Knight Rider, solving crimes with a self-driving and talking car.

I relate buying a car to reducing risk as far as possible using “state of the art,” an ambiguous MDR concept in Annex 1.

Today, state of the art for car safety includes seatbelts, child safety seats, and recently rear-view cameras for backing up. Self-driving cars are available but we don’t have enough history for them to be considered “generally accepted state of the art.” Companies may choose to invest in self-driving cars as a business decision but must manufacture cars with state of the art safety features such as child safety seat connections.

Government regulations can list require simple requirements like seatbelts or anti-lock brakes but are not efficient at complex concepts like medical device state of the art. I provide details in the article and share how to use the concept to reduce risk as far as possible.

This article uses Harry “The Hat” Anderson, magician and star of television’s Night Court throughout the 80’s, to illustrate the “point” of risk/benefit analysis using his needle-through-the-arm routine, where he fumbles for written instructions only after having apparently impaled a giant needle through his arm.

Accidental needle sticks by used needles are a public hazard. The design can’t be made inherently safe because needles must be sharp, so safeguards and written warnings are the only options and the remaining risks are outweighed by benefits to patients.

Reduce risk by applying risk controls. The priorities for risk control in ISO 14971 and the European Union are:

make the product inherently safeadd protective safeguardsadd written warnings or instructions

After applying risk controls to reduce risk as far as possible you must explain why remaining risks are outweighed by benefits.

7) Submit MDR reports

The EU-MDR will require paperwork that’s updated every 1-2 years depending on the classification of your device. Major changes from previous directives include:

Clinical data (Chapter 6 & Annex 14): proof that you investigated current medical treatments, competitive products, alternative treatments, your product’s clinical history when relevant, and any other information that could be used to compare your medical device to “state of the art.” You’re expected to use the methods in MEDDEV 2.7.1.

Post Market Surveillance Update Reports (Chapter 7 & Annex 14): your product’s real-world results, statistical trends, and other information that’s necessary to maintain current clinical data and report adverse events to the European Union. PSUR’s will help Europe monitor safety trends, alert citizens of risks, and develop common safety standards.

Technical Documentation (Annex 2): an extensive list of initial design requirements, production requirements, clinical data, post-market surveillance, etc. This replaces former “technical file” formats.

Clinical data and post-market surveillance must be updated for each device or family of devices to prove that you continuously improve based on state of the art healthcare. That’s fair.

Taking small, manageable steps towards a larger goal is the Kaizen approach to management, based on the Japanese word for “improvement” and with roots in Buddhist philosophy, which was one of the influences for Yoda in the 1980 film Star Wars: the Empire Strikes Back.

Yoda would approve of these Kaizen steps towards the EU MDR:

Appoint an MDR representative in your company.Reclassify your devices according to MDR rules.Schedule consultants to train or advise soon, they will become busy MDR approaches.

To learn more see my article “MDR: the medical device regulation formerly known as MDD.”

For example, Unique Device Identifiers will be required for all devices to ensure traceability throughout distribution, and Clinical Data and Post-market Surveillance reports will be necessary to document that you reduced risk As Far As Possible. These are described in details throughout the 175-page European Medical Device Regulation.

Many details are out of scope for the Big Picture, which is why I recommend doing what Chuck Norris would do.

Chuck would politely ask me to help him.

But that may not be necessary; all requirements are available online, for free. I wrote an article with tips-and-tricks for learning the MDR, which includes using original sources of information whenever possible and consider hiring consultants to help.

OFFICIAL REGULATIONS & PAPERS

CONSULTING & TRAINING

Maetrics

MDI ConsultantsGreenLightQunique, a botique company based in SwitzerlandMe (Jason 🙂

My opinion

My opinion stems from facts.

80,000 to 250,000 people die each yearfrom healthcare errors in the United States. 5 million people die world-wide from low-quality healthcare. Public awareness is increasing through news and documentaries like The Bleeding Edge. European citizens demanded government oversight after 400,000 people received toxic implants, which led to the MDR.

The United States is reviewing our regulations. We have the opportunity to learn from the EU-MDR, but only if we tell our elected officials that it’s important and that our votes depend on their actions.

I believe that the EU-MDR is a starting point towards safer, more innovative healthcare. If a company or entrepreneur innovates safe designs that are beneficial to patients they become the new state of the art. Innovators win and society wins.

Consider the needle example. I said it couldn’t be designed inherently safe but that may change, but at one time people also said cars couldn’t drive themselves. This year several innovative car manufacturers released self-driving cars, which may one day be the generally accepted state of the art.

Companies that excel will be the ones that accept change, embrace ambiguity, and create a culture of continuous improvement.

THANKS

If you found this useful please share it so that others benefit.

KEEP IN TOUCH

I post some articles on Linkedin or Twitter but most are in my blog. I email subscribers once a year or so.

I work to help society have safer, more effective healthcare by helping companies increase efficiency and innovation. My interests include equitable education and innovative healthcare. Equitable means giving a bit more to those who start with less.

Peace.

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:

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.

MaetricsLNE G-MedMDI Consultants

Summary

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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