Jon D. Speer is the founder and vice president of QA/RA at in this week’s Friday 5 is Jon D. Speer. He is the founder and vice president of QA/RA at The Friday 5 is an ongoing feature that poses five questions to a member of the medical device development industry.

If you’re a follower of the MDT Twitter feed, you may already recognize Speer as he’s very active in that social media space and shares many of MDT’s stories (something we certainly appreciate). When not keeping tabs on the industry at 140 character clips, he’s part of the senior management team at, a firm that, according to the company “produces beautifully simple quality management software exclusively for medical device companies.”

As if that doesn’t take up enough of his time, Speer founded Creo Quality, a consulting agency that focuses on the challenges faced by startup medical device companies. Creo offers insight on product development, quality systems, regulatory compliance, and project management. Coupling his regulatory expertise with more than 16 years as a product development engineer in the medtech space, Speer is uniquely positioned to offer critical advice for companies just getting started.

1. What are some significant changes you’ve seen in the medical device development industry since your start in this market?
Speer: Without question, the biggest change I've observed in medical device product development is the emergence of risk management. I can remember prior to ISO 14971 when EN 1441 was the go-to resource for medical device product developers. Over the past 10 years or so, risk management continues to evolve. ISO 14971 has taken hold with regulators. Yet, I still see a disconnect within product development. Don't misunderstand me; most medical device product developers are very much in tune with addressing risks. The most common practices in use, however, are not always in sync with ISO 14971.

2. What’s the most exciting aspect of the medical device industry?
Speer: Right now, the medical device industry seems to be going through a "golden age." I realize the investment funding for the medical device sector still lags the high-water mark from the early 2000s. Despite this, medical device startups seem to be booming right now. In the past few years, I have been fortunate to learn about and connect with hundreds of medical device startups. While most of these are developing high-tech solutions, many are still designing very simple mechanical products to improve quality of life.

It's exciting to see that there are maybe more inventors and entrepreneurs in the medical device sector now than ever before. The “can do” spirit and attitudes are encouraging. Especially when at the other end of the spectrum, the big medical device companies seem to get bigger and bigger with mega-mergers and acquisitions. Today's medical device startups are going to lead the way with innovation.

3. What keeps you up at night?
Speer: The medical device industry has not been too friendly for investors. I believe this is largely fueled by the regulatory environment. This is one area that definitely concerns me. The regulations in the U.S. and abroad seem to be getting more and more stringent. Yes, I know the importance of regulations to ensure medical devices are safe. The gap between the regulators and medical device product developers, however, seems to be increasing. As long as the regulations are increasing (or uncertain), this may keep many investors away from the medical device space.

4. What factor is having the most significant impact on the medical device sector?
Speer: In a word, technology. Specifically, smartphones and apps have been blurring the lines between what is and what is not a medical device. If you go through the app stores today, chances are you will find some apps that, by definition, are medical devices. Yet, I suspect that very few of these apps have actually been designed, developed, tested, and registered as medical devices.

Additionally, the wearable product market seems to be a very hot trend right now. In all of these cases, there are a lot more people developing products that fit the definition of a medical device, yet who are not familiar with medical device regulations.

The volume of these technologies is staggering too. So much so that FDA recently released several guidance documents basically admitting that it does not have the resources to effectively regulate all the apps being developed.

I think this trend is a bit concerning. I often meet inventors and entrepreneurs who are developing novel technology leveraging smartphones, apps, wearables, etc. who have no clue about regulations. And in some cases, the mindset is that the medical device regulations do not apply to them. A common misconception is that FDA is only concerned about products used in hospitals.

5. Where are we headed?
Within the next five years, I envision a collision between the current technology trend and risk management. Right now, the medical device technology sector and the emergence of risk management are not in alignment.

It's clear from a regulatory standpoint that risk management is the next big thing. I believe that risk will be front and center for a long, long time. Regulatory agencies have adopted and implemented "risk-based" approaches. ISO 14971 is accepted across the medical device world (whether 2007 or 2012 version).

While medical device product developers have been capturing risk management activities, companies have done a poor job of embracing risk management as a total product lifecycle process.


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