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.

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.

Peace.

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.
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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:

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

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.

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

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

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.

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

CONSULTING & TRAINING

MaetricsLNE G-MedMDI Consultants

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.

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

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:

$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:

$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:

$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

BSITUV

CONSULTING & TRAINING

MaetricsLNE G-MedMDI Consultants

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.

6 minute read.

This article uses 1980’s pop culture to describe purchasing requirements in ISO 13485 and the Medical Device Single Audit Program, MDSAP.

In the 1986 film “Crocodile Dundee,” a gang in New York attempted to rob a crocodile-hunter visiting from Australia. They flashed a knife, and he replied with a line that’s been quoted for 30 years: “That’s not a knife. This is a knife!”

Crocodile Dundee made a risk-driven decision. A flow-chart for his decision would look like this:

Medical device companies are required to make risk-based decisions by international regulations and standards, such as ISO 13485 and MDSAP, which state that all company process should be linked by a common goal of reducing risk. This article focuses on risk-driven decisions in purchasing processes, but can be applied to any department in your company.

Purchasing is important

To understand why “Purchasing” is so important for risk-based decisions and processes, consider the 1986 Challenger Space Shuttle explosion.Seven people died, including a civilian high-school teacher.

The explosion originated near a small O-ring that was allowing fuel to leak. That O-ring was purchased from a vendor, but no one in the purchasing department knew the significance of that part. 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.

Regulations for purchasing

The scene from Crocodile Dundee that led to a risk-based decision, “That’s not a knife,” has been viewed two million times:

Your company must have an approved quality system to sell medical devices. The international standard for this is ISO 13485, which is the foundation of a new audit method, the Medical Device Single Audit Program (MDSAP). Both require that quality systems function as a “risk-driven process.” ISO 13485:2016 training videos have, collectively, been viewed a few thousand times, but impact the lives of billions of people.

A ‘process approach’ that reduces risk to patients is the foundation of ISO13485 and MDSAP. Together, these programs help improve healthcare for 7.2 billion people. But, they don’t detail how to analyze risk. For that, use ISO 14971, Risk Management, and the supplement used in the European Union, EN 2012 : ISO 14971. Both include using teams to identify, analyze, and document “Hazardous Situations” in which the failure of a part would lead to unforeseen risks.

In the case of the Space Shuttle Challenger, a Hazardous Situation Analysis would have included asking “what happens if the O-ring fails?” and “what if the weather is colder on launch-day than purchasing specifications for the O-ring?” Those questions were being asked by engineers, but there wasn’t a way for their voices to be heard; modern Risk Management standards ensure a diverse team identifies, analyzes, and documents hazardous situations so they can be used by all departments. In the language of ISO13485 and MDSAP, risk analysis would be “linked” to processes used by other departments, such as the NASA launch team and purchasing departments.

That’s not a process.This is a process!

Let’s look at what ISO 13485:2016 considers a process, using a diagram provided by Crocodile Dundee’s home country, Australia, which is one of five countries pioneering MDSAP.

and “Purchasing” surround all departments. The diagram shows that Purchasing is driven by Risk Management, which means that oversight of vendors is based on reducing risk, which requires information from all departments through a series of linked processes.

All of these risk-driven processes create outputs; each output is used by other processes within a company, sometimes in different departments, with the goal of reducing risk to patients. In other words:

A process receives inputs and creates outputs. Outputs become inputs for other processes, creating a continuous flow of information and actions. A company’s quality system oversees these processes, and uses inputs from the real-world to generate outputs in the form of improved products and services.

Risk-driven process

For more clarity on how ISO defines a process, please see my blog, “MC Hammer, Vanilla Ice, & the process approach for quality systems,” where I illustrated concepts for what is, and what is not, a process. The bottom-line is that a flow-chart is not a process; to be a process by ISO definitions, you must show that outputs become inputs for other processes in a closed-loop system of continuous improvement.

MDSAP requires evidence that your company uses risk-driven decision points for purchasing, either for high-risk parts or high-risk vendors. Examples of decision points for vendor selection or oversight include:

Is it a high-risk part?Is this a high-risk vendor? i.e., are they not ISO 13485 certified, not MDSAP audited, have a history of mistakes, etc.Is it a “Black Box” part? i.e., Is the part is assembled by a vendor, and when we receive the part are critical features hidden from our inspection process?Does the vendor use sub-vendors that introduce risk into your supply chain?

An example of a risk-driven purchasing process is:

In this example, processes are linked between departments using “Risk Management Documents,” and receive real-world input for continuous improvement through incoming inspections and CAPA’s (Corrective And Preventive Actions). Risk-driven decisions are made for vendors based on the part they’re making and their capabilities, which complies with ISO 13485, clause 4.1.5:

“controls shall be proportionate to the risk and the ability of the external party…”

In other words, risk for purchasing is a combination of the part and the vendor. You can reduce risk from purchasing in many ways, such as:

Selecting vendors that are ISO 13485 compliant or have passed a MDSAP auditOn-site inspections of their quality systemIncrease the percentage of parts inspected in your receiving departmentRequest first-article inspections for custom-made partsWorking with design engineering to reduce risk from that part

Because there are so many ways to reduce risk from purchasing, I strongly recommend starting with a plan. A plan that includes including scope, goals, team-members, etc. could be the starting point of brainstorming best ways to reduce risk. And, it’s likely that unforeseen situations may arise in your Hazard Analysis. For standardized ways to analyze risk, see my article on “Medical Device Risk,” based on ISO’s standard for Risk Management, ISO 14971. For this article on purchasing, the most important requirements from ISO 14971 and ISO 13485 are:

Documentation could be done in many ways, such as with an engineering change order, ECO, following ISO 13485 change-control guidelines, and should be described in your company’s quality system. A comprehensive Risk Management policy is part of a company’s overall quality system, which is a responsibility of each company’s executive management.

Next Steps

Hopefully, Risk Management policies in your company are sufficient and easy to implement across all departments. If not, consider leading from within your company, proactively identifying ways to improve, and initiating a project to apply new standards of Risk Management. You can use compliance with ISO 13485:2016 and MDSAP to support your case, and use the resources below to help you plan.

Resources

CONSULTING & TRAINING

MaetricsLNE G-MedMDI Consultants

AUDITING ORGANIZATIONS

Summary

Modern quality system regulations reduce risk to patients by requiring pre-determined risk management policies, links between departments, and processes that allow continuous improvement.

requires a medical device company’s quality system to be a series of risk-driven processes.Risk can come from non-obvious Hazardous Situations, as described by

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