#143 | Global Medical Device Research

ATTENTION:  Below is a machine-generated transcription of the podcast. Yes, here at Rapport International we talk a lot about how machine translation lacks quality. Here you see an example of what a machine can do in your own language. This transcription is provided as a gist and to give time indicators to find a topic of interest. 

 

Wendy: Hello, listeners of The Global Marketing Show. Thank you for returning. We're going to have a good episode today. We're going to be talking a lot about, strategies and marketing, in the medical device industries. But before we get to that, just want to remind you that The global marketing show podcast is sponsored by Rapport International a company that connects you to anyone Anywhere in the world in [00:01:00] over 200 languages with high quality written translation and spoken interpretation services and normally, we have a tidbit but today Rapport International Has requested that we talk a little bit about ChatGPT translations and AI. 

And it's just a reminder that if something is important, if it is going to affect your revenues, your liability, your bottom line, make sure to get a human involved. Call an agency like Rapport International to review the work before you release it. Because we are hearing about instances where there has been deaths and lawsuits and, issues with not making sure that your translation is high quality. Anybody that's bilingual has seen the potential problems with it. So on to, our learning time for today, we have as a guest, Maria Shepherd, who is the founder and CEO of Medi-Vantage, a company that helps develop disruptive medical [00:02:00] devices and marketing strategies. 

So she's worked in senior roles at Oridion Medical, which is now Covidien or Medtronic, at Phillips Medical, Boston Scientific, and she's also touched and impacted every phase of the product development life cycle, from concept testing to requirements gathering, prototype evaluations, and product positioning and pricing. 

So I'm really looking forward to this conversation today. Maria, welcome so much. I'm glad to have you here.  

Maria Shepherd: Glad to be here. Thank you so much, Wendy.  

Wendy: Yeah. So in addition to running this company that has global impact, which we're going to get into, you are co-founder of MedExecWomen in the Boston area. 

Why don't you tell me a little bit about that and how you ended up co-founding it?  

Maria Shepherd: So, throughout my years in medical devices, I tried very hard to be able to get involved with female focused organizations, to try to make change at the top of [00:03:00] medical device organizations to be able to get more women involved in the executive suite. 

 It was great to be able to organize those meetings, but they didn't have a lot of impact. So I finally learned that the best way to be able to foster change was to, do it from, try to do it from the top down. I learned about an organization called MedTech Women on the West Coast. After working with them over a year or two, I was able to get, permission from them to copy their model. 

So a shout out to MedTech Women. And I brought the idea to a couple of people, here on the East Coast, specifically Marlou Janssen, who was then president of Biotronik, Mary Beth Moynihan, who is a CCO of Boston Scientific and Laurie Halloran, who was the president of, Halloran Consulting, to be able to assist me and start starting up our first meeting for MedExecWomen. 

Our goal was to be able to pull up more women [00:04:00] to create a community. for women in the executive space and pull up more women into MedTech executive roles. Our first meeting was in New York in 2019. 83 women showed up at that meeting when we had no PR whatsoever. It was all word of mouth. That's when I knew that we had discovered an unmet need and that this was a community that was waiting to be developed. 

COVID got in our way. But in 2021, we had our second meeting, where we had very strict COVID protocols and over 100 women show up for that meeting. Since then, the organization has been growing. In April, 2024, we had over 200 women join us in Boston and we expect to have many more next April in Boston, please join us, in 2025. 

Wendy: Oh my gosh, that's fantastic. Talk about identifying a need and pulling together a community. I love hearing that. [00:05:00] But it's not the only thing you've started. Why don't you tell me about Medi-Vantage and what your company is and does.  

Maria Shepherd: We've been in business now, Medi-Vantage, for 16 years. 

 We do med tech strategy research. We work in the medical device diagnostics. Digital health, now called health tech, depending on who you're talking to, and drug delivery space. We work along the continuum of commercialization from developing marketing specifications, so engineers can develop great products that hit the ground running when they get to market, through reimbursement, price strategy, go to market strategy. 

Any other type of research that might be needed, like portfolio strategy to be able to choose what the next generation product features will be, all the way out to working with, medical device companies that are acquiring new technologies that want to have clinical [00:06:00] due diligence done on the companies they're thinking about acquiring so that they can make sure that the end users. 

Needs are met by the technologies they think about acquiring.  

Wendy: Yeah, so you do a lot and if a company is going to be successful and how to do it and you work internationally, right? Can you tell me a little bit about your international reach?  

Maria Shepherd: Yes, we do Our clients are from Japan, from Australia, from, several, countries in the E. U. and of course, here in the United States, because. The United States is the most homogenous market, , in the world. So we are global, and we do research, in many of these countries.  

Wendy: Okay. And can you give me, like a story, I know you have a budget impact model, which is really impressive. 

Can you talk to me about one that you've done for either a company coming into the US or one that you've done for in another [00:07:00] country for that?  

Maria Shepherd: Sure. Sure. So a budgetary impact model is something that is, very closely related to what is the price that your technology is going to charge. And sometimes we are able to derive a price from it. 

But, I'll give you an example of one that we recently developed. This was a device that is designed to be able to tell, OBGYNs Whether or not, they need to go to C-section or not. Right now the decision to be able to have the mother have a C-section is largely based on the clinical decision making of, the doctor, the surgeon, and here in the United States, 36 percent of all births are done by C-section. 

That's much higher than the 24 percent that we see globally. So the goal and many hospitals are working on this right now, to be able to reduce the number of C sections to the lower number [00:08:00] that is seen globally and the lower number of 24 percent that many doctors say is normal and reasonable. 

So this, device, tells the physician when they should be going to, do a C-section. And because the device is so very different and really quite disruptive, the budgetary impact model shows what the economic value is of this particular device by taking the price of the device. 

And applying to it, the costs that are incurred by C-section, breaking it down into one, one or 100 procedures and taking into account what the actual costs are to the hospital of an actual C-section. There are many more medications. There's sometimes stays in the ICU. The complications can be formidable. 

 We quantified all of those and put those into the budgetary impact [00:09:00] model because oftentimes. Because nobody really sees an alternative to c-section, they don't sit down and figure out what if we didn't have to do this c-section. We put that into the budgetary impact model. Then there's the costs to the mother, of complications of death or extreme impairment or long hospitalization. 

 By the way, death is rare, but it does occur. And then there is the impact on the baby, a stay in the NICU, which can be profitable in some NICU stays, but for excessively long NICU stays, don't turn out not to be all that profitable at all. Then, , because, cerebral palsy is so closely associated with C-sections, we factored that in also and the litigation involved with cerebral palsy, for babies and other complications involved with birth, with C-sections, when it occurs during the birthing process. We were able to [00:10:00] show that this device to be able to reduce the number of C-sections to the more accepted number of 24 percent from 36 percent saves the hospital an extraordinary amount of money and takes out of the physician's hands, the need to make that decision, about whether or not to have a C-section by having this tool to help them decide, because ultimately the physician is the final decision maker about whether or not the mother should have a C-section.  

Wendy: That's amazing. I could see that analysis being really helpful for developing the marketing materials for that or the positioning for it,  

Maria Shepherd: right? 

Wendy: Yeah, absolutely.  

Maria Shepherd: Another area that we work in and that it's a real sweet spot for us is on price strategy. So once we did the budgetary impact model, it became much clearer what price would [00:11:00] be sustainable in the US hospitals, the client had not because the client was going to be launching in the US. He only asked us to figure out what the US price should be. Now we're a global company. We have to figure out also what the global price will be because Pricing is so transparent now, there was a time back 20 or 30 years ago when you could price for the US and do other prices for other parts of the world. 

But that's not true anymore. You really have to be quite careful about how you do pricing. So we were able to determine from the budgetary impact model. What price, the company we recommended to the price. Ultimately, the price is decided by the executive management of the company, but we make recommendations on pricing, with, supporting data to be able to show them why we recommend those prices. 

Wendy: Okay. So that's fascinating. What you just said is that pricing is so much more transparent around the [00:12:00] world. So how, when you're going into doing a research project, do you take into account the global marketplace for pricing? Because insurance and reimbursement and availability and all of that is so different around the world. 

 How do you go about Starting to look at that.  

Maria Shepherd: It's not easy. You take into account what the, reimbursement rates are. You take into account what types of insurance plans are available. There's many, many different factors, but what you want to be sure is that you've got guardrails in place. 

 You know, you can find data for this particular product, what C-section rates are, because everything was based on the C-section rate, and then we took a look at what the actual costs were for, complications. Complications are pretty standardized around the world, although we do a very [00:13:00] good check on whether or not the complication rates are similar in the EU or in Japan to be sure. So we do spot checks on that type of thing, just to make sure that we're not proposing a price that, won't have good fit in some of the first world countries around the world when it comes to third world pricing. It's quite different. Sometimes no matter what type of pricing we propose will still be just too expensive. 

And then it will be up to the management in those countries to figure out how to make the pricing fit for sales in those countries.  

Wendy: The management of your client company to figure that out, right? Because you can't drop the price to sell it in a developing country because then if it's got approval in the US, people from US hospitals could buy it from someplace else at a cheaper rate, and then you're undercutting yourself. Is that kind of what you're saying?  

Maria Shepherd: Well, you know, when you take [00:14:00] a look at pharmaceuticals that are sold at a high price here in the United States, and this is a very simple explanation. 

but if you buy them in Canada, you can bring them back down into the United States for a far lower price. Yes, that situation could exist with these types of devices, although it'd be more complex.  

Wendy: Oh, okay, with doing the cross border, transfers, but that's still why the med device, med tech companies are looking for more of a global pricing. 

Maria Shepherd: Yeah, it's because, like I said, because it's so transparent. What gets sold in India is those prices are available to economic buyers here in the US or in Germany or in in France, for example, or in Japan. So, you know, if you're going in and you're selling to those companies in the EU or, in the Asia Pacific area, [00:15:00] they're going to know what those steeply discounted rates are. 

So you've got to come up with a different strategy.  

Wendy: Yeah. And so what is a different strategy that you could do? Because if the management has to come up with that, what are some of the things they're doing?  

Maria Shepherd: Well, there are different strategies and without going into too much detail, there are things that you can do, such as, providing the capital equipment, on a complimentary basis with the, purchase of, the disposables. 

, if that's relevant. You can do a subscription model. So there's ways to be able to do it, that's transparent also to US buyers and they might want to be able to purchase that in that method also, although many US hospitals don't like, subscription models, for reasons I won't go into now, because there's many, many reasons why. 

Wendy: Mm hmm. All right. So, pricing. The budget impact model was [00:16:00] interesting because with the C-section avoidance device, they'll call it for lack of privacy name, you know, we're not naming it, that you could take the numbers out and you could plug them in and you could get a global plan. 

The pricing, you've got to think global about that. Has this changed? Like, you've owned your company for 16 years. Have you seen big changes in the global marketplace over that time?  

Maria Shepherd: Oh, yes. Not even so much in the pricing, but, you know, reimbursement. We hire experts in every country that we go to, to be able to do reimbursement work because every country is different. 

 So we're always hiring subject matter experts. That's a big part of the value proposition that we offer to our clients. We have to have experts in order to be able to provide, strong service to our clients.  

Wendy: Right. Yeah. That makes a lot of sense. So the changes you've seen are about [00:17:00] reimbursement and how to do the research on that. 

The pricing. What other changes have you seen and that are in the global marketplace that are affecting your clients?  

Maria Shepherd: There was a lot of change brought by COVID, but COVID really just kind of ripped the Band Aid off. All of those issues were still there. But there's been many, many changes. 

 Different standards of how you go about selling in different countries. There are so many changes. All of our big companies like Medtronic, Boston Scientific, others are all, very global. They manage their companies, with an eye towards, you know, being a truly global company, which 20, 30 years ago, they aspired to that they may not have been able to do it as much because the communications and the skill sets probably weren't there, but they certainly were developing because they have really reached high levels of [00:18:00] expertise.  

Wendy: Okay. along with, all the changes in the globalization, I mean, companies are truly going global and I see it in fundraising. 

I see it with companies still struggling how to be truly global rather than multinational. What about in the M and A area? You know, what are you seeing in that area?  

Maria Shepherd: Well, we work for MedTech companies that are acquiring new MedTech technologies, we work for them doing clinical due diligence. 

So what they want to know from us is, does this technology meet the needs of the end user? Um, does it meet the workflows? What could go wrong with using this technology that the end users could tell us? And how do we dig into how this technology performs in the hands of the medical specialty that will be using it, and get a full report on how that works? 

We work [00:19:00] very quickly. We're very small. So we don't have, a large group who will know, you know, if they're in a quiet period when they're not talking about. The acquisition. So we're small enough to be able to keep all this quiet and work undercover. And since we're highly clinical and we only have medical device people working for us, we're able to dig into the technology because we understand the processes of how you use a technology in surgery or whatever the medical specialty is. 

 For example, one of our clients was looking at a technology that on the surface looked really, really great. It was a technology that required two in-hospital procedures originally and the original procedures were two in-hospital procedures, but this new technology was going to take that to one in-hospital procedure and finish it off with an in-office procedure at the doctor's office.[00:20:00]  

That sounds really great for the US healthcare system. And also globally too, because the standard of care was a global standard of care. But they wanted to know, is this a situation where the technology is going to be, accepted by the physicians that are using it? 

How do they feel about taking this product from two hospital procedures to one hospital procedure and one in-office procedure. And by the way, how did the hospital administrators feel about it? We pioneered 15 years ago, 16 years ago now, doing hospital administrative research, to be able to make sure that the economic, buyers were also champions of, what the product was able to do for the hospital. 

What we found out was that the doctors didn't mind too much going from one hospital procedure to an in-office procedure as long as they got paid, but the hospital administrators didn't like it one bit. They [00:21:00] wanted to keep those procedures in their hospital because they needed the revenues. Also, what the doctors didn't like was the second one became an in-office procedure for another medical specialty. 

And that was not, doable for the doctors because for them, it had been two hospital procedures for them. Now it was going to be one hospital procedure for them. Then the patient was supposed to go to another medical specialty for the second procedure. So, on the surface, it looked very, very positive. 

But for the doctors and the hospital administrators. It was not a positive procedure. We dug all this up. We presented it to the company. This is only the second time that we ever said we recommend you decline this acquisition. Most of the time we just say, Hey, this looks great. 

Uh, here's a couple of gotchas in here. This will probably affect your valuation. We don't do valuations. We just say, this is how your valuation is [00:22:00] affected. And then they can figure that out themselves.  

Wendy: That is fascinating. I mean, that's really interesting information when you're going through an M & A (mergers and acquisitions) because people are going to push it off for reasons you'd have no idea. 

Maria Shepherd: It would take a long time to for the sales reps and the marketing people to figure that out. And, um, usually what happens is, like I said before, we'll do our due diligence and there will be a couple of gotchas in there. There always are. It's the hospital system. But this one was a doozy. 

Wendy: Yeah, that really is. So it simplifies, but it also is sad that is that best for the client or is it best for the, self interest of the providers and that it is. Sad to look at. 

Maria Shepherd: It an output of our fee for service hospital system. And that has to be changed from the top. In [00:23:00] time hospital administrators and doctors have to work with what they've got. 

So I don't blame them for pushing back on that, right? The hospital system needs to be changed, but they're not going to be the ones that do it.  

Wendy: No, no, because that's the system they're operating on. And so if they try to, change it in isolation, that's not going to work. Now would that device work in other countries or is there similar, well, that's a hard hypothetical to do because you don't know. 

Maria Shepherd: Well, it's hard to say. Like in Germany where they've got a pretty well established reimbursement system, it might not, in the NHS. And notice I don't say in England's system because all of the European systems have a large private, a decent sized private insurance system. But the NHS is a public system, so maybe, maybe it would work well. 

It would reduce costs. so that would have to be tested in each one [00:24:00] of those systems. So you could sit down and you could see which one of these is very reimbursement-based. In this particular case, we, we projected global impact, but we did not do global research to support that projection.  

Wendy: Right, right. You know, it is a global marketing, show . And so I always ask about kind of translation and language. Do you get into any of that area and the research that you're doing, or are you still doing it all in English? And how do you advise companies in that area?  

Maria Shepherd: We do. When we're doing research in other countries, we will hire translators. 

Almost all the research we do is qualitative research, so if we are interviewing someone in China, for example, or in Japan, or really in any country where the language is not English, even though I speak a little bit of French, I would never interview somebody in French and rely on my own [00:25:00] French speaking skills. 

I would always hire a French translator because I want to be sure that I get every single little nugget, you can't rely on your own language skills unless you are somebody who is clinically trained. And, has been educated in that language,  

Wendy: Right? Okay. So you're really hiring professionals that have medical, expertise in interviewing. 

Maria Shepherd: Yeah, right. Because I believe that when you hire somebody to translate in an interview for you with a medical professional that has to be somebody who has a translator. If you're trying somebody who speaks Italian, it also has to be somebody who understands medical terminology in Italian and in English. 

Wendy: So, you know, it was a good, good introduction from Rapport International Sponsorship. Would you absolutely AI or chat GPT?  

Maria Shepherd: Um, I do use those tools. [00:26:00] Absolutely. For translation. For translation, you know, I don't trust them so much because I use them, but only if I can tell what the result is. 

I have one AI tool that I use that gives me references. That's great because any research that we do, we have to have references for everything. My reports to clients are loaded with references, because they need those. They're clinical, and scientific reports. And so that part is critical. 

Wendy: Right, right.  

Yeah, so what advice would you have for a medical device company that was looking at going international, a US company, and then we'll flip flop it for an international company coming into the US?  

Maria Shepherd: I would say there are, consultants like my company, that can help you, with the tools that you want to [00:27:00] develop. we will help you develop your marketing tools, your budgetary impact models, your value propositions. The impact of selling a medical device can be quite substantial. 

 So it's important to be able to seek out the people who can do the best for you, who understand the medical device specialty. You know, I'm a subject matter expert in 12 different medical specialties. I understand interventional cardiology. I understand gastroenterology. You want people like that to be advising you. 

 When I'm working in orthopedics. I hire an orthopedic subject matter expert to be able to, bring products into the United States. And to bring products into the EU I would hire somebody who is an expert in that country, but also a subject matter expert in that medical specialty to be able to assist that process. 

Wendy: Yeah, and we're coming to [00:28:00] the end of our time, and, I appreciate that advice because that's certainly true, you think, a consultant, but make sure they have that expertise. so I'm going to jump over because I asked this question to everybody who's on the podcast. What is your favorite foreign word? 

Maria Shepherd: That word is makesh. Um, Makesh is, an Arabic word that means there isn't any, and the first time I was in North Africa, and I went to a restaurant, I looked at the menu, and I asked for a certain dish, and they said makesh, which means there isn't any, and then I asked for another dish, and the answer was makesh. 

And so finally I ordered the lamb and there was, that was there. No, I ordered the chicken. Because you can absolutely get chicken at a restaurant in North Africa. But the point of me remembering this word. Is that in the United States, you can get almost anything, but that's not true in the rest of the world and the rest of the world, makesh [00:29:00] is almost the standard and how lucky and fortunate we are to be so, gifted with everything we've got.  

Wendy: Yeah, yeah, that's a good, good point to remember. And, if you're listening to this and you're outside of the country, since I have heard that we're downloaded in over 70 countries, probably close to 80 by now, come to the US. Come, come, here and order and learn. But that's another topic. 

So Maria, where can people reach you? Do you want to share your website or your LinkedIn? Or where can people reach you if they'd like to learn more and have a conversation with you?  

Maria Shepherd: They can come to my website, they can email me. Do I just give them my email address here?  

Wendy: Sure, yeah, why don't you spell it out? 

Mm hmm.  

Maria Shepherd: It's mshepherd@medi-vantage.com. I miss a lot of emails because of the spelling of my last name. So it's M-S-H-E-P-H-E-R-D at medi [00:30:00] vantage, V-A-N-T-A-G-E.com.  

Wendy: Thank you. So yes. And then your website would be www.medi-vantage.com.  

Maria Shepherd: Correct, and you can click on info in there and contact us also.  

Wendy: Okay. Yes. It's a very good website and I've known about you for years and this has been a fabulous podcast. I mean, your information is so valuable and the services that you provide. I mean, the level of research that you're doing is absolutely fantastic. I appreciate you sharing the stories and talking us through some things to look out for when you're crossing borders. 

So thank you so much for taking the time today.  

Maria Shepherd: Thank you very much. [00:31:00]