Medsider: Learn from Medtech and Healthtech Founders and CEOs - How to Optimize Your Medical Device Approval Process

Episode Date: December 4, 2020

We're coming to the end of the throwback mini-series that I’ve been releasing over the past few months with some of my favorite Medsider guests of all time.In this discussion with Sheila Heyer, President of Heyer Regulatory Solutions and former VP of Global Regulatory Affairs at Boston Scientific, we learn where medical device companies are missing the mark when it comes to the FDA approval process. Here are some of the things we chatted about:The three most important steps you can take right now to get your medical device approved faster.Quality submissions and solid relationships: the importance of honing these two concepts in order to enhance your regulatory approval process.The key characteristics that great medtech regulatory professionals all have in common.Check out the full interview here.

One, two, three. Welcome to Medsider.com, where you can learn from a mix of experienced medical device mentors through uncut and unedited interviews. Now, here's your host, Scott Nelson. We all know relationships matter. They matter at work. They matter at home. But are relationships important when it comes to getting medical devices approved through the FDA?

Beyond relationships, what else matters when it comes to improving the medical device regulatory process. In this interview with Sheila Hamian Hire, president of higher regulatory solutions, we learn where medical device companies are missing the mark when it comes to the FDA approval process. Okay, so who is Sheila, Hamian Hire? Prior to starting higher regulatory solutions, Sheila's most recent position was the VP of Global Regulatory Affairs for Boston Scientific. This is what we're going to learn in this interview with Sheila. The three most important steps you can take right now to get your medical device approved faster. Quality submissions and solid relationships. The importance of honing these two concepts in order to enhance your medical device regulatory

approval process. What characteristics do great medical device regulatory professionals all have in common? And how can the FDA and industry work together to improve the regulatory process for medical devices? Of course, there's much more to glean from this interview. But before we dig into the interview with Sheila, you need to listen to these brief messages from our sponsors. And by the way, if you're interested in becoming a Medsider sponsor, our 2012 sponsorships are now open. Go to Medsider.com forward slash sponsor. Again, that's Medsider.com forward slash sponsor. Now listen up. First, did you know that venture capitalists are extremely hesitant to fund a startup medical device company with a direct sales force? Yes, you heard that right. You see, VCs think

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effectively use LinkedIn. Go check it out. Medsider.com slash LinkedIn. Now here's your program. Hello everyone. It's Scott Nelson and welcome to Medsider, home of the free personal medical device MBA. And on today's call, we have Sheila Hemian Higher, or Sheila Higher, who is the president of higher regulatory solutions. She was most previously, before she started higher regulatory solutions, she was most previously the vice president of global regulatory affairs with Boston Scientific. So without further ado, welcome with the call. Shekla, I appreciate you coming on. Thanks so much for having me on. So let's start with a little bit of background about what you're currently doing now with your company, higher regulatory solutions. Oh, sure, thanks. Well,

I started this company just about a year ago, and my goal is to bring my experience in regulatory affairs to the companies out there that really are in need of some good regulatory strategy, solid help with submissions, with the pre-market and post-market compliance side of things, and really I just love working with a wide variety of clients and helping them to solve their regulatory problems. Very good. That's a nice overview. Now you work specifically with medical device companies? That's correct. Okay. And is there a certain type of company demographic in regards to size where they're at in terms of the regulatory process?

No, not really. Like I said, I love the variety. I love working with companies at all stages. So the startups that are really exciting, they're getting their product going, They're really starting to weave their way through the regulatory. More assets can sometimes seem like a maze that you're in and just don't know how to get out of. And so it's really exciting to help those companies to position their product in the best possible light to really understand the regulatory requirements and help them through that process to successfully putting, sometimes their first product on the market. That's really exciting.

And then you have a larger, more established company. that sometimes just are in a period, they may have their own regulatory and compliance staff, but for some reason they need to bring in some outside help, either because they have so much to do, they need some extra hands, or they need a fresh eye on their product to help them with a new strategy,

or in actually many cases nowadays, they have encountered some problems with FDA, primarily with FDA on the compliance side of things and need some folks to come in and help them solve their problems. So I really work with a wide variety of companies and a wide variety of technologies. I think my background is general enough that I can take pretty much any type of device and help the company figure out what's the best pathway to market. Okay. And do you work with any – are you biased towards a particular special?

within the device space, whether it's cardiovascular or orthopedic or, you know, etc., or do you kind of work with all different realms? Again, no, I don't limit myself to a particular specialty. My background, I've been in this business for over 25 years now and spent 15 years of that as a consultant with Medical Device Consultants, Inc. And, again, you know, they have got a wide variety of experience at Boston Scientific. the last six years, of course, that Boston Scientific is primarily a cardiovascular company, but they also have a large neuromodulation group. They have that end of surgery group. So even there, again, a wide variety experience. So I don't really feel like I want to

limit myself to any particular specialty. It's too many exciting new technologies out there. Okay. Yeah, very good. And that actually provides a nice little segue into your background. I don't want to spend too much time kind of digging into the smaller details. But bottom line is you spent, in essence, almost your whole career within the medical device kind of regulatory niche. And can you just kind of go back a little bit and provide an overview into your background leading back to like kind of when, you know, your undergrad and then kind of the steps along the way? Sure, no problem.

So my undergraduate degree was in biomedical engineering. And then I also got a master's degree in biomechanics. And when I had finished my master's degree, I found myself in Washington, D.C., and was really fortunate to find out that the FDA had an open hiring window. And, you know, the government, from time to time, will give FDA the ability to hire a certain number of folks. and I just hit at the right time and was hired to work in the Office of Device Evaluation as a scientific reviewer. So that was my first entry into the world of FDA and really started from scratch.

I really didn't know what FDA did with respect to medical devices. So it was a great education. I was in working with orthopedic and restorative devices and also surgical lasers. So, you know, learned all about the FDA regulations. I had actually done some clinical study work prior to joining FDA, so I was able to, you know, review clinical studies, IVEs, 510Ks, PMAs. So it was a great education. And I loved working for the FDA.

My personal situation changed, and we ended up leaving the D.C. area, and that's when I started working for MDCI and worked as a consultant for many years. And then along the way, I decided I wanted to go back to school and didn't have enough to do. So I went to law school. I really looked at what would be the best pathway for me. And I loved combining my engineering and science background with the law because that's essentially. what I was doing anyway, that, you know, you're interpreting law and regulation and applying those laws and regulations to the science. So the law degree was just seemed to fit perfectly,

and it did. It helped me a lot. It helped me in terms of my analytical thinking skills, my writing skills, being able to look at two sides of the situation and be able to anticipate, you know, questions and holes in your arguments. And that's a lot of what we do in regulatory. We have to know the science background is very important to a good regulatory professional because you have to understand the technology, but also being able to present the product to an audience who may not be, and I'm talking about the reviewers, who may not be into, they have some understanding, of course, of the technology because, you know, you're presenting it to the reviewer within a particular medical specialty, medical area.

But they may not know anything about your device. But you have to be able to clearly present that information. You have to be able to make sure that you're complying with the regulations and the expectations of the reviewers. You have to anticipate what type of questions the reviewer might ask, what type of risks there may be within your submission. And so I bring the law degree in that experience really helps me to best be able to formulate that submission and, you know, comply with the regulations. So, anyway, I did that along the way, and then was very fortunate to be able to join Boston Scientific, which is, you know, a great medical device company with, you know, global.

I got a lot more experience in terms of global submission. I was able to head up a wonderful group of regulatory fairs professionals and not only in the U.S. again, but all over the world. So that was a phenomenal experience for me. Very good. Thanks for providing that background. So in summary, right after your undergrad, you spent some time with the FDA as a reviewer. Spent about 15 years, roughly, with Medical Device Consultants, Inc. got your law degree along the way.

I like how you put it in that you didn't, time wasn't an issue along the way, so you decided to go ahead and get your law degree. That's great. Well, I continued to work. I did that part-time. I continue to work in the regulatory field. Right.

And then most previous, you know, prior to starting high regulatory solutions, which is your own company, you were with Boston Scientific for about five years as the vice president of global regulatory fair. So needless to say, you're well versed in the medical device regulatory arena. Yeah, it's a great field to be in.

It's constantly presenting challenges. Yeah, no doubt. And so when you were explaining the benefits that your law degree has within your own career, your regulatory colleagues that you've worked with over the year, some of the better ones that you've worked with, do they have a law degree as well? Or what stands out to you, you know, in terms of like characteristics and background that when you look at some of your colleagues that you've worked with along the way,

you know, in terms of making someone really good within the regulatory space. You know, there certainly are some regulatory professionals that have law degrees. Not many. I haven't really met too many others. And probably because it's not a career that you have to have a law degree to practice in, as compared to, for example, patent law, which I find to be very similar. in terms of what a patent lawyer does. They represent a client to a government agency. They write patent applications.

And ironically, you do have to have a lot of degree to practice in that space. You don't in the food and drug law space. Now there are a lot of law firms now that have food and drug lawyers who do a lot of what I do. But anyway, you don't have to have a law degree to be a regulatory professional, so there probably aren't that many. But you ask a great question about what makes a good regulatory professional. And, you know, I used to say when I was at Boston Scientific, and if we were hiring into a position, particularly an entry-level position,

what I would look for first and foremost would be a science background. I do think it's important for a regulatory professional to have a science or engineering background so that they can talk with the folks they're working with, the R&D folks, the manufacturing folks. but beyond that, good writing and analytical skills are key. You have to be able to communicate clearly in written word, first and foremost, but then also verbally as well, because a lot of what you do is interacting with the regulators on the phone in meetings.

So that's what I would look for. And then, you know, I could teach someone the regulations. I didn't always need to have someone to come in, you know, already knowing the regulations. That you can teach someone. But good analytical, good writing skills, good verbal communication skills are really key. Okay. And so that provides a nice little segue into really the regulatory environment. There's so much buzz, and I'm sure you would agree, and we talked a little bit about this in our pre-interview.

There's so much buzz going on about, you know, the 510K submission process, the medical device user fees, etc., etc., etc. almost endless the amount of headlines that I read on a daily basis that pertain to the regulatory environment. So I'm going to ask you to make maybe a general comment about that, and then maybe we'll get into some specifics. Sure. Well, I mean, of course, 510K has certainly been in the news, and we could talk quite a bit about that. I think, you know, what's happening there, of course, is that as we advance, and every new technology coming out all over the place, and it's wonderful technology for patients,

we're trying to figure out how these fit into the current regulatory paradigm in the U.S. You know, and we have these two pathways. We have 510K and we have PMA. And, you know, traditionally 510K has been thought to be the quicker pathway because it's for, essentially it was designed to be, quote, Me Too devices. But a lot of these, quote, me-2 devices now have new materials, new methods of operation and so forth and so on. So even though they may fit within a 510K classification, they may raise, the new technology may raise very new questions.

And so FDA has been asking for more and more data under a 510K. So many times the 510K now looks very much like a class 3 PMA. But, you know, and companies have struggled with that. But, you know, it's understandable. The FDA, their charge is to protect patient health, to protect the public health. And they struggle. They are scientists. You know, the folks at FDA are bright folks.

They take their job very seriously. and so, and they don't, again, they don't always understand a device. And so the companies need to work together very closely with FDA to understand, you know, why FDA is asking for more data and to really provide work with FDA to get their products to market. So now, you know, getting back to the buzz about 510K, you know, getting a lot of criticism about the process, it's taking a lot longer, and so FDA has proposed several, changes they'd like to make to improve the process. Many of those were acceptable to industry, better training, for example, better guidance, clarification of different terms. And so I think that

if industry works together with FDA, we can come out with a better process. Now, interestingly, the Institute of Medicine did do their own evaluation of the 510K process, and their recommendation was basically to scrap the 510K and start over, come up with a new paradigm for lower risk products. That was not received well by FDA or by industry, the feeling as I think that that was just too drastic at this time when FDA is strapped for resources, when they've spent so much time trying to fix the process, I don't think the recommendation to start over was received very well.

So we're not sure how this is all going to come out. The IOM issued their report over the summer, and FDA is still digesting it, still working to propose what they want to do on the 15K. Sure. I think, you know, on that issue, we do need to stay tuned. And like I said, I think if industry works at an FDA willing to work together, we can come up with a really good process. Right. And so in essence, you've got, you know, on the FDA side, as you mentioned before, they're obviously acting in the best interest of the patient, which is completely understandable. And I think industry would agree in that a lot of their messaging is, you know,

ultimately we want to develop new technologies for the patients, right? And so you have two different sides. But the problem on the industry side is, you know, the submissions are getting longer. It's taking longer to get an approval. You know, certain devices have been improved in the EU and have had a CETA. and they've had a C-E mark for years and years before they're ever even, you know, approved in the U.S. A lot of companies are beginning to seek approval OUS and even go IPO OUS before they even, you know, because of, you know, and it all stems back, you know, from a regulatory standpoint.

So can these, other than communication, you know, enhance communication or working together, is there certain things that really stand out to you that, you know, would be really valuable for the FDA to maybe do and then also industry to do in order to try to make this work. Hey there, it's Scott, and thanks for listening in so far. The rest of this conversation is only available via our private podcast for MedSider Premium members. If you're not a premium member yet, you should definitely consider signing up. You'll get full access to the entire library of interviews dating back to 2010.

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