Navigating Medical Device Innovation: Insights from Jorg Lorscheider

Navigating Medical Device Innovation: Insights from Jorg Lorscheider


Business Problem Solvers with Eric Alspaugh, Episode 05

In this episode of Business Problem Solvers, Eric Alspaugh speaks with Jorg Lorscheider, Jorg Lorscheider, CEO of TechFlex Development, a medical device engineering and design company. They are a technology partner for startups or large corporations, building cost-effective and rapidly marketable products. Jorg has over 25 years of experience in contract engineering services for startups and established companies, specializing in medical device development.

Tune in to the episode to hear about:

  • Key stages and considerations in medical device development, including when to engage engineering firms.
  • The importance of experience and expertise in navigating the regulatory environment for medical devices.
  • Practical advice for startups on leveraging professional networks and understanding the investment landscape.
  • Insights into current and emerging trends in medical device technology, including the integration of AI.
  • Strategies for effective communication and project management in product development.

Learn more about Jorg Lorscheider:

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About Business Problem Solvers:

Welcome to Business Problem Solvers Podcast, where legal insight meets entrepreneurial innovation. Are you a startup founder navigating the complex legal landscape of entrepreneurship? Are you seeking practical advice, actionable strategies, and expert guidance to propel your business forward? Look no further. In each episode of Business Problem Solvers, seasoned attorney Eric Alspaugh takes a deep dive into the intersection of law and business, bringing you insightful interviews with a diverse range of industry experts, thought leaders, and successful entrepreneurs.

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Read the entire transcript of this episode:

Introduction to Business Problem Solvers Podcast

Voice-Over: Welcome to Business Problem Solvers Podcast, where legal insight meets entrepreneurial innovation. Are you a startup founder navigating the complex legal landscape of entrepreneurship? Are you seeking practical advice, actionable strategies, and expert guidance to propel your business forward? Look no further.

Meet Eric Alspaugh: Your Host and Legal Expert

Voice-Over: Eric Alspaugh is a seasoned attorney. Based in the vibrant startup hub of California. And he’s thrilled to be your host on this exciting journey. In this podcast, we’ll dive deep into the intersection of law and business, bringing you insightful interviews with a diverse range of industry experts, thought leaders, and successful entrepreneurs.

From intellectual property and contract law to corporate governance and regulatory compliance, we’ll cover the essential legal topics that every startup needs to know. Our guests will share their wisdom, [00:01:00] experience, and practical tips to help you navigate legal challenges, seize opportunities, and build a thriving business.

In today’s dynamic marketplace. So whether you’re a seasoned entrepreneur, a budding startup founder, or simply curious about the intersection of law and business, join Eric on business problem solvers podcast, as we explore the legal insights and entrepreneurial inspiration that will fuel your journey to success.

Eric Alspaugh: Hey, Eric, how are you? I want to, 

Jorg Lorscheider: I’m doing well, Eric. Thanks. 

Eric Alspaugh: Great. I want to welcome you to the business problem solvers podcast. I’m glad we were able to make time to have this interview. I’m relatively new to the process and having you as a guest. being a friend and colleague in the medical device industry is really going to make this process easy for [00:02:00] me.

And I’m hoping that I can extract some insights from you, uh, for our listeners. So welcome. 

Jorg Lorscheider: Great. Thank you so much. Appreciate being here. 

Insights on Medical Device Development

Eric Alspaugh: So we didn’t have time to go over a list of questions, but what I’d like to get from you is some of your insights on the medical device development process, how entrepreneurs could engage engineering firms, what to expect, some of the processes, Thank you Um, I’ll, I’ll remind you, I, I really love talking about pitfalls and um, also what happens when to bring in the lawyers, when not to bring in the lawyers and some funny anecdotes, I think are poignant learning lessons.

Jorg Lorscheider: Yes. 

Eric Alspaugh: And then I’d like to just, um, I have a couple of other issues. I know that you’re interested in the community giving back, [00:03:00] but via UCI innovation, um, mentoring and those types of programs. So then just some more of your personal, um, goals and contributions to the Orange County community. So that’s, that’s my overview.

I just made that up. And, um, I know that I typically I give people’s, um, background and their credentials. I know you are a graduate of UCSB. And if you want to give a brief introduction of what some of the, I don’t know, key keynote things about your, your background to help, uh, our audience have some context, that would be great.

Jorg Lorscheider: Well, I’m not sure how interested they will be, but I have a boring background. I, I went to UC Santa Barbara. I didn’t, um, Didn’t really focus a lot on studying, you know, those days was, uh, it’s a pretty fun place to go to school. And I also [00:04:00] happened to be there on a, um, an athletic scholarship. So my college career was really focused on athletics and, uh, and, um, and after, and after college and went to Europe and played, um, played there.

I played sport of volleyball, um, and, uh, But I studied psychology, uh, at UC Santa Barbara. So it was somewhat unrelated to, uh, product development, but I’ve always been a techie. I always loved technology and that’s where I gravitated, um, in my career. And I always wanted to work in technology because that’s what was interesting to me.

And so for the past 25 years, plus I’ve been doing, uh, contract engineering services. for startups and established companies in medical device space. So I’ve seen, seen a lot in that, in that regard. [00:05:00] 

Eric Alspaugh: Fantastic. And I know of a couple of current ventures that you have, and I’m interested in, in hearing about.

Your roles in, in both tech flex and Omnica, as much as you’re able, uh, to share, I understand confidential working with clients and things like that. But I, I’d like to educate these garage inventors and startup guys. The purpose is to really encourage them to take that next step, reach out, find mentors and be comfortable reaching out to engineering firms that have experience with the regulatory environment since you and I both focus on medical device.

Jorg Lorscheider: Yeah. Yeah. I mean, it’s, it’s really important, I think, to leverage that knowledge base. Uh, I find a lot of, so there’s really two sources really of innovation that, that comes [00:06:00] about. A lot of innovation comes out of, obviously, universities. We talked, you touched on UCI and, and so forth. And the, And again, I, I might be totally wrong about this, but the one thing that I observe is that, you know, academics are very smart and very intelligent and they think that just be that they can really learn and do anything, which to a point is true.

Um, but one thing you can’t do, one thing you can’t get is experience, experience takes time, and generally, by the time you have enough experience to do, to do what you need to do, it’s never going to happen. So you really need to leverage, uh, the people out there that are doing it every day, um, and have done it for many years, because there are a lot of, uh, nuances.

Especially with new product development. There’s a lot of, um, you know, it can [00:07:00] go in a million different ways. And, uh, and so if you don’t have someone that has experience, you’re going to waste a lot of time and money, uh, going down the wrong paths. 

Eric Alspaugh: I completely agree having, um, worked with dozens, hundreds of startups and various incubators and, um, Seeing how very young, smart entrepreneurs want to leverage themselves and want to get their hands dirty and do everything.

And knowing, knowing when it’s beyond your scope or understanding that, um, it’s really worth, uh, paying some money. That’s an expert because it will more than pay for itself. 

Jorg Lorscheider: Yeah, it’s always a tough call for for entrepreneurs and startups because [00:08:00] you only have limited funds. And so where to spend that money?

I understand. And also, when you start seeing the costs, you probably gives you some sticker shock because you’re like, you know, uh, working in free labs and colleges and universities and students who are, you know, Basically working for free. Uh, it’s a big jump to say I’m going to spend, you know, whatever it is, 200 an hour on, uh, on an engineering firm or something of that nature.

So it’s, it’s, it’s kind of shocking and I understand that. And, um, But there are ways to, um, again, it’s more about doing the right things than it is about the quantity of the things that you’re doing. Um, and, uh, when to invest in, in product development, I think a lot of people get enamored with their own ideas and they spend too much money and too much time engineering [00:09:00] their.

Proof of concept, if you will. Um, to me, investors, you know, once you’ve established that the thing works, it doesn’t have to look pretty. You have, so you collect some data, you know, it can be done. You should really stop development. And that’s when you should say, that’s when you should start going to investment because investors, they’re going to believe you.

They don’t, it’s not like they don’t believe you. You show them the data, especially in the first rounds, they’re going to. And then get the money because being under capitalized is a, um, is a kiss of death for most endeavors. 

Eric Alspaugh: Absolutely. Absolutely. 

Challenges and Advice for Entrepreneurs

Eric Alspaugh: So I think I heard, uh, a, a milestone to be reached is for, for thinking about reaching out to an engineering firm would be once you have a minimally viable product.

[00:10:00] And can you tell us some of the reasons, uh, why an engineering firm at that milestone is a smart in investment of, um, bootstrap company? Maybe the inventors are, are paying for stuff on their own or some friends and family. What are the, what are the things that they can really leverage? 

Jorg Lorscheider: Well, I, uh, I want to, I want to say.

I want to first I want to differentiate between a minimum liable product and a proof of concept 

Eric Alspaugh: to 

Jorg Lorscheider: me. A proof of concept is, um, The, the, the theory of operation works. Uh, it, it doesn’t look the part. It may be on a lab bench. It may be, who knows what, a strone all over the place, but the basic idea, the basic technology works, that’s a proof of concept, whereas an MVP is often more used in software [00:11:00] where they say, let’s defeature this to the minimum amount of features that, that, um, we can actually launch with.

And start getting feedback in device world. It’s a little different. You tend to not. Yeah, you want to do the same thing, but sometimes you have a minimum amount of things that you have to do in order to in order to launch a physical product. So, uh, So we talk a lot about, I, I think it’s important that the proof of concept point, because that point is, you know, you’ve already done the, the work, the, the hard work is taking that proof of concept and then making it into a manufacturable product.

But that’s the stuff that we do every day. So that’s why I say that’s the time to. But obviously you need funding for that. So having a proof of concept should help you get funding, um, and and collecting data [00:12:00] and showing, Hey, this is what it does. And this is how it does it. And so on and so forth. 

Eric Alspaugh: So the word I’ve heard the key word is manufacturable.

And so that brings to mind scalable. What other adjectives or bullet points? fit into that so that an entrepreneur could say, aha, I can recognize I’m getting close or I’m there. 

Jorg Lorscheider: Yeah. So a lot of, uh, I see a lot of startups, they, they using a lot of off the shelf components, for example, in a design, uh, they’re using raspberry pies and these kinds of things.

These aren’t really production level types of things. They’re great for proof of concept, but they are not something that you put into a production ready design because you pay for things that you don’t need. And you sole source yourself if you. And later on have issues with your supply chain. If you if you try to [00:13:00] use those kinds of products in those off the shelf products in in your device, let’s say.

So I think, um, manufacturable really has two dimensions. One is most of the stuff you’re going to do is custom. Typically, because it’s going to be lower cost, it’s going to be more to develop, but less less to produce. And these are all trade offs that of course you have to deal with. The other thing is, um, manufacturable and testable.

So you have to design in the ability to test various subsystems prior to final assembly, all these things. Uh, and, and, and so there’s, There’s a lot there. You know, design is done. People think of the design is done. When you finish the design, it’s maybe half done because you’re going to have another, uh, large volume of work to get it into a place where you can make [00:14:00] thousands of them.

Let’s say, uh, and, um, that’s a whole nother, um, activity that takes lots of experience, uh, and an understanding of many, many different manufacturing processes. 

Eric Alspaugh: Sure. Um, from your perspective, have you seen or can you opine on the length of time somebody should expect to manage some of these projects and to understand if it’s a class one device, class two device or perhaps a class three, not even trying to get into combination devices or software or 

Jorg Lorscheider: Yeah, I mean, clearly, you know, it is pretty, uh, it’s pretty linear in the sense of, you know, class one versus two versus three in terms of the regulatory.

In other words, class three is going to have a much higher burden of regulatory work on top of the engineering and design [00:15:00] work and more testing and more. Validation, et cetera. Then a class one device, all of them need a quality system. That’s a whole nother area that, uh, we can mention that, you know, companies who develop these products have to have a quality system eventually have to be certified to manufacture, uh, medical devices and things like that.

There’s, that’s a whole nother area of, of effort that, uh, costs money. And again, you need an expert. You can’t hire. You can’t really do that yourself. You need to have an expert that that you hire to do that. So, 

Eric Alspaugh: um, what, what are some things? I’m just trying to think of from the entrepreneur, how do you feel about people very early on in the garage development stage?

How did, do they just give you a call? Do they, do you [00:16:00] suggest they reach out to numerous engineering firms? Do engineering firms have that? specialties or any tips for engaging and reaching out right off the bat? 

Jorg Lorscheider: Yeah, I think that’s the, that’s a tough one. Uh, the answer is yes, yes, yes. Uh, some firms do have specialties, some do not.

Um, I think reaching out via LinkedIn, finding people like myself that you can send a message to or, you know, Even call, um, you know, we’re usually pretty happy to talk to people, um, and and give them advice. Um, I always think that’s a good thing to do. Um, and I, you know, for me, as you probably know, Eric, there’s the the the success rate of.

[00:17:00] New product developments in general is quite low. And so, so what does success mean? Um, success is reaching an appreciable. market penetration in for that product. That’s what I would define as success. I would say the success rate to achieve that is probably very low, 80, 80, 90 percent failure. 

Eric Alspaugh: Okay. 

Jorg Lorscheider: And so it’s, uh, and that’s because the commercialization piece is quite different.

Complicated and very expensive. So everyone focuses on the development and, you know, I’m happy about that because I do development, but I think, um, the reality is once your development is done, your costs are just starting. You’re not, it’s not the end of your costs. That’s the beginning of your costs really, because, um, commercialization is just a [00:18:00] huge, uh, thing, uh, depending on the market you’re trying to, to reach and, uh, So I would say most startups tend to underestimate that.

That aspect. 

Eric Alspaugh: Wow. That’s, that’s great advice, uh, for entrepreneurs starting off to manage their expectations on, uh, and understanding capital requirements are huge and and poorly understood by inventors, you know, inventors have bombarded with, um, I, I invented the pet rock. I invented the flow bee. I invented, uh, I don’t know, Chia pets and may became an overnight sensation.

And those are like the three examples that we all recognize, but those are the three examples out of millions and millions of tries. [00:19:00] 

Jorg Lorscheider: And those are consumer products too. So consumer products are. A little bit of a different animal. They’re, they’re actually more costly and more difficult to get into the market because they compete against so many different things.

Uh, whereas in medical, at least we’re, we tend to know exactly who we’re selling to and who, you know, what those market sizes are. And so whether it’s doctors or surgical centers or whatever it is, so, um, it’s a, And then there’s the whole issue of reimbursement. And I know you’ve spent probably a lot of time on that.

Um, most people don’t really understand how their product’s going to get paid for and by whom. Um, so these are all things that have to be thought of before you even start. A company, I think, you know, why, why spend time incorporating the money, all the things, if you don’t even know you have something that, uh, has a potential to, to succeed.

Eric Alspaugh: That’s a great point. [00:20:00] So, um, pro tip, York is advising everyone after they’ve filed their patents to go out and, uh, speak to reimbursement experts. regulatory experts to understand what the path forward is to understand those regulatory hurdles and think about how to finance it because I didn’t want to go in this direction, but you’re gonna need a CEO.

That’s a full time capital raising expert with deep pockets and friends with deeper pockets. 

Jorg Lorscheider: Yeah, I mean, it’s and and as you know, the fundraising has been difficult in the last couple of years. Uh, it’s been somewhat of a down cycle for the industry. Um, And that will change. It will go back up. I’m not, I’m not worried about that, but, um, it’s, you know, you got to imagine that a lot of these people who [00:21:00] have money, you know, whether it’s venture capital or some people like to call it vulture capital, um, that it’s, they look at literally a thousand opportunities every year, a thousand companies pitch them and they may pick between one and five of those.

Out of a thousand. So it just gives you some idea of scale of, of, uh, why it’s so difficult to raise money because there’s a ton of competition for, for that money. Um, and that’s why it becomes somewhat nuanced in the sense of, um, Investors confidence in the team, uh, past experience with the team past, you know, so it becomes a little bit of a network, um, that.

That you have to navigate and that’s, it takes, that takes time, even, [00:22:00] even if you have the greatest idea, the greatest concept, the greatest plan and the greatest team, it’s still going to take you, could take you years to raise the money that you need. 

Eric Alspaugh: Got it. That’s, that’s good advice. That’s great advice.

It’s true. Uh, take that to heart in ventures and entrepreneurs. So I hate 

Jorg Lorscheider: to discourage people because the one thing about entrepreneurs that is the most, uh, exciting and important is their passion for what they’re doing. Right. And that passion is, is, uh, critical, I think to success. And, um, so I don’t want to pour cold water on it.

Um, I don’t think you can be successful without that, but you also need to go in with your eyes open. You have a better chance of success. 

Eric Alspaugh: Absolutely. So with tech flex, um, you have a [00:23:00] presence here in the U. S. And outside the U. S. What’s some of the, um, projects that you’re working on or industries that might be interesting?

And if you’re comfortable and have the ability to share Some anecdotal stories about development. I’d like to hear about maybe a success. And then it doesn’t have to necessarily be from, uh, tech flex, but maybe some, some pitfalls or some landmines that you run across in the development process, just to educate us and, um, give us some laughs.

Jorg Lorscheider: Well, I’m not sure I’m known for my humor, um, but nevertheless, um, yeah, you know, we’ve, we’ve, we’ve gotten all types, all types of people that I’ve talked to in my, in my life, and some of them, I’ve, I’ve talked to, [00:24:00] um, quite a few, let’s call them crazy inventors, just for lack of a better term, just trying to do things that were just completely off the wall and not realistic.

Okay. And, uh, so I, Those I always find a bit amusing, although sometimes I feel sorry for them that they, that they, uh, spend money on things that are really have no chance of success, at least I guess that would be my opinion. Um, their opinion would be different, obviously. Um, so I, I think that, uh, I’m trying to think of some of the, the, the more, uh.

Crazy ones, but, uh, I, I don’t really want to call anybody out. So I’m a little, a little, uh, but you know, I’ve had people come with pieces of paper and look what I’ve done and look at all this, and I’ve been working on this for seven, [00:25:00] eight years. And, you know, and I’m, I’m just looking like, yeah, I’m sorry. I can’t help you.

Um, and that’s, that’s amusing for me maybe, but not for everybody else. That’s certainly not for them. Um, And then, you know, just as far as pitfalls, I think there’s, there’s so many, I think one of the biggest keys in, in any development is, is communication. You know, we have, uh, in the tech flex business, we have a, um, team of engineers based in Ukraine.

So obviously communication is, is huge just from a language, uh, perspective. They, they all speak English, but English is English is not the same English necessarily. Um, and, and heavily accented. And so sometimes it’s, um, So we really focus a lot on, um, communication and I find that it’s really important regardless of where you’re doing development communication, at [00:26:00] least on a weekly basis, if not more nowadays, we have a lot of great tools for instant chatting and, you know, like WhatsApp and things we use that heavily, um, for quick answers, but at least on a weekly basis, we’re getting together, uh, on a call.

Going through progress, going through design questions, design changes, uh, et cetera. Um, and that’s that, I think as a minimum for anybody doing development. 

Eric Alspaugh: Absolutely. So I, I know that I have been approached, uh, with inventors who have, uh, created time machines. No, there you go. Inventors who have broken the second law of thermodynamics.

The US PTO actually is familiar with these concepts and has. an entire department devoted [00:27:00] to inventors who debunk the the fundamental laws of physics as we understand them. So it’s not infrequent that those inventors pop up every now and again, but do you have any, um, interesting, uh, projects or anything in the, in the works that you’re able to talk about?

Jorg Lorscheider: Well, I can’t. Well, I can tell you in general what they are. I can’t tell you who they’re for what you know, that kind of thing. But we’ve been working on a, um, a ventilator. This ventilator is intended to be used across the continuum of care. So we’re talking about All the way from first responder all the way to ICU.

Um, today, those are all different types of ventilators. And, um, now. And so that’s been a very exciting project, uh, has different new tech, new valve [00:28:00] technology and very, very software driven. So it’s a very software heavy product and project. So that’s been very interesting and very rewarding. Um, we’ve gotten that all the way through animal studies at this point.

Um, and then, uh, We’ve been working on robotic surgery systems. Um, so this is a system that is, um, the, the patents are, is, is, is, um, around single trocar, um, tool exchange. 

Innovative Medical Device Projects

Jorg Lorscheider: So you can use a single trocar and put different tools in and out of the of the body. And so that’s very interesting and been a very also rewarding project.

And we’re doing regulatory as well on that. And so there’s a lot of It’s a multi year, uh, effort. That’s not a [00:29:00] short, it’s not a short project. And, you know, we have, so usually we all have a variety of projects. And I think for us, one of the important things is to have a mix. We don’t want all these big multi year projects that we don’t want all.

You know, three month projects. We want a mix of those because that’s when we can operate most efficiently. 

Eric Alspaugh: Great. That’s very cool. Those are great. Very interesting technologies. How fun. I love that. 

Jorg Lorscheider: That’s why I love the industry, right? I mean, I’m in this industry because it’s something new every day.

It’s something interesting. Uh, so I love it. That’s what’s that’s what’s great. And then, you know, as you know, We’ve been working on other startups, um, that you’ve helped me with. Thank you very much in terms of incorporating and, and doing some of the legal work. So, um, partnership agreements and things like that.

So, um, thank you so much for that help that you’ve given us. 

Eric Alspaugh: Oh, of course. Love to help. 

Networking and Resources in Orange County

Eric Alspaugh: [00:30:00] So do you want to, uh, pivot to, uh, any thoughts on the Orange County ecosystem, uh, resources that you use or want to share to entrepreneurs? 

Jorg Lorscheider: Sure. So, you know, I’ve been, uh, there, there are quite a few, um, organizations that I’m still, you know, uh, have been a member of for many, many years and continue to have membership in.

And that is obviously Octane. Um, if you, if you haven’t heard of that, I should look it up. Um, they’re very active in the, in the industry, trying to help Orange County businesses, uh, in MedDevice, but also other areas, um, to build Good companies and, and build employment in Orange County. But there are others, you know, we have device Alliance, which is more of a networking group meets once a month.

I love that. Been there, been a member there for, [00:31:00] I don’t know how many decades or 

Eric Alspaugh: 10 years, at least 10 years, 

Jorg Lorscheider: maybe longer. And, uh, again, you know, getting to know people going to these events is one way you, you were asking earlier, how does, how do they find. Resources like us. Well, that’s one way. Go to these events.

Get to start meeting people. Go. Don’t go once. Go, you know, go, you know, months and month after month. So you get to, you know, meet people. And then in between have coffee with those people. And, you know, really do networking. Networking is work. Uh, you have to, you have to want to build relationships with people and then they can connect you with, you know, All kinds of resources that you never knew existed.

So, um, and then there’s, um, there’s also the entrepreneurial network. I think there’s, uh, I forgot what it’s called now. I can’t remember. But, um, there are a number of, [00:32:00] uh, startup networks. And I think I would, I would encourage membership and attendance at these, these kinds of events. 

Eric Alspaugh: Absolutely. I completely agree.

And just to echo what you said is consistency. If you have to attend these events, um, month after month to really get a sense of what resources are available, because you can only. Meet and talk to so many people in, in an hour and 

Jorg Lorscheider: yeah, and it’s one of those things where like the first time you go, you don’t know anybody.

You’ve never seen any of these people before. It’s very kind of, um, intimidating, but if you go every month, then I’ll pretty soon, you’re the one who’s, you know, knows everybody and you know, and that takes some time. So you need to do that. So, and then you [00:33:00] can start having those good conversations and. And connect with the people that that can help you.

with your objectives. 

Eric Alspaugh: I, I totally encourage people to do that. 

Challenges and Successes in Medical Device Development

Eric Alspaugh: And, um, so in terms of community giving back, do you want to share a little bit about some of the things you’ve done for the Orange County community, uh, generally, or the, the medical device community first, and then Orange, Orange County, maybe more broadly?

Jorg Lorscheider: Well, I’ve been, uh, I used to be more, a little bit more involved with I don’t think it exists anymore at the Wayfinder program, which is an entrepreneurial program out of UCI. Uh, used to be a mentor there, mentoring these startups. I still do some, um, uh, judging, let’s say for, um, startup pitch, pitch, uh, competitions, both for Launchpad, which is an octane program and for [00:34:00] other programs.

And so I really enjoy doing that. Um, and then, uh, Yeah, it’s a part of giving back is is I don’t know I I don’t I like to see projects get done I like to see projects get made, you know, because the success rate is so low It’s very rewarding when I see things get done And so I really have a vested interest not not a financial interest Just just a general interest in seeing that That people are successful, um, because it is so hard and, um, I, I want, I want to see more successes.

Eric Alspaugh: Fair enough. I, I can appreciate that. And, and I’ve been working in pharmaceutical and medical device industry for 30 years now. And, you know, the fastest you’re going to get through any, uh, [00:35:00] regulatory hurdle in, A class three device or a pharmaceutical is like eight, 10, 12 years. And then, uh, I do, I have one story of one client in the history of Orange County in the last 20 years of them creating a class two device, uh, filing patents, getting manufacturing done, getting terminal sterilization completed it in the U S and distributed in the U S.

In exactly 11 and a half months, I mean, and that’s, and this was a very experienced team that was able to do it. And it was, it was amazing. And they’re the only one it’s only happened once. 

Jorg Lorscheider: And I’m sure they were very well financed as well. 

Eric Alspaugh: They were very smart and they were, uh, very efficient. They really have relationships and [00:36:00] leveraged everything so that they could do this project that fast.

It was amazing project. Amazing product. It’s saving lives now. Uh, it’s a NICU product and, uh, they’re in, it’s great to see. 

Jorg Lorscheider: But I, but again, I think you mentioned this earlier is like people got to understand, you know, if you’re going to bring a medical device and when I talk about a device, I’m talking about, I’m not talking about a consumable, but even that can take a long time.

Let’s talk about something that has a little electronics in it might have. You know, some, some parts, whatever, you know, it’s, it’s, it’s, it’s easily a five year process. You know? Yeah. It’s not like you’re just gonna do this and build it in your garage and then boom, you’re gonna sell, you know, millions of ’em.

It just, this doesn’t work that way anymore. Yeah. Um, so, you know, that’s five years more complicated things as you alluded to, 10 years to, you know, yeah. [00:37:00] On the drug side and other things. So it’s, it is, uh, it’s, it’s difficult. And, and, and the development is actually the. I mean, I say it’s the easy part because that’s what we do.

Uh, but the, the development isn’t really the hard part. You know, the hard part is the, the, the go to market strategy, the, the market acceptance, that’s going to cost you way more money and, and has a lot of risk to it. So it’s, it’s, uh, it’s not for the faint of heart is what I always say. 

Eric Alspaugh: Absolutely. So I appreciate your insight.

The Role of AI and Legal Insights

Eric Alspaugh: Can we talk a little bit about lawyers? That doesn’t have to be me. Should not be about me. Some, some, um, value add. And, and some pitfalls that you might have seen, uh, whether it’s for your companies or companies that you’ve been advising [00:38:00] on, 

Jorg Lorscheider: yeah, I mean, um, there’s, well, there’s all kinds of things that you may or may not need attorneys for.

One, of course, is incorporation and getting the right corporate structure, depending on what strategy that you’re looking at for the company. Um, all the, um, IP, of course, is, uh, really necessary to have attorneys help you with drafting that. And, uh, And, and getting that applied for, et cetera. And, um, and then fundraising, right?

This is, you need, you need attorneys to help you draft, uh, you know, your, your asks and your, your, all, all these, um, rounds of financing, et cetera, et cetera. So there’s really very few places where you don’t need attorneys, I guess. Uh, the question is when, uh, [00:39:00] and, and how. You know, but not all attorneys have experience in the startup world, right?

So that’s the other thing. So we really want somebody that understands what startups are going through, um, and then can figure out when to help on what at the appropriate times. Because you can’t do everything at once. You know, most people can’t. 

Eric Alspaugh: Yeah, of course. So have you seen, uh, have you had ever been approached by a Inventor or small team and started the process and then asked, so who am I talking to, or who’s the decision maker?

And they themselves don’t even know, or haven’t put pen to paper and decided who’s the CEO and who’s the CTO. 

Jorg Lorscheider: Um, not so much in that, in that way. I think, [00:40:00] uh, there is, uh, a truth in that. Startups that we’re working with, um, need, you know, the best the best case is when there’s a good technical person on the other end on on the end of the That has had some experience with product development because because of all the nuance and everything else.

Um, so it’s the it’s the good news and the bad news about startups is that decision making is usually very streamlined. Um, but it may not be good. And, uh, and so it’s not, um, it’s a two edged sword, the bigger companies or people that have done it for, you know, multiple times decision making is much better, um, but sometimes the bigger companies, it’s not fast.

So, and that’s not good for us either. So it’s, [00:41:00] it’s, it’s always. It’s almost hard to balance what’s and nothing’s ever ideal, right? Nothing’s ever, 

Eric Alspaugh: of course, 

Jorg Lorscheider: nothing’s ever. 

Eric Alspaugh: Have you ever had, uh, attorneys step in and put the kibosh on something or done something outrageous or clearly erroneous or? No, I haven’t had that experience.

Jorg Lorscheider: wouldn’t say that we’ve had anything of that nature. I think that, well, this is a whole, you could do a whole nother show about the P tab and inventors and all that stuff that you know, is going on. I have been staying abreast of that and I am finding a lot of. Issues with the value even of IP after the, the, the past legislation where the PTAB was created and invalidating a lot of patents based on, I don’t know what.[00:42:00] 

Um, and that puts a question in my mind, what the, what the value of the IP is. It’s not, it’s not as high as it used to be, at least until maybe they changed the legislation again. 

Eric Alspaugh: Okay. Yeah. I mean, Maybe the IP won’t be as important if you have regulatory hurdles that require millions, tens of millions, or hundreds of millions of dollars.

Don’t worry about somebody making a copy. They just won’t be able to raise the fund to do all of the pre market. Uh, development and clinical and scaling to even compete. 

Jorg Lorscheider: Right, right. 

Eric Alspaugh: Why 

Jorg Lorscheider: would they want to at that point? Yeah. So it’s, so I don’t know, I don’t really know the outcome of that, but there’s a lot of, you know, there’s, there’s legislation on the table right now, uh, trying to get rid of that, um, the PTAB and [00:43:00] changing the system back a little bit.

I don’t know what the outcome of that is going to be, but, uh, As, as I said, that’s a whole nother, that’s a whole nother, uh, session for you. 

Eric Alspaugh: Great. No, I appreciate that. I’ll look into it. So I think we’re getting, uh, pretty close to getting through as much time as you can donate to me. But I did, I’m curious because this has just been showing up everywhere.

It used to be internet of things. Then it was, can we put a token on it? So the next, the next big thing is the generative AI or just general intelligence, artificial intelligence. Have you, have you started to see those products, uh, come across your desk? 

Jorg Lorscheider: Yeah, so, uh, in the, so it’s been kind of a, an evolution, right?

So there was, you know, there [00:44:00] was IOT as an example, and then pretty soon now every medical device had some sort of communication in it, you can refer to it as IOT or something, whatever you want. And then once it, once it has communication in it, now it’s collecting information and that information is now become a part of the value of the To the to the owning company to mine that information for, um, for insights and things going forward.

Um, and of course. AI is now an extension of that. So the next evolution is take that information that you’ve created, all that database, all that knowledge. And now you can actually apply AI to it and make it, um, and get even better insights. Um, so I don’t really see it, you know, AI for AI sake, it’s really just kind of an add on to just about everything we’re going to be doing.

Um, [00:45:00] and it’s not really, uh, New in that sense, from a technical perspective, it’s actually been around quite a long time. There are software libraries for creating machine learning algorithms and everything else, and so we implement that stuff. Yes. Um, but it’s not like it’s some sort of, um, revelation, right?

I think it’s, uh, it’s a, it’s a tool that we can use in certain instances that’s gonna create value. Um, but it’s not an end in itself. Doesn’t do anything by itself. 

Eric Alspaugh: Uh, absolutely. Thank you for letting me know that you are seeing it. It’s, it’s been around in a different form. And, uh, I, I just see it, that label slapped on everything.

And I think exactly, 

Jorg Lorscheider: it’s, it’s very popular. Um, so I tend to not listen, listen to too much about it. It’s, it’s, uh, um, and you’re seeing it pop [00:46:00] up in your own world, right. In your own apps, in your Google searches, you see that they’re starting to generate, um, AI, um, results. From your Google searches and a lot of desktop tools have generative AI.

Hey, help have AI write this. Entry for you or something, you know, so it’s being incorporated, but it’s, I think it’s an incremental improvement for a lot of things. Um, I don’t know if it’s changing the world. I’m, I’m a little more skeptical about that. 

Eric Alspaugh: Great. Well, anecdotally, I’ve been seeing it every day.

It’s popping up. Yes. But 

Jorg Lorscheider: like most things, right? It’s, it’s overhyped and it’s a, it’s a, it’s a great tool. There’s a lot of things you can do with it. And some of the things that you can do with it, we haven’t thought of yet, [00:47:00] but they’re being, being created every day now. 

Eric Alspaugh: Cool. Well, I really appreciate your time and insight in the, um, the process development.

Uh, You know, the industry as a whole and the Orange County. And I just, I think you were able to really give our listeners some solid advice and I really appreciate your time. Do you have any, uh, any final thoughts you’d like to share for Orange County, uh, inventors? 

Jorg Lorscheider: Yeah, I would say. Get out there, you know, get out there and start meeting people.

Usually inventors are not necessarily the, uh, um, personalities that interact with people that well. Um, so you have to fight that and, uh, or at least find somebody else that’s part of your team that is really good at that, that, that, that. that cares about people, that’s interested in people, because ultimately that’s where you’re going to find, um, the [00:48:00] resources that you need to, uh, to accomplish your goals.

You can’t do it by yourself and you can’t do it in a vacuum. And, um, and so I’m, I’m, I highly encourage people to get out and meet me. I’ll, you know, I’m at these events. Um, I know you are, Eric, often at these events. So, uh, let’s, let’s get out there and, and have people connect. 

Eric Alspaugh: Thanks. I appreciate that. And actually that reminds me, do you want to give people, uh, your best email and, uh, best way to get ahold of you?

Jorg Lorscheider: Yeah, so the best way to get ahold of me is on, is on my email. It’s yorg, JORG, uh, at tech flex, DEV dev.com. 

Eric Alspaugh: Perfect. And I’m sure we’ll, we’ll add that to the show notes and, and I can vouch for everyone that Yorg is, uh, very nice and [00:49:00] un understanding. And I’m still not, uh, to this point pushed into that, to the limit.

And so, 

Jorg Lorscheider: no, 

Eric Alspaugh: I don’t, 

Jorg Lorscheider: Well, I love, I love people reaching out and, you know, that’s also part of building relationships, by the way, is asking for help and giving help. So, you know, you can’t, you can’t have a relationship without several elements and, and two of them are really asking for help and getting and giving help.

Eric Alspaugh: Perfect. Awesome. Thanks so much for your time, Jorg. And I look forward to seeing you at our very next event. 

Jorg Lorscheider: Absolutely. Thanks for all your help too, Eric. 

Eric Alspaugh: Bye. 

Voice-Over: Stay tuned for our upcoming episodes. Where we’ll cover topics ranging from business formation and fundraising to contracts and compliance.

Subscribe now and never miss an episode of Business Problem [00:50:00] Solvers. Business Problem Solvers podcast is proudly brought to you by Eric B. Alspaugh, APC, providing comprehensive legal solutions for startups and entrepreneurs. Visit our website at www. alspaughlaw.com to learn more. Disclaimer. The information provided in this podcast is for educational and informational purposes only and should not be construed as legal advice.Consult with a qualified attorney or legal advisor to address your specific legal needs.