How to learn the European Union Medical Device Regulation (EU-MDR)

3-minute read.
The new European Medical Device Regulation will be required for all medical devices sold in the EU. This was motivated by citizens demanding safer healthcare; the United States is considering similar changes. To learn more about the EU-MDR, do what Chuck Norris would do.

You could also read the official MDR and guidance documents online.
The MDR can seem intimidating. It’s 175 pages long, with 191,000 words and a few concepts that are unique to European law. To help you get started I consolidated online summaries, reputable consultants, and tips for searching the MDR for information you need.
SUMMARIES
BSI is one of the most established auditing companies in the world and recognized as a “notified body” by the European Union. They have free online summaries, a “road-show presentation,” and a 20-minute video highlighting the MDR.

TUV SUD is an international notified body. Their TUV America branch has a useful MDR summary and a flow-chart for the new MDR classification rules.
The EU-MDR Big Picture is a 7-minute article using pop-culture to emphasize key points, with links to learn more.

CONSULTING & TRAINING
These consultants and companies are familiar with the EU-MDR and could help your company with training, consulting, resources, and external audits.
Oriel STAT-A-MATRIXThey’ve operated internationally since 1968 with services ranging from training to consulting. (I consult with Oriel.)

Maetrics

LNE group for consulting, and their subsidiary GMED for certification

MDI Consultants

GreenLight

They operate a useful blog
Qunique

Based in Switzerland, and their CEO, Angelina Hakim unites their community in collaborative workshops

Me (Jason 🙂

TIPS & TRICKS
I prefer using an augmented version of the MDR from the consulting company Oriel STAT-A-MATRIX. They added a table of contents with hyper-links to pages, which I find it easier to use than the official version.
Answer these questions to practice using the MDR:
1) What are the core requirements to be on each Unique Device Identifier? Use Annex VI, Part B.
2) What are the minimum requirements of the post-market surveillance plan? Start with Chapter VII, Article 84, which is the technical documentation that will be required for your plan.
3) Learn the new classification rules, given in Annex 8. Consider playing a game where I grouped celebrities who shared common surgical treatments and ask you to classify their medical devices. The game is structured like “Celebrity Jeopardy” from television’s Saturday Night Live.

4) Search the MDR to learn if and when you should add product information to your company’s web site.
5) Search the MDR for the date that UDI will be required for Class III devices.
(It’s difficult to search for this question. As a hint, see “Final Provisions,” Chapter 10 (X), for many miscellaneous dates and conditional requirements, such as what to do if Europe’s medical device software system isn’t operational by 2020.)
To be effective using the MDR learn to search for keywords efficiently. To help, I wrote a guide for search techniques.

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 and I believe that the EU-MDR is an opportunity to learn. Its intention is to enforce methods of continuous improvement; the rules and penalties should encourage private companies to innovate safer medical devices. If a company or entrepreneur innovates safe designs that are beneficial to patients they become the new state of the art. Innovators are rewarded and society benefits.
Companies that excel will be the ones that accept change, embrace ambiguity, and create a culture of continuous improvement.
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.
My interests include equitable education and innovative healthcare. I work to help society have safer, more effective healthcare by helping companies increase efficiency and innovation. Learn more at JasonPartin.com
And, because life should be fun, here are my favorite Chuck Norris jokes:

What would it look like?

Kristy asked me a question I couldn’t answer: How did she receive a risky spine implant two weeks after a class-action lawsuit was settled against the manufacturer of that device?
After two days of thought I replied: What would it look like to ensure that doesn’t happen to anyone else?
This is the result.
Background
This is a work in progress. It will be meandering, run-on, and possibly confusing. It’s not representative of my writing; other blogs are. You’ve been warned.
Kristy received a spinal disc replacement, intended to maintain motion of her spine, compared to other technologies that permanently fuse the spine. Her results were catastrophic, leading to a lifetime of poor health and chronic pain. Since then she’s been a public speaker and advocate for patient awareness.
A motion-preserving spine implant replaces part of your spine that was damaged in an accident or degenerated with age or disease.

There are many designs, but any design is only a part of the success or failure of an implant. Your outcome would also depend on surgeon’s skill and experience with that device, your unique medical history and lifestyle, and your expectations for how you’d define successful treatment.

When a spine implant fails from any cause there can be catastrophic consequences because it’s near the spinal nerve that controls your life-functions. These consequences can be life-altering and forever painful; usually there’s no recourse, which is why many surgeons start with the least invasive option and gradually increase implants only if necessary. Other surgeons choose to recommend motion-preserving devices as the first option.

As a society we do not know if the benefits of spine motion-preserving devices outweigh the risks of complicated surgeries and unproven technologies. A theoretical advantage of preserving motion is to reduce damage to other parts of the spine, which has not been proven to be caused by fusion and would require research studies following thousands of people over 8+ years.
The FDA approved some motion-preserving devices, but insurance companies are not obligated to pay for them. Medicare and Medicaid, our national insurance systems and a source of healthcare for almost half of the country, do not pay for them.
Motion-preserving discs provide 10X more revenue than fusion devices for the companies that make and market them, and there’s no evidence that the benefits outweigh either the risks to patients or the costs to insurance.
Kristy didn’t know this information when her doctor recommended her motion-preserving spine implant. We could discuss why she wasn’t informed about the class-action lawsuit, why the device continues to be sold, or why some insurance companies still pay for risky devices are all valid questions. But I believe those discussions distract us from solutions that could address all problems and give patients more informed choices in their healthcare.
Seeking blame or asking the wrong questions is like being shot by an arrow, bleeding to death but asking who shot you, what was their motivation, which type of bow they used, or how many people were involved. You’d die while asking questions. Similarly, too many of our debates about healthcare are centered around blame or understanding motivations and intentions of companies that may be too complex to answer and won’t help us save our bleeding patient, which is our healthcare system. The treatment for our patient probably looks the same regardless of the blame and questions about who shot the arrow and why.
This article is about what it would look like to make healthcare safer for everyone.
Kristy and me
Kristy was in an accident that crushed vertebrae in her spine. A surgeon implanted a motion-preserving medical device two weeks after a class action lawsuit had been settled against that device. Kristy developed Autonomic Neuropathy and has battled chronic pain for over a decade. She’s an entrepreneur, designing light-weight purses designed for people with back injuries, is a public speaker for motivation and public awareness, operates a podcast, and writes articles on Linkedinto raise public awareness of medical device risks.
I met Kristy when mutual connections on LinkedIn recommended that we speak about some of my posts about healthcare errors and what we could do about them.
I currently consult medical device companies on international regulations and methods for innovating new devices; I also consult on socially-responsible business methods and purpose-driven workplaces. I’ve invented multiple medical implants and co-founded companies around them, served on national committees standardizing testing of medical devices including both fusion and motion-preserving spine implants, served as a liaison for companies with new spine technologies seeking regulatory approval from the U.S. Food and Drug Administration, and performed my graduate studies under a spine surgeon who was chairman of the FDA orthopedic advisory panel; my thesis involved studying the effects of spinal fusion on the rest of the spine. I’ve taught engineering and socially-responsible entrepreneurship at two universities and a public high school; equitable education and healthcare are my life’s work.
Facts
80,000 to 250,000 people die in America each year from healthcare errors5 million people die each year globally from poor quality healthcare

400,000 people received toxic implants from a European company, prompting public demand for increased regulations; the new European Union Medical Device Regulations (EUMDR) will begin in 2020.

The United States Food and Drug Administration hasn’t updated its regulations since 1997; they recently announced they are beginning that process and are soliciting feedback from companies and the public.The FDA reviews new technologies and inspects existing manufacturing facilities, hopefully to ensure consistency in products.FDA or EUMDR approval does not automatically mean the devices are cost-effective or proven on a large scale, consider all complex factors of manufacturing and use, or are beneficial compared to alternative approaches or competitive products.FDA approval is usually based on “predicate devices,” which means that if you’re similar to something already approved you can get also get approved; you can choose which predicate device you use for comparison and you don’t have to make it safer.

The FDA is an agency of the government, bound by guidelines created by elected officials in congress and the senate. The FDA staffing and budget are also set by our elected officials.
There are over 5,000 medical device companies in the United States and we receive medical devices from many foreign companies that need to be inspected by the FDA.
Some people believe the FDA is inconsistent in its requests therefore difficult to navigate, and that the process slows down innovative healthcare.
A 2.5% tax on gross profits was part of healthcare reform. Political lobbying from companies led to senators postponing that tax for two years; it’s scheduled to resume in 2018.
Thoughts
There’s no concise answer for Kristy’s question, or what a solution would look like so that other people don’t have to suffer unnecessarily. Here are some of my thoughts, all supported by respected research sources and my personal experiences.
The information for Kristy’s answer was available. In other words, everything could have helped her make an informed choice was available, online, for free, by combining sources. But no one could expect her to be an informed consumer in the situation at that time. She trusted her doctor.
Her suffering may have been avoided if someone like myself had been there, a knowledgable friend with access to the internet while she was distressed and pressed for time, or if there had been a consumer-protection organization they would have known the risks of her device, possible links between her surgeon and the device company; that surgeon’s success rate; current information about complaints against the product, manufacturer, surgeon, or hospital; current information about the risks of other products or alternatives to the procedure; Kristy’s unique needs, expectations, and lifestyle; and who cared.
In other words, Kristy’s suffering may have been prevented if someone was doing what she hoped her doctor was doing.
I could find the information primarily because that’s what I’ve done for a living for 20 years, and because I have both a medical and an engineering background, but what I do is based on public information and is repeatable and scalable. A simplified, short version would be that I would:
Read current medical literature and understand the condition and terminology. using generally accepted top-tier publications, government summaries, etc.Read treatment options on trusted websites including major hospitals and government agencies.Read FDA recall notices, “warning letters,” and other publicly-available information that is not well-known by the public nor user-friendly in the search features or terminology.Ask other researchers and surgeons detached from industry-funding their opinions on the situation and options.Listen to Kristy to understand her unique needs, expectations, and situations to balance factual data with her human condition.Care.
I’ve done this for friends, family, and people who have asked. In all situations they made informed choices, most of those choices against the first suggestion of a physician who was qualified but human, partially informed about current trends and the patient’s human needs, and with limited time to dig deeper. In all situations they were grateful they made informed decisions.
My process comes from personal experiences that agree with facts.
Even with access to published information we should consider that published research advocating risky medical devices is overwhelmingly funded by the companies that sell those devices. In other words, companies pay physicians to be write reports; though few reports are shown to directly influenced by companies there’s a correlation between favorable reports and who funds them. Reports that cautious or critical are overwhelmingly from independent researchers who do not accept corporate funding.
Also, regardless of the funding source, we should consider what the report means by “success” or “failure.” Most research journals say a surgery was successful if it didn’t fail, or if it achieved a measurable goal that may not be directly related to the patient’s end result. For a spine fusion device a successful implant would not fail and would fuse bones together. But, when independent researchers added patient satisfaction to their studies with a simple question, “would you do it again?” they found that many patients that surgeons classified as successes felt their surgery was unsuccessful; not a failure, but unsuccessful, not meeting their expectations, and they wouldn’t do it again.
When we see that a product is cleared by the FDA, the Food and Drug Administration, we should consider that new products are compared to existing products, regardless of the risks of those products, or tested against a placebo. A placebo is anything that has no effect, such as giving sugar pills to one group and a new medication to another, and current standards are often based on previous placebo comparisons. Because of quirks with math and people that means that many new devices are only approximately 55% successful. In other words, FDA clearance often means that a new product is only as good as existing products which may only be 55% successful. It’s like betting your future on a coin toss.
Many physicians are diligent and put patients first. But they are human, prone to error, biased by what they are initially taught and what they learn from peers, and not always altruistic. They are just as susceptible to marketing and advertising as we are, and are often as confused by all options or uninformed about current news, litigations, or FDA warnings. I’ve met few who admit that openly, which I feel is the biggest risk to patients: false confidence from partially-informed physicians.
Most physicians receive information from sales representatives who earn up to 30% of a commission for each medical device sold. Often the physicians receive a “research fee” for reporting how the surgery went. I’ve also witnessed, multiple times, at multiple medical conventions, attractive sales representatives accompanying physicians of the opposite sex on dinners and other events to advise them. This was common enough that the United States congress became involved, creating laws to reduce and monitor financial and personal relationships between physicians and companies.
I’ve known medical device distributors with a few sales representatives working for them who made much more money than the surgeons. Their success fed back to the medical device manufacturer’s success, leading to large bonuses for senior executives who exceeded sales goals. Again, congress got involved, several executives went to jail, and new laws tried to curb the root cause of all of these problems: financial incentives for healthcare rather than regard for patient care.
This is a problem that many people are trying to address. My graduate school advisor was a spine surgeon who became chairman of the FDA orthopedic panel. One of my favorite memories of him was when he tossed a packet of sugar on the table in front of a spine implant sales representative, saying “my patients have as much chance of improving from your implant as from taking this sugar packet, and it’s less risky, and it’s free.” He paid for his coffee and I realized I had an ethical mentor.
Since then I’ve served on national committees for spine implant safety and testing, worked with some of the world’s most respected spine surgeons, including ones who published research about links between surgeons who publish favorable studies and the companies that sell those devices. I’ve also worked with surgeons who, without corporate sponsorship, published research showing that patient expectations are not met in many research papers that claimed “successful” surgeries.
Despite many people working towards patient well-being and lowering healthcare costs the problems persist, partially because medical devices are a lucrative business. This is not just about spine implants. The same could be said about almost any medical implant or procedure. For example, a few years after President George Bush received a cardiovascular sent his surgeon published an editorial that it wasn’t necessary, just like hundreds of thousands of stents implanted each year.

Surgeons are human, subject to the same confusion about our healthcare system as we are, and it takes brave physicians to admit their learning lessons.
This article isn’t about any specific implant, or to point fingers, it’s about how to continuously improve our healthcare system and how to empower patients to make informed choices.
Information
There are many big-picture changes underway, but they will be slow to implement and we don’t know if they will address situations like Kristy’s. New European Union Medical Device Regulations will enforce a method for ensuring companies reduce risk to patients in a process of continuous improvement. Each product must be compared to other products, alternative treatments, and current medical trends to demonstrate that any risks are outweighed by benefits to patients. I believe this will increase patient safety and give a competitive edge to innovative companies; in other words, patients won’t receive medical devices just because a large company negotiated a hospital contract, they will have assurance that their medical devices were compared against all competition and provide the same benefit with the fewest risks. This information is expected to be posted on a European database with public access.

I can’t emphasize this enough: these regulation changes came after the public demanded it from elected officials after 400,000 people received toxic implants from their former system. The European Commission coordinated the laws of 28 countries into one policy focused on reducing risk to patients through a process of continuous improvement and transparency in corporate policies and safety data.
Similar improvements have come from ethical, concerned people in the medical device industry. For decades a think-tank called the Global Harmonization Task Force, now part of IMFRF.org, advocated improved healthcare regulations that could be universally applied to all countries and would negate human bias between auditors. In words, regulations aren’t effective if the results vary between people inspecting them, and companies are swamped trying to adjust to varying results from varying regulations for each country in which they would like to sell medical devices.

The result of their effort was the Medical Device Single Audit Program (MDSAP), which will be required in Canada by 2019 and is currently accepted by Canada, the United States, Japan, Brazil, and Australia. All countries will forego their current regulatory requirements for companies with MDSAP certification. It’s 95% repeatable between different inspectors, available online, for free, for any company wanting to use it, and focuses on reducing risk to patients throughout the design, supply chain, manufacturing, distribution, and field results of the companies quality system.
The EU-MDR is centered around products and based on a company’s quality system, MDSAP is centered around a company’s quality system by looking at products. I believe that together they paint a complete picture.
Learn More
Learn more about people impacted by medical device errors and healthcare mistakes inthe Netflix documentary The Bleeding Edge:

Learn about the challenges of providing healthcare with financially sustainable and equitable funding in a comedy show about a serious topic: dialysis.

Popular media will be biased in order to create an emotional reaction. Consider reading articles from major news sources and respected scientists about healthcare errors, balancing hyperbole with real-world data.
Learn more about the big picture of the European Union Medical Device Regulations in an article I wrote that hopefully explains a complex topic to a wide audience, from the general population to a healthcare expert, with links to deeper details.

As an example of one of the deeper topics, I compare hip implants to car safety features and share how to make state of the art medical devices.

We wouldn’t consider buying a car without seatbelts, turn signals, child-safety seats, etc. That’s partially because government regulations required them so the public began to consider them “generally accepted state of the art,” a concept used in the European Union Medical Device Regulations. Self-driving cars are new technologies without enough history to make informed choices yet, but car manufacturers can choose to add these features and appeal to consumers. Unfortunately the same approach hasn’t worked for medical devices.

Take the example I use in the article on making medical devices state of the art. We’ve made hip implants since 1940 yet are still sources of errors, with product recalls after thousands of people suffered due to a mistake in manufacturing and quality control of an established design. Over 3,500 had to have recovery surgeries and may never walk normally again.
We’ve had 80 years of history with hip implants, 30 years of FDA guidelines, and extensive case-studies, lawsuits, corporate quality control training programs, physician training programs, etc. and we still aren’t protecting patients.
The products are too diverse and the reasons for failure to complex to simplify into one set of effective regulations. Perhaps it’s time to rethink our approach rather than simply making more regulations. To do it effectively requires everyone learning more about the existing situation then proposing achievable steps in a process of continuous improvement.
The Next Step
I’d like to add one thing to the comparison between cars and medical devices: fruit.

The FDA oversees our food supply. Most of us don’t study the complex farming system, distribution supply chain, and storage requirements for bringing apples and oranges to our grocery store; we trust that it was done safely. We occasionally see recalls of contaminated spinach or cartons of milk, and we trust that the system works. Some of us would like to know more, to know if our food was grown without pesticides, or from local farms, without artificial colors added, etc. Doing this for the entire system would be too burdensome, but we’ve made steps to inform consumers using “organic” certifications that have transparent processes for certification. That system isn’t perfect, but the enemy of “better” is debating what’s perfect. Perhaps there’s a lesson there for better ways to inform consumers about the risk of their medical devices, allowing them to choose doctors, hospitals, and insurance providers that allow a choices based on a patient-friendly certification process, the same way that the USDA organic certification is a niche certification built upon the existing FDA process.
In other words, repeat the process I would have done for Kristy as a certification. It could be build upon existing regulations: the first step would be products that passed the European Union Medical Device Regulation and companies that passed the MDSAP. The next step would be a database of warning letters or complaints against companies, products, physicians, and hospitals. The final step would be a way to identify unique needs of each patient, their expectations, and their level of experience at making complex choices. The result would be a certified organic apple that either keeps the doctor away or steers you to a different product, hospital, or insurance provider. Eventually, customers could influence our healthcare system the same way we influence food in our grocery stores, electronic equipment in our computer stores, or safety features in our cars.
Like most certifications, a medical device “safe and effective” certification would probably need to be a sustainable business, where consumer demand for the certification led to companies, hospitals, and doctors choosing if it were worth paying for it. What’s important it that healthcare becomes influenced by consumer choice.
I believe that patient safety and innovation would come from something in addition to more effective government regulations. Government programs are wonderful because they enforce things for public well-being, such ensuring food safety, that the gas that goes into our car is what it claims to be, that our buildings withstand earthquakes, and that airplanes flying over our homes pass safety inspections. But few people claim that government regulations happen quickly, are efficient when they do happen, or make everyone happy.
The idea in this article is a starting point, a step towards consumer choices in healthcare that increase safety and stimulate innovation. It’s not perfect, there are many flaws, and there would be many obstacles such as how to initial fund and grow such a massive program, how to ensure quality control of the program, how to make it financially sustainable, and how to avoid overburdening an already complex system. But it’s a talking point on which to build.
Consider writing your congressman and senator, letting them know that your vote depends on their action, on collaborating towards gradual solutions that can continuously improve, increased funding towards existing programs and collaborating towards gradual steps in a process of continuous improvement. Consider sharing this article and asking them “why not?” or “what would your solution look like?”
If you’re a medical device professional, consider participating in the IMDRF, a volunteer organization so respected that the FDA uses their consensus papers as guidance for companies.
What do you think?
Thoughts? Improvements? What would your idea look like?

How to apply risk-controls and risk-benefit analysis

4 minute read.
This article shows how to apply risk-control and perform Risk-Benefit analysis for the European Union Medical Device Regulation. You may have reached this from my article on the MDR big picture; Risk-Benefit analysis the final step in reducing risk As Far As Possible. I’ll use Harry “The Hat” Anderson to illustrate that concept.
Harry Anderson was a famous comedian, magician, actor, and producer. He was most known for his role as Judge Harry Stone in television’s Night Court, where he played a judge in New York City who did magic tricks. His career had jump-started in 1983 when he appeared on the famous comedy show Saturday Night Live, apparently shoving a needle through his arm.

I remember him fumbling for written instructions with a needle stuck through is bleeding arm, and this “stuck” in my mind as a way to illustrate the concept of risk control. Companies are required to apply risk control in specific ways, and many companies struggle to balance cost effectiveness, innovation, and applying risk control priorities; this article may help clarify the “point.”
Risk Control Priorities
Harry fumbling for written instructions is why the EU-MDR prioritizes risk control methods:
Make the design inherently safeAdd safeguardsProvide written instructions or warnings

His needle-through-the-arm also represents a real-world challenge in healthcare, accidental needle sticks. Healthcare workers would get stuck by needles that had been in contact with patient blood, which resulted in transmission of diseases. Some of those diseases included life-threatening viruses such as HIV.
Written instructions were ineffective at protecting healthcare workers, and it was difficult to make needles inherently safe because it must be sharp to penetrate patient skin. Innovative companies found cost-effective ways to add safeguards to needle after FDA regulations for needles required more safety, and those companies excelled in the market. Companies that didn’t innovate lost in the market. Society benefited.

Safeguards have proven to be more effective than written warnings, and maybe one day an innovative company will revolutionize needles with an inherently safe design. When that happens they will be the new state of the art; innovative companies that focus on patient safety will continue to win, and society will continue to benefit.
Risk/Benefit Analysis

After risk control the needles still have sharp tips, which is why the final step of reducing risk as far as possible is documenting a risk/benefit analysis. In other words, you must show that benefits to the patients outweigh remaining risks.
The EU MDR requires companies to create two documents for determining risk-benefit, clinical data and post-market surveillance. For this article it’s enough to understand that clinical data is simply a list of everything that could be known at the time, including publicly-available information about the problem and competitors’ solutions.
Public information:

Competitors’ solutions:

Post market surveillance is real-world evidence of your device’s risk, adverse events, and trends that would indicate potential risks to future patients.
Risk/Benefit analysis means comparing post-market surveillance against clinical data to ensure a company’s product is as safe as competitive options. Any remaining risks or any additional risks must be balanced by additional benefits to patient healthcare; this is the Risk/Benefit document required by the MDR.
In a few cases added risk would justified, such as risky cancer treatments for patients without safer alternatives. That’s not true for most medical devices though. If someone you loved needed a medical device, how would you justify using your product if it were more likely to cause them harm than a competitor’s product? Why shouldn’t every company do that for all of our loved ones? The EU-MDR forces companies to do this so that we don’t have to.

Clinical data and post-market surveillance must be updated every 1-2 years for devices classified as high-risk, and “as needed” for low-risk devices. (See my article on classifying devices). A company must continuously improve their products to remain state-of-the-art, showing that their benefits outweigh risks compared to competitive products. That’s fair.
Continuous learning
Learn more by using the 2014 consensus paper for EN ISO 14971:2012and theEuropean Union Medical Device Regulation. Or hire consultants to work with your teams or train them.
Thank you
Please share this article if you think others could benefit.
Follow me on Linkedin, browse my blog, or subscribe for semi-annual updates.
Parting Thoughts
Harry Anderson passed away in 2018. My thoughts were with him and his family when I wrote an article trying to summarize all of the wonderful things that happened in my life due to the humor and magic he shared with us. If you’re not familiar with Harry’s style of humor, here’s one of my favorite scenes of him on television’s Cheers:

Coincidentally, my first medical device job was with a start-up company that had been founded by the original inventor of needle-stick safety features. In our interview he asked me how I would solve the problem. By then I had designed or invented dozen of magic effects, many of them from Harry Anderson’s appearances on Saturday Night Live. That job led to a series of my own medical device inventions, retirement, and transitioning into teaching using hands-on, project-based learning where many of my students design and perform magic tricks to develop engineering and public speaking skills.
If you’re interested, I wrote a rough draft of this article that explains how Harry helped me teach risk, design, and entrepreneurship, where I describe sharing drinks with Harry in his New Orleans bar, where we performed a few magic tricks together. I didn’t think to thank him then. I wonder whom I should thank today.
Life’s too short for many people; I wish you happiness.

Continuous Improvement

This is a work in progress. It’s my first attempt to link diverse topics from my work, and there’s likely an improved version on my blog.
A client’s employee complained about something I said in a workshop. Since then I’ve said it in almost every workshop, monitored it for effectiveness, improved it, and built upon it for this article, which is my first time publishing it and soliciting feedback so that I can evaluate its effectiveness. Here’s what I said and why I said it.

My workshops teach details but relate them to high-level concepts, such as the concept of continuous improvement for our work, students products, organizations, and selves. I illustrate the concept in a diagram that’s on the wall throughout the workshops, which usually last three days. Many people copy it, memorize it, or nod in agreement; few “get it.”
Someone “got it” then asked why there are so many online courses or corporate trainers making their living explaining such a simple concept. I knew he was a religious man and wanted to answer in terms he’d understand. I also didn’t want to emphasize one religion because there were people from diverse cultures in the room, so here’s what I said:
Jesus simplified his teaching into a few words yet there are countless books, interpretations, and schools of thought on what he meant.
The Buddha simplified his teachings into a few words yet there are countless books, interpretations, and schools of thought on what he meant.
Both said that different people need to hear the same message in different ways but it’s always the same message.
Several people seemed offended and one of them complained in writing, saying that I should “lay off the religious references, it offends peoples’ beliefs.” I’m sorry they were offended, and discussed what was said with senior management who felt there was value in using religion as a metaphor that helps more people understand the big picture. Our work is important: global healthcare for 7.6 billion people depends on a few hundred thousand people understanding and being able to apply a few concepts.
I decided the benefits outweighed the risk and said it in dozens of workshops since, varrying the timing and context depending on each group. I’ve also applied it to courses in education reform including how to install skills in innovation and entrepreneurship. The concept is to function as linked processes of continuous improvement.
The process approach to continuous improvement

A process of continuous improvement learns from itself and improves based on real-world, factual information information. This is analogous to a closed-loop process in computer engineering, which adapts itself depending on feedback from the real-world, and is different than an open-loop process that does not monitor itself for effectiveness and will not change it’s program.
For linked processes the output of one process becomes the input of another process. This can be two, three, or thousands of processes, all linked and influencing each other.
To help different people understand the concept I show what is and what is not a process using 1980’s and 90’s pop-culture and relate the lessons to international standards for quality control.

The image is a fun way to choose between the lyrics of two famous hip-hop rappers, MC Hammer (Stop! Hammertime) and Vanilla Ice (Stop! Collaborate and Listen) but it’s not a closed-loop process; I build upon that to show what is a closed-loop process and give examples of linked processes in continuous mutual improvement, the output of one becoming the input of another, all influencing a shared output that is monitored for effectiveness and fed back into the system.
We are all interconnected through linked processes. A chain is only as strong as its weakest link; it’s in our best interest to help others. To do that we must have not doubt the importance of all links and follow a method of creating processes of continuous mutual improvement.

No man is an island entire of itself; every man is a piece of the continent, a part of the main; if a clod be washed away by the sea, Europe is the less, as well as if a promontory were, as well as any manner of thy friends or of thine own were; any man’s death diminishes me, because I am involved in mankind. And therefore never send to know for whom the bell tolls; it tolls for thee. – John Donne ~ 1600 AD
Do not focus on words, understand the concepts
Mohammed, the prophet of Islam, wrote down many of his teachings but neither Jesus nor Buddha wrote down words, both saying that people focus on words rather than concepts or say the words without following through with actions. All used parables to relate their concepts to what was relevant to the people listening at that moment, having empathy for each unique person and saying what needed to be said at that moment, and those words can lead to confusion when taken out of context.
People get stuck on words like an elephant gets stuck in the mud – Buddha, Lankavatara-sutra ~ 550 BC
I speak in parables, so that, “‘though seeing, they may not see; though hearing, they may not understand.’ – Jesus, Luke 8:10, ~ 0036 AD
Men who have hearts with which they fail to grasp the truth, and eyes with which they fail to see, and ears with which they fail to hear. They are like cattle -nay, they are even less conscious of the right way – Mohammed, Koran 7-179, ~ 600 AD
Truth is one, though wise men speak of it variously – Hindu Rigveda, ~ 1500 BC
My finger points to the moon; do not mistake my finger for the moon – Buddha, asking someone to pull his finger, ~ 550 BC
That last one was a joke to see if you’re paying attention. The Buddha did use the quote about his finger, meaning that his words point to the truth but are not the truth themselves.
It turns out that people in Buddha’s time described him as “ever smiling,” always full of joy. He said, in different words but with the same concept, that all things are connected, all are one, linked through processes of continuous improvement.

Buddhists represent cycles of improvement as a rotating wheel; each of the eight parts of the wheel must be strengthened for progress.

I find it fascinating that the Buddhist wheel is similar to the FDA and ISO standards of quality control, which state that for a company to function effectively it must coordinate multiple processes through shared links. The FDA image even looks like the Buddhist wheel, with each spoke being important to overall improvement.

This is also the concept of new standards in education, the Next Generation Science Standards, which has been adopted by over 22 states and introduces engineering as a core science, equal to physical sciences, biologic sciences, and earth sciences.
NGSS uses the term “crosscutting” for linking concepts to different disciplines. For example, physics should be linked to math, and both should be linked to engineering. In an ideal world we’d also link these to reading, writing, history, and almost all concepts in school because in the real world everything is linked.
People in the healthcare and education industries earn their living by not causing harm to others, and not making things that could harm others. (Right Livelihood) We should celebrate our benefit to society.
Any system can improve. Consider that many medical devices cause harm due to design or manufacturing errors, insufficient user-centered design and testing, or incomplete quality control. Between 80,000-250,000 people die each year because of healthcare errors in the United States, and recently almost 400,000 people received toxic implants from a French company.
Similarly, our education system emphasizes written words, isolating diverse learners who are also likely to be from impoverished backgrounds. For example, 19% of the public is dyslexic, struggling with written words, compared to 55% of the prison population.
We can improve. Improvement requires setting aside time each day (Right Effort) to focus on learning (Right Concentration) until we understand concepts (Right Understanding) and apply them (Right Action).
As an example of where to improve, look at the Next Generation Science Standards logo and the FDA quality system regulations; they are “written” as performance standards and contain many words rather that may not enforce the concepts. To improve, brainstorm what it could it look like to get 3+ million teachers and 28,000 medical device companies to understand concepts rather than blindly following written procedures, and how we could measure and reward that understanding.
Don’t follow rules blindly
Jesus and Buddha both challenged existing doctrine and rules, saying people who recite words without practicing deeper meanings are hypocrites, distracting others from the goal, creating other followers of words rather than concepts,” the blind leading the blind.
Then they are like a line of blind men leading more blind men – Buddha, ~ 500 BC
They are blind guides. If a blind man leads a blind man, both will fall into a pit – Jesus, ~ 0036 AD
Being in the midst of ignorance and thinking in their own minds that they are intelligent and learned, the ignorant wander, afflicted with troubles, like the blind led by the blind – Upanashids, 3,000+ year-old Hindu texts
Many of society’s problems stem from the blind leading the blind. Consultants share catchy phrases with managers who then write them down as policies that are misapplied by employees and create mistakes in the workplace that impact the lives of millions of people. Teachers “teach” concepts like entrepreneurship and innovation by having students memorize lessons. Those students become teachers of other students.
We are the blind leading the blind and will only change when how we learn changes, focusing on concepts rather than words. Jesus, Buddha, and Hindu texts say the method to understand the concepts is by practicing moral, humble service and reflecting on what you learn in the process.
Help others
I have learned that people “get it” after seeing the cause and effect of their actions as part of a larger goal with shared, linked processes. They understand that by helping others they are also helping themselves. When this approach becomes part of a larger culture someone will help them, too.
This is a foundation of small-unit military training; you must understand the big picture and how your actions or lack of actions impact others in order to stay focused on your job. That’s why military leadership plans begin with “the situation” followed by “your mission.” It ends with “command and signal,” which are the links to other processes necessary for overall success. We learned this not by memorizing a Five Paragraph Operations Order, but by practicing simulations again and again, failing because we pushed ourselves, then conducting an After Action Review to learn from each step of the process. In other words, we learned about linked processes through our service to others.
For professional clients I often have to override their tendency to want to “know the answer.” I encourage deeper understanding by asking them to learn-by-doing, and try to make all activities shared by a group to develop interdependency. I use a range of projects depending on each client’s background and needs. We create new things, work on challenging concepts, and apply these lessons to the regulations. I serve as a guide rather than a lecturer, a coach rather than a teacher.
As an analogy, we don’t tell a child how to walk, asking them to memorize the instructions for how to walk. We let them try and guide them as they stumble, creating a safe environment. Similarly, we don’t tell someone how to ride a bicycle, play the guitar, how to invent new medical devices, or how to be an entrepreneur. We let them try, fail, learn, and try again until they understand the concept that there is no failure, only opportunities to improve.
“It is failure that brings improvement.” – Henry Petroski, failure analysis professor

As an individual, you must do this on your own. As the Buddha said, be your own refuge, no one else can help you, you must walk the path.
As a leader, consider the parable Jesus used of becoming a shepherd over a flock. For people, this means reducing their fear of failure by earning trust, being humble, and coaching rather than telling. Anyone can be a leader. It doesn’t take a title, and you don’t have to be an expert in anything. You can be a leader simply by contributing to a culture of continuous improvement, recognizing that we’re all linked processes and their success helps the success of everyone else. Don’t judge, help. A way not to judge others is to begin by not judging ourselves. Instead of judging others or ourselves we can put our minds towards improving the overall system through patience and perseverance. All systems can improve through gradual steps each day.
Small steps
The Buddha summarizes continuous improvement:
Every day you do more of what you know to be right and less of what you know to not be right – Buddha
For large corporations or education systems to know “what is right” and “what is not right” requires documentation, paperwork, and measurable metrics. This is were unnecessary bureaucracy begins, but with more people focused on the big picture we can all contribute to a more efficient process based on shared measurable outputs. In the case of medical devices this is reduced patient risk and increased patient benefit. In the case of education it’s healthy, happy, engaged students with wisdom at the level that benefits each individual most.

Gradual steps towards improvement is the essence of Kaizen, a Japanese management style with roots in Buddhism. Kaizen, which means “improvement” in Japanese, applies small, measurable steps to improve corporate quality systems rather than introducing new concepts that may confuse employees and cause more harm.
The Kaizen approach is echoed in the Tao Te Ching, the world’s second-most translated literature after the Bible, first written in China ~ 600 BC.
The longest journey begins with a single step – Lao Tzu (perhaps)
Personal Examples
I try to never repeat words that I haven’t verified as factual or experienced on a deep level of understanding. I don’t always succeed; it’s a process of continuous improvement. Here are a few examples:
Yoda & Dedical Devices
I demonstrate the Kaizen approach for complying with European Union Medical Device Regulations using another teacher based on Asian philosophy, Yoda.

The Yoda article is an example of different ways I use to explain concepts to different people. I created an entire course on quality system regulations related to 1980’s pop-culture. The Yoda article links back to the article you’re reading now, similar to the Buddhist concept of cyclical relationships and inter-dependency. It’s also a concept behind the International Standards Organization guideline for medical device quality control, ISO 13485, the concept of linked processes.
Education, Design, Innovation, Entrepreneurship, & Society
I created and led an engineering design course I created at the University of San Diego. It was “user-centered design,” I couldn’t imagine taking written tests to demonstrate understanding the concept of design and innovation, so I demonstrated the concepts by leading the course through linked processes of continuous improvement.
For their final project I said, “do something that meets the learning objectives of the course, ensures accreditation of the university, and meets the needs of all of you. It’s ambiguous, but if one of you learned the concept it will happen; if none of you learned the course I failed you and we will deal with that if it happens.”
This is what they did: created a shared goal of starting a company based on products they designed, created linked process of design, manufacturing, web design, and community outreach, user needs (the customer), and stakeholder needs (the university’s accreditation requirements).

Each sub-process had other sub-processes. For example, the design, which was a wooden grocery bag holder, went through multiple closed-loop processes of continuous improvement. This was to work with the manufacturing team to ensure the design could be made cost-effective by reducing scrap wood, and could be made by our manufacturing facility.

Multiple iterations lead to innovation, and you wouldn’t iterate if it didn’t fail some criteria. Thomas Edison, one of the most famous inventors in the world, tried for years to design the lightbulb. “I haven’t failed, I found 10,000 ways that won’t work.” And, he didn’t invent the lightbulb, he improved it. You can’t “teach” that, and a written test won’t let you know if someone understands the concept. A teacher must become a coach, a facilitator of continuous improvement where failure in a safe environment is combined with iteration to gain wisdom.
The class linked processes with others in a way I believe would benefit the world. Our manufacturing facility was the downtown San Diego public library “maker space,” which had a computer (CNC) laser-cutter. We designed products in Solidworks CAD software (that wasn’t the class, they learned in order to achieve the shared goal). Our manufacturing team was people in homeless camp that lived near the library – as crazy as it sounds, we iterated products based on the ability of homeless people to manufacture them so that we could sell them at farmers’ markets to help people carry more grocery bags using products they knew would benefit society. In other words, we linked the class processes to society in processes of mutual improvement.
My website and blog came from that class: I never ask anyone to do anything I wouldn’t do, so if students were willing to learn web design, CAD, and risk failure I would too. You’re reading the result.
What I Say in Workshops
Someone complained the first time I used religious philosophy in a medical device workshop. There were 22 participants in that three-day course and it was the worse evaluations I’ve ever received, resulting in a “corrective action” on my part.

I made changes in my timing and the context, monitored results, and improved. I monitor results by participant feedback in written evaluations that include numeric evaluation on a scale from 1-7, with 1 being horrible, 3.5 being average, and 7 being extremely beneficial. I track the results and monitor trends using the same statistical methods that are often part of the workshops.
We’re All Linked Processes
I also link this article with my travel articles because global healthcare will require global empathy. I incorporate these bigger-picture discussions into my workshops, when appropriate, emphasizing that we’d all benefit from linked processes of continuous mutual improvement. Those articles are in my blog. but I’d like to share a photo here, a sign in Nepal, in a remote part of the Himalaya mountains, where there is more poverty and illiteracy than most people reading this blog can imagine. Some parts of their government and some non-government organizations are trying to help them understand the concept of linked processes of continuous improvement, showing the links between education, healthcare, government and village leaders, etc.

In the city of Kathmandu, Nepal, I took a photo that explains it in different words.

Final Thoughts
The world would be a happier place if we all worked together; I have no beliefs higher than that.
Please contact me if you’d like to discuss how to create linked processes of continuous mutual improvement through sustainable businesses providing equitable education and healthcare.
This is a work in progress; I’ll probably always say that.
Please share if you think others would benefit.

This is clear, easy to understand, and unambiguous

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

Why do most people still struggle with understanding and applying AFAP? First, because of “anchor bias,” our tendency to look for similarities to what’s already familiar, to be anchored to our first idea. Most of us first learned the ISO 14971 concept of “As Far As Reasonably Practicable,” and we try to relate the two concepts rather than learning AFAP freshly.
Second, because “As Far As Possible” is a concept, not simply a new acronym, and many people don’t have the time to reflect deeply on how their quality system may need to adapt. Or, their company works in silos, kept in small segments that don’t see the impact of AFAP on the entire quality system.
Finally, companies that haven’t reduced risk to patients As Far As Possible can’t comply. You can’t demonstrate what wasn’t done. If that’s the case, begin making your quality system state of the art by using the Kaizen approach to continuous improvement, taking small steps that are likely to be understood rather than drastically new procedures that cause confusion.
Here’s what you can do about these limitations of ourselves and our companies.
Know that bias affects all of us.

Listen to your coworkers while acknowledging that you both may have confirmation biases. A method to to this is called Active Listening, which is recommended by the U.S. Department of State for training foreign negotiators. If both people are listening communication is more effective.
I also appreciated learning from a TED talk on how to have better conversations.

Take small steps of continuous improvement. This is the Kaizen approach, a management concept that works towards big changes by taking small, measurable steps that are more likely to be understood and implemented. For examples of Kaizen steps towards reducing risk As Far As Possible see my article Take small steps to comply with the EUMDR.

Continuous learning
In 1987 Chuck D, frontman of the hip-hop group Public Enemy, asked: “How low can you go?” In 2017 Europe responded: “As Far As Possible,” and I try to relate these two with other pop-culture references to explain How to lower risk As Far As Possible in a way that’s clear, easy to understand, and unambiguous.

The book Thinking Fast and Slow, written by the psychologist who won the Nobel Prize in economics, summarizes 40 years of research on our biased decisions. It was one of the top ten books President Obama recommends for leaders.

You can learn about reducing risk for the MDR using the 2014 consensus paper for EN ISO 14971:2012and theEuropean Union Medical Device Regulation. Or hire consultants to help you prepare your teams.
Oriel STAT-A-MATRIX (I consult with Oriel)

MaetricsThe Weinberg Group

Qunique (a botique European consulting firm)

Jason (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

Take these steps to comply with European Union Medical Device Requirements

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.

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

How to make state of the art medical devices

This is an older version, kept on my site because other articles link to it. I recommend switching to the newer version.
7 minute read.
Beginning in 2020 the new European Union Medical Device Regulation will protect patient safety by requiring healthcare companies to make products that are “state of the art,” a term that’s often misunderstood by both companies and patients. It does not mean the latest technology, it means the most commonly agreed upon technology, or “generally accepted state of the art.”
This European law is better explained through examples using automobiles, comparing today’s state of the art with new technology in the 1980’s television series Knight Rider, where David Hasselhoff fought crime in a talking, self-driving car.
Watching the 1-minute trailer may brighten your day:

Today, we have talking and self-driving cars, but they are not considered “state of the art” by government regulations, which require state of the art safety features. You’re probably familiar with generally accepted state of the art for automobile safety:
SeatbeltsBrake lightsAir bagsChild safety-seat securing hooksSide-impact safe doors
Self-driving cars exist but they are not mandatory because there’s not enough evidence that they protect public safety yet. Self-driving cars are a new, high-tech feature but are not “generally accepted state of the art.” Similarly, some medical device features seem like good ideas but aren’t “generally accepted state of the art” because there’s not enough evidence that they reduce risk to patients. The MDR requires companies to continuously review competition and public safety reports to prove that they’ve reduced risk to patients As Far As Possible, which includes having state of the art products.
This is easily understood with for cars; in 2016 an estimated 16,000 lives were saved in the U.S. thanks to seat belts. But, healthcare is a bigger risk than automobile accidents, with 80,000 – 250,000 unnecessary deaths in the U.S. each year due to healthcare errors. Similar data worldwide led to the EU MDR, and the U.S. is considering similar healthcare reform. But medical device safety is more complex than car safety, and state of the art is a combination of design, manufacturing process, surgeon training, etc. I’ll demonstrate this with a few examples.
Spine implants:
new technology, not state of the art
This is an example of a new medical technology that’s not state of the art: motion preserving spine implants.

Before motion-preserving spine implants, surgeons used spine-fusion implants to prevent spinal vertebra from moving, usually to protect the spinal cord, sometimes to reduce pain (this is a controversial topic – learn more.)
A concern developed that fusing one set of vertebra caused more motion in other vertebra which led to problems in 6 to 8 years. In the 2000’s several start-up companies developed “motion preserving” spine implants to replace fusion devices.

Motion-preserving devices have not become state of the art because the benefits are unproven and the new technology has higher risks than previous technologies. The added risk come from surgeons having to learn new procedures that are more complex than previous spine implants, and from unknown long-term consequences of the new technologies. The implants shifted over time and many patients suffered unnecessarily. Manufacturers settled class action lawsuits and national health insurance programs refuse to pay for the procedure, especially because it’s 10X more expensive than previous spine implants. Long-term studies of patients with motion-preserving implants haven’t shown benefits that justify the risks or costs.
In other words, new spine technology does not mean it’s state of the art healthcare, it could be adding both risk and costs to public healthcare.
Previous medical device regulations did not enforce state of the art safety, which is why products that add risk and cost are still on the market. Unfortunately, most patients rely on their physicians to advise them despite many surgeons are unaware of the risk/benefit analysis or cost. And, some physicians are incentivised by medical device companies to suggest the more expensive implants. All of this is why the MDR will hopefully benefit society.
Robotic Surgery:
beneficial, not state of the art

This is an example of even new, beneficial technology may not be state of the art because not all hospitals are capable of using the new technology yet.
Many spine surgeries use robotic surgery or some type of nerve-monitoring technology to protect patients’ spinal cords during surgery. This new technology is generally considered beneficial, therefore would almost be considered “state of the art” by the MDR definition, but it is not because it is only true in specific cases where the hospitals have sufficient infrastructure and surgeons are sufficiently trained and experienced. The EU MDR applies to all countries in the European Union, therefore to be state of the art the technology would have to apply to the infrastructure and training of almost 30 European countries.
In other words, a company can sell nerve-monitoring equipment to hospitals based on improved results, but not all spine implant companies would be held to the standard of robotic surgery outcomes because these new technologies aren’t yet “generally accepted state of the art.”
Hip implants:
established technology, not state of the art
Hip implants have been available since 1940, before David Hasselhoff was born, yet we still struggle understanding what is and what is not state of the art because designing, manufacturing, and shipping medical devices is much more complex than automobile safety features like seat belts and child safety seats.
To emphasize the complexity of state of the art for medical devices I’ll use terminology that probably seems confusing unless you’re familiar with hip implants, which is a challenge for patients having informed choices in healthcare.

When a patient needs a hip implant they rarely don’t review the current materials, noting differences between percentages of Chrome in CoChMg femoral heads, hardness and pitting resistance from heat-treating, or smoothness from polishing. We don’t know to investigate the density and cross-linking of UHMWPE in plastic liners, or the pore size, edge sharpness, and structure of nano-material porous structures on the acetabular component and femoral stem. Nor do we know if the coating is Ti6Al4V or Ti6Al4V ELI, much less know if their processing ensures that a titanium oxide layer forms and prevents the toxic material Vanadium from leaching out.
Are the the tools and instruments used for the surgery state of the art? Tools that are improperly categorized or instruments that aren’t user-friendly have led to mis-matched implants that failed and require secondary surgeries. Do the instruments ensure proper alignment of the hip stem? As little as 3 degrees variance can add risk of eventual failure.
Has the company’s quality system ensured replacing all instruments with updated versions? Are surgeon’s adequately trained, especially knowing that research shows that 60% of the reason for an implant failure is the skill of the surgeon. What if a surgeon has higher failure rates, is that tracked and monitored so a patient can make informed choices?
What about how the implant was made? We don’t know if manufacturing processes have state of the art cleaning procedures or if a company’s quality control is state of the art and would catch mistakes.

An example of a quality-system gap in hip implants is the Sulzer hip stem recall. 35,000 hip stems were shipped with toxic machining oil still in them. Over 9,000 were implanted before the mistake was caught, and almost 4,000 people had their femoral bones erode, requiring another surgery and impacting their ability to walk for the rest of their lives. Over $1 Billion in lawsuits bankrupted Sulzer, but patients said they’d rather walk normally than have received insurance money.
The reason for Sulzer’s recall was traced to a seemingly simple decision on their manufacturing line that even today would be difficult to detect and monitor, much less simplify for patients to understand. The Sulzer hip implant recall was just one example, many more exist.
Oh shit, now what?
The EU-MDR can’t define what is state of the art for every situation so it requires that each product be compared to competitive products’ safety features every year for Class III and IIb products, every 2 years for Class IIa, and “as needed” for Class I. This makes sense: the higher the Class, the higher the risk, therefore the more frequently the need to reduce risk. Class I products are low-risk, therefore “as needed” is ambiguous and implies if there’s a “major” design change or safety concern.
This means that “state of the art” will have two supporting documents, clinical data and post-market surveillance. Clinical data includes competitors’ products, safety data, and alternative treatments; post-market surveillance includes the manufacturer’s product safety. For now, companies must do their best to find this information publicly, but in the future all companies and the general public will have access to this information online. The MDR is creating new agencies that will look at this data and see if medical device features truly improve patient safety; if so, those features will become state of the art. This is similar to how governments currently treat automotive safety.
Government regulations require state of the art in new cars but do not enforce all innovations until there’s enough evidence that these features impact public safety. Agencies such as the U.S. National Highway Traffic Safety Administration (NHTSA) keep consumers informed about new technologies that aren’t required.

Over time, these features may prove that they add to public safety enough to be considered state of the art, at which time they may become required by regulations. Similarly, medical devices sold in Europe will be tracked online in the EUDAMED database, which is still being designed and will probably continuously improve.

The EU-MDR will try to minimize risks to patients by ensuring that new technologies are compared to generally accepted state of the art in terms of patient safety, and that new technologies are justified when the benefits outweigh additional risks. See my article on risk-benefit analysis for that step.
Summary
“State of the art” for the EU MDR does not mean the latest technology, it means the features and systems that are proven to reduce risk to patients.State of the art must be established every 1-2 years for Class IIa-III products and “as necessary” for Class III products.State of the art is complex, based on a combination of product features, manufacturing processes, training, and the realities of hospital systems in diverse countries.The MDR will create an online database, EUDAMED, with transparent, public data on medical device safety. That data will be used to determine “state of the art,” but until then companies must seek and use published research data.

State of the art requires complying with Risk Management priorities, which is described in another article Reducing Risk As Far As Possible
Learn more
There’s more to MDR. For example, there are requirements on how to update safety concerns and which information must be displayed on a company’s web page. You can learn in my articles on The Big Picture or, if you’re familiar with previous European medical directives, “MDR: the medical device regulation formerly known as MDD
The MDR will be mandatory by 2020; to be fully prepared consider working with one of these training or consulting companies to help your team prepare.
Oriel STAT-A-MATRIX an international organization since 1968 (I consult with Oriel)

MaetricsThe Weinberg Group

LNE group for consulting, and their subsidiary GMED for certification
Qunique, based in Switzerland and expanding internationally

Jason (me)

Thank you
Please share this article if you think others could benefit.
Follow me on Linkedin for occasional articles. Not all articles are published, so consider browsing my blog or subscribing for annual updates.
For fun…
Someone spent 10 years converting their 1984 Trans Am into a replica of David Hasselhoff’s Knight Rider car, complete with the same voice and 1980’s “state of the art” technology. Watch it here:

The MDR Big Picture

The MDR big picture

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.

Understand what’s unique to your situation and brainstorm your next Kaizen step. As an example, I assumed a typical situation and wrote an article giving Kaizen steps towards As Far As Possible.

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
Oriel STAT-A-MATRIX, an international consulting and training company (I consult with Oriel)

Maetrics

LNE group for consulting, and their subsidiary GMED for certification

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.

How to reduce risk As Far As Possible

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

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

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

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

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

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

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

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

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

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

Hiking over the Himalayas helped me…

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

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

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

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

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

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

People

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

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

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

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

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

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

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

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

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

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

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

And at least two in this photo:

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

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

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

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

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

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

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

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