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:

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

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.

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

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

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.

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

CONSULTING & TRAINING

MaetricsLNE G-MedMDI Consultants

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.

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

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:

$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:

$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:

$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

BSITUV

CONSULTING & TRAINING

MaetricsLNE G-MedMDI Consultants

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.

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.

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:

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

MaetricsLNE G-MedMDI Consultants

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

Please share

If you think this has been entertaining and useful, please “like” it, link to it, or forward it for others to benefit.

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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.

Actors, athletes, & celebrities with dyslexia include:

Alysa MilanoJennifer Aniston

Cher

Mohamed AliTom CruiseJay Leno

Entrepreneurs, CEO’s, innovators, & self-made billionaires with dyslexia include:

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:

International Dyslexia AssociationParent’s Education NetworkUniversity of Michigan’s Dyslexia tests

Summary

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.

5 minute read.

This is the history of hope, happiness, and politics. It starts with the caste system in Nepal and ends with how to recognize truthful hope.

The caste system

and learned that Nepal was recovering from a ten-year civil war, had a new democracy, and would be voting for the second time in their history.

All over Nepal, people hoped for a better life from their new democracy. They discussed life, religion, and politics near temples while street-workers sewed strands of flowers.

The flowers were purchased by people on their way to or from work, who would leave them at the temple as offerings. They did their duty, and helped the person selling flowers do their duty. This exchange dated back thousands of years, and is how the caste system views work.

In the caste system, you do the work your father did, who did the work of his father. Your children will do your work.

You can not marry outside of your caste. Your name includes the work you can do.

You hope that by doing your duty you’ll be reborn into a higher caste.

The caste system has been Hindu doctrine for almost 4,000 years, and was Nepali law until recently. But, Nepali people still obey the rules of their former caste system.

OBEY!

His Obey logo became a popular clothing line. To be inexpensive, clothing was made in China, which borders Nepal and provides most of the cheap clothing worn by lower castes.

Over the next month, I saw people use the OBEY brand to keep warm as they persevered through manual labor, tedious tasks, and shoveling human waste. All came from families of the lowest castes. Despite the caste-system being illegal, their suffering persists. They hope for change, which was exploited as justification for a civil war while people continued doing their work.

Hope

The Greek gods tormented humankind by giving us suffering in Pandora’s Box. They put Hope in the box, too, because hope prolongs suffering. False hope is what keeps a boxer fighting when there’s no chance of winning, taking punch-after-punch while spectators watch.

Many people misinterpret hope as something positive, but hope was made attractive to entice us. Greek writers warned us about hope and fruitless effort with Sisyphus, who is still being punished by the gods. Each day, Sisyphus carries a rock uphill, hoping he’ll reach the top. Every evening, it rolls back downhill. The gods don’t need prisons; Sisyphus obeys his gods because he has hope.

Hope & Change

Charlie Brown has been hoping to kick a football held by Lucy since 1950. He misses because Lucy intentionally moves the football. Millions of fans know he won’t succeed but enjoy watching him try; we are Charlie Brown’s gods.

The creator of Peanuts sent a message to society for 50 years. He used the words “Hope!” and “Change!”when satirizing politics; those words are still used by politicians today, and we still continue to believe in false hopes.

Modern Sisyphus

Politicians use our desires to their advantage, promising hope, change, and to make things great again. We then obey their rules, wars, and calls for a stronger economy that do not bring more happiness.

Hope keeps us trapped. We don’t enjoy the present moment because we hope for a better job, more money, better possessions, and more happiness.

We send our kids to school, not be happy in the moment, but hoping they learn skills that will get them a job that will make them happy, one day.

To be free from the trap of false hope, seek truthful hope.

Truthful hope

There are differences between false hope and truthful hope:

False hope speaks to our desires; truthful hope speaks to our intellect.False hope speaks about the future; truthful hope begins with the present moment.False hope gives goals without a practical path; truthful hope has small steps, with each step being an incremental improvement.

This isn’t new: 2,600 years ago Prince Siddhartha Gautama rejected the caste system in Nepal and India, teaching people to avoid extremes by following the middle-way. His teachings became Buddhism, the world’s 4th largest religion, not an external deity or god, but on human intellect. Siddhartha’s advice was:

“Each day, do more of what you know to be wholesome, and do less of what you know to be unwholesome.”

To do more of what’s wholesome, seek truthful hope that applies to your unique situation in life. Be mindful of each moment, aware of your thoughts and motivations; do not be swayed by politicians, advertisements, or situations that speak to desires rather than intellect. Plan for the future, but don’t become attached to it. View life as an adventure where nothing’s certain except the present moment. At that point, you’ll be able to look at the promises of hope and change objectively, to see them for what they really are, and you’ll know what to do to escape the cycle.

When there is no desire, all things are at peace. – Lao Tzu

I’m making this up as I go. – Indiana Jones

Peace.

JiP