Pen Design Plan

This article demonstrates a plan to design the pen described in another article on Design Controls, and may not make sense if you haven’t read “Design a pen.

In that article I began with a quote from Leonardo DeCaprio from the movie Wolf of Wall Street where he challenged his team to “sell me this pen,” implying a good salesman could sell anything. I believe a good team could design anything so I demonstrated how to use Design Control requirements to create innovative, safe products especially in healthcare. There’s a balance between too many restrictions and not enough freedoms that comes from practice; that article gave advice, this one demonstrates a project-plan and may not make sense without having read the first.
I use this plan as a starting point for more complex products in hands-on workshops and it may not be as useful to a reader without that context.
This article is an initial draft a design plan to demonstrate concepts explained in the article Design me a pen. From this point on it will be referred to as a plan but it’s a discussion point rather than a complete project plan. A useful plan would have enough detail and references so that anyone not familiar with your processes could complete the plan without asking questions or needing more information; they would know why they are working, what they need to do, and how to do it including with whom to communicate.
This plan documents design inputs, the minimum required design reviews, and preliminary examples of tests that will be required for verification and validation. It shall be continuously updated using design change procedures in accordance with company quality control policies.
This plan is only for design controls, from design inputs to design transfer. It does not cover other aspects of development such as process controls, post-market surveillance, risk, or master validation planning.
FDA 21 CFR 820.30ISO 13485

My article on Design a pen

PenUserNeeds.doc (fictional document)PenRegulatoryRequirements.doc (fictional document)ISO-standard-Example-1 (fictional ISO standard)ASTM-standard-Example-1 (fictional ASTM standard)

See our corporate Design Control policy for definitions of the following terms used throughout this plan:
Design & Development Planning 21CFR820.30 (b)Design Input 21CFR820.30 (c)Design Output 21CFR820.30 (d)Design Review 21CFR820.30 (e)Design Verification 21CFR820.30 (f)Design Validation 21CFR820.30 (g)Design Transfer 21CFR820.30 (h)Design Changes 21CFR820.30 (i)Design History File 21CFR820.30 (j)
Deliverables & Design History File
The following documents must be completed prior to design transfer. Any changes to this plan shall be documented with the rational for changes and relevant test data as the Design History File. All changes or updates to this plan will be considered project reviews, but sub-teams may have additional reviews when creating design outputs or tests.
Design Planning, Design Reviews, & Design History File
ThisPlan-Completed.doc (the final report, ensuring all deliverables)
Design Inputs
Design Verification, Validation, & Transfer
PenVerification TestProtocol-3-Results.doc
Pen TraceMatrix.doc
Design Outputs
Pen system-level drawing.dwg
Pen mechanical drawings.dwg1, .dwg2, .dwg3
Ink chemical specifications.spc
Packaging drawings.dwg
Labeling drawings.dwg
Design Inputs
Design inputs are comprised of user needs, risk management, regulatory requirements, and business needs. Design inputs must be verified or validated prior to design transfer using documented protocols with pre-determined acceptance criteria, must be completed before transfer to manufacturing, and must be updated every three months throughout this project including the six months after design transfer and use in the field. Risk Management must be updated on the same schedule and include members of manufacturing and post-market surveillance in the updates.
Company risk management policies shall take priority over other design inputs or requirements.
For simplicity, this plan is consolidates all input documents into this page in an abbreviated format.
User Needs (design document available to all departments):
#UN1 visible on a range of patients’ skin colors#UN2 sterile pen#UN3 sterile and non-toxic ink#UN4 easy to hold and use
Risk Management (shared document used by design, manufacturing, purchasing, distribution, and field service departments):
#RM1 must not risk an unsterile product reaching a patient#RM2 must risk patient safety by slipping in a user’s hand during surgery
Regulatory Requirements (design document available to all departments):
#RN1 Must use ink or marking material that’s approved by regulatory agencies in the United States and European Union
Business Requirements (design document available to all departments):
#BN1 Must be color-coded to match corporate brand: “blanched almond,” hex code “ffebcd.”

#BN2 Must fit into existing packaging of other products (maximum of 6.0 inches long, 0.5″X0.5″ wide and deep
#BN3 Must cost less than $1 for final products made in orders of >1,000 per month
Design Requirements
Design requirements are for the benefit of design teams and must be linked to Design Inputs. Suggestions for how to verify or validate are non-binding, not exhaustive, and must be described in detail in other documents. For simplicity, this plan is consolidates all requirements documents into this page in an abbreviated format.
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*

#MR2 greater than 4.0 inches and less than 6.0 inches long
#MR3 Must be less than 0.5″ wide or deep, and greater than 0.25″ wide or deep
#MR4 weigh between 2 and 4 ounces**
#MR5 the color of the outside must be “blanched almond,” hex color code “ffebcd”
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
Packaging requirements:
#PR1 must hold 6 pens

#PR2 must withstand drops of five feet onto a hard floor at least ten times without loosing functionality
Labeling requirements:
#LR1 must adhere to EU MDR requirements
Verification & Validation
#SR1 and #SR3 shall be verified using the test protocol VerTestProtocol-1.doc and documented in VerTestProtocol-1-Results.doc#SR2 shall be verified using methods described in ISO-standard-Example-1.
#MR1 shall be validated using the test protocol ValTestProtocol-1.doc and documented in ValTestProtocol-1-Results.doc
#MR2 , #MR3, #MR4, & #MR5 shall be verified using Design Output documents on size, shape, and material selection; and by manufacturing inspection protocols Man-Protocol-ex1.doc.
#IR1 shall be verified using Design Output documents on size, shape, and material selection; and by manufacturing inspection protocols Man-Protocol-ex1.doc.
#IR2 shall be validated using the test protocol ValTestProtocol-1.doc and documented in ValTestProtocol-1-Results.doc
#PR1 shall be verified using Design Output documents on size, shape, and material selection
#PR2 shall be verified using Package-Protocol-ex1.doc.
#LR1 shall be verified using Design Output documents on size, shape, and material selection; and by manufacturing inspection protocols Man-Protocol-ex1.doc.
Transfer to Manufacturing
Design outputs must be shown to satisfy all inputs through verification or validation, which shall be demonstrated through Trace Matrix.doc and coordinated with manufacturing goals according to the MasterValidationPlan.doc.
The trace matrix shall list all inputs in the Design Input and show by objective evidence that each need was satisfied by Outputs. The links that must be shown between outputs and inputs include Design Requirements, specifications, verification and validation results.
This plan and the Risk Management document shall be updated after design transfer and throughout the first six months of product sales.
That’s All, Folks!

Veterans Day Advice for Transitioning to Civilian Careers

Nov 11th is Veterans Day and

I’d like to thank Veterans, First Responders, Police, Firefighters, and EMT ‘s who serve without regard to our race, religion, gender, or nationality.

Veterans and first-responders may face challenges transitioning to civilian jobs where their skills may not be fully utilized. To help, here’s my advice for succeeding in a civilian career:
You may not transition to the level you’d like. Be patient.Your boss may be an ineffective leader. Help them.You may not be given opportunities. Demonstrate skills by volunteering.You may need new skills. Learn through classes, online training, & mentors.You may feel discouraged. Seek balance through friends & community.Your coworkers may be toxic. Associate with people who don’t gossip or complain.You are in control of your future. Explore #Freelancing or #Entrepreneurship.
I was a Paratrooper, combat vet, & peacekeeper for seven years and worked as an EMT in college. Veterans Administration education and healthcare benefits allowed me to take risks, invent medical devices, start companies, and teach at universities and inner-city schools. Now I consult corporate teams and blog about Equitable Education & Healthcare.
This article shares resources that may help you.
 It’s a 7 minute read.
TRANSFER SKILLS Veterans often transition into first-responder or law enforcement careers; the skills are similar and easily understood by each group. The U.S. Central Intelligence Agency has information to explain military-to-CIA transitioning, and the US National Park System encourages veterans to apply for park law enforcement or park rangers .
For civilian careers, you may have to learn civilian perspectives and tell them how your skills transfer. For example, military small-teams use prioritized communication in a “five-paragraph operations order” format, designed so each team in a large organization would have enough information to work towards a common goal if communication were cut off. My summary of a five-paragraph operations order is:
Situation: The big-picture, or why are we talking about this?Mission: What’s our goal?Execution: How do we achieve our goal?Command & Signal: Who’s involved and how do we communicate?Service & Support: What are our resources?

A five-paragraph plan is useful to any organization but it’s not their job to learn our vocabulary, it’s your job to relate your skills to their needs in a language they understand. For example, civilian leadership coaches may phrase the concepts behind a five-paragraph operations order as “start with WHY,” then get to WHAT, then HOW.
Considering watching the video version of Start With Why by Simon Sinek, which has been viewed more than 5 million times and may be recognize by civilian managers.Use that example as a starting point then learn the vocabulary of potential employers and practice relating your skills to them.
Volunteering is a proactive way to demonstrate skills, and service to others can lead to gratitude and increased happiness. Nationally recognized volunteer programs include:
LEARN NEW SKILLS Use your college fun wisely; do the math on how long you can receive funding in school and focus on graduating in a timely manner. See if you’re eligible for a VA “kicker” that adds to your college fund.
Research the college that best benefits your goals and finances. University rankings can be misgiving; I recommend using the Economist’s ranking of colleges based on value and personalized benefit.
When you narrow down a few choices contact their veterans affairs office to discuss your needs and their support and community. Use Linkedin to contact other veterans either enrolled in those universities or that graduated from them and ask their advice.
Don’t treat college as the only way to learn. In today’s workforce opportunities are being given to people who demonstrate abilities rather than people who have a degree without real-world experience. For example, many companies no longer require college degrees, including Google, IBM, Apple, and Bank of America.
“In 2017, IBM’s vice president of talent Joanna Daley told CNBC Make It that about 15 percent of her company’s U.S. hires don’t have a four-year degree. She said that instead of looking exclusively at candidates who went to college, IBM now looks at candidates who have hands-on experience via a coding boot camp or an industry-related vocational class.” – CNBC news, “…companies that no longer require employees to have a college degree

Here’s how you get hands-on experience:
Computer Programming & Robotics
Practice creating things that are useful to others: web sites, data bases, phone apps, and robotics can be a greater demonstration of abilities than a college degree that lacks real-world evidence.
Learn to program using free courses online and at your local library. Try Udacity or M.I.T. open courseware or research hundreds of others on the internet.
Learn to design web pages using free online resources. I use to design my web page and blog. Wix has easy templates, tutorials, and a free version to practice. You could practice by designing your page, friends’ pages, and local business’s pages.
Learn to combine computers and physical products; Arduinos are a tiny computers that costs less than $20 and can control almost anything in the physical world, from robots to toys to home-products, putting the potential to change the world in anyone’s hands. Online product examples and courses are free.
Business & Marketing
Inc. Magazine published five free online resources for digital marketing. Or, create a web page and practice promoting yourself; create your own brand. If you were an employer you probably would wonder why you should hire someone for your business or marketing needs if they can’t demonstrate those skills for themselves.
Manage your personal finances. Consider starting a retirement account now and get into the habit of contributing the maximum amount possible each year, usually 14% of your salary or $5,500/year if you’re independent. Retirement accounts have tax advantages to encourage investing, and because of compounding interest a little money invested today can yield more for your future than a lot of money invested later.
I recommend the book The 5 Mistakes Every Investor Makes and How to Avoid Them: Getting Investing Right. My summary of it is to start investing now, invest on your own by choosing index funds, and invest for the long-term without worrying about short-term market fluctuations.
Soft Skills
Today’s workforce requires soft skills, collaborating across diverse cultures and backgrounds in ways that unites people rather than isolates them. Don’t underestimate soft skills, especially for civilians who may have more formalities than we experienced in the military. This isn’t easy; I still find it challenging to not make a point using sarcasm or cursing around civilians who take things too fucking seriously.
That was both sarcasm and cursing. It’s effective for some but offensive to others. Know your audience and strive to be effective for the most people possible.
I found The Seven Habits of Highly Effective People useful, simple to understand, and straight-forward to practice. The book sold 25 million copies and may be recognized by hiring managers. My summary is:
Be proactiveBegin with an end in mindPrioritize your effortsThink win-win for yourself and othersSeek first to understand others, then to be understood by themCombine different peoples’ skills towards shared goalsSeek balance & continuously improve yourself
This video summarizes the “7 Habits of Highly Effective People” in 7 minutes but I recommend reading the book if you have any doubt in your soft skills.

Learn skills and learn to market your services using the resources I already provided. Technical skills are probably the easiest to freelance because many people and companies need occasional help designing web pages, creating computer programs, or using software to design marketing material for events.
Many websites connect freelancers to clients but I found that they are dominated by inexpensive freelancers who live overseas, therefore if you live in the United States you nay be more successful developing a portfolio of your work and marketing yourself.
Entrepreneurship is different than freelancing and difficult to describe. You’ll be trying to do more than sell your services, you’ll be trying to identify an unmet need and creating a business that can flourish without you. I heard that an entrepreneur is someone who works 90 hours a week for a few years so they don’t have to work at all after that, which is probably hyperbole but worth considering to understand the difference between freelancing and entrepreneurship. Or, consider that a freelancer can sell more of their time but and entrepreneur can sell their product or business.
If you think you have an invention that could springboard you into entrepreneurship consider filing a Provisional Patent through the U.S. Patent and Trademark Office for $100. You’ll have a year to continue the patent process. You’ll have to research patent laws and strategy, business plans, and financing options, which are all beyond the scope of this article but available through many online resources. I do not recommend studying entrepreneurship in school, and neither do most successful entrepreneurs. Learn by doing.
Most veterans and first-responders are ready to transition into the civilian workplace. Some are not as fortunate.

Veterans are more likely to be homeless or commit suicide than the general population. Each night 37,800 veterans are homeless and 20 veterans commit suicide every day. If you or someone you know is at risk please contact the

White House VA Hotline: 1-855-948-2311.

Calls are answered by a live agent 24 hours a day, seven days a week, 365 days a year. The hotline is staffed by more than 60 agents who have had extensive training on VA programs and services. Ninety-three percent of these agents are a Veteran, military family member, caregiver or a survivor.
These harsh situations of a small percentage of veterans creates another challenge to entering the civilian workplace: negative perceptions. You can help all veterans by choosing your words and actions wisely and following through with your commitments. Lead by example, an ideal that’s epitomized by the U.S. Army Infantry motto of Follow me! and inscribed on a famous statue outside of the infantry school.

I’m grateful for the opportunities my military service provided and I feel compassion for those not as fortunate, such as the families of lost soldiers, veterans who experienced losses, and people in countries who have not experienced peace in many generations. As President Woodrow Wilson said on the first Veterans Day in 1919:
“To us in America the reflections of Armistice Day will be filled with solemn pride in the heroism of those who died in the country’s service, and with gratitude for the victory, both because of the thing from which it has freed us and because of the opportunity it has given America to show her sympathy with peace and justice in the councils of nations.”
I wish you success in your career and happiness in life.

How to create innovative products using Design Controls

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.

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

. I highlighted things you would have to document, everything else is a recommendation for efficiency or innovation.
Design & Development Planning 21CFR 820.30 (b)
Design Input 21CFR 820.30 (c)
Design Output 21CFR 820.30 (d
Design Review 21CFR 820.30 (e)
Design Verification 21CFR 820.30 (f)
Design Validation 21CFR 820.30 (g)
Design Transfer 21CFR 820.30 (h)
Design Changes 21CFR 820.30 (i)
Design History File 21CFR 820.30 (j)
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

, Planning, & Reviews
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.”

#BN2 Must fit into existing packaging of other products (maximum of 6.0 inches long, 0.5″X0.5″ wide and deep
#BN3 Must cost less than $1 for final products made in orders of >1,000 per month
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*

#MR2 greater than 4.0 inches and less than 6.0 inches long
#MR3 Must be less than 0.5″ wide or deep, and greater than 0.25″ wide or deep
#MR4 weigh between 2 and 4 ounces**
#MR5 the color of the outside must be “blanched almond,” hex color code “ffebcd”
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.
Design & Development Planning 21 CFR 820.30 (b)
Create and follow a development plan.List who’s responsible for all aspects of development and how teams interface.Update plans when necessary using a team-driven process.
Design Input 21C FR 820.30 (c)
Inputs are what needs to be accomplished by a design, including regulatory requirements and business needs.Inputs are not “designs,” inputs are what should be accomplished by a design to ensure user needs are met.Inputs are agreed upon, in writing, by people listed in your plan.
Design Review 21 CFR 820.30 (e)
Reviews ensure plans are followed and updated using a team-driven process.Reviews shall have at least one person attending who does not have responsibility for the stage of your plan being reviewed.Reviews are approved, in writing, by people listed in your plan.
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.
Design Verification 21 CFR 820.30 (f)
Verification compares outputs to input requirements.

Verification must be measurable.For example, for an Input of “weighs less than 2.0 kilograms” the output could be verified by measuring weight on a scale.

Verification is reviewed and approved, in writing, by people listed in your plan.

Design Validation 21 CFR 820.30 (g)
Validation ensures inputs are met for outputs that can not be measured.For example, measuring a mass-produced chemical wouldn’t be practical, but samples could be tested and to validate the process using statistical analysis.
Validation ensures user needs are met.For example, if an input is that a package “must be opened within 30 seconds” the final design couldn’t be measured directly, it must rely on real-world people in a controlled test.

Validation must use production-units in actual or simulated conditions.Validation is reviewed and approved, in writing, by people listed in your plan.

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.”
Design Output 21 CFR 820.30 (d)
Outputs are design features that satisfy inputs.Outputs are typically in the form of drawings, software, procedures, labels, tests, and inspection criteria of features critical to satisfying Inputs.
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
Documenting design changes means having a record of each iteration and linking each version with any other work that was done. This is also part of the Design History File, which is often misunderstood or made overly complicated. It’s simply a record of all work proving that you followed a plan that met design controls; it lists all design inputs and outputs, verification and validation testing, and makes reasons for major changes obvious.

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.
Design Changes 21 CFR 820.30 (i)
Changes to inputs, outputs, and verification or validation methods must be controlled ensure there aren’t unforeseen consequences, including for other products that may share design componentsChanges are reviewed and agreed upon, in writing, by people listed in your plan.
Design History File 21 CFR 820.30 (j)

A Design History File (DHF) is evidence that a product was developed according to a Plan, including references to the locations of all plans, inputs, outputs, verification, validation, and transfer procedures.

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.
Design Transfer 21 CFR 820.30 (h)
Ensure that you can transfer a design to manufacturing without losing control of outputs that were verified and validatedTransfer is reviewed and agreed upon, in writing, by people listed in your plan
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

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.

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

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

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

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

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


LNE group for consulting, and their subsidiary GMED for certification

MDI Consultants


They operate a useful blog

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

Me (Jason 🙂

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

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

My opinion

My opinion stems from facts.
80,000 to 250,000 people die each yearfrom healthcare errors in the United States. 5 million people die world-wide from low-quality healthcare. Public awareness is increasing through news and documentaries like The Bleeding Edge. European citizens demanded government oversight after 400,000 people received toxic implants, which led to the MDR.
The United States is reviewing our regulations and I believe that the EU-MDR is an opportunity to learn. Its intention is to enforce methods of continuous improvement; the rules and penalties should encourage private companies to innovate safer medical devices. If a company or entrepreneur innovates safe designs that are beneficial to patients they become the new state of the art. Innovators are rewarded and society benefits.
Companies that excel will be the ones that accept change, embrace ambiguity, and create a culture of continuous improvement.
I post some articles on Linkedin or Twitter but most are in my blog. I email subscribers once a year or so.
My interests include equitable education and innovative healthcare. I work to help society have safer, more effective healthcare by helping companies increase efficiency and innovation. Learn more at
And, because life should be fun, here are my favorite Chuck Norris jokes:

What would it look like?

Kristy asked me a question I couldn’t answer: How did she receive a risky spine implant two weeks after a class-action lawsuit was settled against the manufacturer of that device?
After two days of thought I replied: What would it look like to ensure that doesn’t happen to anyone else?
This is the result.
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.
80,000 to 250,000 people die in America each year from healthcare errors5 million people die each year globally from poor quality healthcare

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

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

The FDA is an agency of the government, bound by guidelines created by elected officials in congress and the senate. The FDA staffing and budget are also set by our elected officials.
There are over 5,000 medical device companies in the United States and we receive medical devices from many foreign companies that need to be inspected by the FDA.
Some people believe the FDA is inconsistent in its requests therefore difficult to navigate, and that the process slows down innovative healthcare.
A 2.5% tax on gross profits was part of healthcare reform. Political lobbying from companies led to senators postponing that tax for two years; it’s scheduled to resume in 2018.
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.
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, advocated improved healthcare regulations that could be universally applied to all countries and would negate human bias between auditors. In words, regulations aren’t effective if the results vary between people inspecting them, and companies are swamped trying to adjust to varying results from varying regulations for each country in which they would like to sell medical devices.

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

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

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

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

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

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

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

How to apply risk-controls and risk-benefit analysis

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

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

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

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

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

Competitors’ solutions:

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

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

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

Continuous Improvement

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

This is clear, easy to understand, and unambiguous

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

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

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

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

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

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

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

MaetricsThe Weinberg Group

Qunique (a botique European consulting firm)

Jason (me)

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

Take these steps to comply with European Union Medical Device Requirements

This article gives two steps your company can quickly take to prepare for the most confusing requirement of the new European Union Medical Device Regulation, reducing risk As Far As Possible. I use the Kaizen approach to continuous improvement of applying small steps that are likely to be understood rather than drastically new procedures that cause confusion.
If you’re not familiar with the MDR please see my article on the MDR big picture.

If you’re not familiar with the concept of reducing risk to patients “As Far As Possible” please see How to reduce risk As Far As Possible.
All of those concepts can become daunting, which is why I suggest the Kaizen approach of taking small steps even in learning through each of those articles. Now I assume you’re ready to get two Kaizen steps to start complying with the ED MDR:
Assign a qualified person to be your MDR representative. This is required in the MDR, which states that person’s qualifications should be a combination of education and experience and documented in your quality system.Schedule consultants or trainers. Their schedules may be filled as other companies wait until closer to MDR deadlines. Of course this is optional, but I recommend it and list consultants at the end of this article.Modify existing risk/benefit procedures to gradually incorporate the concept of As Far As Possible for products sold in Europe; this may not involve a complete change of your system and will vary for each company.
The last step is difficult to describe in writing because it will be unique to your company. Kaizen is a concept that you must understand then apply to your unique situation; no one can help you determine a Kaizen step without understanding where you are currently. To give examples, I assume your company has an established risk/benefit table and uses Failure Modes Effects and Analysis for risk analysis.
Example of new Risk/Benefit tables
Most of the western world uses Failure Mode Effects and Analysis (FMEA) to quantify risk. The calculated residual risk, RPN, is often based on the severity of harm if a part fails (S) times the probability of that failure happening compared to the acceptable risk table to determine if further work is needed.

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

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

The risk analysis method would not have to be changed at first, nor would many other procedures. After implementing this first step you’d continuously improve your quality system with additional Kaizen steps.
But, the Kaizen step I just showed is just one step, it’s not the final goal. I ask attendees in my workshops to think about the concept of reducing risk as far as possible, discuss their understanding in small groups, and to brainstorm the limitations of what I suggested and what a final policy could look like.

For this blog, think about the limitations of a binary risk table before scrolling down to my answer, which I’ll share after copying the lyrics to Weird Al Yankovic‘s song “Yoda,” which is sang to the rhythm of “Lola” by the Kinks.
I met him in a swamp down in Dagoba Where it bubbles all the time like a giant carbonated soda S-O-D-A, soda
I saw the little runt sitting there on a log I asked him his name and in a raspy voice he said “yoda” Y-O-D-A, Yoda Yo-yo-yo-yo Yoda
Well, I’ve been around, but I ain’t never seen A guy who looks like a muppet, but he’s wrinkled and green Oh, my Yoda Yo-yo-yo-yo Yoda
Well, I’m not dumb, but I can’t understand How he can lift me in the air just by raising his hand Oh, my Yoda Yo-yo-yo-yo Yoda yo-yo-yo-yo Yoda
Well, I left home just a week before And I’ve never ever been a Jedi before But Obi Wan, he set me straight, of course He said, “Go to Yoda and he’ll show you the Force”
The limitation of a binary risk matrix is that it isn’t truly reducing risk as far as possible according to a closed-loop process of continuous improvement. To truly understand the concept there wouldn’t be a matrix, all risk would be lowered as far as possible.
In the context of the European Union Medical Device Regulation, reducing risk as far as possible a continuous process and that even “negligible” risks in former risk management tables must be continuously improved reduced until products are state of the art, additional risk reduction wouldn’t lower risk (severity X probability), products are state of the art, and that benefits outweigh residual risks when compared against competitive products and alternative treatments.
In other words, reducing risk as far as possible can’t be quantified in a table because it’s a continuous process that improves based on evolving real-world comparisons every 1-2 years or “as needed.” Reducing risk as far as possible is a concept that must be emphasized by senior management, the core job of every employee, and part of a company’s daily culture.
“The farther you go along the path the more you realize there’s no path.” – Buddhist wisdom
Continuous learning

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

Or learn more by hiring consultants to work with your teams or train them.
I encourage all companies to discuss original phrasing in the MDR and consensus paper as a team until concepts are clear, easy to understand, and unambiguous. That’s why my workshops focus on teamwork, learning-by-doing, and the bigger picture of how our work impacts the lives of other people.
Thank you
Please share this article if you think others could benefit.
Parting Thoughts
I share this information because I believe reducing risk As Far As Possible will benefit society. This does not mean healthcare will become more expensive, it means that innovative companies now how an advantage over companies that previously had more risky products locked in contracts through business interests rather than patient safety.
Many government regulations can seem burdensome but are simply trying to make companies function as a process of continuous improvement that reduces risks to patients. I discuss my bigger-picture approach to continuous improvement using religions and philosophies from around the world, including lessons from the Buddha, who was an inspiration for Yoda in 1979’s film Star Wars. The Buddha summarized continuous improvement more in a sentence that is clear, easy to understand, and unambiguous:
Each day do more of what you know to be right and less of what you know to not be right – The Buddha
I wish you happiness.

How to make state of the art medical devices

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

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

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

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

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

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

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

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

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

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

MaetricsThe Weinberg Group

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

Jason (me)

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For fun…
Someone spent 10 years converting their 1984 Trans Am into a replica of David Hasselhoff’s Knight Rider car, complete with the same voice and 1980’s “state of the art” technology. Watch it here: