How to Avoid Medical Device Product Development Wipeouts with Meghan Alonso

Getting started in the medical product development process can be a huge undertaking. You might have an excellent idea, but maybe you’re unsure about where to start.

Today we are talking to Meghan Alonso, the CEO of Imua Services, a company devoted to medical device product development firm, and host of the Inspired by Imua podcast.

Meghan has a varied background in the medical field. She started out working with injured athletes during the time that she coached gymnastics. She began working at a general orthopedic rehabilitation clinic, and from there, she says she fell in love with medical devices and the impact that they were having on her patients.

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Some highlights of this episode include:

• Some of the “rough waves” that are common during the development process, including tight budgets and a lack of organization.

• Tips on how companies can choose development partners.

• Her podcast, Inspired by Imua, takes a three-pronged approach to helping those who are designing medical devices. She speaks to industry experts, companies who have already designed devices, and patients whose lives have been changed.

• The types of services that Imua Services provides, which include one-on-one meetings with clients to guide them through the product development process. Imua can help a company formulate a slide deck, write up a regulatory plan, design the manufacturing processes, reduce their costs and identify the strategies and logistics that will go into sales.

• And last, something special for the Global Medical Devices listening audience: a guide to the most common wipeouts in medical product development.

Additional Resources:

Top 5 Most Common Wipeouts In Medical Device Product Development (And How To Avoid Them)

Imua Services

Inspired by Imua podcast

Meghan Alonso on LinkedIn

Transcription:

Announcer: Welcome to The Global Medical Device podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Jon Speer: Have you ever had a wipe-out during your medical device product development? It happens. I hope you can avoid it. And our guest on today's episode of The Global Medical Device podcast, she wants to help you avoid your wipe-outs as well. Our guest is Meghan Alonso with Imua Services.

Jon Speer: She's offered a special guide for the listeners of The Global Medical Device podcast, and you can find that at Imua-services.com/greenlight. Again, Imua-services.com/greenlight. There, you will find the most common wipe-outs in medical device product development, and how to avoid them. Meghan shares some stories about how a Imua Services can help those engaged in medical device product development get to the Promised Land, and that is getting your product to market. So sit back, relax, and enjoy this exciting episode of The Global Medical Device podcast.

Jon Speer: Hello, and welcome to another exciting episode of The Global Medical Device podcast. This is your host, founder and VP of Quality and Regulatory at Greenlight.guru, Jon Speer. Today, I have Meghan Alonso. Meghan is with Imua and she is also known for her own medical device podcast inspired by Imua and her valuable connections in the medical device industry. Meghan is a patriotic military wife, a pet parent, founder and co-founder of four successful companies, who thrives on guiding medical device and IBD companies through development and manufacturing. When she isn't helping others, Meghan is hard at work on her MBA she is pursuing from Auburn University, staying active with her adorable Husky Abby, cross-fitting, enjoying great restaurants and fine wine with her husband, and soaking up the sun in Southern California beaches. Find out more about her insight, guidance, resources, and great stories at Imua-services.com. That is Imua-services.com and get her free top ten medical device development tips at that site.

Jon Speer: Meghan, great for you to join us today. As I was reading through that, I got a little jealous of "soaking up the sun on Southern California beaches." I'll have to admit, it's been a while since I've been on a beach in Southern California, but maybe I should make that happen here soon.

Meghan Alonso: Yeah, we would love to have you and I'll host you. We'll go surfing and just get in the water and escape the crazy weather that you guys are having.

Jon Speer: Well, yeah. I keep thinking spring's gonna get here any day now, here in the Midwest, and the sun's shining today and, and, but the opportunity to go surfing, yeah, I would love that. I've never been. I'm not sure I'm all that graceful on a surfboard but I'll give it the old college try. As much as we could probably spend time talking on this podcast about beaches and surfing and all that sort of thing, I'm sure our audience wants to know a little bit about your background and how you got into medical devices.

Meghan Alonso: I never anticipated that I would end up where I'm at today. When I was very young, I wanted to work at a very nice resort on a small island and live at the resort, and I achieved that dream at the age of 23. [chuckle] I worked at a resort called Four Seasons Lanai at Manele Bay and I actually did get to live in their resort, 'cause they didn't have any housing at the time.

Jon Speer: Right.

Meghan Alonso: And that was really fun. I loved hotels, although I didn't see myself moving up in hospitality. I got back to what I was good at, which was athletics and being involved in that world. I was a gymnast all the way through college, so I moved to the great state of California and San Diego and started coaching gymnastics. I was working, I actually worked with some high school, collegiate, and Olympic level athletes for human performance, and I came across some injured athletes, and that's what really drew me into the medical field.

Jon Speer: Okay.

Meghan Alonso: After that, I worked for a general orthopedic rehab clinic, got an opportunity to help start our own orthopedic rehab clinic. And from there, I fell in love with devices, saw the impact that they were having on my patients, and knew that I needed to jump over into this world. That happened in 2012, and I've been helping companies with their innovations ever since.

Jon Speer: Yeah, that's a really great story. I've shared with others before, my entry into med device was well, unplanned and I'll say somewhat accidental as well, but once you get into it and you realize, "Hey, the stuff that I'm doing is actually going into the medical devices that are saving lives or improving lives." It's a cause that is pretty easy to wrap your head around.

Meghan Alonso: Yeah, and I feel like everybody has to find their whys, I like to say. Why are you doing what you do? What's the passion that drives that? And it's pretty easy with medical devices, and you can just look around and see people and animals and a lot of different applications, testing for bio threat agents of botulism, anything. It's so applicable to our society and it's very important and very needed.

Jon Speer: Right, right. And so, you somewhat serendipitously land in San Diego. You're coming from a resort experience, not realizing that San Diego is one of the hot beds in the med device industry.

Meghan Alonso: Yeah, I got pretty lucky there. [chuckle]

Jon Speer: I mean, you got the sun, the Southern California beach, and this huge med device biotech IBD presence. And so, talk a little bit about that environment and what that's been like.

Meghan Alonso: Yeah. Well, the beach environment and the great weather, that was intentional. But the rest of it was serendipitous, as you say, and unplanned. San Diego's got a great community. We're known to be a biotech hub, as well as an area for lots of diagnostic companies, some pharmaceutical companies. And then, just up the road, in Orange County, we've got a lot of medical devices. I'm specifically in Carlsbad, which is about 35 to 40 miles north of San Diego proper, so it's a great place 'cause it's right in between San Diego and Orange County.

Jon Speer: Right, right. And I guess, as far as a little bit about your company and where Imua Services is going, talk a little bit about that and the kind of support services that you provide and how you really get engaged with medical device companies, how you help them bring their products to market. Talk a little bit about that.

Meghan Alonso: Sure. Imua Service is very new. And by the time you're hearing this, my website will have launched, as well as my new podcast. But, I started the company because I've been, like I said before, I've been helping companies through medical device and product development now for a few years and just identified lots of gaps in the process. And from the point of when someone is actually ready to start with the engineering design and development of their product, that can be a long time from that idea inception of, say, you have a scientist in the lab at UCSD here in San Diego, and they've stumbled upon some technologies that they really wanna commercialize. And they have their PhD, they're smart people, but it takes a lot to get a business started and just knowing everything of, "Okay, how do I organize myself? What type...

Meghan Alonso: Do I go for an LLC or an S corp or a C corp? How do I go through this fundraising process? Who do I need to talk to for fundraising? What about patents? What about user needs? What about market research? And then, once you've done all that, what about starting a regulatory plan, and actually getting the product built? Imua Services started to really help those people early on. And we help people in later stages too, but like I said, that those original needs came from the people that are pretty early on.

Meghan Alonso: I mentioned, I also have a podcast.

Jon Speer: Right.

Meghan Alonso: That that takes a three-pronged approach so it's all geared towards people in medical device and medical product development. We talk to experts in the industry, like Jon here, so he was a guest recently. And so they can give you insight and guidance to how to get things going, and they can also be resources for you to outsource some of the work to, or in Jon's case, it can be a great tool that can help you in development. We also talk with companies that are pretty far along in development or they've just launched a product. That can be helpful guidance to you, someone who's been through it before. And you can hear people talk about what to do all day long, but just hearing from someone that's actually been there, done that, can be a different angle. And then the last part of it, we interview patients whose lives have been changed by medical devices. That's where the inspiration piece comes into play and points back to the why are we in this industry in the first place.

Jon Speer: Right. Right.

Meghan Alonso: Constantly reminding us, hey, this is why we're doing all this hard work. This is why we've been working on this for 10 years now, day in day out. We eat, sleep, and breathe it. Yeah, no, that's great that you're able to take that full circle all the way back to the patient. I'm looking forward to listening to the podcast when it rolls out here soon. I just, not putting you on the spot, but do you have a launch date in mind for the podcast so that we can be sure to inform all the the Global Medical Device podcast listeners as to when and where to go check that out?

Meghan Alonso: By the time this airs, it should be live. I'm pretty sure it's gonna go live this Friday, as of recording. It's April 15th and...

Jon Speer: Okay.

Meghan Alonso: You can check it out. It's Inspired by Imua.com and that's I-M-U-A. And, speaking of Imua, if you're wondering what is that, Imua is a Hawaiian word that means to charge forward, advance despite rough waves. And I chose it because that kind of describes what we go through in the medical device industry. There's always waves that we need to overcome in product development. And of course, it ties back to my love of Hawaii and surfing reference.

Jon Speer: Yeah, and so, talk a little bit about... You mentioned your sweet spot is the earlier stage companies, more or less, but talk a little bit more about if I am that early stage company, what do I come to you for? How do you help me? What direction are you gonna point me in? What kind of support are you gonna provide? Can you talk a little bit more about the specifics of when to call Meghan Alonso and Imua Services?

Meghan Alonso: Yes, so we have built our website and our podcast as just a platform for information, and it's a good resource if you're just poking around wanting to know some more things about development, but specifically, how we help people one-on-one, and I like to do that one-on-one 'cause everybody is in a different spot. Whether you have a diagnostic product or a drug delivery product, or an orthopedic, it's just so specific, and then even more specific into its application. We start out with people that are either just starting out, or they're in development currently or they're pretty far along, and they're looking for manufacturing resources. We can help guide those early stage companies through, "Okay, this is the process that you need to go through. How about you do some early stage research? How about you... This is how you formulate your slide deck for when you're talking with investors," as early on as that.

Meghan Alonso: And then the people in development, really nailing down what is your value proposition to the market. Is the market going to be receptive to your product? Okay, what's your regulatory plan? Who are your development partners? Who are you working with for engineering, for your usability studies, which are actually required by the FDA now.

Jon Speer: Right. Yeah

Meghan Alonso: So your clinical trials, and we have all those resources too. If you're not working with anyone, or maybe you're hunting around for somebody better than who you're working with now, we can help you find those people because we're extremely connected in the industry. And then for those people farther along and looking to scale up to manufacturing, again, we have resources, not only in the manufacturing world, but really defining the manufacturing processes and helping reduce cost there, as well as adding value at the same time. And just thinking strategically about the logistics. Where are you selling your products? And if you're selling it solely in the US, but you want to manufacture, say, in China, that's gonna be a logistical challenge to get the products back and forth in the time you need them. Maybe you're at looking at setting, if you're looking at cost, then maybe setting up in Mexico versus China, and that way, you're still saving some money, but it's just a lot closer.

Jon Speer: Sure, right, right. No, that's great insights there. You hit on a few, and I'll use your term, rough waves, that companies encounter, but share a little bit more about what you see as some of those common rough waves that medical device companies encounter during the product development process.

Meghan Alonso: I see some people, when you just start out, especially when you're tight on budget, you need to make your dollar go as far as you can, and that certainly needs to happen, but I think some people see that and they get focused on that rather than the end goal. A lot of things can be done upfront, like not doing proper research. There's been several examples of companies who thought they had a great idea and went full bore into development and then come to find out later that, "Hey, there's not a market for this," or the reimbursement structure for this product is too much of a headache to actually finish developing it. Just backing up and making sure you go through the proper steps is a big one.

Meghan Alonso: Another one, which Jon and Greenlight guru can help out with, is a quality management system and just having that in place, because it's not only is it necessary for the FDA and other regulatory bodies to have document history files and everything leading into what is involved with this product, but it just helps you to stay organized as a company, too, and especially if you're dealing with... You formed this company. You had some investors, and then some more investors came in. People left, you got new people in. Just in terms of having one space for all of these documents to live is so critical rather than relying on somebody's Word doc on their computer and somebody else has this Excel file on their computer. And again, with those people, moving back and forth, things might get, well, often get lost in translation.

Jon Speer: Yeah. No, and you hit on a couple of things that... Let's dive into a little bit deeper. The company that's just getting started that has, we'll say, limited funds to begin with, and yet, they're pursuing this medical device journey. I think one of the things I try to educate, 'cause of what I'm hearing from you and the conversations that you and I have had prior to today, a big part of what you and I do is about just help educate and inform. Because sometimes others wanna jump into this medical device arena as well, especially inventors and entrepreneurs and such, but you need to understand what that means when you do that. There's certainly a cost associated with bringing a medical device to market, that can be pretty substantial, even for a very simple technology. Number one.

Jon Speer: Number two, you hit on a couple other key points, the need to establish things like a quality management system, and documentation for your design controls, and risk, and so on. Those are entry level, those are barriers to entry, I guess, to the market, but they're also required expected behaviors from FDA and other regulatory bodies. And sometimes it really surprises me when a company says, "We've never done this before, but we're gonna try to figure it out and surely, we'll be just fine. It's just a couple of spreadsheets. We'll be good to go." And they try to make some progress on their shoestring budget, and then they realize, "Oh crap, we need to raise about another five million and go through a lot of testing and clinical studies and all that sort of thing before we can get a market." I'm just always scratching my head how that can be such a surprise sometimes, you know.

Meghan Alonso: Yeah, and it does happen a lot. And part of that is not necessarily the company itself, but just again, you wanna find the right people to really help you, whether it's a VC firm, angel investor, whether it's a development partner or any company that has resources you use, you wanna vet them and make sure that they're the right fit for you. And sometimes, the sources that people are getting money from aren't helping them along, and so they need to find out that information from other resources. And that's, again, one of the reasons why I wanted to start Imua Services.

Jon Speer: Right, right. I think you and me alike, we're both in this space where it's all about value. You have worked very hard in your career in the med device space to build a ton of value and you focus a great deal on doing all the vetting for all of these different resources, development partners, and manufacturing resources. And for somebody else to just jump in and do what you already have done would be a difficult and time consuming thing that, well, frankly, they don't have to because you've already done it. Talk a little bit about the work that, the foundation that you've laid on how companies can choose development partners and why Imua Services is a great resource for them to come to, to help with those types of tasks.

Meghan Alonso: Well, we're very connected in the industry and we've been around so that we're able to know based on what type of product you're developing, what goes around that. There is common threads that everybody needs to have. Everybody needs to have a regulatory plan and a quality management system, and everybody in devices, they need to go through engineering, and then you need to scale up and either bring in manufacturing in-house or go to a contract manufacturer, but then there's specifics around that. For instance, my father-in-law is a regulatory and quality assurance consultant and he has his specialties. He's done a lot in orthopedics, a lot in cardiovascular, but he doesn't know In Vitro Diagnostics, for instance. I would send them somewhere else.

Jon Speer: Right.

Meghan Alonso: And you don't wanna mismatch and for a company just starting out, that hasn't been in the industry, they don't know necessarily who to go to through, so they need to do a lot of homework. And my site and my podcast is based on being that one single resource where you can go to and you can find out, "Okay, this is my product. Who do I need to go to?" Versus, "This is what I'm building over here. Who do I need to go to?"

Jon Speer: Right, right. No, that's great. That's one of the things that I realized many years ago, when I started my own consulting practice as well, is being a guy that knows where to point a start-up, an entrepreneur in early stage can be, where to point them, where to guide them, how to direct them, there's a lot to be said for that because that start-up wants to get, number one, we already talked about. They have limited funds to begin with, and they might wanna get the most value and the most bang for their buck, so to speak. Being able to point them in the direction that aligns with their budget and their resources, that's a pretty key thing to be able to do.

Jon Speer: Yeah, and another example is, if you are developing in a cutting edge knee replacement, well, there's a different engineering method for that. Maybe you're dealing with titanium or different metals or hard plastics, versus, if you're developing an In Vitro Diagnostic device that is dealing with reagents and samples of blood or urine or saliva, it's a totally different animal, even though it's in the same umbrella industry.

Jon Speer: Right, absolutely. Alright, so you told me to throw this out there and you had a surprise, something that you wanted to give our listening audience. You didn't really tell me what that's all about. Do you want it to still be a surprise, or do you wanna give it away? How do you wanna, I guess, share this information with the listeners of the Global Medical Device podcast?

Meghan Alonso: I've created a special guide. It's the most common wipe-outs [chuckle] in medical device product development.

Jon Speer: Keeping up with serving theme, huh?

Meghan Alonso: Yes. [chuckle] The most common wipe-outs in medical product development and how to avoid them. You can access that. You can go to Imua-services.com. Again, that's Imua-services.com/greenlight.

Jon Speer: Nice.

Meghan Alonso: That's where that document will live and you can go there and access it, download it from there.

Jon Speer: Yeah, and we'll make sure...

Meghan Alonso: Especially for your listeners.

Jon Speer: Great, thank you for doing that and we'll make sure, in the text that associates this podcast, that we'll be sure to put a link there too, so that people will have access to that. I appreciate you doing that. Meghan, anything else on your mind that you wanna share, kind of a last minute tip before we wrap up our conversation today? The gotcha or a wipe-out [chuckle] that you want med device companies to be aware of, especially as you've been growing your business and establishing this podcast, and continuing to work within the industry. What wipe-out should I try to avoid that you can share right now with me?

Meghan Alonso: Hmm... A wipe-out that you can avoid.

Jon Speer: I know, I just put you on the spot, didn't I? I mean, we'll say it another way. Is there one common thing or theme that you hear or see over and over and over again, that you just want to make sure that the listeners of this podcast take care of and deal with, because it's something that you just hear so often?

Meghan Alonso: Yeah, so that, I would say, start with the end in mind. What is the product gonna look like? What is it gonna feel like in the end? And we'll work backwards in development.

Jon Speer: Well, that's pretty good advice. And I think that aligns very well with a design control strategy, understanding how your user needs feed into the entire process and align with your indications for use and intended use. Meghan, I appreciate you being the guest today on the Global Medical Device podcast. Again, folks, check her out. It's Meghan M-E-G-H-A-N Alonso, A-L-O-N-S-O. You can find more about her company at Imua-services, again, that's Imua-services.com and check her out on LinkedIn. Reach out to her and be sure to take care and get that free wipe-out guide that she's published by going to be Imua-services/greenlight to learn more.

Jon Speer: This has been Jon Speer, the founder and VP of Quality and Regulatory at Greenlight.guru. Greenlight.guru has an amazing software platform that makes managing your entire quality management system, your design controls, your risk management, so easy and so simple that it's really hard to imagine how much your life is going to change after you start using Greenlight.guru. Be sure to go to Greenlight.guru, request the demo, learn more about our software package, and how that can help save you hundreds of hours over the next 12 months of your life. Again, thank you for listening to the Global Medical Device podcast.

About The Global Medical Device Podcast:

The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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