Interview with Dr. Paul Hercock
This episode is a replay from early 2022 that explains how to prepare for a great job at a medical device company. This is by far the most listened-to PNC Podcast episode released to date.
Dr. Paul Hercock is an expert at landing a medical device company job, particularly in the European Union. He even wrote a book about it called “Beyond The Ward: A Doctor's Guide to Careers Outside the NHS.”
Paul graduated from Nottingham Medical School, UK, in 2002. After initially training as a surgeon, he pivoted to a career in Emergency Medicine. He also has a law degree from Nottingham Law School.
While working as a clinical doctor, Paul became interested in medical devices. He set up and established Mantra Systems, a medical device start-up focused on improving infection control, followed by a move to full-time as a medical advisor.
Paul is now the CEO of Mantra Systems, a consultancy business that provides medical and regulatory support to medical device companies. His company employs physicians as medical advisors. He has taken what he has learned and built a training program for physicians interested in pursuing a job in the industry. It's called the Medical Affairs Associates Program.
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How to Prepare for a Great Job at a Medical Device Company
Paul's training enables physicians to adapt their existing skills to apply to this area. The Medical Device Regulation (MDR) is new European legislation. To sell a medical device, the manufacturer has to provide evidence that it's safe and effective. Therefore, it requires scrutiny of clinical evidence and reports based on that evidence.
The training program provides broad education on this topic. And it will boost confidence in your skills to be able to work in the industry.
Students can access live and recorded training webinars. The training is inexpensive. And income generated by working on one or two projects in the industry will more than cover those costs.
Also, the program is flexible. Students can participate between existing clinical commitments.
A Fantastic Nonclinical Career
The MDR has created a need for more physician advisors. The cost to start is minimal. And physicians can begin part-time, thereby NOT jeopardizing their current work. And Mantra Systems will direct you to the work opportunities, so there will be no delay in finding work.
These medical device company jobs are open to physicians in the U.S., U.K., and select other E.U. countries. Over time, you can increase your hours and ultimately do this work full-time. And Mantra Systems' Medical Affairs Associates Program will be there to get you started.
Summary
The combination of training and immediate access to medical device company jobs make this a great opportunity if you're looking to pivot to the medical device industry with minimal risk. You can learn more about the training at nonclinicalphysicians.com/mantra. If you're looking to learn how to prepare for a great job, this is an excellent option for many physicians. [Note that there is no financial relationship with Mantra Systems.]
NOTE: Look below for a transcript of today's episode.
Links for Today's Episode:
- Mantra Systems
- Mantra Systems Medical Affairs Associates Program
- MDR Regulations
- How to Prepare for a Job in the Medical Device Industry – 169
- Paul Hercock's Book, Beyond the Ward
- NewScr!pt
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Transcription PNC Podcast Episode 238
How to Prepare For a Great Job at a Medical Device Company
John: We have a fantastic interview today. I get a lot of questions from my listeners about, "Well, how do I get started in industry?" They usually mean the pharma or medical device industry when they say that. They say "I have no experience. I don't know where to apply for a job." So, this is going to be a great interview because today's guest solves both of those problems. Hello, Dr. Paul Hercock. Welcome back.
Dr. Paul Hercock: Hi, John. Thanks very much for having me back on.
John: Yeah. Because things are changing and when I heard about what's going on with you and Mantra Systems, I thought we got to get you back on. So I really appreciate you. By the way, he's in the UK. This is one of those long-distance interviews, which is working fine. So I love it.
All right. You were here last in about November of 2020, a little over a year and a few months ago. And we did talk about your book then. It's called "Beyond the Ward". It's got a longer title, but it's an awesome book. I've referred many people to it and they've really enjoyed it. And he's an entrepreneur because he started his own company and he is a CEO. But I think you've been expanding and you've got some new programs. Just fill us in since our last visit.
Dr. Paul Hercock: Absolutely. Yeah. It has been a busy year and a half. Things move quite quickly in the medical device space. And I've said to other people, one of the great things about being a comparatively small business is that you can change direction and you can move, perhaps faster than some of the big boys.
When I spoke to you last, we'd identified that there's a real need for connecting medical device companies with clinicians. Because clinicians have really vital skills in abundance that are in fact a real shortage in the medical device industry. And what we're really talking about here is the ability to work with clinical evidence at a high level.
Since I spoke to you last, that's the side of the business that we've been able to expand because our clients in the medical device industry are really, really finding value in having access to doctors, through our program, and thereby to the skills that doctors have. We've really tried to expand that side of the business and hopefully, that's creating more opportunities for doctors as well.
John: Well, it sounds like it to me. I love to hear that because my audience is just looking for those opportunities. They want to get out of clinical medicine for whatever reason. We won't go into the laundry list of why. I always use a disclaimer. I do want people to practice medicine. It's not like we want to siphon everybody off, but there's a need for physicians doing some of these nonclinical jobs. And there's a whole bunch of you out there looking not knowing what's available. So that's why this is just a perfect situation. Last time we spoke, you were doing some training, but the thing that kind of prompted this is that you have a really formalized training, expanded the training. Tell us about that. Why did you create the training, and what's going on with your industry?
Dr. Paul Hercock: Yeah. We can back up slightly and just put a bit of flesh on the bone around that. The initial requirement for this came out of a new piece of European legislation called the MDR, the Medical Device Regulation. And that's modeled quite closely on the FDA model. Which is if you're going to produce a medical device, you need to produce evidence that it's safe and that it works as it should do. And that, therefore, requires scrutiny of clinical evidence, and so on.
That's where the opportunities come from. As I mentioned before, doctors have the core skills, but they don't necessarily have the ability to translate that to a new sector. So the way you look at clinical evidence in practice is slightly different from the way you might use it in the context of medical devices.
The training is there to allow doctors to adapt their existing skills so that it can be applied to this area. Yeah, you need an understanding of, "Well, what is the medical device regulation? What does it say that medical device manufacturers have to do? What role does clinical evidence have in this context and how does it fit into everything else?" It's not possible to operate in a vacuum.
We want everyone on our program who's doing work for us, to have that broad education about how what I'm doing will fit into things. And so they understand why different bits are important. But also, to give them the confidence really, to use the skills they already have in the right way.
What we've done is, previously people who were interested in being part of the program, had access to, I would say, fairly ad hoc online training webinars hosted live, and that had several disadvantages. You and I are in different time zones. So that's one automatic problem with doing it that way. The other disadvantage is that clinicians are busy people and this program is designed to work around existing clinical commitments.
And we thought, actually, if we have this training hosted, on a server so that it's on-demand, people can access training, resources, videos, documents, everything else at a time that suits them. It means it's more flexible. And so we can encourage more people to participate in the program without a barrier, based on time or access.
John: Very nice. Let me ask you this, there might be a question about this. You're hiring people part-time and full-time to help you with this process, with doing this service. What would be the official title? Is it an advisor, or is it a medical director?
Dr. Paul Hercock: This is something that I'm keen to convey. What we're doing is we're offering a range of opportunities really, but it starts with just ad hoc contractor opportunities that people can do as and when they like. That end of the spectrum is for people who are still in clinical practice. And so it's the start point, it's to try before you buy life in the industry. We just call people on that part of the program, associates, medical affairs associates.
And so, what it means is if you thought to yourself, okay, I either want to get some experience or, hey, I've got a week, two weeks off work, or I've got some time at my disposal this weekend and next. The idea is that you can look up the program and the live opportunities that are available and register for a block of work so that you can use that time to earn a second income, but also to gain direct exposure to industry-type work.
And ultimately, what we want is to offer multiple levels to the program that do form a continuum all the way through to full-time employment, for people that are interested, for people whose skills are aligned with this kind of work. The level one foundation training, as we call it, is so that people can access entry-level work, which is mostly literature reviews and medical writing. So working with some of the technical documents that we need to put in place, and that is available to people immediately after doing the level one foundation training. But they don't need to leave their clinical careers, which means they don't need to take any risk to get experience in the industry.
John: Well, that's very helpful, obviously, because that is often a barrier to people to how do they make that transition? But it sounds to me like you put a lot of work into this. There must be some demand that's not being met. With the MDR and the changes, is there just this kind of unmet demand for these reviews and the writing and so forth?
Dr. Paul Hercock: Absolutely. This is a huge thing. What's happened is that the MDR came in and actually, it was supposed to be fully implemented in 2020, but they put it back to 2021 because of the pandemic. But the big change was this requirement to reduce a lot more clinical evidence and to interpret clinical evidence broadly. For example, it's not just the evidence related to the subject device, but the whole of the clinical background as well.
And this is something that some medical device manufacturers really struggle with. Why do we need to look at evidence related to the clinical background in so much context? And the analogy I use is to say, imagine you had a car and the car had been involved in 15 road traffic accidents in the previous three months. That's the evidence related to the car. Is that good or bad? Well, we don't know unless we get safety and performance benchmarks. And when you get into clinical background, well, that could be a huge amount of clinical evidence.
There just aren't enough people in the industry to meet this work demand. What we're able to provide, because we have this program whereby people are mostly in clinical practice, and they can be a flexible resource for us. It works the way around for them as well. We can help meet that demand as it arises without having vacant capacity. It also means, as I said before, for the doctors, who are involved in the program, it's direct exposure to something with no risk.
John: Yeah, that's fantastic. Well, now, as we mentioned earlier, you're in the UK, I'm here in the US. So I'm assuming that my listeners are assuming that I'm not interviewing someone who can't help them if they're in the US. I mean, I do have listeners in the UK and elsewhere. So from what I understand, there are definitely opportunities in both places.
Dr. Paul Hercock: Oh, absolutely. Currently on the program, we have doctors based in the UK, Europe, the US, in several parts of the US, including Hawaii, and also South Africa, and now India as well. We've had some interest from Australia as well.
But the people we have on the program from the US, honestly, and I'm not saying this just because your audience is predominantly in the US, they've been fantastic. I don't know whether that's the function of the type of training in the US or some knowledge of the way the FDA operates, which as I said before, is what the MDR was really aiming for.
But the other great advantage is that all good size medical device companies that sell in Europe either have the headquarters in the US or certainly have a presence in the US. And so there's a real draw there as well. From a client's perspective, what we would say to the client is, "Look, we can link you with a medical reviewer, a medical associate who's based in the US." That's very attractive to them. So, there are definitely, definitely opportunities for people based in the US.
John: Okay, good. Well, obviously that's one of the reasons I wanted to have you on here today. So, we could share that with my listeners and give them one more opportunity to consider when they're thinking of a nonclinical career, particularly something they can do as a pilot. That's just fantastic. Tell us more about the program and anything else we need to know in terms of considering this.
Dr. Paul Hercock: Yeah. Another reason it exists actually, and this ties to that question is that I remember my own journey from clinical practice into the industry. And there were really two things that were missing. One was knowledge of what the opportunities were, and how to get them. But the other was exposure. There's always that dreaded interview question. "Well, what experience have you got?" And it's so easy to be in a catch 22. You think, "Well, I haven't got any experience because nobody will give me the opportunity because I don't have the experience that would unlock that door." And that is a common barrier that's faced by doctors looking to move from clinical practice into the industry.
Well, this program, we think at least, can help overcome that to an extent because the work that people do on the program can be used as direct experience, and can be cited as experience. So if you are asked by a future interviewer or recruiter, "Well, what experience do you have in the medical device industry? Or how do you know you'll like this type of work?" To be able to say, "Well, actually, I've been part of teams that write clinical evaluation reports for the European MDR. I've been involved in writing reports for digital medical devices for implantable orthopedic devices," et cetera, et cetera, et cetera. That's quite strong, but also it's not just about ticking the box on a CV, people on the program themselves start to understand whether or not this type of work is for them, which is really important to know.
We have had people that have done the training, found it useful, found it interesting, but that have said, "You know what? It's not for me, but that is really useful information because I didn't know whether it was for me or not before, and now I have an outcome." Even in an outcome like that, that could not be perceived as a negative, it was actually perceived as a positive. But we do certainly have people on the program that have gone on to full-time positions using this as experience. That was really a big part of the motivation about giving access to experience to people, as well as the second income and everything else.
John: It sounds really useful and interesting. If I was only younger, I might look into that. Because of what happens sometimes, I wait till the end to share the information. I think I want to stop here for a minute and do a couple of things. First, I want to recommend everybody pick up the book "Beyond The Ward: A Doctor's Guide to Careers Outside the NHS". Just got to plug the book because there aren't that many books like it out there.
That's number one, but number two, on the medical affairs associates' program, I've got the link here and I'm going to do a shortcut, but it's at mantrasystems.co.uk/medical-affairs-associates. It is kind of hard to remember. So, I'm going to do nonclinicalphysicians.com/mantra and it'll take you right to that link. The page that's got the information has pretty much everything you need to know about it so that you can make a decision. I'm sure there's a question arising about what it costs. And because this might be listened to now or in a few weeks or a year from now, can you just give us a ballpark, of what the training might cost someone if they're looking to pursue it?
Dr. Paul Hercock: Yeah. In the end, we had to put a charge on it because as with anything you end up with a lot of people just from completely outside the scope. The other thing is, there is a slightly proprietary aspect to this as well. At the moment we charge 200 pounds sterling, for the training, which is quickly recouped when people do their very first work block. The hope is that we attract people who are really motivated and interested to take part, and we hope to maintain that cost into the future.
John: Yeah, that is so reasonable. I mean, I know courses right now in certain consulting fields and so forth, they're $1,500, $2,000, $3,000. So that's a low barrier right there if you have any interest at all.
Dr. Paul Hercock: We don't really make revenue from that. The revenue is from the work we do with clients, it's just about finding really good people to be part of the program.
John: One of the most common companies that employ people, or that use your services, what kind of devices? I'm thinking back to when we first spoke and you started doing some kind of infection control devices or something like that, but I assume that everything has evolved and there are some new products out there. So what are we looking at?
Dr. Paul Hercock: Yeah. We've been really surprised with the variety of devices that we've worked with and also the variety of companies that have come to us for this service. Our initial assumption would be that perhaps we'd be working with companies on the smaller side of the spectrum, and perhaps with less complex devices. And the reason we thought that was that the really big boys, the really big companies would surely have enough resources in-house to be able to meet this demand. And actually, those assumptions have been completely wrong. As I speak to you today, we have five active clients that are stock exchange-listed. We're working with devices of all risk classes. So class one, and the really simple devices, class three might be high-risk implantable devices and everything in between.
We've worked with digital devices. Under the MDR, a piece of software can be a medical device. So we've worked with several of those and that's actually an area that's really starting to grow for reasons we can come to. We've got a real variety. What we try to do now that we're getting bigger and the scope of work is broader, where possible we like to link a project to an associate's area of subject matter expertise. So if we have a gynecological implant, let's say, then if we can link to somebody in the associate's program who's in that clinical field and that's great value for the client, but of course, it means that it's an area of natural understanding for the person doing the work. That's starting to work extremely well, and there's no substitute for that subject matter expertise. It's yet another area where doctors on the program add huge value to our clients. And they love it, they just love it. So that's been really good.
The other thing we have access to because we're so international is different languages as well. And so some of the people on our program speak multiple languages and that can be amazing in really helping to meet client expectations. But yeah, we've had a real variety of all sorts of different companies, devices, clinical fields. And so, if somebody listening to the program is thinking, "Well, I'm in this sector, surely there won't be anything." Then that assumption is probably wrong. There is as much variety as you can imagine.
John: It hasn't matured to the point though, where you say, well, we really need to get someone with orthopedic background or some other background, pretty much anybody can do, although having that specific interest might help enhance it.
Dr. Paul Hercock: Yeah. The specific interest is the cherry on the cake. The core skills are possessed by every doctor. And it's just about understanding how to tweak and adapt those to this particular space. So, there's no need to. I worked in the emergency room, which is a clinical specialty, but I wouldn't say that would give me or someone in that specialty as much in-depth knowledge of orthopedics as an orthopedic surgeon. Of course, it doesn't. But a generalist as I would've considered myself is still well suited to this program. Definitely, we have general practitioners and people from all sorts of different specialties that are very active and happy on the program.
John: Now, here's another question about money. I hadn't thought about this before. And you, of course, can't make any promises, but let's say someone who'd been doing this for a year full-time, they're really into medical devices and this whole process, and they've mastered everything they need to know about MDR. What kind of salary range might they have working a full-time job like that?
Dr. Paul Hercock: Full-time opportunities in the industry, even at entry-level would be six figures sterling, certainly. But even through our program, the level one of the program, people working as members of teams, doing medical writing, literature review projects. We've got several people on the program that are well into five figures now. One person on the program actually takes more per year than I do. Because as a company founder, anything you earn goes straight back into the company. So people are doing pretty well.
But it's really a question of how many projects and complexity of projects and so on. Typically, people can expect four figures per project, with a project taking anywhere between four and six weeks, but that's not a course of continuous working. That might be a couple of hours at the weekend, in the evening, one day, two days a week. This is very much designed to work around somebody's existing career. And if it's getting to the stage where it's dominating life, that's not the intention.
Now, as I said before, we are putting in place a runway all the way through to full-time employment for people who want it. But that's really something for tomorrow through the lens of this particular program. But there's nothing about this program that means you only work for Mantra Systems. It can be used as a springboard to the industry in general. And all we'd ever do is show people by the hand and wish them well. This is not about us keeping hold of people and being possessive. It's just about saying, look, if you want to make a start, this is available to you. And if you enjoy it, we're happy to give you more and more opportunities. And then if it turns into something else, then that's fantastic.
John: Let me ask this question too because I think people just have to have the right expectations. When you're doing this kind of work, especially at the beginning, is it based on completing a particular project, or is it an hourly rate? How do we expect to be submitting our time?
Dr. Paul Hercock: Great question. The way we do this is that for each project, we invite people to a kick-off call, and projects are done as members of teams normally because it's way too much work for one person to do a loan. At the kick-off call, we always ask people to agree to a confidentiality agreement so that the client's interests are protected. We present headline information about the work, what's the device, what are we producing, whether it's a clinical evaluation report or literature review, or something else. We usually have divided the work into specific segments and we'd offer a segment to each person on the call. Once we do that, we agree to a contract, and in the contract will be a set fee for the work. So, people know exactly what they're going to be paid from the outset.
And we try and be really, really transparent. Sometimes we have an idea how many, let's say, literature sources will need to be appraised by each person. We divide them equally and pay people the same as each other. Sometimes we have a project that calls for a lead author. That would be extra responsibility. Normally these are people who've got a bit of experience in the program as well. They've got a few projects under their belt. The lead author might earn a little bit more, but it's not an hourly rate. It's a set fee in advance. And that reflects the way that we charge our clients because we charge them a set fee.
We have had occasions in the past where it becomes clear that initial assumptions about the amount of work were unfair, were perhaps not correct. And in that situation, what happens is that we, as the core team, take some of that excessive way. So we don't expect people to be working too excessively. The program works best if people are happy, feel like they're valued, but not so that they've been given excessive work for the pay. We think we pay very fairly for what people do.
John: I've noticed in the past at least in other forms of medical writing and in research and so forth. There is a learning curve, so you get more efficient over time. Does the same apply here?
Dr. Paul Hercock: Yeah. Massively. The first couple of projects will take longer. For the first couple of projects, we'd probably offer slightly lower remuneration as well because there's more requirement for either the lead author or for the core team, to spend more time reviewing the work. We also like to set up feedback calls as well. We take the time to say, "Look, these bits were great, but the only bit that you need to perhaps look at is these areas here. And these are the reasons why." That applies to post-course work that we require people to do after the training. And it applies to the live client work as well. And so, the idea is that it's educational and constructive, as much as anything else. And then as people gain experience and become essentially autonomous. We certainly have people in the program who produce work of such a high standard. I don't know who would be in a position to critique it really, they essentially are working on their own. To reflect that we can remunerate at a higher rate and that's what we seek to do.
John: Excellent. All right. Well, that is like a lot of different things. When you start out, you're not quite as familiar or it takes you longer to do things. You got to double-check your work. Just like a clinician. It used to be, oh, I can only see a patient an hour, now I'm seeing a patient every 20 minutes and just as efficient and accurate. That's to be expected.
Well, I appreciate you sharing all this information about the program and giving us an update. This has been fantastic. Any last thoughts you want to just say to physicians, either in general that are struggling with clinical or that are thinking about going into some aspect of the medical device industry?
Dr. Paul Hercock: Yeah. I suppose there are a few things that are always in my mind from my own experience. The first thing to say is, I'm going to use the word don't be embarrassed or ashamed even. I don't know if this applies as much in the US, it may do, but certainly, in the UK, there can be a stigma actually, to people that talk about leaving clinical practice. "How can you leave us? We're so busy. How can you even think about that?"
This is your career. And you are the only person that can have that career. It has to be right for you. Take positive steps, and that links to the second comment, which is "Act." Always make sure if you have a desire to do something, one of my favorite quotes ever is from Henry Ford, "If you always do what you've always done, you'll always get what you've always got." And I think it's brilliant. It applies in this sector so much. So you have to do something, whether it's buying a book, whether it's speaking to somebody in the industry, whatever it is. Hopefully, the program is one part of that.
And don't be afraid to fail or make false starts as well. I had so many false starts and got nowhere for so long, and that's in the "Beyond The Ward" book. But I remember it and feel as though am I ever going to find a way to use my training in another context? And so, just expect that it's not necessarily a smooth process and that's completely normal.
John: Now, those are very wise words, and I will just add my 2 cents as well. Number one, if you get into a nonclinical career, you're still a physician. And can you imagine if you're working in the medical device industry and you're helping to make a medical device safer and maybe more comfortable, whatever it might be, you're going to be helping a lot more patients than seeing them one at a time in your clinic. I'm just reiterating in a different way, what you said. And it's so true, and we've got to get over those myths and those self-limiting beliefs. We all deserve to be happy in our careers. That's for sure.
Dr. Paul Hercock: Definitely. And I think it's so important. That comment about the ability of a clinician in this context to really promote patient safety is massive. And the work that we're doing, looking at clinical evidence in a new way with the skillset of clinicians, this is things like the medical device regulation starting to work properly. This is what it was put there for. Too many people in the industry, too many companies view it as just a barrier to overcome. And it isn't because when clinicians get involved, they can say to manufacturers, "We found this. There might be a problem here or even better, this is an area where your product perhaps isn't working as well as it could do, but look what an enhanced version might look like." And that kind of value is massive to medical device companies. And so, the involvement of clinicians more and more in this sector can only be a positive. Definitely.
John: Absolutely. All right, good. We're doing great work here. It's excellent. Well, Paul, I want to thank you. We're about up with our time for today. I really thank you for taking the time and explaining all this to us and encouraging us as we move forward in whatever nonclinical careers we're doing. I guess with that, I'll just have to say goodbye.
Dr. Paul Hercock: Fantastic. Well, thanks so much for having me back on, John. I look forward to seeing you soon.
John: It's my pleasure.
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Transcription PNC Podcast Episode 238
How to Prepare For a Great Job at a Medical Device Company
John: We have a fantastic interview today. I get a lot of questions from my listeners about, "Well, how do I get started in industry?" They usually mean the pharma or medical device industry when they say that. They say "I have no experience. I don't know where to apply for a job." So, this is going to be a great interview because today's guest solves both of those problems. Hello, Dr. Paul Hercock. Welcome back.
Dr. Paul Hercock: Hi, John. Thanks very much for having me back on.
John: Yeah. Because things are changing and when I heard about what's going on with you and Mantra Systems, I thought we got to get you back on. So I really appreciate you. By the way, he's in the UK. This is one of those long-distance interviews, which is working fine. So I love it.
All right. You were here last in about November of 2020, a little over a year and a few months ago. And we did talk about your book then. It's called "Beyond the Ward". It's got a longer title, but it's an awesome book. I've referred many people to it and they've really enjoyed it. And he's an entrepreneur because he started his own company and he is a CEO. But I think you've been expanding and you've got some new programs. Just fill us in since our last visit.
Dr. Paul Hercock: Absolutely. Yeah. It has been a busy year and a half. Things move quite quickly in the medical device space. And I've said to other people, one of the great things about being a comparatively small business is that you can change direction and you can move, perhaps faster than some of the big boys.
When I spoke to you last, we'd identified that there's a real need for connecting medical device companies with clinicians. Because clinicians have really vital skills in abundance that are in fact a real shortage in the medical device industry. And what we're really talking about here is the ability to work with clinical evidence at a high level.
Since I spoke to you last, that's the side of the business that we've been able to expand because our clients in the medical device industry are really, really finding value in having access to doctors, through our program, and thereby to the skills that doctors have. We've really tried to expand that side of the business and hopefully, that's creating more opportunities for doctors as well.
John: Well, it sounds like it to me. I love to hear that because my audience is just looking for those opportunities. They want to get out of clinical medicine for whatever reason. We won't go into the laundry list of why. I always use a disclaimer. I do want people to practice medicine. It's not like we want to siphon everybody off, but there's a need for physicians doing some of these nonclinical jobs. And there's a whole bunch of you out there looking not knowing what's available. So that's why this is just a perfect situation. Last time we spoke, you were doing some training, but the thing that kind of prompted this is that you have a really formalized training, expanded the training. Tell us about that. Why did you create the training, and what's going on with your industry?
Dr. Paul Hercock: Yeah. We can back up slightly and just put a bit of flesh on the bone around that. The initial requirement for this came out of a new piece of European legislation called the MDR, the Medical Device Regulation. And that's modeled quite closely on the FDA model. Which is if you're going to produce a medical device, you need to produce evidence that it's safe and that it works as it should do. And that, therefore, requires scrutiny of clinical evidence, and so on.
That's where the opportunities come from. As I mentioned before, doctors have the core skills, but they don't necessarily have the ability to translate that to a new sector. So the way you look at clinical evidence in practice is slightly different from the way you might use it in the context of medical devices.
The training is there to allow doctors to adapt their existing skills so that it can be applied to this area. Yeah, you need an understanding of, "Well, what is the medical device regulation? What does it say that medical device manufacturers have to do? What role does clinical evidence have in this context and how does it fit into everything else?" It's not possible to operate in a vacuum.
We want everyone on our program who's doing work for us, to have that broad education about how what I'm doing will fit into things. And so they understand why different bits are important. But also, to give them the confidence really, to use the skills they already have in the right way.
What we've done is, previously people who were interested in being part of the program, had access to, I would say, fairly ad hoc online training webinars hosted live, and that had several disadvantages. You and I are in different time zones. So that's one automatic problem with doing it that way. The other disadvantage is that clinicians are busy people and this program is designed to work around existing clinical commitments.
And we thought, actually, if we have this training hosted, on a server so that it's on-demand, people can access training, resources, videos, documents, everything else at a time that suits them. It means it's more flexible. And so we can encourage more people to participate in the program without a barrier, based on time or access.
John: Very nice. Let me ask you this, there might be a question about this. You're hiring people part-time and full-time to help you with this process, with doing this service. What would be the official title? Is it an advisor, or is it a medical director?
Dr. Paul Hercock: This is something that I'm keen to convey. What we're doing is we're offering a range of opportunities really, but it starts with just ad hoc contractor opportunities that people can do as and when they like. That end of the spectrum is for people who are still in clinical practice. And so it's the start point, it's to try before you buy life in the industry. We just call people on that part of the program, associates, medical affairs associates.
And so, what it means is if you thought to yourself, okay, I either want to get some experience or, hey, I've got a week, two weeks off work, or I've got some time at my disposal this weekend and next. The idea is that you can look up the program and the live opportunities that are available and register for a block of work so that you can use that time to earn a second income, but also to gain direct exposure to industry-type work.
And ultimately, what we want is to offer multiple levels to the program that do form a continuum all the way through to full-time employment, for people that are interested, for people whose skills are aligned with this kind of work. The level one foundation training, as we call it, is so that people can access entry-level work, which is mostly literature reviews and medical writing. So working with some of the technical documents that we need to put in place, and that is available to people immediately after doing the level one foundation training. But they don't need to leave their clinical careers, which means they don't need to take any risk to get experience in the industry.
John: Well, that's very helpful, obviously, because that is often a barrier to people to how do they make that transition? But it sounds to me like you put a lot of work into this. There must be some demand that's not being met. With the MDR and the changes, is there just this kind of unmet demand for these reviews and the writing and so forth?
Dr. Paul Hercock: Absolutely. This is a huge thing. What's happened is that the MDR came in and actually, it was supposed to be fully implemented in 2020, but they put it back to 2021 because of the pandemic. But the big change was this requirement to reduce a lot more clinical evidence and to interpret clinical evidence broadly. For example, it's not just the evidence related to the subject device, but the whole of the clinical background as well.
And this is something that some medical device manufacturers really struggle with. Why do we need to look at evidence related to the clinical background in so much context? And the analogy I use is to say, imagine you had a car and the car had been involved in 15 road traffic accidents in the previous three months. That's the evidence related to the car. Is that good or bad? Well, we don't know unless we get safety and performance benchmarks. And when you get into clinical background, well, that could be a huge amount of clinical evidence.
There just aren't enough people in the industry to meet this work demand. What we're able to provide, because we have this program whereby people are mostly in clinical practice, and they can be a flexible resource for us. It works the way around for them as well. We can help meet that demand as it arises without having vacant capacity. It also means, as I said before, for the doctors, who are involved in the program, it's direct exposure to something with no risk.
John: Yeah, that's fantastic. Well, now, as we mentioned earlier, you're in the UK, I'm here in the US. So I'm assuming that my listeners are assuming that I'm not interviewing someone who can't help them if they're in the US. I mean, I do have listeners in the UK and elsewhere. So from what I understand, there are definitely opportunities in both places.
Dr. Paul Hercock: Oh, absolutely. Currently on the program, we have doctors based in the UK, Europe, the US, in several parts of the US, including Hawaii, and also South Africa, and now India as well. We've had some interest from Australia as well.
But the people we have on the program from the US, honestly, and I'm not saying this just because your audience is predominantly in the US, they've been fantastic. I don't know whether that's the function of the type of training in the US or some knowledge of the way the FDA operates, which as I said before, is what the MDR was really aiming for.
But the other great advantage is that all good size medical device companies that sell in Europe either have the headquarters in the US or certainly have a presence in the US. And so there's a real draw there as well. From a client's perspective, what we would say to the client is, "Look, we can link you with a medical reviewer, a medical associate who's based in the US." That's very attractive to them. So, there are definitely, definitely opportunities for people based in the US.
John: Okay, good. Well, obviously that's one of the reasons I wanted to have you on here today. So, we could share that with my listeners and give them one more opportunity to consider when they're thinking of a nonclinical career, particularly something they can do as a pilot. That's just fantastic. Tell us more about the program and anything else we need to know in terms of considering this.
Dr. Paul Hercock: Yeah. Another reason it exists actually, and this ties to that question is that I remember my own journey from clinical practice into the industry. And there were really two things that were missing. One was knowledge of what the opportunities were, and how to get them. But the other was exposure. There's always that dreaded interview question. "Well, what experience have you got?" And it's so easy to be in a catch 22. You think, "Well, I haven't got any experience because nobody will give me the opportunity because I don't have the experience that would unlock that door." And that is a common barrier that's faced by doctors looking to move from clinical practice into the industry.
Well, this program, we think at least, can help overcome that to an extent because the work that people do on the program can be used as direct experience, and can be cited as experience. So if you are asked by a future interviewer or recruiter, "Well, what experience do you have in the medical device industry? Or how do you know you'll like this type of work?" To be able to say, "Well, actually, I've been part of teams that write clinical evaluation reports for the European MDR. I've been involved in writing reports for digital medical devices for implantable orthopedic devices," et cetera, et cetera, et cetera. That's quite strong, but also it's not just about ticking the box on a CV, people on the program themselves start to understand whether or not this type of work is for them, which is really important to know.
We have had people that have done the training, found it useful, found it interesting, but that have said, "You know what? It's not for me, but that is really useful information because I didn't know whether it was for me or not before, and now I have an outcome." Even in an outcome like that, that could not be perceived as a negative, it was actually perceived as a positive. But we do certainly have people on the program that have gone on to full-time positions using this as experience. That was really a big part of the motivation about giving access to experience to people, as well as the second income and everything else.
John: It sounds really useful and interesting. If I was only younger, I might look into that. Because of what happens sometimes, I wait till the end to share the information. I think I want to stop here for a minute and do a couple of things. First, I want to recommend everybody pick up the book "Beyond The Ward: A Doctor's Guide to Careers Outside the NHS". Just got to plug the book because there aren't that many books like it out there.
That's number one, but number two, on the medical affairs associates' program, I've got the link here and I'm going to do a shortcut, but it's at mantrasystems.co.uk/medical-affairs-associates. It is kind of hard to remember. So, I'm going to do nonclinicalphysicians.com/mantra and it'll take you right to that link. The page that's got the information has pretty much everything you need to know about it so that you can make a decision. I'm sure there's a question arising about what it costs. And because this might be listened to now or in a few weeks or a year from now, can you just give us a ballpark, of what the training might cost someone if they're looking to pursue it?
Dr. Paul Hercock: Yeah. In the end, we had to put a charge on it because as with anything you end up with a lot of people just from completely outside the scope. The other thing is, there is a slightly proprietary aspect to this as well. At the moment we charge 200 pounds sterling, for the training, which is quickly recouped when people do their very first work block. The hope is that we attract people who are really motivated and interested to take part, and we hope to maintain that cost into the future.
John: Yeah, that is so reasonable. I mean, I know courses right now in certain consulting fields and so forth, they're $1,500, $2,000, $3,000. So that's a low barrier right there if you have any interest at all.
Dr. Paul Hercock: We don't really make revenue from that. The revenue is from the work we do with clients, it's just about finding really good people to be part of the program.
John: One of the most common companies that employ people, or that use your services, what kind of devices? I'm thinking back to when we first spoke and you started doing some kind of infection control devices or something like that, but I assume that everything has evolved and there are some new products out there. So what are we looking at?
Dr. Paul Hercock: Yeah. We've been really surprised with the variety of devices that we've worked with and also the variety of companies that have come to us for this service. Our initial assumption would be that perhaps we'd be working with companies on the smaller side of the spectrum, and perhaps with less complex devices. And the reason we thought that was that the really big boys, the really big companies would surely have enough resources in-house to be able to meet this demand. And actually, those assumptions have been completely wrong. As I speak to you today, we have five active clients that are stock exchange-listed. We're working with devices of all risk classes. So class one, and the really simple devices, class three might be high-risk implantable devices and everything in between.
We've worked with digital devices. Under the MDR, a piece of software can be a medical device. So we've worked with several of those and that's actually an area that's really starting to grow for reasons we can come to. We've got a real variety. What we try to do now that we're getting bigger and the scope of work is broader, where possible we like to link a project to an associate's area of subject matter expertise. So if we have a gynecological implant, let's say, then if we can link to somebody in the associate's program who's in that clinical field and that's great value for the client, but of course, it means that it's an area of natural understanding for the person doing the work. That's starting to work extremely well, and there's no substitute for that subject matter expertise. It's yet another area where doctors on the program add huge value to our clients. And they love it, they just love it. So that's been really good.
The other thing we have access to because we're so international is different languages as well. And so some of the people on our program speak multiple languages and that can be amazing in really helping to meet client expectations. But yeah, we've had a real variety of all sorts of different companies, devices, clinical fields. And so, if somebody listening to the program is thinking, "Well, I'm in this sector, surely there won't be anything." Then that assumption is probably wrong. There is as much variety as you can imagine.
John: It hasn't matured to the point though, where you say, well, we really need to get someone with orthopedic background or some other background, pretty much anybody can do, although having that specific interest might help enhance it.
Dr. Paul Hercock: Yeah. The specific interest is the cherry on the cake. The core skills are possessed by every doctor. And it's just about understanding how to tweak and adapt those to this particular space. So, there's no need to. I worked in the emergency room, which is a clinical specialty, but I wouldn't say that would give me or someone in that specialty as much in-depth knowledge of orthopedics as an orthopedic surgeon. Of course, it doesn't. But a generalist as I would've considered myself is still well suited to this program. Definitely, we have general practitioners and people from all sorts of different specialties that are very active and happy on the program.
John: Now, here's another question about money. I hadn't thought about this before. And you, of course, can't make any promises, but let's say someone who'd been doing this for a year full-time, they're really into medical devices and this whole process, and they've mastered everything they need to know about MDR. What kind of salary range might they have working a full-time job like that?
Dr. Paul Hercock: Full-time opportunities in the industry, even at entry-level would be six figures sterling, certainly. But even through our program, the level one of the program, people working as members of teams, doing medical writing, literature review projects. We've got several people on the program that are well into five figures now. One person on the program actually takes more per year than I do. Because as a company founder, anything you earn goes straight back into the company. So people are doing pretty well.
But it's really a question of how many projects and complexity of projects and so on. Typically, people can expect four figures per project, with a project taking anywhere between four and six weeks, but that's not a course of continuous working. That might be a couple of hours at the weekend, in the evening, one day, two days a week. This is very much designed to work around somebody's existing career. And if it's getting to the stage where it's dominating life, that's not the intention.
Now, as I said before, we are putting in place a runway all the way through to full-time employment for people who want it. But that's really something for tomorrow through the lens of this particular program. But there's nothing about this program that means you only work for Mantra Systems. It can be used as a springboard to the industry in general. And all we'd ever do is show people by the hand and wish them well. This is not about us keeping hold of people and being possessive. It's just about saying, look, if you want to make a start, this is available to you. And if you enjoy it, we're happy to give you more and more opportunities. And then if it turns into something else, then that's fantastic.
John: Let me ask this question too because I think people just have to have the right expectations. When you're doing this kind of work, especially at the beginning, is it based on completing a particular project, or is it an hourly rate? How do we expect to be submitting our time?
Dr. Paul Hercock: Great question. The way we do this is that for each project, we invite people to a kick-off call, and projects are done as members of teams normally because it's way too much work for one person to do a loan. At the kick-off call, we always ask people to agree to a confidentiality agreement so that the client's interests are protected. We present headline information about the work, what's the device, what are we producing, whether it's a clinical evaluation report or literature review, or something else. We usually have divided the work into specific segments and we'd offer a segment to each person on the call. Once we do that, we agree to a contract, and in the contract will be a set fee for the work. So, people know exactly what they're going to be paid from the outset.
And we try and be really, really transparent. Sometimes we have an idea how many, let's say, literature sources will need to be appraised by each person. We divide them equally and pay people the same as each other. Sometimes we have a project that calls for a lead author. That would be extra responsibility. Normally these are people who've got a bit of experience in the program as well. They've got a few projects under their belt. The lead author might earn a little bit more, but it's not an hourly rate. It's a set fee in advance. And that reflects the way that we charge our clients because we charge them a set fee.
We have had occasions in the past where it becomes clear that initial assumptions about the amount of work were unfair, were perhaps not correct. And in that situation, what happens is that we, as the core team, take some of that excessive way. So we don't expect people to be working too excessively. The program works best if people are happy, feel like they're valued, but not so that they've been given excessive work for the pay. We think we pay very fairly for what people do.
John: I've noticed in the past at least in other forms of medical writing and in research and so forth. There is a learning curve, so you get more efficient over time. Does the same apply here?
Dr. Paul Hercock: Yeah. Massively. The first couple of projects will take longer. For the first couple of projects, we'd probably offer slightly lower remuneration as well because there's more requirement for either the lead author or for the core team, to spend more time reviewing the work. We also like to set up feedback calls as well. We take the time to say, "Look, these bits were great, but the only bit that you need to perhaps look at is these areas here. And these are the reasons why." That applies to post-course work that we require people to do after the training. And it applies to the live client work as well. And so, the idea is that it's educational and constructive, as much as anything else. And then as people gain experience and become essentially autonomous. We certainly have people in the program who produce work of such a high standard. I don't know who would be in a position to critique it really, they essentially are working on their own. To reflect that we can remunerate at a higher rate and that's what we seek to do.
John: Excellent. All right. Well, that is like a lot of different things. When you start out, you're not quite as familiar or it takes you longer to do things. You got to double-check your work. Just like a clinician. It used to be, oh, I can only see a patient an hour, now I'm seeing a patient every 20 minutes and just as efficient and accurate. That's to be expected.
Well, I appreciate you sharing all this information about the program and giving us an update. This has been fantastic. Any last thoughts you want to just say to physicians, either in general that are struggling with clinical or that are thinking about going into some aspect of the medical device industry?
Dr. Paul Hercock: Yeah. I suppose there are a few things that are always in my mind from my own experience. The first thing to say is, I'm going to use the word don't be embarrassed or ashamed even. I don't know if this applies as much in the US, it may do, but certainly, in the UK, there can be a stigma actually, to people that talk about leaving clinical practice. "How can you leave us? We're so busy. How can you even think about that?"
This is your career. And you are the only person that can have that career. It has to be right for you. Take positive steps, and that links to the second comment, which is "Act." Always make sure if you have a desire to do something, one of my favorite quotes ever is from Henry Ford, "If you always do what you've always done, you'll always get what you've always got." And I think it's brilliant. It applies in this sector so much. So you have to do something, whether it's buying a book, whether it's speaking to somebody in the industry, whatever it is. Hopefully, the program is one part of that.
And don't be afraid to fail or make false starts as well. I had so many false starts and got nowhere for so long, and that's in the "Beyond The Ward" book. But I remember it and feel as though am I ever going to find a way to use my training in another context? And so, just expect that it's not necessarily a smooth process and that's completely normal.
John: Now, those are very wise words, and I will just add my 2 cents as well. Number one, if you get into a nonclinical career, you're still a physician. And can you imagine if you're working in the medical device industry and you're helping to make a medical device safer and maybe more comfortable, whatever it might be, you're going to be helping a lot more patients than seeing them one at a time in your clinic. I'm just reiterating in a different way, what you said. And it's so true, and we've got to get over those myths and those self-limiting beliefs. We all deserve to be happy in our careers. That's for sure.
Dr. Paul Hercock: Definitely. And I think it's so important. That comment about the ability of a clinician in this context to really promote patient safety is massive. And the work that we're doing, looking at clinical evidence in a new way with the skillset of clinicians, this is things like the medical device regulation starting to work properly. This is what it was put there for. Too many people in the industry, too many companies view it as just a barrier to overcome. And it isn't because when clinicians get involved, they can say to manufacturers, "We found this. There might be a problem here or even better, this is an area where your product perhaps isn't working as well as it could do, but look what an enhanced version might look like." And that kind of value is massive to medical device companies. And so, the involvement of clinicians more and more in this sector can only be a positive. Definitely.
John: Absolutely. All right, good. We're doing great work here. It's excellent. Well, Paul, I want to thank you. We're about up with our time for today. I really thank you for taking the time and explaining all this to us and encouraging us as we move forward in whatever nonclinical careers we're doing. I guess with that, I'll just have to say goodbye.
Dr. Paul Hercock: Fantastic. Well, thanks so much for having me back on, John. I look forward to seeing you soon.
John: It's my pleasure.
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