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

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.

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?

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

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

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

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

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

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

Example of new Risk/Benefit tables

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Continuous learning

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

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

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

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

MaetricsThe Weinberg GroupGreenlightJason (me)

I encourage all companies to discuss original phrasing in the MDR and consensus paper as a team until concepts are clear, easy to understand, and unambiguous. That’s why my workshops focus on teamwork, learning-by-doing, and the bigger picture of how our work impacts the lives of other people.

Thank you

Please share this article if you think others could benefit.

Parting Thoughts

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

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

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

I wish you happiness.

7 minute read.

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

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

WHY

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

WHEN

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

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

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

HOW

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

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

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

1) Assign an MDR representative for your company.

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

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

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

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

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

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

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

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

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

For the big picture, the MDR requires:

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

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

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

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

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

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

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

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

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

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

make the product inherently safeadd protective safeguardsadd written warnings or instructions

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

7) Submit MDR reports

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

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

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

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

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

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

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

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

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

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

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

Chuck would politely ask me to help him.

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

OFFICIAL REGULATIONS & PAPERS

CONSULTING & TRAINING

Maetrics

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

My opinion

My opinion stems from facts.

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

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

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

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

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

THANKS

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

KEEP IN TOUCH

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

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

Peace.

I hiked over one of the world’s highest mountain passes in a four-week journey, offline, without plans. This blog describes people I met, life in the Himalayas, altitude sickness (and rescues), and methods I used to develop mindfulness that allowed me to overcome a decade of suffering from chronic pain. It began in the town of Besisahar and ended in Beni Bazar 28 days later.

The hike was part of a longer backpacking trip through Nepal and India, where I arrived in Kathmandu, learned basic Nepali phrases, then traveled through both countries without plans, adapting each day based on people I met and lessons I learned.

I’ve traveled this way for 30 years, flying into one country and out of another. This trip was different because I had a goal to hike without pain medications. Doctors at the Veterans Health Administration had prescribed pain medications to me for over nine years to postpone surgeries that have low probabilities of relieving pain. The meds treated symptoms, but my mind became sluggish and it was difficult to make wise choices for long-term health. And, as I would later realize, something had been going wrong with my mind that reminded me of when I first started noticing symptoms of physical diseases, mistaking symptoms for being sore from exercising or stiff from sitting at a desk. Similarly, I was now noticing slips in my mental capabilities, especially with simple math and remembering details even when I made a conscious effort to do so.

I share a few techniques I used to develop mindfulness throughout blogs about this trip, hopefully helping others.

The trail

I took a bus from Kathmandu to the village of Besisahar, being dropped where the dirt road ended and a hiking trail began. I had a backpack with two months worth of clothes. I carried a day’s worth of food and water, a few books, a camera, and a Frisbee.

The trail cut into the sides of mountains, crossing rivers with suspension bridges swinging hundreds of feet in the air. Two people could not pass on the narrow bridges, so we’d coordinate who went first. Goats, cows, and buffalo used the bridges; I gave right-of-way to anything with horns, and played with anything that was cute.

Sleeping & eating

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

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

Part of what’s in everyone’s control is our kindness towards others. Nepali culture encourages compassion, shown by how kids would run into the street to greet me when I approached a village. They’d clasp their hands, bow, and say “Namaste,” the Hindu word for “I see the divine in you.” I’d clasp my hands, bow, and wait to feel the sentiment before returning the word, “Namaste.”

Feeling compassion and speaking truthfully makes everyone happier. Imagine if our culture encouraged pausing to seek compassion for a person before saying, truthfully, “I hope you’re well.”

The poorest backpacker is wealthier than these kids can imagine, and many share treats. A consequence is a that kids start seeing backpackers, most of whom are caucasian (white), as sources of things rather than as people. They don’t say Namaste, they shout, “Money! Chocolate! Sweet!” You can’t see the divine in each other with a hierarchical relationship, so I gave the most valuable thing I have, time.

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

Kids took many of these photos, letting us see the world through their eyes.

People

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

Most guest houses were people’s homes, and they juggled family duties while preparing our dinners. One host, Narme Llama, was a third-generation Tibetan with newborn twins. He had a warm smile, had learned four languages, and helped take care of his new daughters while running his business.

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

Sometimes a guesthouse would have other backpackers, or travelers with a guide, and we’d share time around a fire learning different perspectives on the world.

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

Elevation

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

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

Mules resupply villages with gas tanks and food that can’t be grown in high elevations.

Democracy

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

In the town of Manang, we had to wait four days because all guest-houses in the region were full of people from Kathmandu, who had traveled to vote in the national election. In Nepal, people must vote in the town they’re registered, usually where their ancestors were born. This was Nepal’s second election; their democracy was new, and followed a ten-year civil war that had divided the people between the poor and wealthy.

Nepali soldiers patrolled the streets, enforcing a curfew with guns rather than logic. Nepal uses their soldiers as defense, police, and national park protection. Until the civil war, they were the only people with guns, and without checks-and-balances they abuse their power in rural areas. I believe this will change now that Nepal has a democracy; I’ve never had a gun pointed at me in a country with a functional democracy.

The curfew didn’t affect our stay in Manang because there was nothing to do at night, especially when temperatures were below freezing. We’d walk up and down the street then return to our guesthouse to get warm around a yak-dung fire.

The guesthouse where we stayed was decorated for what the owners imagined a typical traveler would enjoy. Their home look like a rustic version of a 1970’s television sitcom; for some reason, they assumed that a typical traveler expected a Tiki bar. We’d sit under the Tiki bar, heating our tea in steel mugs on the yak-dung burning stove.

Frisbees are surprisingly useful for meeting people. One of our group used my Frisbee to prepare wild herbs he had found hiking in the lowlands earlier on the trip.

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

Silence

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

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

And at least two in this photo:

Altitude

Many people do not get altitude sickness. I’m not one of them.

This photo was taken from the window of a shelter, where I stayed for three nights to recover.

For almost a week, I had been hiking at over 3,400 meters (~11,000 feet), gaining 300-500 meters each day. I had a headache and craved oxygen. My body fought two needs: deep breaths to get oxygen vs. tightening my windpipe to keep out the cold, dry air. I have asthma, and my breath “wheezed” on steep sections of the trail.

When you’re emotionally detached from discomfort, you’re able to differentiate between transient discomfort and symptoms of altitude sickness. At 4,880 metres (16,010 ft, ~ 3 miles) I realized that my headaches and dizziness were signs of trouble, so I descended to a shelter at 4,540 meters.

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

By sunrise, my pulse was down to 80 beats per minute. I didn’t move that day, and by that evening my pulse was ~ 60 beats per minute, still more than my normal resting rate, but reasonable considering I was 3 miles high.

I acclimated by hiking to higher elevations during the day, descending to sleep at night. On one of these hikes, I found an emergency satellite phone. Three years prior, almost 400 people were trapped at this location by a surprise snowstorm; 42 died, and 175 suffered frostbite. I was not reassured by the satellite phone, which was made from a coffee can and something that looked like the dish-drying rack by my sink at home.

I’ve sumitted mountains all over the world, and frequently rock-climb in the Sierra Nevada mountains, where the amount of focus for each motion makes you not notice almost all other thoughts or feelings. This requires concentration; your mind is sluggish from high altitudes, low oxygen, and physical exertion, and it wants to be anywhere other than the present moment. Hiking above 17,000 feet can require 10 to 15 seconds of focus per step, requiring 6-8 hours of unbroken concentration. For me, I also must remain aware of the nature of pain in my body. For example, the metal screws in my ankle can wear into the bone, leading to a risky situation if I can’t walk effectively, and my normal headaches must be continuously evaluated to ensure it’s not progression to severe altitude sickness.

If you think about how difficult it is to concentrate on something unpleasant, you have an idea of the real challenge of high-altitude hiking, which is maintaining that level of focus for 6-8 hours per day for several weeks.

Here’s my metaphor for being mindful while hiking, which applies to anything in life. You’re the pilot of a bus, a driver with passengers, navigating a road with other drivers. You are the pilot, and the bus is your body and the passengers are your thoughts. The road and other drivers are external situations often out of your control. In other words, you’re in control of piloting your bus and maintaining it’s well-being, and sometimes you must pilot your bus on and rough and bumpy road despite deflated tires, weak shock absorbers, pain from screws in your ankle, pain from spinal disease. Your passengers are loud and all talk at once, like kids on a school bus shouting things that may or may not help you. They constantly tell your about your deflated tires, weak shock absorbers, pain in your ankle, pain in your neck; they warn you to look out for other buses even when the risk is negligible; they worry about where you’re going or question where you’ve been; they ask about work project you need to finish, wonder what other people in your life are doing, and talk about other aspects of your life not relevant to the immediate situation of piloting your bus over a rough road with weak shock absorbers and the potential to get a flat tire. But, some of those voices are telling you when to rest, ensuring your headache is not a symptom of life-threatening altitude sickness, notifying you of potential risks to avoid such as slippery ice or a possible avalanche or another driver on the road out of control, and other things critical to your safety at the moment. Your challenge is to acknowledge the voices of all passengers while maintaining focus on piloting the bus; you acknowledge pain, worry, anxiety, fear, and even joy or elation while concentrating on being in control of your bus.

When you pilot your bus 6-8 hours per day for several weeks you begin to recognize that you can listen to passengers while being detached from them, to acknowledge without judgement, and to make choices based on what’s important for your safety and peace of mind regardless of the condition of the road, your tires, or other passengers sharing the road.

I had been focused on piloting my bus, which required ten seconds for each step, for six hours when I saw a tea shop.

Seriously. I shook my head to ensure I wasn’t mistaken.

A cheerful entrepreneur had brought gas stoves and tea to a shelter at 17,900 feet. I paid $1.50 for a cup of hot tea; I would have paid a hundred.

Over the next few hours, his hut saved someone’s life.

I reached the summit, sat down, then got up as I realized something was wrong with one of the four other people. She was suffering severe altitude sickness. Her eyes were rolled back into her head, her breathing was in brief gasps, and her pulse was more than 150 beats per minute. She was in shock, and it was likely that pressure was building insider her brain.

None of us spoke the same language; we carried her into the tea hut while her guide was trying a satellite phone to call help. Over the next few hours, we kept her warm in the tea shop while preparing a helicopter landing zone. We carried her and her bags onto the helicopter, which would prioritize getting her to a lower elevation, and then to a hospital.

The helicopter cost $10,000. It was a private service, and the patient’s guide received a commission for calling it. The tea shop entrepreneur made $1.50. Three years ago, when the storm trapped 500 people here, local people dug through snow without concern for how they would get paid. There’s no right or wrong, just facts. Mindfulness is being aware of facts, but differing judgement until those facts are necessary to make a decision.

When the helicopter left, I was alone again. I started walking down the other side of the pass.

Mindfulness & a transformational moment

I had been so focused on the rescue that I hadn’t felt pain or symptoms of altitude sickness. I started to notice the pain again. Descending steep trails is harder on your joints than hiking uphill, and my head and joints screamed with pain. People become addicted to temporary relief from pain, either from medications or by pouring themselves into their work, so more doctors are recommending mindfulness, which can allow someone to become detached from discomfort while maintaining mental clarity.

When I had descended enough to reduce the effects of altitude sickness, I stopped to eat a Snickers candy bar. It was the first food I could hold down in 24 hours; at that moment was the most delicious thing I had ever eaten. In the time it took for my teeth to break through a peanut, all discomfort faded. I had no thoughts, just awareness. The sky was brighter, the air cleaner, rocks more beautiful than before I began taking that bite. This experience lasted for a month, and, to a lesser extent, remains now that I’m home. I’ve tried to share the continued experience throughout my blogs; this one remains the most challenging to describe because few people have that experience therefore it’s difficult to relate.

I had read writings from the historic Buddha who described the feeling of Nirvana, complete peace, as “all that needs to be done is done.” That’s apt, but only for people who have experienced that before. For me, it applies because I’m a person who takes several months off at a time to backpack or travel without anything else to do. But it was more than that; I truly and deeply understand many things now that became clear in that brief moment that lasted the time it takes to bite through a peanut.

First, a little background on me: I’ve taught physics, among other topics. But, I don’t have a physics degree, I enjoy physics as a hobby, and have had the opportunity to apply my understanding in medical research and aerospace engineering, and a lot of my free time is spent trying to deepen my understanding of the overlap between theories of relativity, quantum mechanics, gravity, and time. I can pass any exam, test, or conversation about physics because the people who write exams or test or have conversations about physics are simply repeating the words, not understanding the concepts, and definitely unable to apply them. But I did not truly understand what it would feel like to ride a beam of light in the eight minutes it takes to reach Earth from the sun; what it would be like to ride the gravitation wave that recently passed through Earth and originated 130 million light-years away; why my body disintegrates as the laws of Entropy ensure will happen to all of us.

The Buddha said that there are only four truths, and that Nirvana is seeing them. One of the truths is that we all will grow old, get sick, and die. That’s entropy, which is also the foundation for surprisingly recent explanation of life on earth beginning and, possibly, the arrow of time. I wouldn’t realize that part until reading books by Carlos Revelli. But, sometime between the moment I started biting through the peanut and before the peanut broke apart in my mouth, I gained a deeper level of understanding about the works of Einstein, Hawking, and many other physicists. I also gained a deeper understanding of what the Buddha taught, and how it applies to mindfulness and wisdom. I wrote about the books I read on this trip that contributed to that understanding in another blog.

I eventually learned that mindfulness can be permanent, but takes as much concentration as hiking at high altitude. The same concentration that allowed me to hike over the Himalayas without suffering from pain, the same focus that allowed me to assist in a helicopter rescue without noticing pain or worry, is possible in our daily lives without external motivation. As the Buddha said, peace comes from within. Over the next two months in Nepal and India, and the following six months back in the United States, I’d learn that, for me, being mindful while piloting a bus on a challenging road is easy compared to piloting a bus in daily life. The moment I transformed while eating a Snickers bar allowed me to feel mindfulness for many weeks, so I had evidence that it was possible, which gave me the conviction that I could learn to make it permanent.

It happens that Buddhist philosophy on meditation and mindfulness are useful tools in a deeper understanding of what these words mean. Just like memorizing physics words or formulas doesn’t ensure understanding, using words or citing philosophers doesn’t ensure understanding, and hearing words does not mean you’ll understand what you don’t practice, just like hearing someone describe riding a bicycle doesn’t mean you’ll be able to ride a bicycle without practicing yourself.

I decided to practice the methods with an open-minded approach (ha!) to see if I could understand mindfulness on the same level I understand physics. I had an advantage, I had experienced it. The focus and concentration on my body and mind’s reactions for a couple of weeks, combined with my attempts to practice yoga and meditate for the year before, had led to me experiencing what could not be denied: I could become detached from physical discomfort and mental worry, I could understand things on a deeper level at a rate faster than words allow, and that these feelings could be maintained over weeks if not longer, including a lifetime.

This is explained by how our brain connects neuron cells to other neuron cells to form complex patterns of association, creating present experiences based on a combination of past experiences and expectations for the future. This was famously seen in the experiment with Pavlov’s dogs. Does that name ring a bell? (Ha!) Pavlov was a psychologist who noticed that his dogs began to salivate when he conditioned them by ringing a bell before serving food; over time, they would salivate with only the bell, without smelling food or being near dinner time. Mind and body, perceptions and situations, thoughts and feelings, are inseparably linked and those connections are difficult to distinguish. Our discomfort or worry in a moment are almost indistinguishable from a complex network of past experiences and expectations that combine to make us salivate at the sound of a bell. Almost. I learned to distinguish the two on a daily bases, just as I learned to acknowledge all voices on the bus in a way that was detached and allowed me to pilot the bus despite bad tires and an icy road. What could be conditioned could be unconditioned through practice.

Einstein would often talk about detaching himself from conditioned thoughts that were obstacles to seeing reality. The Buddha’s final words were, “All conditioned things are impermanent. Practice diligently.” We don’t understand physics or our minds by reading about them, we must concentrate and practice diligently until we can ride our bicycle or pilot our bus effortlessly.

I walked downhill for a few more hours, found a guest house, and enjoyed the sunset. The sunset was beautiful because of ice crystals forming in the air; the lenticular clouds coming from mountain peaks indicated pressure was building and snow would arrive. Two days later, it began snowing on the mountain pass I had just summited, and it was raining in the areas of where I would spend the next two weeks. I started hiking through the rain, going off-the-beaten-path and into the Kingdom of Mustang.

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

Many of my side-stories are interesting in the context of main stories in these blogs. If you and I meet, I hope we spend enough quality time together to share stories.

Continue to:

Or, jump forward two weeks: