035 Medical Device Development Advice: Roundup from Experts at the Medical Device and Investor Forum

Ever wanted to get advice from lots of medical device development experts or find out what mistakes they see over and over again?

Well, I asked, and have it here for you. While at this year’s OCTANe Medical Device & Investor Forum in October, I collected audio from a VC investor, mechanical, software, firmware, electronic, and optical engineers along with strategy consultants.

Got an idea for a medical product and wondering how to get started and how to get funded? Find out in our new “Invention Idea to Profitable Product” program for FREE as a beta tester. Hurry as space is limited!

  • Quick reminder: Eight days to go for the Application period for IIPP (Invention Idea to Profitable Product) [2:02]
  • Dac Vu’s greatest piece of advice for startup companies [3:17]
  • Francisco’s take on what the biggest mistakes companies make in software development [4:44]
  • Tom Hunter & Matt Romey from Azzur Group on why they think multi tasking is one of the biggest mistakes startups make [6:10]
  • Steve Maylish, Fusion Biotec & Len Brandt, Brandt Ventures – why every startups should own the reimbursement question [7:11]
  • Should ventures be all about money? Three keys to money. [8:42]
  • Robert Winn, K&L Gates – IP advice for startup companies [11:18]
  • Robert’s thoughts about FastTrack [11:46]
  • Listen to Ron Sully, from Omnica on his best advice when going through product development [12:22]
  • Manage expectations – thoughts of Peman Montazemi & Albert Yi, Saritasa [14:42]
  • Save time and money by keeping your focus [16:41]


Next Steps:
Text INVENTION to 44222 to stay updated about upcoming beta launch of program for entrepreneurs and inventors or click here.

Host: Meghan Alonso
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Host Company: Imua Services
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PhageTech: www.phagetech.com

Velox Biosystems: www.veloxbio.com

Avento Technologies: www.aventotech.com

SugarCube: www.thesugarcubeapp.com

All Podcasts:
iTunes: bitly.com/Inspire

Full Transcription:

Recorder: 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. Here is your medical device product development expert that Hawaiian hearted hostess who will help you hang ten. Meghan Alonso.

Meghan: So on today’s episode, I did something unique. I tried it a few weeks ago and I would really appreciate if you let me know if you like this format or not. I thought it would kind of cool to mix it up. So a few weeks ago we heard from several start up companies. I was at OCTANe Medical Device and Investor Forum here in Orange County and where a lot of start ups gather; a lot of service providers and experts in the industry gather. And investors are there, checking these start up companies seeing if they want to invest. So we did an episode where it was input form start up, sharing their journey and giving advice, just encouragement to keep going. And today I mixed some audio from the experts that I talked with. There’s people in Chemical, Software, Mechanical, Engineering; we’ve got some regulatory, some strategy, you’ve got venture capital. All kinds of stuff for you to listen and get some advice on what mistakes they see over and over again and what you can do to avoid those mistakes. Tune in for this and hey we’ve got two more weeks actually a week and a half left, it’s the 22nd today and eight days left of the application period for the beta program Invention Idea to Profitable Product. So what that is if you have an idea about a product you want funding, you need funding of course. But there are some steps you need to know before you get that funding. So this program walks you through that what development product is and everything you can do to put your pitch deck together and to go wow investors. So I’d love to have you in there. You can for one of my free beta spots, head on over to imua-services.com/iipp. That’s a forward slash thingy and that’s iipp Invention Idea to Profitable Product. And again Imua is spelled as I-M-U-A or if you’re walking the dog or if you’re in the gym and you’re not near on your computer, you can text the word INVENTION to the number 44222. So that would get you all to fill up the application and I’d love to have you in my program. So I’ll let you enjoy the show and talk to you later.

Speaker 1: This Doc Drew with device lab,I’m the General Manager there.

Meghan: Hey doc! You’re greatest piece of advice for start up companies and medical device, what would it be?

Speaker 1: I would say, I see a lot of start ups coming on that door and I think they don’t know what they’re getting in to. They have to know the road map. They have to know all the pieces that take to get the medical device to market. People think it is a short road and straight path but there are a lot of pieces that need to go into it. I advice talk to people who knows, who’ve been there before to the element that take to get the medical device to market. It’s not a consumer product.

Meghan: Yeah. Sounds like they need my new program Invention Idea to Profitable Product.

Speaker 1: So here’s some of the things you need to think about is intellectual property, product development and product development has a lot of step to it. There’s proof of concept, there’s alpha prototype, beta prototype; there’s pilot production and there’s documentation for safety and regulatory, the design history side and the 510ktrack. So there is a process.

Meghan: Well, thank you so much.

Speaker 1: Okay.

Speaker 2: I’m Frances Kho, I’m Prominent Software President of Prominent Software.

Meghan: So Frances, what is the biggest mistake you see companies when they are just starting out, start up companies. What’s the biggest mistake in software development that they make?

Speaker 2: I’ve seen a lot of companies lose focus and lose track of their main product, minimal viable product. That’s key because you can’t get out of the door if you want everything. And if you keep adding features, it will delay you for no reason. So we always try to encourage our clients to stick with that minimal viable product. And it’s very hard for them because they want a lot of software features and they think of that they want to compare themselves to some current apps or whatever their model is. But keeping focus gets them out of the door and gets them quickly and connects on the next release. They need to understand that especially with software there’s can be next to this.

Meghan: Yeah, that’s really good advice and also once you get out of the door, you can start making revenue and you can always improve up on it.

Speaker 2: Exactly! And surprisingly it’s hard to convince customers that they think they need this feature because they’re in love with but it’s not their minimal viable product. They don’t need it and letting go of that is quite.

Meghan: Well, thank you so much.

Speaker 3: Tom Hunter of Zorpia. Matt Rommy also with the Zorpia.

Meghan: So what do you see the biggest mistake that companies when they are just starting out or the start up company, what mistakes you see them make?

Speaker 3a: For the mistakes that I see companies make in start up mode is that maybe one or two people try to do everything all at once. And they are not going outside to the actual expert consulting companies and maybe bring in short term resource to help them get into the next phase of the product development.

Speaker 3b: I find it to be true as well especially when the innovators who are the ones are good at starting companies but they are not necessary the people that are required to bring the company across the finish line. We need to bring in the expertise in medical device industry as well as operations and design to cross all the tees and dollar the ice and bring in the money. The CEO, contract manufacturers, consultants and everybody with the expertise to help get across the finish line.

Speaker 4: Steve Maylish Chief Commercial Officer of Fusion Biotech.

Speaker 5: Len Brent, Chief Cook and Bottle Washer of Brent Ventures.

Meghan: So we’re here today at the medical device investor forum and just capturing some audio here. So Steve what would you say is the biggest mistake that you see start up companies make or even before their company that solo entrepreneur that inventor pursuing their dream for the medical device.

Speaker 4: Well Meghan I’m glad you ask that. I just sat to a panel where they we’re talking about the reimbursement and big data and getting on to the market and a lot of companies don’t think about the market and how they’re gonna get reimburse and who’s gonna pay for their product and I know it’s complicated sometimes because there’s multiple users and multiple purchasers but it’s something that every start up should start first with after they got their idea.

Meghan: That’s good. And Len what about.

Speaker 5: I won’t answer that one. You never let me have the easy question. Well first of all I just want to agree with Doctor Steve Maylish because I’m told never disagree with him or I’ll get in trouble. In fact, what he said is really the hottest topic is that you have to own the reimbursement question. That’s the hottest topic that I’ve seen the last five years. But I also want to add another couple of thoughts. If you were starting a venture, it’s always about money and the key to money is always about three things. First is management really knowing what you’re doing. Second one is management, really knowing a lot of doing and being incredible. And the third one is you could probably guess. If you’re not that solution, that’s not you completely. Like I’ve done this before through the drill, get a friend and have that friend work with you so that somehow there can be that sort of transfer and where we don’t have to learn the hard ways and spend all our money trying to make something that you already have. So having the first point and old school answer.

Speaker 4: And Len has been known to be a friend.

Speaker 5: Yeah.

Meghan: A good friend of that.

Speaker 4: And I don’t charge much for being a friend. And the second thing I wanna say and this is really my piece of advice that I had ever ever. I’m not kidding, ever. No matter what you’re selling. You’re selling your opportunity to money; or you’re selling your innovation to a doctor or you’re selling me a house no matter what you’re selling and it’s innovative. There’s always gonna be an explanation what the heck it is and I gotta care. The first point is you have to credible before I will listen to what you say and believe you. Obviously you sell yourself first before you sell whatever you’re selling. But here it is the best piece of advice ever, you use to hear this once maybe four to five times; analogy. Get the analogy and makes it easy. If you say look this deal is very similar to this well known dealer that everybody knows innovator that crap out at something.

Meghan: It takes something well known not something that’s not well known or not something that’s failing.

Speaker 4: Yeah, the analogy is gotta be legitimate, it’s gotta be real and it’s gotta be an excellent one that goes, Oh so I do what that does but I do in this space. Oh but I do that because like they did this and I did the next step. And it revolutionized the industry. So an analogy gets me into willing to go to the complication and I know where I am going. And I’ll even answer that as if I was talking with my children which is, ‘Fine give me the long answer after you answer the question. I ask you this question, and now give me the answer. And now you explain why that is the answer and you can interrupt, ‘I don’t wanna hear that.’ But if you’re risking me the long story to get to the answer I lose interest sometimes.

Meghan: Yeah.

Speaker 4: How about that for the ten minutes of a five second question?

Meghan: Well, thank you so much.

Speaker 6: My name is Robert with Kate O’gates. I’m a panel attorney specializing in chemicals and pharmaceuticals, and medical devices.

Meghan: So Robert you must have a lot of start ups come to you quite often, what’s your best advice around IP for the start up companies?

Speaker 6: File early and file as much as you can. Prior pops up like crazy and you wanna be the first one out there with your idea.

Meghan: What about the fast track? What are your thoughts on that?

Speaker 6: Fast track is great. It will cause a little bit more money but you definitely get results much more quickly.

Meghan: And then what mistakes do you see often maybe people come to you too late where they should have done this, they should have done this and that.

Speaker 6: Yeah, that’s basically coming too late or filing something early on but not pursuing it and letting it die and then thinking later I wanna go back and get that when it’s too late and the opportunity has passed.

Meghan: Thank you very much!

Speaker 7: Hi I’m Ron, Marketing Director of Annik Incorporation in Inervine where I design in an engineering firm.

Meghan: So Ron you come across with people with idea that are wanting to turn those ideas into a product and you work with a lot for start up companies, what is the best advice you can give someone when they are going through product development?

Speaker 7: Meghan thanks for asking me that question. I get these calls all the time and some answers the phone and that’s most of the new prospects. The thing I’d like to see from people that call me is to have them being prepared. If they have a business plan, we’ll give them some directions, it gives me a reason to call, it gives me a good feeling about talking to someone who earns for what they are doing and poise for success not for failure. I am always concerned that when the people call and they don’t know about their product. For instance know how much they’re gonna sell for and haven’t refined their customer based; they don’t who is they gonna sell it or distribute it. It’s a yellow flag for me. It makes me feel that I am dealing with someone that really hasn’t done their homework before they called me.

Meghan: Then what about projects that are going very well and they just sort through the processes, what’s the difference? What’s the measure of success that you could see?

Speaker 7: The ones that go through the process easily are mostly the common dear by a really affected project manager on their part. And if I can have access to a person that can answer questions in an expedient manner and is accessible when we need the answers it makes our job so much easier. People that are prepared and know the business and developed a products before, knows the product development is not just a linear process. It’s not something you expect that you conveniently go from point A, B, C, D, E. Sometimes things are skipped and sometimes we have to regroup and make some changes. But the good project manager really is the baseline for what we need if we wanna work for someone with a successful project development.

Meghan: Well, thank you!

Speaker 8a: Albert Yee with Seratosa.

Speaker 8b: Raymond with Seratosa.

Meghan: So you guys are working, helping start up companies and entrepreneurs with internet of things with medical devices and that’s a huge industry right now. I’m sure you see a lot of companies doing lots of different amazing technology. So if you have one piece of advice for a start up company looking to get involve with internet of things with their device, what would it be?

Speakder 8a: So I would say it’s managing expectations and not biting of more than you can chew. So it’s the whole idea. People have big dreams and ideas. And they want to do everything all at once and not taking into consideration the time, the money, the resources that they have built right now. So our advice would be facing enough and be realistic in terms of what you can afford to do, in what stage, how you’re gonna fund this, and launch the project not just the product development in launch but right to the customary acquisition or user acquisition.

Meghan: Great! Then what are, what’s the biggest mistakes you see people make when they’re in development?

Speaker 8b: Sure, the biggest mistake that we see that people come to us with the initial prototype proof of concept prototype that is typically are not created using and are doing all kits or like one of these bigger bone kits or even the raspberry pie. And most of start ups do not realize that these are not cost efficient solutions. So when you wanna go to production, do mass production to a thousand or ten thousand units for your first batch of orders, right there the entire business design and business model completely collapses.

Meghan: So getting them realize, yeah that’s great for prototype but then we need this scale and that’s not a scalable design.

Speaker 8b: Exactly.

Speaker 8a: And another thing that we see with a lot of start ups is that they have a great idea and then fund and pay for and build something and then they go and talk to investors or other customers. And then customers and investors always have a new idea and new features and functions. And when they come back they would say ‘I’ll gotta add this, I’ll gotta add this.’ And then what happens is they stray away very easily from the original intent and focus of the project and what it’s meant to do. And it becomes a mismatch of stuff. I think that it burns a lot of money; it burns a lot of time that’s unnecessary. So stay focused on the original version and plan and holding chip to that force and mind your first question along the way, and knowing when and you to influence by as suppose to react to the every bit of advice that you’ll hear from everywhere.

Speaker 8b: Right. Take the first product out with the minimum viable product out that would actually creates returns and phase out as I was mentioning the development of the product and create a bucket list of those features. Sure we can implement them but it gonna be in ref2, ref3, and ref4. And plan out based on the return of investment that you have put instead of trying to put all the features at one in the first product because nobody does that in the professional world out there.

Meghan: Yeah, and that’s something that we’ve heard quite a bit in this conference. Thanks for reinforcing that.

Speaker 8a: Sure.

Meghan: Well thank you very much!

Speaker 8a & 8b: Pleasure.

Meghan: Hopefully you enjoy that little audio round up and again let me know if you like this format. I can always do it again. We did get some audio from lots of different people. I can always get that from different groups too. Maybe we wanna do a regulatory round up or a engineering round up. Whatever you guys want; just let me know and again I’ll see you in the beta program for Invention Idea to Profitable Product go check out that application and I will catch on the next episode. Imua!

Recorder: Mahalo for joining us. If you’re 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 hang ten that’s all one word H-A-N-G-T-E-N to 44222. We’ll send you the most common wipe outs companies make in product development so you can avoid them and reach master wave status. Again, that’s hang ten 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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