Medical Devices

Industry Viewpoints: The Keys to Running a Start-up Med Device Company

Medical Devices

12:00, June 28 2017

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CTA sits down with a clinical professional who describes the challenges of running a virtual company

CTA sat down with a clinical professional from a medical device company that, up until recently, was entirely virtual. In a compelling interview, below they discuss a range of issues, from the practicality of running a virtual company, to the challenges medical device companies face in getting a product into the market.

Clinical Trials Arena: Explain some of the difficulties in working for a virtual company

Industry Expert: There are various challenges that I face on a regular basis. In terms of virtual companies, they have a set of challenges that are specific to being virtual. I would say that communication is an imperative. There are different methods in which people can communicate, such as teleconferencing, which is very helpful. It’s also important because it’s very easy for misunderstandings to arise based on a phone conversation when you don’t see people’s reactions. A lot of the times over the phone, people can speak over one another and it becomes an issue of practicality, and how to get people to express their opinions in an organized manner. Getting visual feedback is essential not only from just being organized, but also to gauge whether people agree with you from body language and facial expressions.

CTA: What other challenges do you face in your role?

Industry Expert: You have to ensure people are productive. We have people who are hired and others who are contracted. Some of our core staff at the beginning was contracted because we were a virtual company. I think if we started our company all in one place, we might have had few contractors to begin with. It’s nice to have people with specialized skill sets. While on the surface it’s good to have contractors, I think over time, you want to have those people to be part of your company, part of your ethos, and have them in-house.

Furthermore, it’s very expensive to have people scattered all over the place where they’re constantly travelling (from a contractor perspective, but also in terms of travel expenses). But that’s the nature of the beast as we’re all travelling frequently. Trying to keep the costs in line with what your goals are is important, too. You want to make sure everyone is productive and on the same page.

Given all I’ve said, I think one of the biggest challenges is finding qualified people to work with the team. People can really make themselves look great in an interview. They may list their achievements, but it’s hard to know, from a qualification standpoint, and even from a personal interaction standpoint, whether the people you’re interviewing (and later hiring) will be good fits for your team.

In this area, people can be all over the map with their skill set, and for some people, as much as you vet them, you can never be sure whether they’re a good fit for your team.

CTA: What are your thoughts on the trial process for a medical device compared to a drug?

Industry Expert: There’s so much talk about pharma, but not a lot about device, and device is hard. That isn’t to say pharma isn’t hard, but with most pharma companies, they possess deep pockets and work with long timelines. For example, in an orphan drug clinical trial, pharma companies are dealing with a relatively small patient population.

For medical devices, however, you’re looking at getting an approval for a device that will impact millions of people. So you have to do your trials differently, you have to be more efficient, you need people who are on the ball; the problems are innumerable. There’s a lot of work to do, a lot of requirements and regulations to follow, and it seems there’s not a lot of discussion on how to streamline processes for med device companies. While pharma companies of course have their own challenges, med device companies face challenges that are singular.

CTA: How should the med device industry go about streamlining processes?

Industry Expert: It’s a challenge because we rely on our clinical sites. Hospitals are busy and don’t have a lot of time to do research. There are a lot of them that do like to do it, but are bogged down by new requirements and regulations to see more patients, to move quicker, to do more work in a shorter amount of time. When it comes to doing a clinical trial for a sponsor, I don’t feel they have a sufficient support network in their institutions to do that. And I even mean academic institutions that are very slow; their IRB approval process can take a year, so how can you do research when you’re dealing with those sorts of roadblocks? There can be a lot of bureaucracy in institutions that deal with a higher volume (of staff).

It’s really difficult to study new devices and indications when under such time constraints and it doesn’t support further study, and it’s a real problem. How do you fix these problems? I don’t know. These are multifaceted issues on how medical practices function. There are no easy answers in this  environment of diminished returns and decreased reimbursement from insurances for the same amount of work. So you have to do double the work to get what you were reimbursed before leaving little time to do other things.