021- My Life With Medical Devices + Mistakes to Avoid in Development

In this episode we flip the script and I have Laura Petersen interview me to discuss the top mistakes people make in medical product development and my personal journey in the space.

  • Meghan’s personal history with medical devices [2:55]
  • Why she felt prepared to get her eye removed [8:49]
  • Why she has a medical device installed in her hip [12:16]
  • How she performed as a gymnast all through college [21:08]
  • How she got started with product development [22:35]
  • What she does at IMUA Services [27:37]
  • The top 5 mistakes people make in medical device development [30:07]

The Five Most Common Medical Device Development Wipeouts

  1. Not conducting market research
  2. Taking the wrong regulatory path
  3. Infringing on another company’s patent
  4. Ignoring formative usability studies
  5. Setting unrealistic development timelines and cost

Get the full list by texting WIPEOUTS to 44222

Guest Host:
Laura Petersen (@lsp_s) is a teacher turned entrepreneur and a life-long learner. She is a co-founder and the Lead Content Strategist at Podtent Marketing, a co-founder at Student-Tutor, and the host of the Copy That Pops podcast.

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Resources:
Meghan’s Salsa Dancing
ZeroTo510
Y Combinator
015 – Avoid a Warning Letter from the FDA with Al Alonso

Connect:
Guest Host: Laura Petersen
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Host: Meghan Alonso
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Host Company: Imua Services
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All Podcasts:
iTunes: bitly.com/InspiredbyIMUA

Podcast Transcription:

– [Announcer] Are you ready to master the waves of medical device product development? Well wax up your surfboard because you are listening to Inspired by Imua, and here is your medical device product development expert, that Hawaiian-hearted hostess who will help you hang ten, Meghan Alonso.

– [Meghan] E komo mai and aloha! You’re listening to Inspired by Imua, where we help you master the waves of medical product development. Each week we interview guests that educate, guide, and inspire to give you the skills that you and your product need to hang ten. If this is your first time listening, Imua is spelled I-M-U-A and it’s a Hawaiian word meaning to advance forward with passion despite rough waves. There are plenty of those in medical product development, but keep listening because we’ve got you covered. So today is going to be a little bit interesting interview. I haven’t done this before, but I think it’s a pretty cool idea. I have with me today someone that’s going to interview me and we’re going to talk about mistakes that are made in medical product development and how to avoid them, and we’re also going to talk more about my story and my interactions with medical devices and what drove me to do what I do today. There is a freebie download for you today. If you text the word “wipeouts” that’s all one word, W-I-P-E-O-U-T-S, to the number 44222, again that’s the word wipeouts, no spaces, to 44222 you’ll get a copy of what I am covering today just so you can reference it in the future, The Top Five Wipeouts Made in Medical Product Development and How You Can Avoid Them. Be sure to download that, and I will bring on my interviewer since I’m the interviewee. So, welcome Lara Peterson. Lara, are you ready to hang ten?

– Oh my gosh, I totally am. And, I think it’s time to flip the script and turn the tables and ask you some questions since you’re normally the one asking questions.

– All right, well I’m ready to go.

– All right, cool. Well one thing I really wanted to start with was a bit more of your background, medically speaking, because I know you say that you’ve got two different medical devices in your body personally, so tell us a little bit more about that.

– Well, so my history with medical … I’m an anomaly, or I used to joke when I was little, I said I was a mutant, because I grew an extra body part, I grew half an extra vertebrae, so it’s like a wedge shape in my spine between L4 and L5, like sticking a doorjamb in there and it changes the curvature. That’s where I get my mutant reference from. Actually my parents saved this picture, because it was just kind of funny, but it’s a picture of me as a baby sitting on a blanket, kind of hunched over so you could clearly see. The doctor wanted a picture like that every few months, just so he could monitor the growth of my spine, because I did have pretty– Well still do, have pretty severe scoliosis. That’s just that story. As far as the medical devices, so when I was born I had a folded retina in my eye. So the retina is the part of your eye that reflects light, and it’s in the back of your eye. Mine was folded so it didn’t quite reflect that light very well. I was blind in it. It looked normal, it looked like a normal eye. If you look at my baby pictures they’re just fabulous.

– I want pics to prove it, by the way. Maybe we can put something up on the show notes.

– I’ll put some on the show notes for you. Let’s see, so fast forward, I was three years-old, it was Thanksgiving weekend. My brother and my dad were out in the yard playing football and I was out there kind of pretending to chase them and pretending that I knew what was going on. I just had this incredible pain in my eye. I remember this because it was just so stark. They rushed me to the ER. They kind of knew that something was going to happen with my eye, but at that point the retina totally detached. It was just very painful, and that caused glaucoma in my eye Glaucoma usually happens when someone is elderly. Following up with the doctor after that I was going to the glaucoma specialist and here’s this three year-old running around in the office. Clearly all of the other patients are not under– There’s not anyone under 70. That was pretty interesting for the doctor, and probably kind of cool for them to work on. It’s not something that you see very often. So we controlled– No, I was not on medical marijuana at age three. I do get that question quite often.

– I didn’t even think of that, that’s funny.

– We controlled the pressure through eyedrops. So I had to take those. There is times that I would just wake up in the middle of the night, just screaming from pain. So I did that for a while, the pressure stabilized, and it just looked– I had this cataract in my eye that was silver so it looked like I had a silver pupil. I should dig out one of those pictures too and put those on the show notes page. I was teased a lot. I think I mentioned that story in episode 0. If I didn’t, then I’ll just quickly cover it right now. But I had this kid tease me every day in kindergarten and call me “Cat Eye.” One day I just got tired of it and I, I kicked him in a place that hurts for boys. The teacher saw this and had this– Immediately wanted this parent-teacher conference with my parents saying, “Oh your daughter is so violent.” She didn’t know the full story and I was crying because I thought I was in big trouble. My parents were just kind of laughing. They told me that I did a great job.

– Oh, that’s good that they supported you.

– They’ve always taught me to stand up for myself. I let it go on as long as I could and it needed to stop. So I had a huge infection in my eye when I was in college. Before that I had tried to cover up the silver pupil, I had these colored contacts, kind of like, when people in Hollywood want to change the color of their eyes, or I guess anyone can buy those now. But my contact just had a big, black dot on it that was meant to cover up that silver. I did that for a while, but then with this infection it just got really irritated and I couldn’t wear it anymore. There was a time when it didn’t– I honestly didn’t care anymore what people thought if they saw that so I just wasn’t wearing it at all. End of college this infection happened. I knew I was going to get kicked off my parent’s insurance, so I decided that it was the time to just have the eye removed and get a prosthetic made. That was a really cool procedure. It’s so funny because since that’s happened so many people tell me that I have the most gorgeous eyes they’ve ever seen, and I just kind of laugh to myself inside and say thank you. Depending on who it is, sometimes I’ll tell them, “Oh, actually this one’s not real.”

– And you, sorry to interrupt, but like you say that in such a calm way. I decided it was time to, yep, let’s have it removed. Was that an emotional, stressful time? Because I would just be beside myself. But maybe you were kind of prepared for it just because of all the problems and pain?

– I was prepared for it. It was still emotional because, more emotional because I was scared of having surgery.

– Yeah.

– I had had some doctors tell me, “You should get it removed right away.” Back even when I was in first grade. When it originally happened when I was three a doctor told my parents that they should have it taken out and they didn’t want to do that. They thought, “Well, you know, “it’s not life-threatening, it’s not hurting her too much.” Well, I mean obviously I had some pain. It wasn’t that big of a deal, and they didn’t want to do it because they wanted me to make that decision. So it had always been in the back of my mind growing up. There had always been talk around it, but I just wasn’t in that place where I was ready to do it.

– Right, and I mean the technology also got better, and better, and better as you aged. So it’s like kind of good to wait until later.

– Yeah, I am really glad I waited. Go figure, the kid– Since I did have a lot of medical problems growing up medical things just were not fun for me, and it was scary. Go figure, now I work in the medical industry and over time I just got really interested in it.

– Yeah, that is an interesting development. So the extra vertebrae, and is that managed now, or do you have another device back on that first?

– Well that, I just control the pain through that by exercise. Before I was in the medical industry I really went through some intense training for, I have a masters in exercise science. I went through probably every certification you can get in the health and fitness industry, and kind of the gold star certifications, like the certified strength and condition– Certified strength and conditioning specialist, that’s a mouthful. The American College of Sports Medicine Personal Trainer Certification, which is one of the hardest. And then also I went through Stott Pilates Certification, so I’m a full-fledged Pilates instructor, and the Stott method is a mixture of physical therapy and the best of Pilates. But they wanted to make it applicable to every body type, because the original or classical method of Pilates is more geared towards dancers and just some things are not realistic for the everyday person. I’m very diligent about that. I have a very strict morning routine where I do exercise and self-maintenance with my back. There’s not really much that they can do with surgery unless I want to have a huge fusion surgery, which that’s not that great anyway. I have a ball that I can sit on at work, I stand up at work, I take breaks often. So it’s just that preventative maintenance with that. My other device is not necessarily related to my back but it kind of is, because it’s in my hip. That, of course, when you have a doorjamb stuck in your back it’s going to throw off your anatomy. Specifically, mine is curved towards the right, so my right hip, even when I was younger. Speaking of when I was younger, I did have a great orthopedic surgeon just monitoring. Just bringing back up those pictures that my parents had to take every few months and show him the progression of my spine. So luckily, he thought gymnastics would be a good idea for me, and I was really interested in dance and gymnastics. That’s great, because some doctors would say, “No way.” But he knew a lot about exercise and how it can keep the muscles strong yet flexible. I remember, even maybe sixth grade or so, I remember getting off of the bars and just feeling my hip pop when I walked. I never had any pain, it was just this popping thing. But then in, I guess it was 2007, it really started bothering me. That’s when I was working in the physical medicine clinic, teaching patients orthopedic rehab and taking them through their own rehab process. Again, I went back to, okay well I did this for my back, let’s diagnose my own hip pain, and really work on it myself. I was surrounded by a great team, so I don’t want to say I did it myself, because I had the assistance of a few awesome doctors, physical therapists, other personal trainers, chiropractors, massage therapists, so we all worked on this together. I really tried, I tried and tried from 2007 to 2012 to do everything on my own that I could. It just kept coming back. And I knew that it was just time for surgery. I sought out the best surgeon in the world to do that. When I decide to do something I do it. So Dr. Mark Filipon in Vale, Colorado was the one that pioneered this orthoscopic surgery that I had. So what was going on with me is I had a torn labrum, which is the lining of your hip socket. So there’s this lining, it’s almost like the head of the femur fits into the socket, and when your hip is moving, that ball and socket joint has to have something that lubricates it, so that’s the acetabular labrum. There’s the synovial joint fluid in there. I had this tear, and then it was also leaking the synovial fluid, and then it had developed a bone spur on the head of my femur, making it even worse.

– And is all this because of the extra vertebrae in the back?

– Well, I also discovered that I had never, we had never analyzed my hip x-rays that well, because I hadn’t ever seen a hip specialist. He gave me the insight of, “Hey, by the way, “you have hip dysplasia.” No wonder I was …

– And that’s completely separate from the vertebrae?

– It was completely separate from the vertebrae. I was thinking, “Oh, no wonder I can do “the spits really well and I have all this great “range of motion in dance.” So it was a combination of the biomechanically I am not sound with the back, and then I have the hip dysplasia. Then on top of that, it’s just that I naturally gravitated towards gymnastics and dance, especially around that time I was on a competitive …

– Salsa.

– Salsa performing dance team.

– Around the world.

– Around the world. That was my second job, I was dancing 20 hours a week and dancing through the pain. That didn’t help either.

– What kind of pain did you have? Because you’ve got the back issue, the hips.

– So the pain felt like it was in the hip flexor, and that’s what I thought it was originally, just kind of a muscular, hip flexor type injury. It hurt in extreme flexion, like if you’re bringing your knee to your chest, and then also extreme hip extension, so if you’re kicking your leg behind you. It hurt in both of those. In Salsa dancing, on the right for girls, the step is you always take a step back with your right leg. So it’s not– As with many sports, it’s not a balanced exercise for your body, because you’re always stepping back with your right, you’re always stepping forward with your left. Now the guys are the opposite. So maybe I should have, maybe I should have dressed up like a guy and balanced that out a little bit. My surgery, what he did with my surgery is he went in there and I was hooked up to a traction device that kind of pulled my hip socket apart to give the instruments more room to go inside. He cleaned up the joint, was able to repair that labrum. So it was sewed back together with some anchors that are in there.

– What?

– Yeah, and then they shaved the bone spur down. It was incredible. I remember waking up from surgery, and they really wanted me to have movement right away. I had the surgery early in the morning, they wanted me on the exercise bike that afternoon.

– Wow.

– Sometimes they just got to take that for– Or play it by ear, see how the patient is doing. With me, I was heavily medicated, and I don’t like pain medication, it does not do well with me. I was too medicated, and I was kind of a wreck. Anyway, I was definitely not in any shape or form to get on that exercise bike. We did it the next morning. We had cut down on some of that pain medication, which, that was better. It immediately felt better. I could immediately tell getting on the bike, because it always bothered me, that range of motion before, I knew that the head of the femur was jutting up against that acetabular labrum tear. The tear was kind of hanging down into the joint and rubbing up against the head of the femur. I did not have that pain anymore. I thought, “yes, this is incredible.” Of course I had the post-surgery, it hurt, I was sore, but the pain inside the joint that I felt before was gone. That was amazing.

– And so did he leave any medical devices behind inside? Or is it just the surgical procedure to kind of clean it up and get it back?

– I have some hip anchors in there. So when they sewed the labrum back on they had to have some way of securing it. There’s some thread, which I actually know exactly– It’s made out of peek, which is a polymer that you can actually make peek into a hard medical device, but you can also have it in thread form. I have that thread with some anchors into the hip socket itself, just to hold the stitches in place.

– Wow. That’s incredible. So hip issues, spine issues, eye removed.

– Yep.

– And through of that, you’re a professional Salsa dancer, amazing gymnast. Weren’t you a gymnast in college or something. I saw something about national championships on your LinkedIn. I don’t know if maybe you were a commentator on that, or did you actually?

– I was a gymnast through college.

– That’s incredible.

– I mean this just goes to– It’s imua, baby, that’s what it is. If you want to do something there’s no reason why you can’t do it. You’ve just got to make it happen. I wasn’t going to let all this stop me. I don’t want to say that to sound– When you have pain, I did push through it too hard with the dancing, I should have stopped. It was really hard for me to do that at that point because we were going through our season on America’s Got Talent. I knew if I just got through six more weeks then I could stop and have the surgery. But if I stopped and we went back on TV then I would miss out on it. There was that, looking back on it, I probably would have made the same decision again, but it wasn’t the best decision.

– Oh my goodness, I think you need to post the videos to that as well if you haven’t yet, in the show notes, the America’s Got Talent Salsa dancing performance.

– Those are in the show notes for episode 0, so you can see that.

– Okay, so take us now to the transition. How did you then start Imua Services, and what inspired you to start it?

– I was working, I mentioned I worked in orthopedic rehab, that’s where I really learned about devices and how they interact with people, and just got more first hand view for it. The recession was happening, health care was changing. I knew, like oh great, I’ve got to get out of private practice because this– Our reimbursements were being cut from Medicare, where I worked we didn’t even take Medicare anymore because we were losing money on Medicare. So I moved over in medical devices. The first job that I got, I worked for a product development company. People would come to us if they needed their design made into a real-life product. Even sometimes taking a sketch on a napkin and turning that into a product that can be manufactured in the millions. That’s a big deal, that’s a big process. It was great for me because I got to be exposed to so many different products from orthopedics to drug delivery, like an infusion pump, or a pre-filled syringe, to diagnostic type devices. It was actually mostly diagnostics. I just like meeting with all different companies and seeing what they wanted to do, what the newest innovations in medical devices were. Which is a huge blessing, because originally I thought I would be an orthopedic device sales rep, which it’s a pretty hard lifestyle and you can get called to the hospital at 2AM bringing parts, or “Hey, well we need this kit, “it’s in San Diego, you need to drive it up to LA now, “a patient needs it.”

– Wow.

– So I’m actually really glad that I didn’t end up there. Working with these clients throughout product development, my job was to go out and get business, I was in business development. It’s kind of a combination of sales and marketing, and PR, and web development. In small companies you wear a lot of hats. I got to do a lot of that. What I was seeing with my prospects, when I was going out and talking with these people, is not everyone was ready to be a client of ours. To be a client of ours they, well number one they needed to have funding to pay us. Number two they just needed a really good understanding of the whole product development process, because we were offering one segment of that. At this point in time, the company that I still do a lot of work with now, Toolbox Medical Innovations they do a lot more and it’s more holistic development. But still, people need to know a lot of different things before they go into this. I identified that people were really struggling with that and they were asking all different kinds of questions. Since I was their point of contact, “Hey, how do I get this done? “Who do I go to for market research? “Who do I need to go to to learn how to do this? “Do you know any investors that you can point me to?” I was also getting, when I said, “Sure, I know some investors,” they would send me these 50 page documents about their product. And I thought, no one is going to read this. Obviously they needed some coaching. So I tried my best to help them, and give them resources. “Hey, why don’t you look into this program, “or this one is right by where you live, “they can really help you.” Which, there are some great programs out there. But sometimes it’s difficult. Certain programs, like there’s Y Combinator, and I learned about one just the other day called Zero to Five Ten, which they’re programs that you apply for that coach you through the whole development process. They’ll give you seed money towards the end to get your product off the ground. Not everybody has access to those. You have to apply, they only accept certain companies. So if your company doesn’t get accepted what do you do then? Maybe you can find a mentor, but there’s not a lot of mentors out there. Sometimes people are going to charge you a lot for that. I knew that there needed to be some resource out there. So I created it.

– That’s awesome. So what do you do now then with Imua Services? What do you specialize in, or what kind of clients do you specialize in helping?

– I would say, I’m going to give you a short story of someone that would utilize Imua Services. Henry is post-doc at UC Santa Barbara and he comes across this great diagnostic technology, although he doesn’t really know the commercialization side. He’s very used to writing grants, and getting grant money and working off milestones for research, but that’s not really geared towards commercialization. Those people that know commercialization aren’t really in his network either. He’s first trying to learn, what does he need to do to get it commercialized, then also he’s trying to learn, well how do I raise money for this? That’s the type of person I would work with. There’s lots of other types. Basically anyone interested in product development and just needing resources. I’m a great resource for that.

– Yes, it sounds like you’ve got great network and resource connections across the board. It sounds like you work a lot with scientists who need help with kind of the business side and the marketing side, and bringing the product to market process.

– Yeah, and not only– I used a scientist as an example, it could be an engineer. It could be someone in undergraduate, and maybe they are a business student, but they don’t have the engineering background, and just that technical background of what it takes to move a product to market. I do that. If it’s okay with you, Laura, I have something that I wanted to get into as I mentioned earlier. I wanted …

– I’m dying to hear it.

– I wanted to do a deep dive into the five most common medical device development wipeouts, and what they are and how you can avoid them. So we’ll kind of close with that, if that’s okay.

– Sounds good. Yeah, I totally want to hear that because I’m kind of a newbie to this space. I’ve listened to all of your podcasts, but I want to hear kind of like where do people really hit a wall, or a wave wall, I don’t know. You can say a wave is a wall, right?

– Sure, it is, yeah.

– Yeah.

– So the first one, and again, all of this is downloadable for you, so you can go to the show notes page. So I say the show notes page, that’s InspireByImua.com, or you can also get there from ImuaServices.com and just click on Podcasts. If you want, if you’re listening to this while you’re walking your dog, or you’re on a run, or at the gym, or in the car, you can, not while you’re driving, but you can text the word “Hangten” that’s all one word, H-A-N-G-T-E-N, to the number 44222. Again, that’s Hangten, all one word, to 44222. That will give you the sheet and it will kind of go into what I’m about to cover. So the first wipeout, or mistake, or failure, and then we all want to get back up after these anyway, so it’s not conducting market research, or not enough. So if you find this technology that you think, “Hey, this is really great, it needs to be on the market,” Well there’s a lot of different factors that determine something that is marketable and going to make profit. So maybe it is a great idea, and people want it, but can you actually sell it. So there’s stories that I can tell you on a different day, but just about something, like someone had the idea for a contact lens cleaner. It was this certain polymer that it was made out of, was combined with the saline solution, that it was meant to extract the proteins off your contact lenses, making them last longer. So you didn’t have to spend as much money buying contacts. Really, if they would have studied the market beforehand they would have learned that, okay, who are the big players in this industry? Well, it’s the saline solution and the contact lens makers. So it’s going to be very hard to sell this product because they don’t want the product to be sold. Things like that that you wouldn’t think of. The idea–

– I wonder if it’s a big enough problem for people, because there are so many disposable ones, it’s like, “Who cares, I’ll just buy new ones “instead of sitting here and cleaning it.”

– And so all that needs to be figured out beforehand. Then, again, external forces like where is the health care market headed? Right now, maybe it’s a great product and it fits into the health care system right now. But talk to the experts later on in a few years, what’s the reimbursement model going to be then? And how can your product be positioned well to anticipate that change. That’s number one. Again, that’s not conducting market research, or not enough. Number two is taking the wrong regulatory path. And this kind of gets back to who you’re working with as a regulatory consultant. You want to find one, there’s– I interviewed my father-in-law, Al Alonso, that was episode 14 or 15, and he has a background in cardiac devices, he has a background in orthopedic devices. He knows those niches inside and out. If you wanted to work with him for in vitro diagnostics he would say, no. But here, go talk to this guy. So you need to find one that’s really in line with your product, and they know how to shuttle your product through the FDA and get the submissions. Even if you’re submitting to other regulatory bodies, like the Chinese FDA, or if you’re looking to get a CE mark, those again have specificities about them that you want an expert to handle versus trying to do that yourself.

– And what’s a CE mark, real fast?

– So CE mark, you can basically turn over any product that’s sold in Europe, and you’ll see this CE, and that means they’re able to sell it in Europe.

– That’s true, and I’m in Rome so I’m going to go look at some stuff right after this interview.

– And it’s not just medical devices, it’s pretty much any product that’s over there. If you turn over your computer you’ll see a CE mark.

– Very cool.

– So number two, taking the wrong regulatory path. Number three, inadvertently infringing on another company’s patent. A thorough patent landscape check needs to be done beforehand. So if you think of a great idea, chances are today, in 2016, that it’s probably been thought of already. So even if it has been thought of already, what are some things that aren’t patented? Even if you have the same idea that someone’s already developed, what can you do differently? Or is there some sort of valve in that device that you can patent? Or is there a delivery mechanism that’s different? So that’s what you can look for. Again, a patent attorney can help with this, you can also do a Google search on patents, or the USPTO.gov, you can check there. That’s a good place to start, don’t let that hold you back.

– That’s good to know.

– Number four, ignoring formative usability studies. So I see a lot of people doing this, and they don’t think they need to do usability studies. So what usability studies are is how the user is interacting with your device. Do they use it like it’s intended without reading the instructions, basically. We need to be super careful about that in the medical and diagnostic industry because people’s lives depend on it, and if you’re not using it properly it can cause injury or death to the patient, or for the operator. There’s a story with EpiPen actually, so EpiPen had this certain cap that was– People thought it was used a different way, so first of all you’re in this high intensity situation where someone’s needing an EpiPen right away, they can’t breathe. You, as the operator, so maybe it’s your friend. So Laura, you have the EpiPen in your hand, you’re about to deliver it to your friend.

– I would have zero clue what to do.

– Well you should be able to do it without thinking about it. And they had a certain cap that clicked, and people were used to clicking it, and then the needle, you could deliver the shot, but the EpiPen had that reversed, so actually when you clicked it the needle came out of that end. So you would be the one getting the shot of Epinephrine, not the person that needed it. So this all could have been avoided by doing a formative usability study. A formative usability study is doing it when the design is still in progress, so you find out things like that that go wrong, and then you can take that data and you can go, “Hey engineering team, “can you do this differently, “because this is what we found out. “People are using it wrong.” You can correct it, the FDA likes to see that, they like to see that history. Then, “Hey great, you fixed this problem. “Okay, now run the test again, everybody uses it correctly. “All right, you’re cleared to be on the market.”

– Yeah, that sounds so important.

– You want to find out those user errors early, and often. And then the last one is setting unrealistic development timelines and costs. So a few episodes ago in episode 16, we talked with Dr. John Alderetti, and he mentioned one of the big things that he mentioned, and he just brought his product through development, he said when you’re doing cost estimates for your investors you want to double or triple what you think it’s going to cost, and that’s some great advice because it’s kind of like building a house or any construction that you think, “Oh yeah, it’s going to cost this much, “and it’s going to be done in nine months.” We all know that pretty much nine times out of ten it takes longer and it costs more than you expect. Same thing with development, you’ve got to leave that room in there for it to be a fluid process and for it to be done right. Let’s briefly cover those steps again. Number one, not conducting market research or enough market research. Two, taking the wrong regulatory path. Three, inadvertently infringing on another company’s patent. Four, ignoring formative usability studies, and five, setting unrealistic development timelines and cost Again, you can get these for yourself if you text the word wipeouts to the number 44222, or you can go on the show notes page at InspiredByImua.com and you can find it there.

– Cool, and what will they get? Will it be a list, will it be link outs to different things? Tell me about the …

– I should have covered that. This is a PDF guide. So it talks about each one of these and how to avoid it.

– Nice, cool. Yeah, and then it sound like there’s lots of different episodes to go back and get even more in depth as well if you want to hear an expert talk about different elements of those, so that’s really cool.

– Yeah.

– Awesome. Well make sure that those are in the show notes, so people can just click.

– For sure.

– Well, awesome, this has been so fascinating for me. I could probably ask you a million more questions, but we’ll have to save it for the next time.

– Sounds good. Thanks for conducting this interview all the way from Rome.

– Yeah, my pleasure. I’m going to get off the phone and go turn some stuff over and look for the …

– Look for the CE mark, yeah. Well thank you, Laura.

– Yeah, thanks for having me on.

– You’re welcome. So guys, I hope you enjoyed that episode and you’ve learned about some great resources to look into today. And if you already know them, then maybe there’s some other episodes that you can go back and listen to. And also, if you’re looking for other people to connect with, I do have a resource for that. So other people going through product development with that you can just kind of share that journey, find out what they’re going through and just support one another. So it’s at Facebook.com, you can search the group Inspired by Imua, and I’ll see you in there, or I will catch you on the next episode. So until then, Imua!

– [Announcer] Mahalo for joining us. If you are new to riding the waves of medical device product development, or if you’ve been in development for a while already, Inspired by Imua is here to surf with you. Want to be a master of the waves? Text hangten, that’s all one word, H-A-N-G-T-E-N to 44222. We’ll send you The Most Common Wipeouts Companies Make in Product Development so you can avoid them and reach master wave status. Again, that’s hangten to 44222. We publish a new episode every Tuesday, so catch us at InspiredByImua.com. Imua!

About the Author

Meghan M. Alonso

Meghan M. Alonso, referred to by Shark Tank’s Kevin Harrington as a medical device development expert, is known for her award winning medical device podcast, Inspired by Imua, the chapter she wrote in best selling book “Put a Shark in Your Tank, and her valuable connections in the medical industry. According to the Huffington Post, she helps clients navigate the complicated process of bringing their ideas to the marketplace. She’s a patriotic military wife, pet parent, founder and co-founder of 4 successful companies who thrives on guiding medical device and IVD 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, crossfitting, enjoying great restaurants and fine wine with her husband, and soaking up the sun the nearest beach.

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