In the movie Wolf of Wall Street Leonardo DeCaprio challenged his team to “sell me this pen,” implying that a good salesperson could sell anything.

This article helps teams “design a pen” using methods that benefit almost any project and includes tips for encouraging creativity and innovation. I wrote it for the biotech or medical device industries but the concepts apply to any company that must share work among a team.

I wrote a Pen Design Plan to demonstrate the concepts I’m about to describe; you may benefit from having it open at the same time.

Background

Governments require that companies selling medical devices adhere to design control regulations. The most common references are the FDA 21 CFR 820.30 and ISO 13485. You can learn more in my article on Design Control regulations.

What you’re reading now will jump into the design process using terms from the FDA

Step 1: Phrase Your Goal Wisely

Your ability to innovate happens when you’re stating your intentions or testing a new market, before design controls are required. Consider the differences in these goals:

Make this penDesign a penSolve the customer’s needsRevolutionize the pen market

There’s no right or wrong, just be aware that your choice will impact your team’s work. “Make this pen” could result in a high-quality writing instrument but won’t lead to innovation. “Revolutionize the pen market” is difficult for most companies and works best for entrepreneurs or researchers. The middle way between these extremes may be “design a pen,” which is a close to “solve customer needs” but with enough constraints to be a wise business decision.

Beware of advice on how to be creative; nothing is more effective than learning-by-doing and being the user of your own inventions. Practice phrasing how you’d solve a problem around your home, for work, or with your kids. Over time you’ll become wise at phrasing the first question so that other people have just enough information to begin but with enough ambiguity to bring out creativity.

Step #2: Understand User Needs

Understanding user needs is more than just listening to your customers, it’s also trying to understand their situation and acknowledging that they are conditioned by previous experiences. With practice, you learn the middle-way between making what they ask for and innovating something they appreciate.

A way to innovate medical devices is to immerse with healthcare providers, looking at their situations with a fresh perspective, identifying the underlying user needs. This is the method behind the Standford University BioDesign program, a year-long process where participants spend three months in operating rooms before brainstorming new product ideas.

Intended Use:

For our pen, let’s say that we immersed with surgeons and learned that they’d benefit from a pen that can mark on a patient’s body during surgery, allowing a team to visualize and agree upon incisions path for procedure modifications during a surgery.

User needs:

#UN1 visible on a range of patients’ skin colors#UN2 sterile pen#UN3 sterile and non-toxic ink#UN4 easy to hold and use

Describe your typical user and include it in your user needs documents to help team members understand their work or develop tests that simulate use. We’ll define our typical user as a surgeon, experienced with operating-room procedures but busy with many other things during surgery and unlikely to focus on a complex design. Also, consider who would be impacted other than your user; medical devices are unique in product development because our final user, the patient, is often not our customer and is rarely asked their opinion.

Step #3) Inputs

Design controls are not required for early-stage brainstorming but are required after you commit to designing a product [21 CFR 820.30(a)]. Three of the first things required are the Project Plan, Design Input, and a Design Review.

A plan is a detailed method for designing your product, including design input, or what the product must accomplish, who’s responsible for each aspect, how you’ll measure success, etc. The plan and inputs are agreed upon in a design review, conducted by a diverse team of people who will later have another review ensure that your product meets all inputs and was designed according to the plan.

You’ll have many different reviews, some for high-level, such as the development planning and design inputs, and some for detailed work such as mechanical design teams, packaging design teams, etc. The FDA requires that each review has at least one person uninvolved with that responsibility; this is to maintain diversity in thinking and minimize conflicts of interest.

Most companies have separate documents or at least separate sections of all things that contribute to design input, the most common being:

User needsBusiness or marketing needsRegulatory needsRisk Management

Note: Risk management is a relatively new, high-level document required by modern quality control policies. To learn more, see my article where I re-analyze the 1986 Space Shuttle Challenger explosion using modern Risk Management methods.

Design inputs need to be solved, but how you solve them is where innovation occurs.

There’s no clear definition between where needs or inputs end and design features begins; the balance between these two comes from experience of balancing structured design with innovative freedom, practical boundaries with freedom to explore new ideas, and clear direction with open-ended problems.

For this article, let’s assume a few “needs” documents, which may also be called “requirements.” Don’t get stuck on words, many other documents are often referred to as “requirements.”

Regulatory needs:

#RN1 Must use ink or marking material that’s approved by regulatory agencies in the United States and European Union

Business needs:

#BN1 Must be color-coded to match corporate brand: “blanched almond,” hex code “ffebcd.”

You could use your input document to outsource research and development. I’ve worked with innovative companies sent our input document to contract design companies to get diverse solutions to the same problem; our contract ensured we would own any patents.

Optional step: requirements

Many companies create requirements that clarify user needs, removing ambiguity so that design engineers can meet objective criteria. Too much clarity can reduce innovation, so there’s a balance between clarity and ambiguity that combines efficiency with innovation. The balance between “design input” and “design requirements and features” is open to interpretation that comes from awareness and practice.

Examples of design requirements for our pen could include:

System-level requirements:

#SR1 ink must not leak when pen shaken by a typical user*#SR2 ink and pen able to be sterilized using gamma radiation#SR3 able to be used 10 times without failing**

Mechanical requirements:

#MR1 must not slip out of hands in a typical hospital surgery room environment*

Ink requirements:

#IR1color = black, hex code “000000”*

Similarly, you could have packaging requirements, labeling requirements, etc.

Keep the end in mind…

Design inputs are what a product must accomplish. Design outputs are how the product accomplishes them. Start with the end in mind, recognizing that design inputs must be defined well enough to envision how tests would look to verify them, but ambiguous enough to allow innovation. Your requirements are this middle ground. Ultimately, anything you choose must be validated against user needs.

Think about this…

Defining requirements is an art, not a science, and requires diverse people contributing throughout product development.I recommend testing your product throughout the design process with diverse users, always keeping an open mind to user needs that may have been missed in input documents, especially new risks introduced by design features.

In my workshops I emphasize this situation because an underlying problem with medical devices where we often forget that our users include patients, and their voice is often overlooked. This isn’t intentional, it’s the result of a society where most executives, managers, and even engineers are white males.

Consider this simple example from an automatic soap dispenser that used infrared lasers to turn on water but only for white hands:

Last year the person filming a soap dispenser that only worked on white hands Tweeted:

“If you have ever had a problem grasping the importance of diversity in tech and its impact on society, watch this video”

Not considering diverse users for a soap dispenser is inconvenient; not considering diverse users for medical device design can be life-threatening.

Let’s assume we went back and changed the requirements document, which would be controlled by our company documents system so that old versions are archived and the latest version is used by designers.

Ink requirements, version 2:

#IR1 color = silver, hex code “??????”#IR2 color able to be seen on typical patients’ skin, including diverse races, in typical operating room lighting

Your requirements may continue to evolve as you learn more, including learning that what you originally stated is ambiguous for other team members. For example, phrases like the pen should be “able to be used 10 times without failing” is ambiguous; under which conditions?

Words are ambiguous to everyone except the person saying them, so I advise companies to have test protocols defined during early-stage input meetings. This can be as simple as “able to be used 10 times in a worse-case scenario of being dropped from 5 feet and stepped on,” which clarifies the design intent to a diverse team.

Summary:

Step 4) Verification & Validation

Design validation ensures you met user needs. For example, a user need of “easy to hold” can’t be tested in a laboratory and must be validated by user testing in simulated situations. As an example, our pen may work well in a laboratory but could be dropped by a surgeon wearing gloves made slippery by body fluids.

Requirements like “greater than 4 inches and less than 6 inches long” can be verified in a laboratory without user testing. The requirements unambiguous; for example, 4.0 inches tells us that the accuracy must be to +/1 0.01 inches, and a color’s hex code of “ffebcd” is unambiguous and can be measured rather than interpreted.

Some requirements must be tested to worse-case extremes, such as “able to be used 10 times without failing.” You could simulate a worse-case scenario in a laboratory by removing the cap, dropping it, and stepping on it 10 times before writing with it. This is a form of validation usually combined with manufacturing requirements; when you can’t 100% of your products you must test a small percentage of them and validate that the results are statistically relevant for all products manufactured. As an example, we wouldn’t test each pen to failure, but we could test 10 out of every 1,000 manufactured to ensure quality-control between each batch made.

My advice is for your project plan to include a brief statement of how you would test each user need. For example, an input “easy to use” would include a brief description of the test, such as “ten new users must be able to open the packaging and use the pen within five seconds.” Those initial descriptions would also guide teams in designing thorough test protocols. For example:

Verification tests:

Ver#1 Scales used to weigh shall be accurate to at least +/- 0.01 ouncesVer#2 Colors shall be verified using color-codes, either hex or RGB

Validation tests:

Val#1 The design must work after having 10 tests of being dropped from 5 feet and simulated being stepped on by a 200 lb person wearing tennis shoesVal#2 All design features that can not be simulated or tested, such as “ease of use” shall undergo a validation test with real-world users representing the typical user defined in our input document (education level, experience level, cultural background, etc.)

For initial design planning it’s fine to have generalized test descriptions, but all tests should be refined throughout the development process, becoming complete and unambiguous so that anyone would have all information necessary to repeat the tests, including which equipment to use and the level of accuracy required. Consider this: if a future team had to modify your product they would need to repeat the tests you used; and if problems were discovered during real-world use they would need to improve test protocols to better represent the real-world. So, for the patient’s benefit, and for complying with Design Controls, please continuously improve your verification and validation protocols to be thorough and unambiguous.

Summary:

Step 5) Outputs

Each team uses the input document or their requirements document to design solutions, often starting with simple drawings or prototypes that can include software codes, electrical components, mechanical features, regulatory labels, packaging, final-product inspection criteria, etc, all of which are considered design outputs.

In other words, you’re given inputs and you create outputs.

Caution: Many companies have a product and then create their design controls by making their inputs match what they’ve already created as output. This limits innovation and creates unnecessary bureaucracy.

For our pen example, consider the requirement for ink to be visible on diverse patient’s skin colors. One solution could be a silver-colored ink, which I believe should be considered an output; this allows room to learn and improve the color of ink and to change the output documents without needing to also change input documents. If the input requirement were “silver” then teams would stop looking for more effective colors that still meet input requirements.

Overlapping input and outputs is often done when regulations are treated as an afterthought, something done to “check the box” of having inputs after a product has been designed. Though not illegal, it’s ineffective, discouraged, can lead to patient harm, and almost invariably adds bureaucracy because all small changes to outputs would also require updating input documents and having high-level design reviews. I advise keeping input documents high-level to allow teams to focus on continuously improvement by iterating outputs. High-level inputs allow a team to “design a pen” rather than “make this pen.”

Summary:

Iterate

Make sure you plan time to iterate; many companies become overburdened manufacturing flawed products. More time sharpening an axe during design means less time chopping wood during manufacturing.

A way to ensure iteration throughout the design process is to continuously test prototypes using your verification and validation tests, document changes to both the design and the tests, and, if necessary, iterate your inputs or requirements, especially when you learn things not addressed in your initial Risk Management.

An effective company will also have a closed-loop quality control system, continuously improving designs based on real-world feedback. To learn more about closed-loop quality systems, see my articles on the process-approach to medical devices and the European Medical Device Regulations.

Design Changes & Design History File

A reason Design History Files are required by law is that medical devices were failing in people after innovative companies were acquired by larger companies that re-introduced bad designs into the products.

I recommend making the Design History File and the plan the same document, just as I recommend making the plan and the final report the same document. You’d start with a plan, documenting all changes.

Summary:

Design Transfer

Design transfer is nothing more than ensuring you recorded all design features and it’s ready to be manufactured; it’s “make this pen” and be ready to make thousands of them.

Design transfer requires a design review to ensure that all inputs were satisfied by verification and validation testing of production-equivalent designs. This step is often part of validating your manufacturing process, and from this point design and manufacturing processes are linked: usually you can’t change one without re-validating the other.

A best-practice is to create a “trace matrix” that shows hall all inputs were satisfied by outputs by verification and validation, and agreed upon by a design review. In other words, make it easy for someone outside of your company to see that you met all needs through design features; this is especially important for risk management solutions.

User need #UN1 (or UN2, or UN3, etc)Described in “our input document.doc”Described in requirements #MR1 (or MR2, MR3, etc) and #IR3 (or 4 or 5, etc)Addressed in design features (outputs) “_____” and “_____”Verified by tests #Ver8 (or 2 or 3, etc)Validated by tests #Val4 (or 9 or 10, etc)

Many companies create a trace matrix and discover that they either missed an input or that some design features (outputs) do not come from a need, a phenomenon known as “project creep” that can add cost and complexity to designs without providing benefits. A trace matrix used throughout your design process can minimize creep and help team members prioritize their work.

Summary:

Summary

These steps are required:

When you commit to developing a product, follow design controls. Start with a plan, list all inputs, and have a design review. Create outputs. Use verification and validation tests to ensure that your outputs meet all input requirements. Document all changes in your Design History File. Have a final design review to transfer your design to manufacturing.

This is my advice for using the requirements for innovation and efficiency:

Start with the intention to be innovative: phrase your questions wisely and seek to understand your user’s needs. Ensure that you test designs throughout development so that people keep focused on what the user needs. Document all work.

Next step

Read about Manufacturing Process Controls in my article, “Make this pen.”

Keep in touch

My goal is to educate others so they’re able to do more things that benefit themselves and society. I consult corporations on international regulation requirements, teamwork, and innovation; and public schools on incorporating engineering and entrepreneurship into curriculum requirements.Connect on Linkedin, where I infrequently post articles. Subscribe for yearly updates, or browse this blog for articles.

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.