5 Lessons from a “Lost”​ Game of Thrones Script Dated May 26, 2017 – the Day the EU MDR Came Into Force (a humorous read)

A portion of a lost, alternative script was found recently, so I’m told

In this version of the script, the character Jon “David” Snow becomes the 998th Lord Commander of Evaluations of the Night’s Watch in Game of Thrones Season 05, Episode 02, which was supposed to premiere May 26, 2017.

One photo was found of Jon David Snow from this episode. Facial recognition software suggests it bears a striking resemblance to this article’s author when he attended a recent Halloween party.

After narrowly winning the vote, he slowly moves to the front of the darkened room. Less than half of those in the chamber did not vote for him and many just hate the new Lord Commander. There is silence.

He has an introspective, reflective and cold look on his face as he remembers that the European Union (EU) Medical Device Regulation (MDR) comes into force today. It gives manufacturers three years to meet the new requirements.

The enforcement deadline for compliance with the EU MDR is May 26, 2020. That deadline is looming large for many in the room. Some think it is a long time away. Others, like Jon David Snow, have more immediate concerns. He turns around and raises his finger for dramatic purposes.

Jon “David” Snow Addresses the Room

“My name is Jon David Snow, Lord Commander of Evaluations. We are not friends. We have never been friends. I suspect we won’t become friends today. This is not about friendship. This is about survival. Survival from the MDR White Walkers.

I give you this bag. Please pass it around. This is a gift. In it, you will find daggers made of Valyrian Steel or as you know them, sufficient clinical evidence daggers. One of my servants used this to kill an MDR White Walker. 

Shortly afterward, a small group of Notified Bodies known as Wildlings started chasing me. One of them, a very desirable, known and appealing one, started shooting arrows at me, telling me that, ‘You know nothing about the MDR, Jon David Snow.’

I know in my heart that those Notified Body Wildlings are not our enemies. They have their unique concerns with the MDR White Walkers themselves. We need to work together.

It is not the MDD/AIMD Kings and Queens that we should fear now. It is those White Walkers! The only known weakness that the MDR White Walkers have shown thus far is that they are killed instantly when struck with ‘sufficient clinical evidence’ weapons made of Valyrian steel. 

Don’t forget your past submissions. They were hard and it took time; time away from the ones we love. I won’t forget mine. What I am asking you today is to think about your future submissions. Winter is coming. MDR is just around the corner. Certificate renewals are coming. New product submissions are coming. It will not be like it used to be.

Your senior leaders can’t stop it. Our associations can’t stop it. Lords, Presidents, and CEOs can’t stop it and none of their knights can either. Notified Body Wildlings cannot stop it (He pauses to look at several Notified Body Wildlings in the room).

Only together, all of us, can we overcome this and even then, it may not be enough. But at least we will give those MDR White Walkers a fight. Who is willing to stand with me?”

Those in the room start chanting, thumping and pounding the tables, “Save our device. Save our device. Save our device!”

A raven suddenly flies into the room delivering Jon David Snow a message. It simply states, “EUDAMED will be delayed two years, but you won’t hear about it until Q4 of 2019.” The scene ends.

 

Lesson 1 – MDR date of application is coming

Characters in almost every other episode allegedly quote that the MDR “winter is coming,” referring to the date of application being May 26 2020. While you shouldn’t spend all of your time worrying about the future, you need to be mindful that hard, stressful, difficult times can happen, usually at the most inconvenient moments. It is the only way you can be prepared for them. If you need statistically and scientifically sound, compliant clinical data you have a few choices. Take a risk-based approach and use surveys (e.g., Likert), big data from large hospital networks (e.g. 1MData), investigator-sponsored studies, national registries, or single-arm or randomized clinical investigations. Some devices may require several approaches. Be sure to get the question correct in terms of what you are asking and ensure it aligns with either filling in a gap or helping to better understand the current information that exists on the device.

 

Lesson 2 – The mind needs the MDR like the sword needs a sharpening stone

Take the time to read the EU MDR and more than once. The preamble tells you why we need this legislation. The articles inform what needs to be done. The annexes suggest how to do it. Knowledge is power. The medical device directives have been out since 1990 and 1993 and we spent years discussing, challenging, and questioning that legislation. We will do the same for the EU MDR too, but a fundamental principle will be that you need solid, first-hand knowledge of what is written. Don’t rely on what others say it says.

Lesson 3 – A device’s death comes for everyone

Don’t get too emotionally attached to your medical device as it exists today. Iterations, advances in technologies, and changes in the state-of-the-art will occur. Quality management systems are set up to be living systems with one goal of incorporating feedback into medical device design. Challenge the device. If you don’t ask the right questions, you won’t get the right answers. Be analytical and critical of the inputs and outputs into the quality system and provide both alternatives and innovative solutions.

Lesson 4 – Sometimes you have to answer the call when it comes

Like Jon David Snow, usually, time picks you. You don’t pick the time for greatness or opportunities within an organization. The industry needs your personal leadership today. Optimism is not data. Confidence is good. Facts on your side are better! We are long past the days of relying on, “We believe the device is safe.” The EU MDR Chapter VI, Article 61, Annex I, and Annex XIV clearly speak to the need to have evidence or clinical data to base decisions on.

Manufacturers shall specify the level of clinical evidence. It needs to be aligned with the characteristics of the device and intended purpose in order to to demonstrate conformity to General Safety and Performance Requirements (Annex I). Discussing these requirements with senior leaders and those controlling budgets requires your leadership. Preparing for the MDR is like laughing with your family and friends. You never have enough time. Plans need to be in place, and execution on those plans is urgent.

Lesson 5 – Listen to your Notified Body

If the Notified Body wants chocolate, quit trying to sell them vanilla. One of the best ways to persuade a medical or scientific reviewer is with your ears—by listening to them. Scrutiny has never been higher, and decisions made by the Notified Body on why devices were approved and what levels evidence they required will become transparent to all when reported publicly through the new MDR-required Summary of Safety and Clinical Performance document for implantables and Class III devices (Article 32).

It’s Okay If You “Know Nothing”

It’s not an insult. The medical device world is vast and full of different cultures, histories, and viewpoints. We have the EU MDR, and although it is filled with useful and great information, there is still much to learn. You should always be open to learning and listening to other perspectives. We will figure this out together as Jon David Snow implies.

A closing thought. Finding clinical data or evidence in your clinical evaluation or technical documentation should not be a scavenger hunt for the reviewer. Remember, the value of your company is determined, in part, by the quality of your data. Survival from the MDR White Walkers is possible, but not simply by saying, “We believe our device is safe and performs as intended.”

Working together with your Notified Body and listening to their current interpretation of the EU MDR is an approach that could increase the likelihood of successful applications if they contain the evidence necessary to make those approval decisions. Draw your Valyrian steel “daggers of sufficient clinical evidence” now, all of you who are willing to fight! Survive the MDR White Walkers.