How to apply ISO 14971 risk-management (it’s easier than you think)

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6 minute read.
In 1986 the space shuttle Challenger exploded, killing the crew and a high-school teacher that had trained with the astronauts.

The explosion originated near an O-ring gasket that sealed rocket fuel. The gasket protected a known design flaw that could expose fuel to fire. NASA’s purchasing department had bought the O-ring based on expectations of warm conditions at the launch-site in Florida. The launch was delayed until January. A rare cold day lowered temperatures below the specified rating of the O-ring, decreasing its ability to seal the design flaw. The incomplete seal led to leaking fuel, which led to an explosion at takeoff.
The explosion is shown in this video. An important aspect of Risk Management is alluded to at 1:30; NASA had been under pressure to launch on that day.

I’ve simplified the situation because I wanted to focus on the need for risk management standards and transparent communication. Engineers had warned of the risk, but NASA didn’t have processes linking risk analysis with purchasing and launch-team decisions. In fairness, it would be hard to see the significance of an O-ring, which emphasizes that Risk isn’t just about the part, it’s about what happens if that part fails, and the hazardous situations that would have to align for that failure to occur.
The international standard for risk management is ISO 14971, which was updated in 2007. If it had been available in 1986 the Challenger probably would not have exploded and the astronauts and first teacher in space would be alive. If we could travel back in time, this is how modern risk management would have looked for NASA and the space shuttle team, with ISO 14971 sections (in parentheses)
Plan
A risk management plan would have been created by before doing any work, when the team is not under pressure (3.4). The team would document what other risk management documents are required and who’s responsible, acceptable levels of risk, priorities for how to reduce risk, how to monitor assumptions, and how to update and improve the plan based on new information.
Brainstorm hazardous situations
A diverse team would have ensured understanding of intended use of the space shuttle and it’s parts, including the o-ring (4.2). They would have listed high-level hazards, including “The space shuttle could explode if fire reached the fuel tank” (4.3). The team would brainstorm sequences of events that could lead to hazardous situations (4.4). For example:
The launch date could be postponed from a warm month to a colder monthThe weather in Florida, where launch occurs, could have an unusually cold day where the temperature drops below o-ring specificationsThe o-ring could “shrink” due to the cold weather, becoming unable to seal the pathwayThe launch team could not know the risk of cold weatherAfter takeoff fuel could be exposed to fire, causing an explosion
The hazardous situations would be documented and updated based on new information (4.4). I believe it’s advantageous to document the sequence of events, too.
Estimate risk levels
Risk would be quantified for each hazardous situation (5). Risk is the combination of the severity of an event and the probability of that event occurring (2.16).
Risk = Severity X Probability
Teams would assign numbers to severity and probability, multiply them together, and the result would be compared to pre-determined acceptable risk levels in the plan (3.4). In this example the severity of an explosion is so high that risk control would have been required.
Risk levels would be documented and continuously improved based on new information.
Control risks
The team would have prioritized risk control (6.2):
Improve the designAdd protective measuresAdd warning labels, instructions, or procedures
For this example, options could have included:
Improve the space shuttle design, such as eliminating the path to rocket fuel.Add safeguards to reduce risk, such as changing the o-ring specifications to be resistant to cold weather.Create procedures to reduce risk, such as a policy for the launch team to delay a launch if the temperature is below 40 degrees.
Risk controls would be verified and documented (6.3), and the hazards document would be revisited to ensure all hazards were addressed (6.7) and new hazards were not introduced. Any residual risks would be evaluated to ensure the benefits outweigh risks (6.4, 6.6).
Monitor for effectiveness
The risk management plan would be continuously improved using real-world data to adjust risk assumptions. For example, current, real-world information about probability assumptions would have been adjusted. There are two probabilities in risk analysis:
P1 = the probability that a sequence of events will occur
P2 = the probability that the sequence of events will result in harm
P1 must be proactively researched and documented because hazardous situations are rarely recognized or reported. For example, it’s possible that other space shuttle launches had the same sequence of events but had not exploded because of slight differences in temperatures or air currents between the leaking fuel and fire. Many other teams of astronauts may have unknowingly come close to a similar explosion, but this wouldn’t be known if we weren’t monitoring P1 assumptions. P1 is proactive risk management that reduces P2.
P2 is reactionary, resulting from deaths or catastrophes.
Please focus on P1.
Link risk management to all department policies
All departments would fall under risk management, and the risk plan would be referenced for all decisions. In the space shuttle example, information from design engineers would be fed into a risk management policy used by purchasing, manufacturing, and the launch-team.
Links within an organization and monitoring and improving a plan are known as the “process approach” to risk management. Modern quality system standards require risk-based decisions in a process of continuous improvement.
Documents
All risk management work would have been documented (3.5). The final document would have been be a trace-matrix ensuring all hazards are addressed by risk control, and that work was carried out according to a plan. This would have allowed subsequent teams to continuously reduce risk by adjusting probabilities based on new information, adding newly identified hazardous situations, and using state-of-the-art risk analysis methods.
Standards
Lessons from the Challenger explosion are part of current, international standards for quality control and risk management. The most common international standard for quality management is ISO 9001, and the standard specific to medical devices quality systems is ISO 13485, which is the foundation of a new audit method, the Medical Device Single Audit Program (MDSAP). They require that quality systems function as a risk-driven process of continuous improvement, which is also emphasized by the FDA quality system requirements and the European Union medical device requirements (EU MDR). All use the concepts prescribed by ISO 14971:2007, Risk Management. and the supplemental version for Europe, EN ISO 14971:2012.
Regulatory requirements are emphasized by a MDSAP diagram showing Risk Management as the highest level of guidance for companies.

Practical application
In the case of the case of Challenger explosion, it’s obvious in hindsight how a series of disconnected processes led to harm. What’s less obvious is how to apply risk-based decisions into your existing quality systems. I give an examples of how to apply risk management to decisions in purchasing, vendors, and supply chains in another blog, That’s not a knife! How to make risk-based decisions, which uses another phenomenon from 1986, the film Crocodile Dundee, about an Australian crocodile hunter in New York City, as a fun way to learn risk management techniques.

Risk management requires a corporate that culture understands and applies the concepts. These consulting companies can help your organization continuously improve.
Oriel STAT-A-MATRIX (I consult with Oriel)

MaetricsLNE G-MedMDI Consultants

Me(Jason 🙂
Summary
Plan

Pre-determined acceptable risk levelsHow to monitor risk assumptionsHow to update plan
Hazards analysis

Sequence of eventsHazardous situations
Risk analysisRisk = Severity X Probabilty
Risk control

Improve the designAdd safeguardsCreate warning, labels, instructions, or procedures

Continuously improve

Europe has additional risk requirements in .

Consulting companies can help you continuously improve.

Please share
Risk affects all of society, and the more people who think in big-picture concepts the safer our world becomes for everyone. Please share this article if you think others would benefit.
Parting thoughts
The space shuttle Challenger explosion was a rare event that in hindsight had preventable sequences of events. History has many similar examples, such as the , the , and every . These events are often referred to as “” because of the book “,” which emphasizes that we can’t predict outlier events but we can build robust systems resistant to their impact and able to adapt to changes.
But, no amount of quality-control and mathematical modeling can replace humans working together and communicating effectively. In the case of the space shuttle example, individuals struggled to have their voices heard. To improve your company, focus on culture, communication, and transparency.

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Meditation on the Buddha’s final words

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This article shares what I learned while meditating on the Buddha’s final words, while backpacking the route of his life from birth to death, from Nepal to India.
Read more

How to be efficient with “internet searches” OR find information in documents

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8 minute read (4 if you ignore one part).
This article is to help anyone who would like to improve their electronic search skills. Over the past couple of years, I’ve noticed a wider range of people unsure of, or unaware of, search techniques I take for granted. To cut to the chase, read these two articles from Lifehack.org and Lifehacker.com
LifeHack for internet searchesLifeHacker for keyboard searches (any document)
Or this list of search operators from Google’s support site.
Or, Scroll down to the video tutorials below, because before I give search tips I’ll write why I’m doing this. I won’t put much time into editing it; as Mark Twain said, “I’m sorry I didn’t write a shorter letter, but I didn’t have time,” so scroll down to the techniques if you’re not interested in my ramblings. I’ll indent my missive. so you can more easily scroll down to my tutorial.
I used to be surprised how few people new how to efficiently find information on the internet, or within long documents, until I read an article that 90% of people don’t, according to research by Google employees. (I’m not making that up. To verify that statistic, JFGI.)
All joking aside, these techniques are important. But surprisingly few people are good at it. I have, unfortunately and regrettably, been sarcastic to the point of being cruel when joking about internet search skills when people, including clients, have asked how I “know so much” (their words, not mine).
I realized I was being hurtful after helping a local nonprofit with a wide range of things, helping them help at-risk kids in our community find free and fun resources for education. When they asked how I “knew so much,” I replied, “The internet, just like we’re trying to help the kids learn how to do!” I thought I was attributing my knowledge to publicly-available sources of learning, for which I’m grateful, but the looks on their faces indicated that they felt stupid. Ouch! That’s especially cruel considering that they were trying to help under-served kids in my community, which is a euphemism for kids living in poor neighborhoods, often from multiple generations of poverty, obtain an equitable education.
That story is a primary reason why digital search skills is important; when the majority of teachers in under-served aren’t efficient at using the internet or searching electronic documents for information, they are perpetuating an archaic education system where the teacher gives “facts” for kids to memorize and regurgitate on tests, missing the point that the future of education, and the future for these kids to change their situations, depends less on “facts” and more on what they’d like to accomplish, how to access, critically analyze, create, and use information that helps your team obtain their goals.
This approach to education is part of “Project-Based Learning,” where kids are coached rather than taught, starting with a common goal that teams try to achieve, similar to how the real-world works when a project-manager leads a team, or an inventor starts a new company and hires people who haven’t learned the new invention yet, or a civic leader wants to coordinate community action. In other words, we start with a goal, and learning occurs along the way, sometimes guided by a person who doesn’t know all of the information but is good at embracing ambiguity and adhering to a general process rather than a rigid formula.
This is also key to the Next Generation Science Standards, NGSS, which are new science standards for over 20 states that focus on observing phenomena and learning through observation, research, and experimentation. Again, information is no longer valuable; what you can do with existing information, and the process for discovering new information, is education for the future.
It’s worth noting that NGSS introduces “engineering” as a core science, which, like internet searches will be challenging to teach if the teachers don’t understand it themselves, or aren’t comfortable embracing ambiguity and being a “co-learner” with students.
If you’re interested in helping provide equitable education, find schools in your community that could use your help helping kids, especially under-served communities. To find them, JFGI.
Finally, to the point of the bad joke earlier (“which one?” you ask), if you doubt anything, or would like to confirm something before repeating to to others, it’ critical to have effective internet search skills. If more people had these skills our society wouldn’t be plagued with “fake news,” and we’d all be happier and at peace, discussing what we’d like to accomplish and how we obtained information rather than arguing over what to do about inaccurate information.
For me, it continues to surprise me how, as a consultant, I end up answering questions available, for free, on the internet in less time than it takes to review my consulting contract. I started subtly incorporating search-skills into my workshops, mixing teams for group-work to distribute skills, and noticed that people seem to learn quickly without realizing they’re learning, but only when starting with a team-centered goal, similar to project-based learning.
As your first goal, what does JFGI mean? As a hint, one answer is the Jewish Federation of Greater Indianapolis. Neither is it the Jacob’s Financial Group, Inc. Neither are what JFGI means in the context of this article, though several of my friends refer to the Jewish Federation of Greater Indianapolis when someone asks an easily-answered question. The point is, words are weaker than context, so use the context of what you’re looking for, and why you’re looking for it, to help you phrase searches or navigate results.
Search any document or web page
Please, please, please learn to use cntrl+F on a personal computer (PC), or cmd+F on an Apple computer. When a document or web page is open on your computer, simultaneously press the “control” button and the letter F on a PC, or the “command” button and “F” on an Apple computer. This will open a small window to Find any word, symbol, or combination of words or symbols. You type what you’d like to find, our computer will list them, or highlight them, and take you to them. Smart phones have similar features.
Personal Computer:

Apple Computer:

Practice:
use cntl+F to find every time I wrote “JFGI” in this articlefind every time I wrote the phrase, “search for phrases”
For more keyboard tips, read LifeHack for keyboard tricks.
Search the Internet
Don’t rely on Google. Try Bing,Yahoo, or DuckDuckGo. As a society, if we all use the same source of information we may become biased towards incomplete or inaccurate information, more so than we already are.
How to choose words or phrases to search
This is a genuine and useful skill that will become better with practice. There’s no “shortcut key” for rewiring your brain to think like a computer search engine, but it happens so subtly that you’ll eventually take it for granted. In other words, it’s not like a golf score or bowling handicap where you can track progress, you simply get faster at it, with results closer to what you really need. To get started, watch this video, or read the text below it, or both.

Here are basics:
Use quotation marks to “search for phrases.” In this example, typing search for phrases would return search results for all combinations of those words, but typing “search for phrases” would return results for the one phrase you needed.
Conversely, if you want random combinations of words, not just the sequence in which you type them, don’t use quotation marks. In the previous example, search for phrases would be similar to for phrases search, and would show results from Yoda (just kidding, I am).
Use an asterisk (*) when you don’t know a word in a phrase, and Google will replace your * with probable words. For example, “Jewish * of Greater Indianapolis”
Use a hyphen (-) to omit words. For example, type JFGI -jewish to omit the word “Jewish.” (Whether or not you use capital letters is irrelevant to most searches.)
Use the word “site” and a colon (:) to search specific sites. For example, search for colon cancer in the government’s national cancer institute by typing colon cancer site:cancer.gov.
Combine techniques. For example, “colon cancer” site:cancer.gov
Use Google’s tips for refining web searches in Google, which, unsurprisingly, was the #1 ranked result from Google. They may seem obscure, but can be useful. For example, when I was designing medical implants by researching competitive products, used “cache:” to find files from sites that no longer available, perhaps because the owners had deleted them but didn’t know that Google ‘caches’ search results. I believe this is ethical (it was originally public information), and am sharing that information so you’re reminded that the internet is public, even for “secure” sites, and even after you delete something, so don’t upload anything if you’d be uncomfortable if someone saw it.
Practice
A great way to practice is using the internet to play Jeopardy! or any trivia game for random information, especially if it’s drastically different than your most common sources of information, which will exercise your search-engine skills more than doing what you already know. For example, Who was the childhood actor famous from the 1980’s television show “Different Strokes” and running for governor of California?
If you’d like to try a trivia game I wrote, try this game of Celebrity Jeopardy that I created to teach medical device regulations. I created it for a similar reason as the blog you’re reading now, to help people focus less on “facts” and more on the process of asking the right questions to find information, and using that information to achieve goals. If you used the internet, you could become an expert in almost any law or regulation, especially if you cross-reference that information with things you already know, called “lateral transfer,” which is a technique for, and indication of, deeper understanding.
Learn more techniques by, you guessed it, searching the internet. But, nothing beats practice, so I’ll reiterate that you’ll get faster and faster without noticing it. One day, people will ask you “how do you know so much?” and you can reply, “JFGI.”
Advanced Tips
Sometimes searching for images, even when you want text, can be more effective.The second tip is the reason for the first tip: understand Search Engine Optimization, or SEO.
Many web pages are great at Search Engine Optimization, SEO, which is a fancy word for they know how to show up in your searches more than they know how to answer your question. But, for some reason, they aren’t as careful with their images, so finding an image that matches your search and then going to that web site may help find information, especially specific information that is swamped with SEO-driven sites trying to sell you something rather than help you.
Watch this video to understand SEA, or read the following text, or both.

SEO is a reason most articles you find using text-based searches are written with the same words being repeated again and again, like:
So you are a Jewish person in Indianapolis, who wants to learn more about what a Jewish person can do in our city of Indianapolis? Or, you’d like to find greater knowledge about the Jewish faith, and perhaps you live in Indianapolis, or are a Jewish person who knows there’s no greater place to visit than the city of Indianapolis. Well, you’ve come to the right place, home of the Jewish Federation of Greater Indianapolis, a federation in the Indianapolis greater region, for Jewish people, in Indianapolis.
The first clue that this not a useful page, but is a page designed to rank high in SEO for a wide range of search styles, using any combination of Jewish Federation of Greater Indianapolis, including people who didn’t type quotation marks when searching for the “Jewish Federation of Greater Indianapolis,” or for someone who typed “Jewish Federation of * Indianapolis,” is that it assumed someone wanted to visit Indianapolis. I mean, come on.
The second is the phrasing. Legitimate sites don’t need all of that. In fact, many fake web site are generated by computer programs that mix up keywords from legitimate sites to gain viewers, which, unfortunately, increases their rank in search engines to get viewer “hits,” not to solve your problem.
For more advanced tips, JFGI.
Finally
Now, you’re ready for nerd humor, like this video where a guy looks up information asked as if people were typing on Google. Warning: it’s PG-13, which doesn’t mean to omit the number 13. If you’d like to know more, JFGI.

MDR: the Medical Device Regulation formerly known as MDD

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In 1993, the rock musician Prince changed his name to an unpronounceable symbol, confusing record companies, concert venues, and even fans. It turned out to be one of the most productive times of Prince’s esteemed career, releasing two albums each year during this transition.
In 2020, the European Union is changing their Medical Device Directive (MDD) to the Medical Device Regulation (MDR). It’s confusing companies, distributers, and even auditors.
Yes, they’re related. Well… they’re related a little bit. This article is trying to help people understand the MDR by making it less daunting. The MDR is a 175 page document, with almost 191,000 words that include terms and concepts from other quality and regulatory standards. The best short summary I’ve been able to develop is:
Why:The former directive, MDD, allowed risky products to reach hundreds of thousands of European citizens; the MDR protects people
When:

May 2020, only MDR can be used for new products and “significant changes” to existing productsMay 2024, only MDR certified products can be sold in the European Union
What are some minor requirements

a qualified person must be dedicated to MDR compliance for each companyadditional and more strict pre-market classification; for example, some Class IIa devices will become Class IIb
What are some major changes:

Unique Device Identifiers (UDI) for all products throughout distributionComprehensive post-market surveillance and reporting according to strict methodsExtensive clinical data for each device or device class, depending on its risk categoryTechnical documentation replaces technical files; technical documentation includes all information from initial product requirements to post-market surveillance for each device or device class, depending on its risk categoryAll device risks must be reduced As Far As Possible (AFAP)
Let’s get back to Prince and the MDR.
In 1993, there was confusion about The Artist Formerly Known As Prince: How did you use a symbol to alphabetize his albums? How did you write his name on a contract? Why is he doing this? Despite that confusion he produced two albums per year, the record industry made millions of dollars, and everything turned out okay.
The transition from MDD to MDR will be the same. The companies that embrace change will become more effective and gain more market share. It will take 8-14 months for your transition, so I suggest starting as soon as possible. Don’t expect to understand every detail just yet; a first step could simply be appointing a qualified person who has existing knowledge, a desire to learn, and an ability to lead from within. Give them the time and resources to help your company while maintaining their work/life harmony.
This article digs deeper to help you prepare for the next steps.
BACKGROUND
Prince
In 1993, Prince, the rock musician, changed his name to a symbol.

At the time, The Artist Formerly Known as Prince (TAFKAP) was one of the world’s most famous musicians. But, Warner Brothers Records owned his music and, practically, the name “Prince.” But, they did not own the new symbol, which he created and copyrighted it. Warner Brothers had to scramble to create fonts for the symbol, change contracts, explain the changes to record stores, vendors, etc. Concert venues didn’t know how to advertise his shows, Record stores were confused about how to alphabetize his albums, and lawyers didn’t know how to type his name on contracts.
From 1993-1996, TAFKAP released two albums per yer, accelerating the end of his contract with Warner Brothers Records, then signed to a different record company. In 2000, he changed his name back to Prince, after demonstrating that innovation and creativity can come from confusion.
Prince was one of the most creative musicians of our time, releasing 39 albums before he passed away in 2016. He died from an overdose of opioid-based pain medications. He suffered from epilepsy, and several sources reported that he had hip-replacement surgery due to pain. I wish him Peace.
Medical Devices in Europe

Formerly, the European Commission provided guidelines for selling medical devices in Europe through the Medical Device Directive (MDD) and the Active Implantable Medical Devices Directive (AMIDD); these have been combined to for them new Medical Device Regulation (MDR). The MDR is only for medical devices, not for in vitro diagnostic equipment such lab tests for blood or genetics. In vitro diagnostic equipment is covered by the new In Vitro Diagnostic Regulation (IVDR); this article only applies to the MDR.
Why change?
Medical device scandals in the European Union increased public awareness of faults in the previous MDD that allow risk to citizens. People demanded more protection from their public officials, which led to the MDR.

An examples of patient risk under the former MDD are breast implants manufactured by a French company, Poly Implant Prothèse (PIP). PIP used industrial silicone instead of medical-grade silicone; the industrial silicone was 7X cheaper than medical silicone, but was more prone to bursting, resulting in harm and suffering for patients and lawsuits against the manufacturer and regulators. 400,000 women were affected, many of whom continue to suffer.
The MDR provides more safety regulations, re-classifies some devices to emphasize potential risk to patients, and creates a way to track each device through importers and distributors.
Time-Lines
2017: The MDR “entered into effect” already, which means that parts of it can be applied. This is nuanced, and beyond the scope of an overview article
May 2020: MDR is your only option for new products or “significant changes” to existing products; this is left ambiguous and it will be difficult to justify what’s not a “significant change”
May 2024: No product without MDR certification can be sold in European Union, even products that have been on the market for many years without changes; in other words, there’s no “grandfathering” and all products must comply with the MDR or they will be removed from sale
Minor Changes
Many requirements are the same as or not very different than previous directives.
Each manufacturer must designate at least one “qualified person” in their company who ensures compliance with MDR, and that person’s qualifications must be documented for review.Each distributor and importer must be trained and able to use the Unique Device Identifier system. These entities can be inspected by auditors, just like the manufacturer.”Technical documentation” replaces “technical files” as a more extensive list of documents that include pre-market planning, device design, manufacturing, and post-market surveillance; most of these documents should already exist for companies with ISO 13485 certified quality systemsMore products will be regulated. This won’t impact most companies, but products not previously considered medical devices, such as colored contact lenses and cosmetic implants, will require MDR compliance.Regulatory authorities and notified bodies can inspect any product at any stage of manufacturing or distribution to ensure it conforms to quality-system requirements for that stage.

The European Union is creating more agencies and programs to coordinate between countries and assist manufacturers with clarifications of requirements. This won’t significantly affect companies, but are useful to know because they’re for your benefit. For example:

The Medical Device Coordination Group (MDCG) advises the European Commission, coordinates activities between national agencies, and other high-level duties
Expert Panels provide technical and scientific expertise, and will be developing common specifications for some products to ensure uniformity between manufacturers.
Technical Working Groups are more focused than expert panels, offering classification of novel devices and detailing common specifications
EUDAMED database for Unique Device Identifiers (UDI), allowing full traceability of every medical device
Medium-Level Changes
There are several new regulations or additional requirements that may require more effort on your part, depending on your products and existing quality system.
More pre-market classification rules, and more strict risk classificationsUnique device indicators (UDI’s) for each product throughout its distribution chainAdditional post-market surveillance for for each device or device family that must be provided to the EU in Periodic Safety Update Report (PSUR)Additional clinical data requirements for each device or device group, depending on its classification
I’ll share details of these changes; skip to the next section if you’d rather not read them.
Pre-market classification
There will be a few changes to pre-market classifications. Don’t underestimate this step: the extent of your technical documentation and other time-consuming requirements all start with the device class, so ensure you’re on the right path before beginning any plan.
Class I products, which are the lowest-risk, such as bandages and thermometers, has these sub-categories:
Class I, generalClass IS, sterileClass IR, reusableClass IM, measure
Class IIa, IIb, and III categories haven’t changed, but they have additional rules and may be more strict than before; for example, some Class IIa devices are now Class Ib. Classifications are based on situations such as:
Duration of contact with the patient, such as a short procedure vs. a one-week implant vs. a permanent implantHow it’s introduced into the body, such as through a surgical procedure or natural oraficeIf the device is disposable or reusableWhere it’s used, such as on the skin vs. near the spinal chord.
Rather than list all of the situations, I created a “MDR Game and Quiz“so that you can learn-by-doing. Classifications aren’t challenging, they just require going through the process a few times. My strongest advice is to do this step with a diverse team. Most mistakes I’ve seen were miscommunications from using medical terminology or interpreting the MDR, but a team would know more than any individual therefore teams should collaborate on this important step.
Unique Device Identifier (UDI)
A UDI will be required for all classes of medical devices, and must be on each device or the device’s label. UDI’s will be scanned and tracked, creating a record of each medical device throughout its distribution chain. Each UDI will be a combination of two parts:
A Device Identifier (DI), with the company’s identification and the device version or model

The Production Information (PI), unique to each, single device, which includes information such as:

Expiration dateManufacture dateManufacturing siteDistributors of each device, storage of each device, etc.
As I write this article, the European Union doesn’t have software in place to handle UDI’s, but it will eventually be hosted by the European Databank on Medical Devices, EUDAMED. Further guidance is expected to unfold over the next year. European Union UDI’s will probably look like FDA recommendations for UDI’s. In the example below, the UDI is given in a bar code, in addition to other information required.

The barcode uses a standard format, allowing automated scanning by all distributors, hospitals, etc., and can be read by a people without needing scanners.

In this example, the numbers in the parentheses indicate the different parts of the UDI.
Device Identifier (DI) – 12345678901234

Production Identifiers (PI):

Expiration Date: 140102Manufacturing Date: 100102Lot Number: A1234Serial Number: 1234
It’s important to re-emphasize that a UDI will be scanned by distributors, allowing complete traceability of medical devices. Currently, it won’t be required on external packaging, which seems to go against guidelines for traceability, so UDI requirements may evolve.
One difference between the European Union’s planned UDI process and the existing FDA process is that the FDA doesn’t require UDI’s for low-risk devices, but the EU will require them for all device classifications.
Post-market surveillance
Post-market surveillance means that a company proactively monitors real-world data of their products and similar, competitive products, reports adverse events to regulatory agencies, and uses all information to continuously improve products and company quality system processes, especially risk-management methods.
The MDR requires more diligent post-market surveillance than previous regulations, and prescribes how to to perform the surveillance. First, MDR requires a plan. This seemingly simple step is often overlooked by companies; specifically, it’s overlooked by project-planners and senior management in those companies. In my experience, companies that don’t focus on effective planning, which is different than extensive planning, have inefficient projects that are chaotic and introduce risk to patients.
More time sharpening an axe means less time chopping wood.
Good planning practices are a separate topic, but, generally speaking, a plan will describe be an exact, detailed, proactive process, including how to monitor adherence to the plan. That last step is often overlooked despite being critical for a process of continuous improvement: plan when and how to update and improve your plan based on real-world data and new regulations. The MDR gives specific, detailed requirements for what must be in your post-market plan in Annex III of the official regulation.
Each manufacturer must provide periodic reports for high-risk devices, which are Class III and implantable Class II devices, Classes IIa and IIb. This is through a Periodic Safety Update Report, or PSUR, which requires updates for Class III and IIb devices annually and to IIa devices at least every two years, or when there’s a “significant” change to the device risk through adverse event notifications or design changes.
Post-market surveillance also protects public safety: Each manufacturer must notify regulatory agencies of any serious incident within 15 days, and deaths within 10 days. If there’s a chance of public risk, this must be within 2 days.
The format and details of PSURs are out of scope for this article, but are easily found through your EU representative or an online search. What’s important is to know they will require more planning than previously, will be updated more frequently, and will be used with clinical data for technical documentation of each product or group of products, depending on the device classification.
Clinical data
Clinical data is a combination of medical literature review, current competitor information, and each product or product group’s unique information. The extent of clinical data depends on the device classification, and is ambiguous in the MDR. To help plan how much you need, consider that your clinical data will be submitted along with your post-market surveillance to justify if your product is “state of the art” and has reduced risk “As Far As Possible.”
Major Changes

In 1989 Chuck D, frontman of the hiphop band Public Enemy, asked the question: How low can you go?
In 2017 Europe replied: As Far As Possible.
I believe that most companies will struggle with the requirement that all medical devices must reduce risk As Far As Possible (AFAP). This is based on my experience consulting; your company may be an exception. I wrote an article explaining AFAP based around the 80’s hiphop group Public Enemy, giving examples of where confusion may originate and steps you could take to gradually work towards complying, a technique from the Kaizen approach to continuous improvement.
The phrasing of AFAP guidelines in the MDR is almost identical to EN ISO 14971:2012, the European Union version of the international standard for risk management, ISO 14971:2007. In short, the MDR requires that for each product a company demonstrates:
All risks are reduced AFAP compared to state of the art, which is a combination of clinical data and post-market surveillanceCost can not be a factor in not reducing risk; if someone has found a solution to reduce risk you must, tooBenefit to the patient outweighs any residual risks

Reducing risk As Far As Possible requires understanding what is “state of the art.” In European law, this doesn’t mean the latest technology, it means the “generally accepted state of the art.” I demonstrate how to make state of the art medical devices using a 1980’s television show about a self-driving, talking car. In 2018 we have self-driving cars, but that’s not “generally accepted state of the art” because there’s not enough history of driver safety yet. But safety features such as seatbelts, child safety seat connections, and anti-lock breaks are state of the art. Medical device state of the art is more complex than car safety features and I demonstrate this using case-studies from medical device failures that impacted society.
I consider reducing risk As Far As Possible a major change because it will impact all functions in a quality system. You can’t demonstrate AFAP if you don’t have a strong post-market surveillance system, clinical data process, or risk management policy that complies with EN ISO 14971. Also, and perhaps most importantly, many companies will not be able to comply with MDR risk requirements because they haven’t reduced risk As Far As Possible and will need to make design changes that require more time and resources than expected.
Challenges and Solutions
The MDR creates several challenges, not just in the work companies must perform, but in getting started. For example, the UDI database in EUDAMED doesn’t exist yet, which can be intimidating for anyone preparing for UDI’s. Also, “Common Standards” are still works-in-progress, “Notified Bodies” are over-scheduled and overwhelmed, and this is a new process for everyone, including consultants. But, just like everyone that adjusted to Prince’s new symbol, we’ll be fine.
The first few steps on your journey may look like this:
Designate a person in your company to be responsible for MDR complianceEnsure all of your distributors and importers are able to use the UDI bar-code system.

Create a list of your company’s internal documents that reference MDD by name, or by specific paragraphs, that will need to be updated as you re-certify your products

Create a list of your productsWrite their current MDD classificationWrite their new MDR classificationGive links to existing Technical Files (CE mark files)Give links to existing clinical data”Check off” things that haven’t changedMark things that have changed, such as a Class IIb becoming a Class IIICreate a Y/N column for “yes,” we may need more clinical data, or “no,” we definitely won’t need more clinical data.

Use the resources in this article to answer specific questions as they arise, or to find further training or consultants.Schedule internal audits as soon as possible.

My strongest advice is to start today, declare your intention, and put on earphones and listen to Prince on Spotify while you maintain a positive attitude, focus on patient safety, and create work/life harmony for yourself and coworkers. If you do that, everything will be fine, and you’ll look back and realize you didn’t have to understand every detail if you have the right intention and the right method, which is a philosophical way to describe a quality system that continuously improves with the goal of reducing risk to patients.
Resources

We can’t all be Chuck Norris. I suggest reading the official regulations and online help guides, and hiring consultants who can help with concepts.
OFFICIAL REGULATIONS
PRIVATE-COMPANY SUMMARIES
PRIVATE-COMPANY TOOLS & FAQ’S
EU MDR “Readiness review” to prepare for the transition, by BSI.
“Table of contents” for the EU MDR, which is, surprisingly, missing from the official document. This one includes a copy of the 175-page MDR, provided by Oriel STAT-A-MATRIX.
CONSULTING & TRAINING
Oriel STAT-A-MATRIX(I consult with Oriel)

MaetricsLNE G-MedMDI Consultants

Me(Jason 🙂
AUDITING ORGANIZATIONS
IntertekBSI GroupTUV SUDUL
MY BLOG

Example: Play Celebrity Jeopardy! to learn the MDR: I grouped celebrities that share common medical treatments and created a game where I give hints and you guess their treatment then classify the medical device under MDR rules.
If you found this useful, please “like” and share it so that others benefit.

How Harry “The Hat” Anderson helped me learn Design, Risk, & Entrepreneurship

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Harry Anderson passed away last month; my thoughts are with his wife, son, daughter, and family.
The following is unusual, but truthful. It’s how Harry “The Hat” Anderson helped me learn, and teach, design, entrepreneurship, and risk management.
7 minute read.

Harry Anderson was a television star on Cheers, Night Court, Dave’s World, It, and other shows for almost 30 years. He was most known as Judge Harry Stone on television’s Night Court, where his character was a kind-hearted prankster, magician, and fan of jazz music.
Judge Harry Stone was an iteration of Harry “The Hat” Gittes from television’s Cheers, where Harry was a good-natured con-artist and magician.

Harry’s career jump-started in 1983 when he appeared on the famous comedy show Saturday Night Live, apparently shoving a needle through his arm.

Today, I use Harry’s Needle Through the Arm routine in workshops for medical device companies, teaching them how to comply with Risk Management and European Union Medical Device Regulations in ways that balance patient safety with innovative products.
Risk (this may get “Hairy” 🙂
I use Harry’s needle-through-the-arm routine in corporate training for medical device development on Reducing Risk As Far As Possible and applying Risk-Benefit Analysis, concepts that are often confusing. I believe the needle example explains the “point.” (ha!)
During the Saturday Night Live performance Harry fumbled while looking for the instructions to his trick while he had a needle stuck through is bleeding arm. This “stuck” in my mind (ha!) as a way to illustrate the concept of designing products that don’t require written warnings to protect people. The international standard for medical device risk management, ISO 14971, requires three priorities for reducing risk to patients:
Make the design inherently safeAdd safeguardsProvide written instructions or warnings

New regulations in Europe require that each medical device prove that the highest level of risk reduction were applied. Harry’s needle-through-the-arm represents a real-world challenge in healthcare, accidental needle sticks, that helps explain why these priorities are enforced.
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 government regulations for needles required more safety, and those companies excelled in the market. Companies that didn’t innovate lost in the market. In all cases the reduced risks benefited society.

If an innovative company improves needle designs to be inherently safe, which is priority level #1, then that would become state of the art and society would once again benefit. Similarly, all medical devices are now required to “reduce risk as far as possible,” but companies struggle balancing cost effectiveness, innovation, and applying risk control. I provide guidance in a full article on risk management that uses more analogies from Harry and other 1980’s pop-culture.

Design & Education
I saw Harry perform his Needle Through the Arm on television’s Saturday Night Live in 1983. I wanted to replicate it so I started brainstorming how it could be done, prototyping ideas, and testing them in front of audiences. I’d repeat this process until audiences enjoyed the trick and my presentation.

Over the next few years, Harry performed a total of eight times on Saturday Night live, including when he opened the show by saying the

famous words, “Live! From New York! It’s Saturday Night!” with his mouth full of a guinea pig he apparently ate live because it wouldn’t jump through hoops on television.
I would repeat the same process with each Harry Anderson skit: brainstorm, prototype, test, improve, repeat. This process is how I teach design, and is the basis of engineering design and the method of Next Generation Science Standards, NGSS, which include Engineering Design as a core science, the same as Physics or Biology.
Engineering Design is now a requirement for kids from Kindergarten to 12th grade in 22 states, but that doesn’t mean we know how to teach it yet. I’ve used Harry’s magic to help students learn design and innovation at two universities, a public high school, and in several countries; teaching teachers how to lead project-based learning where kids learn-by-designing, where the teacher is a coach, encouraging iteration and providing hints to overcome obstacles. I’ve also started incorporating the design process into my consulting on how to apply government regulations in ways that create more innovative designs.
Many of Harry’s magic effects were mechanical innovations, and even later in life, famous and wealthy enough to retire, he maintained a workshop to prototype ideas for the joy of observing a product evolve. Imagine that instead of reading text books to learn the mathematics behind mechanical engineering mechanisms students prototyped ways to swap cards or dollar bills when you activate the mechanism arm by dropping your pants on national television and moving the trigger connected through your pants, coat, and sleeve.

We loose some of our most creative students because they don’t fit traditional education models. New education standards like the NGSS are trying to improve education for all students, moving away from memorization, job training, and competitiveness towards critical thinking, design, and teamwork.
In hindsight, it makes sense that minds Harry Anderson was dyslexic, and had to find non-traditional ways to earn a living after high school.
“My high school teachers were always asking me what I was going to do. Cheers’ was my first acting job, but it was basically the character I had developed on the street,” he said. “That’s now I made my living, hustling drinks in bars and quarters on the street.”

Harry published a book sharing his good-natured con-games, “Games you can’t lose, a guide for suckers.” His”cons” were usually plays on words, but were often based on mathematics and probability, which is a more engaging way to learn the concepts than traditional teaching methods. I use those concepts in both high school classrooms and corporate workshops to help students learn math by practicing applications rather than reading concepts.
Harry wrote Games You Can’t Lose with Turk Pipkin, a writer for Night Court and other shows and movies. They co-founded The Nobelity Project for “bridging gaps in education at home and abroad.” It turns out that a many celebrities, athletes, and entrepreneurs are dyslexic, and also had to find non-traditional ways to earn a living that didn’t depend on written words.

Entrepreneurship
Entrepreneurship uses a similar process as designing: brainstorm, prototype, test, improve, repeat. Like design, entrepreneurship can’t be taught but it can be experienced. Almost every successful entrepreneur or inventor has more stories of failure than of success.
Magic and designing magic tricks is an ideal way to make iterative design fun, remove the fear of failure, and enforce the public speaking skills necessary to communicate with diverse people. Performing for real people develops skills that lead to other opportunities, like Harry discussed on television’s Late Night with Johny Carson, who was also a magician.

All of my classes incorporate some form of entrepreneurship, even if only how to communicate complex topics confidently. Innovators benefit from the iterative design process, getting a product closer to what is useful to a larger market, and everyone benefits from the hands-on skills and mathematical concepts that result from prototyping. I incorporate how to patent ideas and ways to build a business, which, like design, comes more from practice than lectures. As an example, rather than taking tests one of my Design Engineering classes created an online company that sold products they designed and continuously improved throughout the course using the process of brainstorm, prototype, test, repeat.
Combining all of Harry’s influences on me
My first medical device job had been with a start-up company founded by the original inventor of needle safety features, a serial entrepreneur who continues to invent products and start companies. In our interview he wanted to see how I brainstormed new ideas; by then I had designed or invented dozen of magic effects, starting with Harry Anderson’s 1983 Needle Through the Arm. I got the job, learned from mentors, invented medical devices, co-founded companies, retired, taught, and now consult on all of these things while incorporating my childhood love of magic.
In lieu of payment, I will exchange my service for corporate donations to non-profits or benefit-corporations that provide equitable education. Some of the work funded hands-on engineering laboratories in inner-city middle schools, and programs that incorporate community service into design engineering courses. I also perform magic shows for corporate events and private parties under the same arrangement.
I enjoy the work I do and feel gratitude for the good luck and influences that helped get here.
This is leading to my point.

A common theme in regulations I teach is “linked processes,” a concept that’s complex and difficult to apply in large organizations or government policies; I use Harry as a metaphor for linked processes, that we’re all connected by our words and actions in small but measurable ways. A lot of my luck and opportunities can be tracked back to seeing a guy in a hat apparently shove a needle through his arm on Saturday Night Live in 1983. Harry’s influence had ripple-effects that continue to help me help others.
I was fortunate to share a few drinks with Harry and his wife in their magic shop in New Orleans. We performed magic and discussed our love of the city and people who live there. I wasn’t consulting then, and I probably wasn’t self-aware enough to piece together the series of events that led to my career, so I didn’t share the positive ripples he created.

I don’t have the writing skills to convey what I’d like to say or to summarize my thoughts in one point. Maybe it’s that I was happy to see him doing what he loved, performing magic, 35 years after I first saw him on Saturday Night Live.
Or, maybe the point is that everything we do influences others in ways we may never know.
There are probably many points I could make from this article, and maybe one day I’ll have the skills to express them. If I do, it’ll unlikely to happen from luck, it would probably happen from the process of brainstorming, prototyping, testing, and improving.
Maybe that was the point.
For now, there’s no point, but I’m enjoying practicing writing while reflecting on influences in my life that have brought me joy.
Rest in peace, Harry Anderson, aka Harry “The Hat” Gittes, aka Harry Masters, aka Judge Harry Stone.

Play Celebrity Jeopardy! to learn the European Medical Device Regulation

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I grouped celebrities who share a common medical treatment and ask you to classify the device using the new European Union Medical Device Regulation rules. I give the answers, you respond in the form of a question. If you need to see it in action, watch the video of Saturday Night Live’s Celebrity Jeopardy spoof. (warning: it’s rated PG-13)

Use these resources
If you’re unfamiliar with the EU-MDR, please see this article on the MDR “Big Picture.”otherwise use these resources to play Celebrity Jeopardy using MDR rules
The official MDRthe classification rules for this game are in Annex VIII
Use the internet for pop-culture references, and don’t take anything too seriously. Give the movie role or rock band if you don’t know a name. The point is to learn the MDR while having fun, and part of learning is embracing ambiguity and using the internet.
MDR Device Classifications

category: HAVE A HEART
Hints are given in each category.
$100: They are known as:
the host of television’s “Late Night” throughout the 80’s and 90’s
the 42nd presidentof the USA
the 43rd president of the USA
$200: This medical device has been implanted in the three celebrities shown.
$300: This MDR classification and rule apply to the device.
$400: This presidential candidate played the saxophone on a late-night comedy show in 1992, which is credited as changing all subsequent political strategies to reach out to younger voters.

KEEP UP THE PACE
$100: They are known as:
a singer, knighted by the Queen of England
a clown on television’s The Simpsons
$200: This medical device, which was first prototyped in 1899, is implanted in the celebrities shown, and controls their heart rhythms.
$300: This MDR classification and rule apply to the device.
$400: This celebrity, one of the four shown in the photo above, had their heart stop when they overdosed on drugs, but doctors revived them with a shot of adrenaline into their chest.
$500: This MDR classification and rule apply to “Automated External Defibrillators,” or AED’s, which are publicly available devices that can revive someone without the need to shoot adrenaline into their chest.

IT’S HIP TO BE SQUARE
$100: They are known as:
$200: This medical device, which is implanted in more than 300,000 Americans each year, is implanted in all four celebrities shown.
$300: This MDR classification and rule apply to the device.
$400: This 1987 science-fiction film, about an alien that hunts humans, stared two of the celebrities, before they both were elected as state governors.

BEAUTY AND THE BEAST
$100: They are known as:
$200: Both celebrities became deaf as children but obtained limited hearing thanks to this medical implant that converts sound to electrical signals sent to their nervous system.
$300: This MDR classification and rule apply to the device.
$400: This 1977 documentary film profiled one of these celebrities and the future governor of California as they trained for “Mr. Olympia,” and led to both of them starting in action films in the 1980’s.

HELLO. YOUR DONATION SAVED MY LIFE.
$100: They are known as:
$200: All received this general type of medical treatment, using a donation from another person.
$300: This MDR classification and rule apply to the device that transported the donations to the operating rooms of the celebrities shown.
$400: This celebrity, pictured above, lost the election for governor of California to Arnold Schwarzenegger in 2003.

BABY GOT BACK
$100: They are known as:
an Oscar-winning actor and star of the films Ocean’s 11, Batman, and Syriana who was 1997’s People Magazine “Sexiest Man Alive”
$200: Both celebrities had chronic pain for this part of the human body (see the hint).
$300: This MDR classification and rule apply to the dancer’s implant, a total disc replacement.
$400: This MDR classification and rule apply to the actors implants, permanent fusion devices
Please consider this: Classification is a first step for the MDR and will impact the amount of work you need to do over the subsequent years. These two devices seem similar but have different classifications based on a nuance in terminology that could easily be overlooked by a single person or department. In this case they call a fusion device a “wedge,” which is unclear because not all fusion devices are shaped like wedges. Nuances like this are why I encourage using diverse teams to make decisions throughout the MDR.
$600: This 1978 science-fiction film about tomatoes that become sentient and revolt against humanity was the first movie role for the academy-award winning star of Syriana, Batman, and Ocean’s Eleven.

FINAL JEOPARDY
bet as much as you’d like
This company used industrial-grade silicone instead of medical-grade silicone for breast implants, creating pain and suffering for thousands of patients and a lifetime of health risks for the 400,000 people who received the implants, and was a major reason for the new medical device regulations.

There’s a lot more to MDR. If you’d like to learn more, or work with a training company or consultant, please consider the resources below.
Resources
OFFICIAL REGULATIONS
PRIVATE COMPANY SUMMARIES
CONSULTING & TRAINING
Oriel STAT-A-MATRIX(an International company; I consult with Oriel)

MaetricsLNE G-MedMDI Consultants

Qunique (based in Switzerland)
Me(Jason 🙂
My Opinion

As a society we’re learning that healthcare should improve. You can help.
For example, consider the spine implants and cardiovascular implants of the celebrities shown. They have access to the any healthcare money can buy, yet are still subject to the same risks as billions of people on the planet who hope our healthcare companies and providers are informed and ethical.
But, spine implant companies are often the subject of lawsuits and federal investigations for conflicts of interests when doctors advise patients but are paid by medical device companies that receive revenue from the procedures.
Similarly, For example, Cardiovascular stents are implanted in millions of people each year, including David Letterman, Bill Clinton, and George Bush, but have been criticized as often being an unnecessary procedure, even for the president, and by the president’s surgeon who implanted the stent.
This is a problem globally. 400,000 people received toxic implants from Europe, and in the United States 80,000 – 240,000 people die from healthcare errors each year, and globally 5 million people die each year from low-quality healthcare. The MDR is a step towards data-driven decisions in healthcare that’s less influenced by marketing and false views. Learn more in my MDR blogs about reducing risk as far as possible.
As professionals, we can help society by understanding regulations like the MDR that intended to protect people, practicing leadership skills that let us influence our organizations, and letting our elected officials know that healthcare safety and cost-effectiveness is important to us.
Rock on
Please share this game if you think other people could benefit.
Keep in Touch
I post a few articles through my Linkedin page but most articles are in my website’s blog. I update subscribers once or twice a year with big-picture summaries of different disciplines.
My work is focused on equitable healthcare and education globally, and combines my experiences as a medical device developer, teacher, and traveler in ways that I hop provide immediate benefit to each reader. It’s part of my work-life harmony, a concept I integrate into corporate consulting and teacher training.

Understand the ISO process approach by using 1980’s pop-culture

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Three of my skills in this world include medical device development, teaching, and 1980’s pop culture. This article combines all three, using pop culture to illustrate concepts behind medical device quality system regulations that require a “process-based approach.” It’s starts with this, which will either confuse you or make you chuckle:
Was that a process?
Before I give my answer I’ll share the background of MC Hammer, Vanilla Ice, and the Process Approach to quality control so that everyone can make an informed decision.
Background
1990’s?
MC Hammer was famous in the 80’s, especially for the lyrics, “Stop! Hammer Time!” His video for “Can’t Touch This” has been viewed 500 million times.

Vanilla Ice was famous in the 80’s, especially for the lyrics, “Stop! Collaborate & Listen!” His video for “Ice Ice Baby” has been viewed 250 million times.

If you knew hip-hop music from the late 1980’s and 1990’s, answering questions on the first diagram would make you either Stop! and Hammertime; or Stop! Collaborate, and listen.
International Standards Organization (ISO)
Medical device companies must have an approved quality system to sell their products. The international standards for quality systems is ISO 13485, which was updated to emphasize risk-driven processes. ISO 13485 training videos have, collectively, been viewed a few thousand times, but impact the lives of billions of people.

500,000 million people know about MC Hammer, but only a few understand the process approach to quality control of medical devices, which affects billions of people. 44% of medical device recalls could have been prevented by process controls, and healthcare mistakes lead to 250,000 deaths in the United States each year. The process approach could save more lives and make the world a healthier place.
The process approach
The international standard for quality management, ISO 9001, defines a process in clause 3.4.1 as:
“… a set of interrelated or interacting activities that transforms inputs into outputs.”
Inputs and outputs could be things, such as drawings or parts, or information, such as documents or test results.ISO 13485:2016, which is based on ISO 9001 but focused on medical devices, defines a process as:
“Any activity that receives input and converts it to output can be considered as a process. Often the output from one process directly forms the input to the next process.”
and the process approach as:
“…the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach.”
with a goal of:
“…improving processes based on objective measurement.”
Clause 8.2.5 of the standards adds that all processes:
“…should be monitored and improved for effectiveness.”
In other words, all processes should be controlled by an overall process of continuous improvement. But, that still doesn’t tell us what is and what is not a process.
Is this a process?
The first example leads you through a series of choices that result in a a decision, either to “Hammertime” or “Collaborate – Listen.”

Is this a process as defined by the ISO process approach? Why or why not?
I’ll provide space before my answer with lyrics from MC Hammer’s 1989 hit song, “U Can’t Touch This”:
Every time you see me that Hammer’s just so hype I’m dope on the floor and I’m magic on the mic Now why would I ever stop doing this With others makin’ records that just don’t hit I toured around the world from London to the bank It’s Hammer go Hammer It’s a Hammer yo Hammer and the rest go and play
You can’t touch this (oh-oh oh oh-oh-oh) You can’t touch this (oh-oh oh oh-oh-oh) Can’t touch this (oh-oh oh-oh-oh) Yeah u can’t touch this I told you u can’t touch this (oh-oh oh-oh-oh) Too hype can’t touch this Get me outta here u can’t touch this (Oh-oh-oh-oh-oh-oh-oh-oh-oh-oh-oh-oh)

Here’s my answer: The example is not an ISO process according to the process approach.
It’s a flow chart, and useful way to choose “Hammertime” or “Collaborate and Listen”that could be used within a process to help visualize written instructions, but it’s not a process in the context of ISO 13485 because it doesn’t use inputs to produce outputs.
Someone may perceive that it has implied inputs and outputs, but it’s unclear how implied outputs could be used as inputs for other processes that would be linked in a cycle of continuous improvement.
Let’s look at another example from Devo’s 1980 song, “Whip It.” I encourage you to listen to the video while reading the example. Crank up the volume so that everyone in your office can jam with you.

Is this an ISO process-approach? Why or why not?
I’ll provide space before my answer with lyrics from Devo’s 1980 hit song, “Whip It!”
When a good time turns around You must whip it You will never live it down Unless you whip it No one gets away Until they whip it
I say whip it Whip it good I say whip it Whip it good
Crack that whip
Give the past the slip Step on a crack Break your momma’s back
When a problem comes along You must whip it Before the cream sits out too long You must whip it When something’s going wrong You must whip it

The “Whip It!” chart is not the process approach. It’s elaborate and a lot of work went into it, but it’s not monitored for effectiveness. In other words, the song remains the same.
Another way to view this could be to use a term from Systems Engineering, “closed-loop process.” A closed-loop process is also called a “feedback” process because outputs are fed back into the process so that the process improves. Conversely, an open-loop process does not improve.

The Whip It flow chart would always result in the same song, and The MC Hammer flow chart would continue giving two choices but would not improve, would not stay relevant, and would not maintain effectiveness over time. In other words, neither example was a process in the ISO definition of process approach.
This is a process
Let’s look at what ISO considers a process using the

which is based on the process approach.

In the diagram, arrows show the flow of information between departments, which means that each departments processes are linked, and that “Risk Management” is the basis all processes.

“Purchasing”

is shown to link to all departments, because to monitor and control supply-chains so that things external to our quality system don’t become a weak link in our processes.

The diagram doesn’t show inputs from the external world that are described in the text of ISO standards, which includes inputs for “Design and Development” that come from real-world feedback based on the needs of customers, users, and patients; and international regulatory requirements. These regulatory requirements are continuously improved based on outputs of all medical device companies, such as products and patient outcomes, creating a closed-loop system of continuous improvement for global healthcare.
As an example of a process within a company linked to other processes within that company, consider “Design and Development” and the FDA design-control guidance:

The written descriptions state that Design Input includes:
user needs (shown in the flow-chart)regulatory requirements

post-market surveillance of existing productsfrom outputs of linked processes in Measurement, Analysis, & Improvement
risk management policiesfrom outputs of linked processes overseen by Management.
The work of your design team converts design inputs into Design Output, which can include:
part drawingssoftware codesservices to customers

risk analysis documentsbecome input to Purchasing through linked processes
After verification and validation, Design Output becomes input for other departments, such as manufacturing and purchasing. In this way, each company functions as a process of continuous improvement.

A company’s quality system should monitor effectiveness of it’s products and feed that information back into product design in a process of continuous improvement. ISO summarizes the process approach as:
For an organization to function effectively, it needs to identify and manage numerous linked processes. The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach.”
Processes should be linked to form a closed-loop system of inputs and outputs. If an output isn’t used by other processes it could be an unnecessary use of resources. In the words of MC Hammer and Vanilla ice, it’s time to Stop! that process, then Collaborate and Listen! to make team-based decisions on prioritizing value-added steps in a process of continuous improvement.
Process symbols
Process maps aren’t required, but they can help you and your team analyze any part of your quality system to ensure it’s a risk-driven process, or to look for gaps to close. They don’t have to be elaborate; simple process maps can be more effective because a diverse group of people can use them without formal training. Common flowchart symbols are shown here:

Resources
CONSULTING & TRAINING
Oriel STAT-A-MATRIX (I consult with Oriel)

MaetricsLNE G-MedMDI Consultants

Me (Jason 🙂
AUDITING ORGANIZATIONS
Summary
Processes receive inputs and creates outputs that become inputs for other processes, creating a continuous flow of information and actions.A company’s quality system coordinates these processes

The FDA and the EU-MDR require processes that reduce risk and continuously improve.
Please share
If you think this has been entertaining and useful, please link to it or forward it for others who could benefit.
Parting words
Vanilla Ice wrote at age 16.

I listened to “Ice Ice Baby” at my high school prom. It’s a fun song, but my taste and choices have evolved, especially with haircuts.

Today, I help corporation improve by becoming more efficient and innovative while reducing risk to people. I focus on life-work harmony for employees, and keep the perspective that we can help >7.6 Billion people have healthier, happier lives.
Life, like a quality system, is process of continuous improvement. I wish you well with both.

.

How 1980’s pop culture can help us make risk-based decisions in healthcare

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6 minute read.
This article uses 1980’s pop culture to describe purchasing requirements in ISO 13485 and the Medical Device Single Audit Program, MDSAP.
In the 1986 film “Crocodile Dundee,” a gang in New York attempted to rob a crocodile-hunter visiting from Australia. They flashed a knife, and he replied with a line that’s been quoted for 30 years: “That’s not a knife. This is a knife!”
Crocodile Dundee made a risk-driven decision. A flow-chart for his decision would look like this:

Medical device companies are required to make risk-based decisions by international regulations and standards, such as ISO 13485 and MDSAP, which state that all company process should be linked by a common goal of reducing risk. This article focuses on risk-driven decisions in purchasing processes, but can be applied to any department in your company.
Purchasing is important
To understand why “Purchasing” is so important for risk-based decisions and processes, consider the 1986 Challenger Space Shuttle explosion.Seven people died, including a civilian high-school teacher.

The explosion originated near a small O-ring that was allowing fuel to leak. That O-ring was purchased from a vendor, but no one in the purchasing department knew the significance of that part. In fairness, it would be hard to see the significance of an O-ring, which emphasizes that Risk isn’t just about the part, it’s about what happens if that part fails.
Regulations for purchasing
The scene from Crocodile Dundee that led to a risk-based decision, “That’s not a knife,” has been viewed two million times:

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

A ‘process approach’ that reduces risk to patients is the foundation of ISO13485 and MDSAP. Together, these programs help improve healthcare for 7.2 billion people. But, they don’t detail how to analyze risk. For that, use ISO 14971, Risk Management, and the supplement used in the European Union, EN 2012 : ISO 14971. Both include using teams to identify, analyze, and document “Hazardous Situations” in which the failure of a part would lead to unforeseen risks.
In the case of the Space Shuttle Challenger, a Hazardous Situation Analysis would have included asking “what happens if the O-ring fails?” and “what if the weather is colder on launch-day than purchasing specifications for the O-ring?” Those questions were being asked by engineers, but there wasn’t a way for their voices to be heard; modern Risk Management standards ensure a diverse team identifies, analyzes, and documents hazardous situations so they can be used by all departments. In the language of ISO13485 and MDSAP, risk analysis would be “linked” to processes used by other departments, such as the NASA launch team and purchasing departments.
That’s not a process.This is a process!
Let’s look at what ISO 13485:2016 considers a process, using a diagram provided by Crocodile Dundee’s home country, Australia, which is one of five countries pioneering MDSAP.

“Risk Management”

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

All of these risk-driven processes create outputs; each output is used by other processes within a company, sometimes in different departments, with the goal of reducing risk to patients. In other words:
A process receives inputs and creates outputs. Outputs become inputs for other processes, creating a continuous flow of information and actions. A company’s quality system oversees these processes, and uses inputs from the real-world to generate outputs in the form of improved products and services.
Risk-driven process
For more clarity on how ISO defines a process, please see my blog, “MC Hammer, Vanilla Ice, & the process approach for quality systems,” where I illustrated concepts for what is, and what is not, a process. The bottom-line is that a flow-chart is not a process; to be a process by ISO definitions, you must show that outputs become inputs for other processes in a closed-loop system of continuous improvement.
MDSAP requires evidence that your company uses risk-driven decision points for purchasing, either for high-risk parts or high-risk vendors. Examples of decision points for vendor selection or oversight include:
Is it a high-risk part?Is this a high-risk vendor? i.e., are they not ISO 13485 certified, not MDSAP audited, have a history of mistakes, etc.Is it a “Black Box” part? i.e., Is the part is assembled by a vendor, and when we receive the part are critical features hidden from our inspection process?Does the vendor use sub-vendors that introduce risk into your supply chain?
An example of a risk-driven purchasing process is:

In this example, processes are linked between departments using “Risk Management Documents,” and receive real-world input for continuous improvement through incoming inspections and CAPA’s (Corrective And Preventive Actions). Risk-driven decisions are made for vendors based on the part they’re making and their capabilities, which complies with ISO 13485, clause 4.1.5:
“controls shall be proportionate to the risk and the ability of the external party…”
In other words, risk for purchasing is a combination of the part and the vendor. You can reduce risk from purchasing in many ways, such as:
Selecting vendors that are ISO 13485 compliant or have passed a MDSAP auditOn-site inspections of their quality systemIncrease the percentage of parts inspected in your receiving departmentRequest first-article inspections for custom-made partsWorking with design engineering to reduce risk from that part
Because there are so many ways to reduce risk from purchasing, I strongly recommend starting with a plan. A plan that includes including scope, goals, team-members, etc. could be the starting point of brainstorming best ways to reduce risk. And, it’s likely that unforeseen situations may arise in your Hazard Analysis. For standardized ways to analyze risk, see my article on “Medical Device Risk,” based on ISO’s standard for Risk Management, ISO 14971. For this article on purchasing, the most important requirements from ISO 14971 and ISO 13485 are:
Start with a team-driven risk management plan, including what’s an acceptable level of risk. Remember the Space Shuttle time-line pressures? Pre-determined risk analysis reduces the human tendency to push boundaries when pressured.
Share Risk Management processes between departments through linked processes. In the example I created, “Risk Management Documents” would probably begin with Design Controls, and extend through manufacturing, purchasing, supplier audits, field maintenance, etc. Again, the Space Shuttle illustrated that one department knowing the risk was insufficient risk management because not all departments had access to that information.
Document all assumptions, ensuring there’s a process linking post-market surveillance to update assumptions. In a way, that’s what every iteration of ISO 13485 and 14971 are doing for us; they use information from events all over the world to continuously improve standards so that patients have safer healthcare.
Documentation could be done in many ways, such as with an engineering change order, ECO, following ISO 13485 change-control guidelines, and should be described in your company’s quality system. A comprehensive Risk Management policy is part of a company’s overall quality system, which is a responsibility of each company’s executive management.
Next Steps
Hopefully, Risk Management policies in your company are sufficient and easy to implement across all departments. If not, consider leading from within your company, proactively identifying ways to improve, and initiating a project to apply new standards of Risk Management. You can use compliance with ISO 13485:2016 and MDSAP to support your case, and use the resources below to help you plan.
Resources
CONSULTING & TRAINING
Oriel STAT-A-MATRIX (I consult with Oriel)

MaetricsLNE G-MedMDI Consultants

Me(Jason 🙂
AUDITING ORGANIZATIONS
Summary
Modern quality system regulations reduce risk to patients by requiring pre-determined risk management policies, links between departments, and processes that allow continuous improvement.
requires a medical device company’s quality system to be a series of risk-driven processes.Risk can come from non-obvious Hazardous Situations, as described by

Purchasing is critical for ISO 13485 and , and purchasing decisions should be traced to risk-driven processes that are linked to processes in other departments.
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Steps away from addiction

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2 minute read.
I define addiction as:
Acknowledging an action has consequences harmful to yourself or othersAcknowledging that you’d like to stop an action, then repeating the action

I took this photo in 2010 while laughing with friends after I had surgery and was diagnosed with medical conditions associated with chronic pain. By 2017 the United States was experiencing high levels of opioid and alcohol addictions, which can creep up on you if you’re not mindful. I was prescribed opiate pain medications by the Veterans Administration for nine years, then hiked over the Himalaya Mountains without them; I had surgery, again, in 2018 and didn’t use pain medications.
All addictions have moments when you can make a choice, and you can take steps towards or away from freedom. Take the following steps towards freedom:
Acknowledge that actions can have consequences harmful to yourself or othersObserve your actions and be mindful of whether or not they harm othersIf your actions could be harmful to yourself or others, try changing themIf you can’t change your actions, express this to friends, family, or healthcare providers
Obstacles to freedom include:
You’re unaware of consequences of actionsYou have a false understanding of consequences of actions

You have chronic pain, which leads to depression and addictions
You have a biologic disposition to pain or addiction: 40-60% of risk to addiction comes from genetics
You have an emotional disposition to pain or addiction because of poverty, childhood exposure to addictions, or post-traumatic stress
Defer judging the obstacles or yourself. Instead, focus on observing if there’s a problem, then solving the problem by removing obstacles, such as reducing suffering from chronic pain. Consider professional assistance or the following resources:
If someone you know is addicted, learn how to help them through Al-Anon.
Good luck; you’re not alone.

Dyslexia

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6 minute read, unless you’re dyslexic, then it’s 9
19% of us have it, and so do 55% of prisoners and many celebrities. Dyslexia has many forms, and many levels, and we may not even realize we have it. What’s saddening is the correlation between dyslexia, school dropouts, and prison.
Conversely, many famous actors, CEO’s, and entrepreneurs are dyslexic, implying there could be a correlation between dyslexia and success. Less obvious are the 20% of our friends, family, and coworkers who may not realize they have dyslexia and aren’t realizing their potential.
This article summarizes who has dyslexia, the benefits from thinking like someone who’s dyslexic, and what we can do to help anyone communicate more effectively.
Background
People with dyslexia often have difficulty manipulating sounds, poor spelling, delayed visual-verbal responding, or a combination of these traits. We’re not sure why, but it could be related to differences in eye structures for people with dyslexia, or different ways the brain can work. Dyslexic people typically have average to above-average intelligence despite reading more slowly; this may be because everyone’s brain has different regions of strengths.
This image is a simplification of brain functions to illustrate a concept. Note that the dyslexic brain has a larger “Broca’s area,” indicating stronger analysis when speaking.
Dyslexia can be passed genetically. A child can exhibit traits of dyslexia without either parent being aware.

This image is a simplified example of genetic traits not exactly related to dyslexia; it emphasizes that traits such as dyslexia can skip generations and that people can have varying degrees of traits passed through genes.
Kids ability to adapt to dyslexia depends environmental factors such as family behaviors and whether or not an education system recognizes and adapts to diverse learners.

Reading together while pointing to images helps form connections. Even better would be to have real-world situations correlating with the images and words, such as reading about a cat with pictures of a cat while playing with a cat.
Famous people
Many successful people have dyslexia including scientists, actors, politicians, and writers. Many of them

emphasizing their creativity and ability to make complex connections that written words may have hindered.

Who succeeds, and who doesn’t
Most successful people with dyslexia express gratitude that their families, teachers, or peers who allowed them to experience self-esteem during school and build upon their strengths.
Many people don’t have this opportunity at home and suffer in schools that don’t have resources to support diverse learners. The result is a high dropout rate of kids with dyslexia, often leading to prison where the majority of inmates exhibit learning disorders.
My experiences
When I read, my eyes dart across the page and I focus on context rather than individual words. This is common for dyslexia; researchers use cameras to track eye movementsthat may identify reading disorders.
When I focus on reading, it’s difficult for me to combine letters phonetically. I mispronounce words that are new to me, but develop long-term associations if I practice saying them because other areas of my brain are used for verbal processing.

If you’re dyslexic, try saying words as quickly as you see or hear them to create associations in your brain.
If I don’t practice saying the word out loud, I still retain concepts described by the word and form connections with other concepts. In other words, I don’t need to know a word to understand the concept. This has been useful to me throughout my career, allowing me to read faster, ironically, and quickly apply concepts in inventions, programs, and guiding teams. It’s also helped me empathize with people who may not realize they’re dyslexic.
I was a Court Appointed Advocate for two young adults in the foster system who were diagnosed with dyslexia after 10 years of being placed in “slow-learning” classes. They pursued their strengths outside of school, where they felt accepted, and dismissed academic pursuits, where they didn’t feel accepted. Both have been incarcerated several times, which could have been avoided if they had different learning environments at younger ages; we can help all of society by learning communication best-practices for schools and workplaces.
What to do?
Communicate differently.
Methods for helping people with dyslexia learn and communicate are also best practices for effective communication across all of society.
Use audio-visual presentations; when possible include real-world objects or contextProved frequent opportunities for others to reply verbally and confirm understanding, leading to long-term retentionIf possible, allow others to create audio-visual responses in your classroom or meeting. An audio-visual response can be as simple as a piece of paper with visual representations of concepts as they discuss their interpretations.

This image isn’t verified, but shows the concept that most people understand new concepts and retain information longer if they can create mental connections and present their understanding with immediate feedback.
If you think you may have dyslexia, try discussing new concepts without judging your ability to understand them at first. Discussing new concepts without judgement can form permanent connections in regions of your brain that associate words with concepts and allow long-term retention.
Be patient with anyone who hesitates when reading or explaining new concepts.
What to do at school
In the past, classrooms were places where students listened to teachers and did homework on their own to hopefully make connections. Progressive classrooms incorporate project-based learning, where all students learn-by-doing with frequent feedback from diverse audiences to ensure that new concepts are understood correctly and can be communicated with others.

Dyslexia advocate Dean Bragonier leads a hands-on class that puts concepts into context.
Progressive classrooms with sufficient resources encourage students to explore modern communication methods in addition to writing, such as video, animation, art, and physical projects that can convey concepts more effectively than words.
What to do at work
In the past, workplaces had long meetings, people were given written handouts, someone talked a lot, and most people used acronyms that were difficult for everyone to process quickly. Modern workplaces… well, most are still boring and ineffective.
Progressive professionals create audio-visual presentations, minimizing acronyms and jargon. They allow participants to express understanding. They fun with it because most people learn more in a fun and interactive environment.
Resources
If you have children, learn about the symptoms of dyslexia. Consider finding local schools with inclusive learning philosophy. Many will be project-based, catering to a range of learning styles, and may be free, public charter schools within close distance to your existing school.
National, online resources include:
Summary
Dyslexia:

is a difference in audio-visual processing affecting up to 19% of the populationis not an indication of intelligence or characterdisproportionately impacts low-income and minorities due to a combination of genetics and environmental factors
If your child may be dyslexic,

seek professional assessmentsat home, put context behind words and encourage diverse ways of communicatingseek schools that are inclusive of diverse learning styles and incorporate project-based learning
If you may be dyslexic,

zoxRrvW Nosres (just kidding :)Accept limitations and embrace strengths; learn by speaking and doing
If you’re in a work environment,

prepare for meetings with audio-visual presentations using minimal words, acronyms, and jargontake breaks every 10 minutes to have participants re-phrase concepts; be patientencourage team members to do the same

Remember:

I think this image is hilarious! It’s from Pinterest. But, there’s no evidence that people with dyslexia “reverse” letters. Learn symptoms of dyslexia from the Mayo Clinic.