How Leading Medtech Scaleups Are Accelerating Time to Market

Speakers

Nick Tippmann

Nick Tippmann

Chief Marketing Officer, Greenlight Guru
Read Biography
Kwame Ulmer

Kwame Ulmer

Venturen Partner, Wavemaker Three-Sixty Health
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Daniel Powell

Daniel Powell

CEO, Spark Biomedical
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Mina Fahim

Mina Fahim

CEO & President, MediView
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Jessica Richter

Jessica Richter

COO & Head of Business Development, Regulatory, Clinical & Quality Services, Veranex
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Isabella Schmitt

Isabella Schmitt

Director of Regulatory Affairs, Proxima Clinical Research, Inc.
Read Biography
This panel gives the different perspectives on how to acclerate time to market from the view of operators, servive providers, and investors.

Nick Tippmann  0:06  
We appreciate it Scott. Yeah, what a fantastic event and how, how much fun it is to be back in person with everyone here in beautiful Southern California. Really excited for the panel that we got here today. As Scott said it's it's a little hard maybe being the last panel of the day, but we wanted to have some fun. So we're here at the Greenlight Guru St. Patty's Day reception at LSI. And we decided would take a couple Guinnesses up here today, as we talk about how leading med tech scale ups are accelerating their time to market we got a really great panel here for you today with a bunch of great panelists. Really going to be educational, inspirational. Really excited for today. So let's get into it today. Um, go down the line here. Got Daniel Powell CEO of Spark biomedical Danny like a quick intro.

Daniel Powell  0:52  
Sure. I'm Daniel Powell, the CEO of Spark biomedical. We have a wearable Neuro Stimulator for opioid withdrawal fighting the opioid epidemic and it's a pleasure being here. And I'd like to say we are an early adopter of Greenlight guru and one of their favorite customers.

Nick Tippmann  1:08  
Definitely one of the favorite customers appreciate it. Thank you, Danielle, and Isabella Smith.

Isabella Schmitt  1:13  
Hi, Isabella Schmitt, Director of Regulatory Affairs at Proxima clinical research. We were a contract research organization. We do quality clinical and regulatory services.

Nick Tippmann  1:22  
Thank you, Isabella, and Jess Richter.

Jessica Richter  1:25  
Good evening. My name is Jessica Richter. I'm the Chief Operating Officer of our regulatory quality and clinical services business unit within Veranex. We are an end to end solutions provider for medical device companies.

Nick Tippmann  1:38  
Thank you. And we got Kwame Omer, venture partner at WaveMaker 360.

Kwame Ulmer  1:43  
Good evening. I'm Kwame Ulmer. I'm a venture partner in WaveMaker Three-Sixty health. We are a healthcare only, What's so funny, right health care only focused fund that invests in seed to series A in med tech, digital health and diagnostics. Thank you.

Nick Tippmann  1:59  
And last but not least, Mina follow him CEO at medi view XR,

Mina Fahim  2:06  
That's a okay. It's a pleasure to be here. And so I President CEO of MediView XR, we use augmented reality to give clinicians X ray vision during percutaneous procedures. So walk up to the patient, see all the anatomy under the skin get to where you got to go safely. And I am so thankful for Greenlight because we started out with a paper QMS who said oh, this ain't gonna work. And Greenlight really saved our butts in a couple different times. So make our process super easy, though. Thanks.

Nick Tippmann  2:33  
I appreciate that. Mina and I got to be in the hotel room with him yesterday with a couple of stocks there and demo. Oh, it's okay with with a couple of VCs to demo their technology. Yes. And they literally said we are here to see the future of healthcare. So yeah, you take it with you, please. It is gonna be a fun panelists. So

Daniel Powell  2:54  
guys, so can we just it was gonna be so we we keep track we got the first customer and the first annual window. Let's see. Everybody. Yes, yes.

Jessica Richter  3:06  
Every time we say Greenlight guru, it's the time to drink.

Nick Tippmann  3:11  
You're in trouble down there, then. All right, well, we'll get this kicked off, because we do have some fun and educational content here for you today. But first, we'll we'll kick it off. So obviously, there's a lot of things that you can do to help accelerate your time to market and there's a lot of different perspectives here on stage tonight. We have the operators, we have the service providers, we have the investors, but I'll kick it off. What are you guys seeing what some of the best companies are doing to accelerate their product development and get approval faster? Versus maybe some of the slower companies out there? And Daniel, you're you're looking me right in the eyes? Why don't you kick it off?

Daniel Powell  3:49  
Thank you. So it crosses in and out of quality and not not to totally tie in. But the faster companies to get adoption are the ones that are not cutting corners, you're doing the solid clinical work. You're doing the solid engineering, and you're absolutely making sure you're doing everything by the regs. There's nothing worse than remediation. Everybody this is a dirty word remediation. It is the biggest time suck. And if you have to go back and rework finished work, it's a disaster. I've been through a warning letter I've been through these type of situations with bigger companies. And with Spark one of our major goals and why we're your favorite company is you know, one of the first things we did was put in a quality management system and run things the proper way. And it takes longer upfront, and it saves you a ton of time in the end.

Nick Tippmann  4:45  
Appreciate that perspective, Dan, it's been in fact. We will take payment at the end, but Oh, well. Let's get let's get another so that's the operator perspective. How about the service provider? Okay, we We can go down the line. Okay, kick it off.

Isabella Schmitt  5:01  
Yeah. So from my perspective, it's really, the companies that are most efficient are the ones that kind of know what they don't know. So they know enough to know what they do know and know enough to know what they don't know and hire the service providers who can help them with things that they don't know. And navigating the relationships with those service providers and making sure that they know enough to manage the service provider relationship well, and to pick the right service provider. So someone selling them really, really hard or trying to take a ton of equity from their company, probably not a good idea to work with that service provider. But they they know what they don't know. And they know how to get the players in place to get what they need.

Nick Tippmann  5:39  
That's fantastic. And Jessica.

Jessica Richter  5:41  
Yeah. Okay. So efficiency to get to market. I think clarity around products. So one of the things that we sometimes see is that innovative innovators get really excited about all the possibilities and all the things that their product can do. And I think when companies get laser focused on what their product is the intended use the indications for use and the claims they want to make, it makes it much easier to define your regulatory strategy, your reimbursement strategy, and then really underpin that. And I agree with that commitment to quality. And if you do that, right, I think it enables you to have a laser focus and bringing your product from inception to commercialization a little bit more quickly. Fantastic, easier said than done,

Nick Tippmann  6:21  
Focus to win, Kwame,

Kwame Ulmer  6:23  
So we talk with a fair amount of early stage companies that are going from 2 to 20, or 2 to 15 employees. And what we look for are signals around their clarity around regulatory clinical quality. And if they're really good reimbursement, and it normally looks something like this, we had a pre submission with the FDA, or we know day 64 or 510K is next week, they have a certain level of clarity and crispness, crispness that lets us know that they have people who are being held accountable for those key functions, where they'll say, and I'm on the green green light guru team as well. They'll say we're working with green light guru, or we're working with Experien or Veranex, they have clarity and crispness about the key people who are helping them drive those, those verticals.

Nick Tippmann  7:14  
Fantastic. Mina.

Mina Fahim  7:16  
Yeah, I mean, the, you know, the thing that we're doing internally is really identifying like, what is the regulatory pathway based on release, and one of the things, you know, a big shout out to head of our regulatory Adam Cargill, is he's implemented a very special project scaling. So you know, a class one versus a letter to file versus a 510K, it you can scale differently, depending on the release type. And it allows us to do additional value add on top of our minimally viable product on a faster cadence on a more regular cadence, a more predictable cadence. And so that project scaling, it's not one size fits, all right, and if you can figure out how to do that, which it's, again, to address this point, not easy. But if you figure it out, and we're right on the cusp of that, you start to actually help that inflict that influences your roadmap as well. What products should we release when it all comes with a project scaling relative to feature?

Nick Tippmann  8:08  
So say here, a common thread through here and maybe a trend as well, you're you're talking about outsourcing getting the right service provider? Jessica, you're talking about focus and scaling quantity, you're talking about seeing a lot of companies go from 2 to 15, 2 to 20. How do you build your team? How are the best teams building their team? How are they building the right culture? How are they going about the strategy of taking it in house versus out of outsourced? What do you guys see him working well, right now?

Daniel Powell  8:40  
I'll jump on that because as a consumer of the services of this downstream. Except for Isabell's. Okay. We said we want to talk about

Isabella Schmitt  8:55  
There's an inside joke there, now you opened yourself up.

Daniel Powell  8:58  
She called me out in the last panel, we were on that I hadn't hired her yet. So yeah, okay. So in honesty, as a as a neuro device startup. We could have the hubris, this was a lot of opinion here, but we could have the hubris that we need to own everything and hire everything. I'm a personal believer, that's a really bad idea. I want to outsource regulatory all day long as an 18 person company. I don't need somebody who knows how to fill out all the forms and that in the response, it's more than I know, it's a lot more than that. See, I'm giving you and we promised to make this entertaining tonight. And, and so a lot of this the success comes in having our core competencies, what do we need to be a Spark biomedical to be really successful? It definitely is owning our market, owning our clinical strategy, not necessarily all the execution but who we want to be. And I think you were saying, clarity on indication, on intended use, on claims, how we're going to take this to market, but then not having the hubris to try to own every aspect of and sometimes manufacturing may be absolutely your core competency. And you should have that in house, we don't, we have a piece, don't tell my investor, we have a PCB, it's not that exciting. Anybody can make it, like it's a file, you send it off, somebody can manufacture like, I don't need that in house. But what I need in house is absolutely the understanding in our market, our domain. So we we've subdivided it like that, and then really tried to find good partners to outsource the rest, and it's far more affordable and far more efficient.

Nick Tippmann  10:47  
I love that, what a great perspective and really focusing on what you do best, and what is your core competency and let the experts do the rest. You don't have to have to take it over, and MENA from an operator's seat as well, I'd love to hear your perspective on it till

Mina Fahim  11:02  
Is it okay, if I disagree? A little bit? No. No, I actually I agree on like, 70% of actually that, but for us,

Daniel Powell  11:12  
I'm normally 50% Wrong. So you're great.

Mina Fahim  11:16  
20% better than us. Right? Excellent. Awesome. So not mean, we, I mean, really, the part that just like we have a different opinion on is because we are bringing something so different to the patient bedside, regulatory is actually played a big role in product roadmapping in helping understand, hey, there's a subset here that falls into a different classification of product to get the product to market sooner, so we can learn from it. Right. So for us, like figuring out how do I get through IT review? How do I get through value analysis committees, right, though those things are I don't want to say as important as the actual solution. But fundamentally, I don't think we would have been attuned to that, if our reg partner internally wasn't like, you realize you have a solution here. That's a subset of the Ferrari, right, more of like a, you know, Honda Civic, that can get you from point A to point B. And it allows us to learn very, very fast. So the technical and business risk burned down for a class one solution to market sooner informs future 510 K and forms design controls, and it really scale. So I guess I'm actually like, 84% aligned with you, and I'll take you really 16% difference. So do that math, right. I mean, this, again, is a setting and so so no, I mean, that's regulatory plays a huge,

Daniel Powell  12:35  
But you make a great point, and you have to own your strategy, you cannot outsource the critical thinking of your business, but outsource the labor in which you articulate it. That's when I did.

Nick Tippmann  12:51  
That was what it was well said I think talking about competitive regulatory strategy versus doing the work which I, I'll come back to that one. But Kwame I'd love to hear your perspective from sitting in the investor seat on how you think about companies doing things in house versus outsource. So

Kwame Ulmer  13:07  
sometimes when we meet this type of company, I'm John, my co founder is Jane, we're building a pretty simple device. But we think we can scale quickly. And we're going to farm out everything, we're going to be super lean, super light. And the biggest we're going to get as 10 employees, but we're going to be we're going to farm out everything. And I think for simpler products with a pretty clear regulatory pathway, maybe minimal or no clinical, pretty straightforward. They need a pretty straightforward QMS that can work. The more bleeding edge technologies, sometimes companies say as soon as I raised my series A I'm bringing an in house regulatory, I'm stopping with the consultants, I'm going to flip that switch quickly because the complexity is such that I have to control these variables with someone who's full time shoulder to shoulder with me, because a regulatory strategy is not simple. It's complex. And then most companies fall in the in the middle. But I would say most companies that we deal with around series A definitely Series B are flipping regulatory quality to be full time employees. They're keeping with Greenlight guru from C even sometimes pre C all the way through. But they may be shedding some of the regulatory consultants and just bringing people in house. So that's that's what the patterns I see

Isabella Schmitt  14:28  
Can I add something to that. Yeah, I think that on that point, too. Like it's hard when you have complex products, like if there's even if they're using consultants still right if there's no one on the team who's owning regulatory or quality, because if you have a bunch of engineers or physicians working, they just want to do the engineering and they want to do the design. Are you offended by that? Are you an engineer or physician, just a little vote but but you hired people.

Mina Fahim  14:57  
You're sorry,

Isabella Schmitt  14:58  
but you know they want do their thing, right? They don't want to do all the documentation and all the form filling, though it's way more complex than that. But they don't want to do all of that. Right. So but they should have someone, ideally at some stage in house who's going to own that internally, because it's hard for a consultant to design their product and do all of their documentation and do all of their regulatory. I mean, we could, but it's just going to be overly expensive for the companies and probably not in their best interest overall, especially with complex products.

Nick Tippmann  15:31  
Yeah, I would agree. And maybe at this point, I would turn it around and ask you to give me the answer to my question around manual processes. But what I'm hearing is that you basically want to automate, get rid of those low value add activities, the manual, add that the grunt work that needs to be done, automate those in a system purpose built for med device, and then focus on the strategies and the innovation that actually is going to drive your business forward. Agree, disagree, actually give the practical advice. I mean, I'm obviously splitting my thing back. But it sounds like it is the best practice. Agree,

Daniel Powell  16:07  
Agree. All right. All right. Oh, no, we just use all spreadsheets.

Nick Tippmann  16:11  
I'm not even getting in the spreadsheet. But what you guys are saying, what does that allow you to do? So then what are the best companies doing? So what are you doing with that time? So Mina talks about he brings in an amazing regulatory resource like Adam Cargill, to now focus on this competitive regulatory strategy. I see like, what are some of the other advanced tactics, strategies that our companies are doing? That we know it's like a given that you might as well and automate as much of the manual stuff? What are the more advanced strategies and tactics that these companies are using to get their products to market faster?

Isabella Schmitt  16:48  
I could talk okay. So I think sort of to answer your question is, after COVID, we all moved into like a remote world, right. And so some of these digital solutions allow us to exist in a remote world a bit easier, because we have the ability to esign things right, as long as it's part 11 compliant, we have the ability to communicate through means, you know, different platforms, whether it's zoom, or teams or green light, you know, communicate on documents, to communicate on things, clinical trials, trying to move towards decentralized trials, which is also like a remote aspect of it, but also reduces the cost as well. So all of these things moving more digital, I think, is something that we've seen as a result of COVID, sort of in an industry that was that typically lags a little bit behind that, as far as not innovating products, but innovating, how we do our processes a little bit slower, and COVID kind of forced us into going into more of a remote environment. And I think obviously, digital technologies plays into that.

Nick Tippmann  17:50  
Yeah, and I totally agree. Jessica, from your perspective at Veranex, kind of see in all aspects. And then from the services perspective, what are some of the better strategies and tactics that you're seeing your guys's clients do?

Jessica Richter  18:05  
You know, I think Isabelle hit, hit it on the kind of nail on the head when it comes to operationalizing as much of the the mundane tasks as possible. I think companies do that. Well, some tech companies that love technology, especially companies with software as a medical device, sometimes over digitize. And so just because you have a cool software solution doesn't mean that you should actually utilize or implement that I think compliance becomes really important. So that commitment to quality, whether you're using Greenlight guru, or other practices, as far as implementing quality across your organization is one thing that I think companies can really embrace at the outset to ensure they have success early on. Because it doesn't matter how many times you're iterating, if you have the right documentation in place, you're set up for success to either shift your strategy to bring that forward to FDA to think about that outside with, you know, as you think about international penetration and geographies. And so really, it's that commitment to good processes, good practices across the whole organization, not just within engineering.

Nick Tippmann  19:06  
Yeah, that's fantastic. I'm glad I'm glad you brought that up on the quality versus compliance. And we talk a lot about green light and the tools but there's people processes and tools, what have you guys seen some of the better companies do from a quality perspective of implementing a quality culture? Because that's really where it starts like we can only do so much we can only help you so much your quality person can only do so much. But as CEOs as investors as people that are advising the CEOs and investors, what what are you guys seeing?

Kwame Ulmer  19:39  
To me we look at signals because we're we're not in the day to day trenches with the companies but we have the signals of companies that have quality in their culture. One is things like when they share the an audit findings, they tell us these are the major findings we've had, this is what we're doing to fix it. Or here's the feedback we got from the FDA, here's the person or the team that's going to really put together a tiger team to address it quickly. So you get these signals that they don't run away from problems, but they have people who are accountable to deal with them. And quite candidly, deal with them, not in a, in a manner where you're panicking, but you have people who have rapid response processes in place to, to really tackle these things. Yeah.

Mina Fahim  20:31  
Yeah. I mean, actually, the point that was brought up earlier in regards to sometimes you have a quality culture internally, but if you outsource something, the quality culture for like the external OEMs. So, you know, for us, we develop novel software, but we interface with the physical world and devices and hardware, but we don't want to build right from production perspective and invest in you know, huge manufacturing, and, and, you know, steel, you know, steel, safe molds and all this stuff. And so we actually, like, don't go the cheapest route for an OEM, if there's gaps from a quality perspective, not cutting short, no, we're not taking those shortcuts. So I think there's a comparison of you can implement that quality culture internally. But when you're working with outside third parties, using a filter of quality that, you know, what does your supplier quality checklist look like, and actually subjecting people to it? And when we actually have moved away from a vendor, and they say why, quite frankly, you don't stand up to the quality that we want. But we had the best price. Well, yeah, you might have, but we might pay less with you today. But we're going to pay a hell a lot more later down the road. Sorry, for a

Daniel Powell  21:47  
Second customer. Same person.

Mina Fahim  21:51  
No.

Daniel Powell  21:55  
So I'd love to add on to what you're saying. And not talking about my current company. I used to work for a fortune 500. You can look at this on LinkedIn. But I'm not naming names. So I'm not violating an NDA. I worked in a culture once where we had a problem, and I went to open a cap and I was actually threatened to be fired. That's that that is not that's not how it goes. It was such a misperception our CEO used to brag. Again, LinkedIn, you can look or CEO used to brag we've never had a recall. Never. And we were all proud of that. It's a horrible, actually a horrible claim. The older you get, you will have a recall, the FDA is not concerned with you being perfect. They're concerned with what you do when you when something goes wrong, because we're we have a bunch of human engineers, and they will mess up and we will have a problem. And we will have a recall in the leadership and the culture is when the CEO, the head of quality, the VP of quality, whoever COO says, Yeah, let's let's address this, that's a letter to file that's a kappa. That's, that's a corrective action. And I learned this the hard way through a five year warning letter. And it shaped what we're doing at Spark. So in the first week of being commercial, we had a complaint and open to kappa in I was like, I was so excited. I was like, like, let's show that, like when we get audited, they'll be like, Yeah, we had something weird happened. And we didn't expect it. And of course, we didn't. We're a brand new company. And I think the culture of good quality is hung out let the helicopter go by is one that acknowledges human failures and shortcomings and problems in the field, owns them, treats them respectfully addresses the problem head on. And that was for me, an invaluable learning experience earlier in my career, when I watched one set of leadership, deny all problems, try to hide it, not address it. We had this we had this thing where it's like whatever we do, don't create a submission to the FDA. They were the evil in and that's totally changed. And now it is we have 5, 6, 7 letters to file in the first two years we we've made changes we address them. And that's it really has to come with a culture of we're human just face the challenges and we're not perfect in and do the right thing.

Jessica Richter  24:51  
And that starts at the top and that's one of the things when we sit down and we speak with companies about their commitment to quality if the CEO is not at that meeting that's a red flag, if they're planning to outsource all of that to a single responsible person, which there will be in there should be, but that CEO needs to be as committed to quality and lead from the top, everyone within that executive leadership team needs to have the same commitment to quality, they're signing off on it. So whether they're, you know, that culture comes from there. And if they, if you don't have that buy in, unfortunately, you get those experiences, and it degrades the quality of your product. I mean, quite literally, the quality of your product, it compromises what we're trying to do here, which is deliver excellent patient care. And FDA is not looking for perfect. That's not the bar, right? It's this constant innovation. It's this total product lifecycle. It's this emphasis on when we make mistakes, how do we learn from them? How can we identify those risks, mitigate that, and then incorporate that into the next design to ensure that we're constantly evolving.

Kwame Ulmer  25:51  
You made me think of a company that we invested in, who got a communication from the FDA, an Untitled letter, and they reacted to that risk appropriately, and eventually submitted a 510 K to address the issues outlined in the letter. They didn't overreact it in under react and what I loved about this CEO, they didn't spin and try and there's an expression, don't piss on my leg and tell me it's raining like they didn't spin it through third party. So there's this person, there's a new us about particularly early stage CEOs, that that and everybody can tell when they're being spun, who are spending something as opposed to say, this is the problem. This is the relative risk, this is what you need to know, investor. And this is how we're going to fix it. It's very clear 123, this is a 123 communication.

Nick Tippmann  26:42  
I love that what what great perspectives all across and I mean, the quality code is starts and ends with the culture and it starts at the top. And it starts with the CEO. How about when it starts at the beginning of the company? So Isabella, I know you guys work with a lot of very, very early stage companies. How does someone like I don't know, as someone who at how do cultures like this thing? What actually is it we've defined it a green light guru, it's a big thing we say it's how culture is how you feel at work. But quality culture probably needs to have a little more metrics and a little more definition around it when we're talking about med devices and people's lives. But I'd be interested in how do you guys advise companies on building a quality culture from the beginning, especially with more early stage or inexperienced leaders?

Isabella Schmitt  27:30  
Yeah, so they're often kind of resistant to it at the early stages, again, because usually, they're a small team. And a lot of these earlier stage companies are coming from academic or engineering or physician backgrounds, which is great, but it lacks sort of some of that industry kind of knowledge. And what we typically advise, you know, is to start with a few SOPs to start off, so it's not overwhelming, and they don't really need a total package for you know, they don't need ISO certification at the early stages. So we usually start with obviously, if you start with document controls, because that's foundational, you can't really have SOPs, if you don't have document controls. And then, you know, record controls, risk management and design controls, things like that. We talked about supplier earlier understanding, you know, risk based kind of supplier analysis. So if you have a supplier who is making your hardware and your hardware is a pretty important part of your product, and they're taking over all of that you really want to have good controls over that supplier. So those are usually like the bucket of SOPs that we start with for companies, and then they grow from there. And so they don't need, like I said, ISO certification at those early stages, they may not have intense Kappas or anything because they're still kind of doing r&d and designing and all of that. But getting started early so that they're not having to go towards the end of their lifecycle and backfill all of these things because ultimately, that takes up more time and likely a lot more money to do that in the later stages because they're ultimately going to have to pay for it at some point. And so why spend all the time for consultant to come in. I mean, obviously consulting groups love it. But why spend all that money to try to bridge all those gaps going through like documents that are here and there and everywhere with like little bits of information in different places and putting it all together in one.

Daniel Powell  29:16  
That's prompt me. So I'm going to an advisory to consultants who are watching this. The way you describe that as the consultant I want who is very as the operator hiring potentially, not yet,  consultants one of the things we need. So when we're at 7, 8, 9 people, we need doers, consultants, not pointers. And that is actually one of the downfalls in the this just popped in my head while we're sitting here. One of the real challenges for startups in the quality consulting realm is we get pointers. I had a quality consultant. He was super knowledgeable. He was fantastic. And he kept giving me to do's, you ought to do this, Dan, you ought to do that. And I was like, Dude, I am busy, I'm hiring you write the SOP write that, like I, like, don't tell me I need to write an SOP so that so in the way you described, it was a doer and a deliverer. And that is, I guess, not to change direction on this. But that's a challenge in this. When you run into the quality consultants who tell you what you ought to do, dude, and I need you to do it, I need you to give me SOPs and work instructions and edits. And I, because I don't have a framework. I went through a full FDA warning letter and on remediation, and went through audits and had my butt kicked by, much better, by the FDA. I mean, the FDA ships, the lady auditor had a uniform on with metals. That's how intimidating this auditor was, I was just like, why are you wearing a military uniform? This is an FDA audit.

Nick Tippmann  31:12  
Intimidate you intimidate you did exactly like she did,

Daniel Powell  31:15  
She did. So I shook her hand and made her have human contact. And that shook her. Because they're FDA, sorry. But when, when this whole thing was over I, I went to put this in place. And I was like, I did all that. And I'm still didn't have the skill sets, to put all the stuff in place. I mean, I was a participant in an observer and an experience, all this audits and everything. And when it came time to do it, I realized I still didn't know how to do it, I needed help. And I can't imagine somebody coming into this industry, who didn't even have my experience, and they're trying to be a CEO, they're an engineer, and they hadn't gone through a warning letter. And whoever I think you said earlier, know what you don't know. I feel sorry for people that that are entering this and you're running into an auditor or a quality consultant, they're going yatta you ought to have a document control policy. And they're like,

Nick Tippmann  32:16  
what what does that even? That's what I that's a great, I think that's a great it's a great lens and great view on it. And I think we're getting up right close to the to the end of time here. But I think that'd be a great way for us to end. Here's we've talked about a lot of best practices tonight. talked about a lot of things companies can do. How about things that they should watch out? What are the what's the one landmine what's the what's the gotcha that you've learned from a quality regulatory getting your device to market faster that you should look out for that you should warn? Yeah, well, we're gonna we're gonna end with a warning, Dan, you took us there, you took us there. So you're going to end it? Because

Daniel Powell  32:57  
let me let me have last save them a second. Let me let me think of Whoa,

Nick Tippmann  33:01  
all right, who's gonna take me

Mina Fahim  33:02  
while I'm happy to mean that projects live and die by design controls and requirements from cost to time. And I think that's something we haven't touched on. And it goes back to your previous point, like what is culture? At its core, we have four pillars that are the 4 Ts of the medieval culture in order trust, transparency, treatment, track record. And fundamentally, they're like, well, track record remains results. So why is that at the end? Well, it's not at the end, it's just a consequence, right? So if you don't have trust, that's gone. Right? You might as well board up the windows. And if you don't have transparency, which fundamentally different functions of competing priorities? So one of the things that we've learned is, when do you close a phase of the design control process to ensure verification and validation? You know, you shouldn't be learning anything new at the validation phase, right? So one of the things that we spent a lot of time with his formative usability testing, where we are putting things in the hands of the end users saying, hey, try using this in this in cross the risk spectrum. And what we end up doing is, hey, we create user needs and design inputs that really become the lighthouse of a project, that it's that guiding true north. And we iterate in the design phase, until we can always point back and say, we've landed on an embodiment that does represent the user, sorry, the design input, and will fulfill the user need. And only then, and we've actually developed an asynchronous, but compliant way to go through the different phases. So when this part of the product is done, hey, we know that from a v&v perspective, we're going to close it out successfully. And it doesn't always work, things fail, right? And you you react to them, but you don't try to justify things and you know, one of the terms that we use in house is don't become a justification factory, because that factory eventually is going to go up in flames. And that's one of the things that we are very careful about Where do you justify? Where do you provide evidence? When do you close a phase out? When do you leave it open? Because at the end of the day, if you look at the time, time versus cost scale, if you get past the design inputs stage, and you start the mistakes that happen, you can start closing out design phase early, those costs become exponential, when a project doesn't quote, when you close them out at the wrong time, I won't say too early or too late. But before, you know, hey, my outputs truly are going to be able to be compliant and meet the design inputs and user needs.

Kwame Ulmer  35:39  
To add to that, the companies we invest in that have scheduled slip, when we double click and peel back the onion, they are growing so fast that they can properly organize their people and processes, so that they don't have cross functional teams to get through those design control steps properly. If we really peel back the onion, and then tools. So those are my three people, processes and tools are weak.

Nick Tippmann  36:02  
Love it. Love it. Thank you. Yeah, that's a great story. All right. Oh,

yeah. Give us give us your top 123. What do we got? What are the mistakes, common mistakes these companies. So

Jessica Richter  36:17  
I think a common mistake is to become so through the lens of your technology that you aren't that you become afraid to make change or to shift as you see what's working, what's not working, because you have that vision. So sometimes you got to you've got to shift. And the other one is to surround yourself with people that actually are going to bring their own perspectives and diverse thought. If you surround yourself with Yes, people you miss, you miss the misses, you miss the obvious signs along the way that something isn't working, and you need to make a shift. And they go hand in hand.

Nick Tippmann  36:50  
Love that. Gotta have people are willing to critically think and bring it up. Thank you. All right, Isabella.

Isabella Schmitt  36:57  
All right. So I would kind of like jump off of what they said. So design controls, I think is a big one. Because if you don't pay attention to that and design the right product early on, and then you go through clinical trials, if you don't do formative studies, for example, and you wait till the end to do your usability and you find out, hey, nobody wants to use this device, or there's major problems, not the time because you've already paid for a clinical trial. And so then that that kind of sucks for you. And then the other thing about it, is that something you just said when now I can't remember what it was. That's that's what it was. If you a lot of you know, entrepreneurs and founders think like, their baby is the most beautiful baby in the whole world, like everybody does, right. And so they're not open to feedback. They're not coachable. And so we a lot of us work with MedTech Innovator. And one of the things that we do is coachability. And if a company is if a founder is not coachable, it's really hard to get them to move the needle because they don't listen. They don't know what they don't know. And they don't want to hear about what they don't know. Because they think they know everything, and they don't. And so I think that coachability part is really important. Go for it,

Daniel Powell  38:05  
feel well called out here.

Nick Tippmann  38:08  
Before Dan brings us home then with this last amazing piece of wind, I mean that that can go across all spectrums of companies of people and everything. Being coachable, and the fact that coachability is so high up in the ranking scale of such an elite program like MedTech Innovator that it's like one of the top things talked about as CEOs and founders in that room. I think it's just a good realization for all of us to have in our in our day to days and our lives and with our teams. And and yeah, it's it's important, it was well said.

Daniel Powell  38:46  
Yeah, I'll change my answer. Because of that. I actually had a mentor early in my career. One of my early entrepreneur ventures, which was a complete bust, I lost a ton of money. But I had an advisor, who officed next to the CEO of Kentucky Fried Chicken. And he said it must be really difficult to have 5000 Fried Chicken stores under your any goes No. Because I just have to make 51% of my decisions right every day, and we're good. And he goes, What's scary is owning one chicken store. And if you're wrong, you're dead. And it left an impression on me with to your point. We have to be humble. We have to be, I'm wrong all the time. And I tell my team I was like I think I know what I'm talking about. But like let's bring all the minds together. And we pivoted and we pivoted we pivoted in product design we pivot pivoted in clinical. Oh my God our first you know first five patients and we're learning and into your point. Stubbornness is the death of your company. Humbleness is the life and you just got to be. And one of the best things I've learned to say in my career is like who I'm wrong, and you really get all. You can really get on track really quick when you're like, Ah, I'm open, that there's pivots and changes and everything going on. So I really appreciate that I try to live that in our own, like, our own leadership at Spark. And then you see it replicate very quickly, you create a culture that is afraid to fail or you create a culture who's like, wow, we learned something, let's pivot and go nobody's getting the finger pointed out us are getting that micromanage blame so. So I think that brings it home really well for tonight.

Nick Tippmann  40:48  
And I agree, let's give it up for these guys. Thank you very much,

Unknown Speaker  40:51  
Greenlight guru. Thank you. Thank you all.

Daniel Powell  40:55  
Thanks. Thank you, California.

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