podcast_devon-campbell

Rapid Acceleration of Diagnostics (RADx) is an initiative launched by the National Institutes of Health (NIH) aimed at accelerating the development, commercialization, and implementation of COVID-19 testing technologies that shorten viral detection cycles and increase access to reliable, accurate testing on a widespread scale.

In this episode of the Global Medical Device Podcast, Jon Speer talks to Devon Campbell, founder of Prodct, who has been a major contributor to the RADx project through his support of the RADx teams and their ongoing efforts.

Listen as Jon and Devon share five actionable lessons learned from Devon’s involvement with RADx, each of which can be applied by medical device companies across the board.

 

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Some highlights of this episode include:

  • What is RADx Tech? Initiative that aims to speed the development, validation, and commercialization of innovative point-of-care and home-based tests. Also, it tries to improve clinical laboratory tests to specifically detect COVID-19.
  • Common characteristics of RADx team projects include companies: 
    • Generating abundant data and running experiments quickly.
    • Without medical device leadership or product development experience.
    • Managing development while building infrastructure and fundraising.
  • Lesson 1: Protect the data, build credibility, and remove vulnerabilities to capture credit and establish indelible data for those that invalidate data or question work.
  • Lesson 2: Start documentation, introduce design controls, and review/revise product development.
  • Lesson 3: Build and maintain Technical Advisory Boards to offer feedback that accelerates product development/commercialization based on experience.
  • Lesson 4: Interconnect different functions involved to develop a product. Start with the end in mind to develop a strategic roadmap to take fast but small steps. 
  • Lesson 5: Manage risk mitigation from product, business, scalability, manufacturability, and other perspectives.

 

Links:

National Institutes of Health (NIH)

RADx

Small Business Innovation Research (SBIR)

FDA - Medical Devices

FDA Guidance Documents (Medical Devices and Radiation-Emitting Products)

Emergency Use Authorization (EUA)

FDA - Code of Federal Regulations (CFR) - Title 21 

FDA - Part 11, Electronic Records; Electronic Signatures - Guidance Document 

International Organization for Standardization (ISO)

Prodct LLC

Devon Campbell’s Email

Devon Campbell on LinkedIn

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

 

Memorable quotes from this episode:

“Its aim is to speed the development, the validation, and the commercialization of innovative point-of-care and home-based tests. It’s also looking to try to improve clinical laboratory tests, anything else in that diagnostic space, specifically to detect COVID-19 and the virus.” Devon Campbell

“It’s amazing, the number of hurdles that are cleared in order for some of these technologies to be able to find their way to the market, still in a safe and efficacious way.” Devon Campbell

“There’s a lot in this situation that forces the teams to be hyper-sensitive to efficiency and speed, while still maintaining safety and regulatory expectations.” Devon Campbell

“These are teams that are used to gathering data and running experiments. They’re not used to being a medical device company.” Jon Speer


Transcript:

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

Jon Speer: Did you know that there's a really exciting NIH-funded program right now called RADx. It's pretty cool. Lots of exciting, innovative, creative products and technologies that are being developed to help with the pandemic. And joining me on this episode of the Global Medical Device Podcast is Devon Campbell from Prodct. Devon has been supporting some of the RADx teams, and we decided to dive in and share five actionable lessons that have been learned from the RADx program that would also be applicable to early stage medical device startups. So enjoy this episode of the Global Medical Device Podcast. Hello, and welcome to the Global Medical Device Podcast. This is your host and founder at Greenlight Guru, Jon Speer. Happy new year hope everybody's 2021 is off to an amazing start. Today, I've got a familiar voice, someone that frankly I'm quite fond of and really enjoy talking with him the opportunities that he and I have. So joining me is Devon Campbell. Devon is the founder of Prodct, P-R-O-D-C-T. So Devon, welcome to the Global Medical Device Podcast.

Devon Campbell: Thanks Jon. Always happy to be here.

Jon Speer: So what I thought we could dive into a little bit today is talk a little bit about this... And I think it's kind of an exciting program. This program is called RADx, I thought we'd explore that a little bit, but I guess before we dive too deep, what is RADx? Maybe give folks a brief overview of that program.

Devon Campbell: Sure. So we're going to be talking about the RADx Tech Initiative, and what that is? It's a program done through the NIH and its aim is to speed the development, the validation, and the commercialization of innovative point of care and home-based tests. It's also looking to try to improve clinical laboratory tests and anything else in that diagnostic space specifically to detect COVID-19 and the virus there. So it's very focused on a lot of different technologies that are out there and how can the NIH, how can the government step in to as kind of a Kickstarter incubator program to help companies bring their technologies to market that can help in this battle that we're all engaged in.

Jon Speer: Yeah. And I don't remember exactly when I first became aware of this, but this is I think it was mid to late Q or I'm sorry, 2020, when they first announced this program. How long has this program been around, can you remind me?

Devon Campbell: It's been funded for quite a while I don't remember the date that it actually got started. I know that rolling submissions and selections for projects began end of April, I think April 29th, that's when they started looking out there and see what might be available. And then they had like a phased process where there is kind of a Shark Tank-like selection process to select down to a smaller number. And then there's some validation and risk review where more and more folks get involved to take a look at some of these companies. And then the very last piece is a more select group gets chosen and then they're supported very heavily through the NIH program to help with clinical tests and regulatory approval and quality system build up and everything that you need to scale up the company in manufacturing with the goal of being able to then have a number of tests out there that can detect and in variety of different use cases and environments.

Jon Speer: Some of the program, at least what I'm aware of anyway sounds somewhat analogous or similar to the SBIR program that's been around for a while. It seems like there's an element or elements of RADx that are similar to that. But I liked your comment about Shark Tank that might be a little bit more appropriate as far as describing the process.

Devon Campbell: Yeah. And I think it's a little different too, because the further end you get when you become kind of a finalist in this space, within the program, you're then matched with technical business and manufacturing experts provided to you through the program to help fill the gaps that the companies may have in order to increase the odds of success. So there's a lot of different programs out here that are really exciting technologies that the government and the NIH is investing in these companies to try to bring them to the point where they can make a difference. And I think that that's a big difference with compared to the SBIR or STTR and things like that. Where you're really getting a ton of handholding and support in places that you don't necessarily... Where you have vulnerabilities within your team.

Jon Speer: True. And the other thing that, that I think differentiates RADx is the speed. I mean, I have been involved with companies and initiatives where they've gone SBIR or different grant funding routes, NIH, whatever the case may be and that process is painfully slow. I mean, months and months and months and the period of time that since RADx has been around, I mean, I don't even know. I mean, there's probably been thousands of companies that have applied to the program and probably a hundreds going through the process right now. And it's like you said, it's handholding, it's very quick. Which is sort of interesting like the classic description of a medical device or an IVD or something of that nature usually don't use the word quick and fast when you're describing the process.

Devon Campbell: I think it definitely applies here. It's amazing the number of hurdles that are cleared in order for some of these technologies to be able to find their way to the market still in a safe and efficacious way, meeting FDA expectations. So there's definitely no corners being cut, but I would give you an example if you want to get feedback from the FDA on a specific aspect of it, you basically kind of raise that up within your team and within the RADx resources that are there to help you. And then within a couple of days so there's just a pace and you get on the agenda and you have audience with the FDA and you get into them right away and you get full notes back and decisions are made, then you get suggestions about what you should do next from them. And just the real-time feedback it's moving at breakneck speeds and it really allows some of this stuff to move very fast.

Jon Speer: It's a whole different topic for a whole different day, but I'll plant the seed in your brain and maybe we can talk about it later. But there's been a lot of things through COVID and seeing the responsiveness from FDA that some of the positive momentum on things like EUAs and things like that. And this RADx program begs the question maybe there's an opportunity for this to become the norm? But again, that's a whole different topic for a whole different day, but I guess getting back back on topic, you and Prodct have been very involved in this. So what was it for you that was compelling and intriguing about this?

Devon Campbell: So, we were talking before about how finalists are matched up with technical business and manufacturing experts, right? And regulatory and quality experts, all sorts of things. And there are a number of different kinds of companies involved in the program. Some of them are much larger, some of them are medium-sized, but then there's a subcategory of emerging entrepreneurs and earlier stage technologies that haven't... You know it's not a mature company that's already on market and they're trying to pivot their technology to be able to detect COVID-19. There are groups that are definitely doing that, but there's also this group which is kind of my specific niche and specialty where I focus a lot of my attention and that's helping these emerging entrepreneurs and these earlier stage companies get through kind of that how do we scale up the company? How do we build it? What do we invest our attention and our limited funds into to be able to contribute to this overwhelming need we have nationally and internationally? So there has been on this specific subset had been noted in a few cases, that's a tricky pivot to make, to be kind of an academic to folks in their PhD thesis, right? And a lot of my clients and a lot of the work that I do is in that earlier, really early stage. Like how do we build a medical device company out of this research that we've done, or this academic work that we've done? And those companies needed some additional help. So a lot of the RADx experts that were involved, they kind of take a look at it and they ask, " Is there anyone within the networks that you guys have that can help these companies kind of figure out how to do this pivot? Especially in this pressure cooker situation where we're moving so fast. And fortunately for me and my network, a few folks there on the inside had suggested me as a resource to be able to help kind of coach and mentor these projects like I do professionally and like I do with MassChallenge and with other groups. So that's how I got pulled in and got involved as one of those technical business manufacturing experts to help these companies figure out how are they going to get to there from here?

Jon Speer: I mean, you just hit on I think a really important point. I've worked through my career as well with a fair amount of, I'll say academic researchers and the research is phenomenal a lot of the times, but the challenge, the obstacle, the barrier is shifting from the proverbial R into D. Taking that research and actually with an eye towards the development and an eye towards productization. I think that's a word that is a big challenge. So I think that's really insightful that the powers that be behind this program saw that and realized, " Hey, there's people like Devon out there, who's been there, done that and very knowledgeable about moving from R to D and D to market." So, that's really cool. I know from a Greenlight perspective we've been working with, I don't even know the exact count these days, but let's just say probably a couple dozen RADx companies at least, I have been working with in the Greenlight construct as well. Our involvement with that is to your earlier point, the part of moving from research to development. And of course there's advance in the product and the technology of course, first and foremost, but with an eye towards go-to-market things like quality systems become important and good design controls and risk management, those sorts of things. So, that's the part that we've been playing from a Greenlight perspective. So I thought-

Devon Campbell: Yeah, absolutely and I've been thankful that you have been because it's been a useful resource for me to be able to lean on as well with some of these teams. But one thing that I thought was really interesting for us to explore today, in the time that we have remaining was, and we've kind of set the stage, right? We've talked a little bit about this RADx program and specifically the kind of team that I've been helping, and that I've been blessed and fortunate enough to be able to help support. I think that there's a lot in this situation that forces the teams to be hypersensitive to efficiency and speed while still maintaining safety and regulatory expectations. And as I've been building strategies for a lot of the teams that I'm associated with and helping them think through, all right, well, what will our quality strategy be? How should we approach product development? The regulatory team has given us a guidance to say, we're going to go this direction from a regulatory perspective, how do we maintain that and inch toward it? And I've noticed my mentoring and suggestions and strategic design has shifted a bit for this subset in this situation, compared to what I might normally do with companies I'm involved with. So I thought it was interesting, and I reflected on that, and I thought that a lot of these learnings are definitely applicable outside of this RADx construct. It makes sense for really all kind of early stage medical device, med tech, even therapeutic companies to at least consider a few of these kind of common observations that I've seen that are applicable to almost all the projects that I'm supporting.

Jon Speer: Okay. I'm intrigued, I mean what are some of those learnings that you think are worth sharing that apply to RADx companies and, or any other company, frankly?

Devon Campbell: Yeah. Cool. Let's get into those. We should acknowledge... Let's talk for a second about some common characteristics with a lot of the projects that I'm supporting. I have to be a little obtuse where we don't talk about the projects in any detail or the technology, or name them through the RADx program, only that I'm involved and that I give some guidance. But I would say kind of on a grander scheme, some common characteristics would be that these companies are generating an amount of data, and they're running a ton of experiments. They're doing it really fast and they're generally doing it kind of outside of a deeply experienced medical device, such a leadership team or product development team, at least. So generating a ton of data, really cool technology, running tons of experiments. In most cases, they're racing toward an EUA, as kind of a stop on the road and not even a stop, but as a toll booth that you fly through on the highway on your way toward full FDA approval or authorization or clearance, depending on what they're trying to do. So a third kind of common characteristic between them all, we touched on it, they're all generally relatively inexperienced with medical device development. But they're all very smart, very anxious and excited to learn and to apply what they might've learned from other industries that they're now in this, or what they might've learned from academic or from research situations. But generally there's a lot of coaching and mentoring that's needed to help folks kind of understand core medical device development and the regulated space that you and I both live in. And then the last thing that I think is important to point out is that in all cases, they're simultaneously trying to manage development while building infrastructure, while fundraising. So it's kind of like jumping out of an airplane and you're trying to sow the parachute while you're falling, and you're trying to make money to buy the material to sell the parachute with, but you're falling and you're doing all of it simultaneously.

Jon Speer: Falling at a rate of terminal velocity too, right? So you're going really, really fast and as you're trying to-

Devon Campbell: You're moving fast. You're moving really fast. Yeah. So I think it's an interesting kind of paradigm and situation that a lot of these companies are in. And let me tell ya they are rising to the occasion, there's a lot of really cool work that's being done out there. So crosstalk

Jon Speer: I was going to chime in for a moment those characteristics, at least a few of those, that these are teams that are used to gathering data and running experiments. They're not used to being a medical device company. They're probably not used to fundraising. They're probably not used to building a team, building a company and their normal pre-COVID days had jobs probably not really focused so much on go-to-market with our technology. So it's a really interesting dynamic.

Devon Campbell: But, and I like the way you articulated that, Jon, but if you abstract it just a tiny little bit take away the COVID overlay that's on top of the whole thing. I feel and my thesis here is that this experience and the lessons being learned from this is still highly applicable, even in a non-COVID context inaudible companies in this space to be able to look at what's happening there, why are they able to move fast and what can I learn from that to apply to my medical device company that has nothing to do this COVID? And I think there's a lot here for these early stage startups.

Jon Speer: For sure.

Devon Campbell: All right. Want to jump into them?

Jon Speer: Let's do it.

Devon Campbell: All right. So one observation that I think will resonate, so a lot of these companies that we talked about, they're running a lot of experiments. They're running a lot of data, they're doing the right things, right? It's not that they're engaged in poor science or poor engineering practice and designing or developing whatever it is they're working on. They're doing the right things. It's solid science, it's foundational engineering but it's being done in a way that the teams can't really take credit for it later. So one of the first things I've kind of coached the teams that I'm involved with is to protect the data, build credibility, and take away those vulnerabilities for anyone else outside your company to look at what you're doing and invalidate your data, or to otherwise question your hard work. You're doing the right things but if you're not, you know the old quality adage of it's not written down, it didn't happen. You're doing thoughtful work, it's just not being captured in the right way. So rather than trying to build out, for example, like quality system stuff and say, " Okay, let's start with quality manual and then let's put in management responsibilities and let's kind of build piecemeal as we go and kind of start building it." I say, " Just don't worry about all that. Let's take away excuses. Let's take away vulnerabilities where people could try to invalidate your work. I want you to document your protocols. I want you to document your reports, including the configuration of whatever it was you were testing when you did the testing and establish some form of data indelibility." So in a lot of cases, the data is being shared, it's on different people's computers, or maybe it's in Dropbox or whatever. Like at least we can take baby steps we don't have to have a fully 21 CFR Part 11 compliant repository and an approval system yet. We need to get there. But for right now, I want you to at least take what you've done and put it into secure drive somewhere. All the data just flows into one spot and make sure that you wrote down what you did. What was the protocol? And then stop. You obviously are looking at the data, you're making a decision. " Hey, we need to optimize the assay so that we can do some X, Y, and Z." Great. You looked at the data, you made a smart decision, you have data that supports it, but you didn't write any of that down. So just take a breath and write small reports. I don't care if it's one page, but write a report that says, " This was the protocol I followed. This was the configuration of the system I tested with. My data is all stored somewhere safe and point to it and then this was the result and the recommendation I'm moving forward with." And don't get hung up with formatting and using templates and using a specific tool that you put it all into. Let's at least get that stuff written down we'll worry about where we put it later.

Jon Speer: Yeah, I think that's so smart. And to your point it's definitely good advice for RADx companies, but frankly it's just good advice for any startup to be quite frank. Because I think this is something that can trip up a lot of companies sometimes, and can also be a reason that some folks get a little disenfranchised about Med Device and working in regulated industry is, you know there may be 10 steps ahead of where they actually are as a business. I always described this as a crawl, walk, run approach, build it as you go, build it as you need it and I think this is just really smart. So first action document your protocols and reports, just write down what you did and have a common shared space where your entire team is contributing and has access to the same sources of data and information and reports and things of that nature. Really smart.

Devon Campbell: Yeah. Common shared space, but I would want it to be some sense of write-only, I mean like a read-only folder that you put everything into.

Jon Speer: Right. Control is important.

Devon Campbell: Yeah, control's important. And the whole point of it is to build credibility when someone else looks at it later, whether that someone else is the FDA and they're considering some of your earlier work in support of your EUA, or if it is take COVID off the table, if it is investors that have tech savvy, due diligence people on their teams coming in to take a look at you. And this was a part of my role with a prior company, was to come in and take a deep look at this sort of stuff to have that in a secured location and say this was the protocol I ran. This is where the data is and look, the data is not adulterated. There's no one could have touched the data, it's in a safe location. Of course someone could say, " Well, sure maybe you did a tweak between from the time the device generated the data to the time you put the data into the secure folder, somebody could have edited." Maybe. Sure. But doing something is better than doing nothing and I'd rather you put it there and let it be.

Jon Speer: For sure. All right. What about the second?

Devon Campbell: Well, this kind of leads us to the next one, right? That eventually, you're going to need to have some document control. You're going to have some documentation and design controls in place, you can't get away from that in our industry. I've long been, 20 plus years, been a proponent of start documenting really early and revise often. I don't like waiting till the last minute to bring something into design controls. As long as the process that you're using is lean and agilent doesn't really get in the way of product development. And I'm talking about the earlier product development maybe before you might normally snap the chalk and say, " Okay, we're under full design control now." Especially with these specific teams they are running so fast and you don't know what you're going to try to take credit for later because you're moving so quick. I want in the same spirit of taking away vulnerabilities and taking away people's excuses in our last comments about protocols, reports and data, I want you to start having some document control. And so putting together some review processes that are fast enough that you can say, " Yeah, I did have somebody review it." It might not be that I had every single department review. I haven't had quality and regulatory and manufacturing and sales and market, and everybody else signed off." Because these companies don't have those people yet, they're moving really fast, but they're very early in their size, which is not atypical for a lot of earlier stage startups. It's not like you just hit the ground running and you have an entire product development and commercialization team. So start with documentation, do introduce some design controls, but do it in a way that kind of lowers the bar as much as possible to say, all right, I want at least one person to review your work. Just one, can we start with that? And so now you're taking away these hesitations people have about doing design controls and bringing stuff into a document control system like Greenlight Guru to say, look, just do one person right now. As the company grows, as the product matures we'll add in more layers, as appropriate and as directed by the regulators and ISO and FDA expectations. So we can build that and in time, but I'd rather you start now than procrastinate and wait till much later. One thing I've found is that you can maintain this really fast development change order in parallel with your more commercial, more robust one, and you can run them at the same time. So if you're doing a product development project to encourage these teams to start documenting really early, if you're taking away all of the old hurdles and say, " Look, I'm going to push this in and the only person, Jon, you're going to review it and approve it in the system." That can work. In a Greenlight context it would mean for your listeners that are users it would mean you kind of give document control privileges to the rest of the group, if you have a four-person team, everyone gets doc control privileges. It's not really a safe space to persist in, but it's a way to get started and start documenting stuff and now you have it there. And then you can layer in the security that you need to make it more robust and take away that doc control privilege from everyone. But it's better to start than it is to wait.

Jon Speer: Well, and I hear this myth, I'll put it in the category of myths all the time where folks, a lot of people are like, "I can't get into design control it's too structured. It's too rigorous. It's too burdensome." And I always tell people that I have that opinion I'm like, " If that's the system you're used to working in, then you've been working in the wrong system. Because that is not the intent of design controls." And start early the whole idea of any development, even with medical device development is it's iterative. You document something, you have a form of peer review, call it a designer view, call it a technical review, whatever the case may be. But then you learn something from that and then you might make an iteration so that you can evolve the product a step or two further and eventually toward that path. So, all right. Anything else on this before we go to the next point?

Devon Campbell: Yeah, one little kind of dynamic to weave into the story. Sometimes I'm questioned to say, well, how frequently should I snap that chalk? How often should I put a revian and stop time-based? But I mean, I had an idea should I put that in? And kind of my feedback or my coaching there has been, look, if you're going to manufacture a reagent, you're going to make a reagent. You're going to manufacture a part, you're going to 3D print something and do an experiment with that. At that point, I think it's a good idea to have that rev. I don't care if you're up to rev 322 crosstalk Yeah, numbers are free. And as long as the process is fast it doesn't get in your way, fine. But at least the configuration management windfall that you get from being able to say, I ran the experiment with this version of the formulation and this version of the component which was 3D printed. You have it and you can reflect back to it later and say, Hey, you can do some sophisticated work. You still write it all down. Yeah. You're still going to come to the same conclusion, but when you want to go back to it and look at it a little bit later, it's going to be really hard to tease it out. And if you want to take credit for what you did, that you say, Oh my God, this worked great. Let's do this. You're going to have to repeat some of that work under more control if you didn't do it to begin with. So it actually speeds things up.

Jon Speer: Totally speeds things up-

Devon Campbell: But that's kind of the... Yeah, go ahead, Jon.

Jon Speer: I just said totally speeds things up and I think a lot of people... It sort of defies conventional wisdom unless you've actually had that experience, but Devon you've been there, I've been there. I can take our words for it. And our combined nearly 50 years, or maybe more than 50 years in the industry, it works and it works better.

Devon Campbell: Yeah. And it saves you time later and that's actually a great introduction, Jon, to the third point I wanted to bring up.

Jon Speer: It's amazing how this flows, Devon.

Devon Campbell: It's amazing how it flows. That's why we have fun when we do these sessions.

Jon Speer: Absolutely.

Devon Campbell: So the other folks that are part of like the RADx faculty and the other expert specialists that I have the privilege to be just one of many, the value that these voices bring in accelerating the product development process and the move towards scale up and commercialization. We're all deeply experienced resources that are helping and we've got great conversations amongst ourselves and we can bounce ideas off each other back and forth. And I was reflecting on this experience and thinking, you know it's not that dissimilar to a startup bringing on or kind of leaning into this idea of technical advisory board. Where you have a team, an advisor network, but maybe a little bit more structured than just a cultivated advisor network. But a specific group of people that you have access to and who work well together like a board would, to be able to help you figure what you're doing. They're not necessarily diving into the business aspects of the company, who are really focused on is the science there how do you prove it? How would you scale this? How do we do the regulatory aspects of things? How do we manage the quality and the QA and RA side of the whole thing? And these technical advisory boards, which have become really popular this just reinforced for me this experience of the last many months, that the value that technical advisory board can bring. And I think a lot of startups are hesitant to move towards technical advisory board and instead they just say, " Well, we have lots of advisors that are in our network and that help us." And I think there's a big difference there between talking to individuals versus kind of talking with a team who has a single purpose, which is accelerating your company and your product to market. As opposed to advisors that you sit around and have a coffee with and might give you great feedback, but outside the context of a group conversation where we can bounce ideas off of each other and say, " Oh, you know what, Jon, that's actually a really good point. I think that I support that we should move forward with that for the company." And so the third actionable lesson here for the startups is to take a second look, if you aren't already looking at building and maintaining technical advisory board through you company.

Jon Speer: Any tips on who might be good candidates or what kind of personas would be good folks to consider for a technical advisory board?

Devon Campbell: Yeah, you don't want too many to begin with, so you want folks that care, right? They're not there to rubber stamp it and to try to like bolster their resume or their background to kind of do it. They're there because they want to help, they like coaching and mentoring, they're open to being critical of the team that they're working with, the support because sometimes you have to be pretty critical. But at the same time open to being criticized yourself because collectively a group like this does so much better when you meet as a group and I'll throw out an idea and someone else will kind of take it and run with it in a slightly different direction that they think it's maybe better for the team and here's why, and I'll look at it and say, " Yeah, you know what, I think that's really good idea. I endorse approaching this using the strategy." So I think really open and honest folks that are there to help not there for the glory, and enjoy working with I think that's definitely important. Take a good look internally to a company where you have gaps and where you could benefit from having experienced folks on your technical advisory boards. It's not a medical advisory board. It's not a scientific advisory board is more like, how do you get through parts development, quality commercialization, manufacturing ramp up that sort of stuff I think is deeply valuable to startups in our space.

Jon Speer: Yeah. And my advice to folks is choose wisely. Don't identify people who are going to tell you what you want to hear. It's like being a child and asking your mom or dad for their feedback on something. They're probably going to give you positive feedback. Oh, well, that's really great. Jon, you did an amazing job. That's not really what you're looking for on a technical advisory board. You're looking for somebody that's going to push you a little bit and maybe a little bit more critical and maybe ask a tough question or two from time to time just to make sure that you're thinking about things from a lot of different perspectives. They should, to your point compliment your in-house experience.

Devon Campbell: Yeah, yeah, absolutely.

Jon Speer: All right. What's next?

Devon Campbell: So what's the next one? Let's build on what we just talked about. So I am by nature a systems thinker, I think very broadly. I think about the interconnection, the interconnectivity between major elements of a system, not just the system itself. And there's a lot of interconnectedness between different functions within a normal kind of medical device company. Think about assay dev in the case that we're talking about here for RADx where we're developing IVDs, you know assay dev and engineering and quality, all these different functions that are involved. But they're really developing a product that is the culmination of all of those different functions working together. And I like, we've talked about this before on previous podcasts, Jon, where I like to start with the end in mind and using a technical advisory board to be able to help you think about what that end might look like gives you the ability to try to articulate a strategy or a roadmap that will help you get there in time. They need to take very fast, but small steps, but understanding where you're going and the interconnectedness of, well, if we do these things and we run really fast in this direction, it might not be good from a manufacturing context, or if we do all this work that's just to drive to the manufacturing efficiencies, it might drive down assay efficiencies. So understanding the balance and the push and pull on all of those different things to come up with that strategy to say, " Well, here's where we want to get. And here's how we think we're going to do it." And then just start executing really early and taking those very fast, but small steps to get there. We talked about it earlier, when we were talking about document control, doing something is better than doing nothing. And if you procrastinate for too long, especially taking kind of a wide systems view and thinking about where are we trying to get, that procrastination kills your future agility. I would rather be running forward, eyes wide open into the rain than kind of huddling from it and just waiting for the rain to end because you may have missed your opportunity.

Jon Speer: Well, and I think just to carry that metaphor a little bit further, I think sometimes when people look outside they're like, " Oh my gosh, it's torrential down pour. We better build an umbrella. You know, let's go see what kind of materials we have and start constructing one." And by the time they build the umbrella the rain has gone and the sun is out and it's like, you know, maybe you should have just grabbed the newspaper and put it over your head or to your point is, go full ahead into the rain, knowing that at some point in time you're going to walk through it or it's going to stop or whatever the case may be.

Devon Campbell: Right. Right. Or just acknowledging, maybe it's okay to get wet and I don't care because I know where I'm going. I have a goal in mind that I know if I get there, if I run now and who cares if I get drenched, if I run now I'll be the first one when the sun does come out to be in line for whatever it is you want to get, you want to do next.

Jon Speer: Yeah. I like that.

Devon Campbell: So starting with the end in mind and then building your strategy accordingly is that fourth lesson that I've noticed consistent with a lot of the teams that I'm helping out.

Jon Speer: All right. So as we've been talking I've thought of something that, I mean, it's-

Devon Campbell: Great.

Jon Speer: I guess as we've been talking what comes to mind to me about... All of these actions speak to this in some respect, but the action is manage your risk and I don't just mean product risks. Yes. Product risk, I think is very important and there are methodologies and tools and different approaches you can take to assess and evaluate product risk from that vantage point. I mean, this is the whole benefit that Devon shared, or one of the benefits that Devon shared about documenting your ideas, your thoughts and ideas when you're running experiments. Those are all risk mitigation activities in and of themselves. So I think that's really important, but just the technical advisory board that's another way to mitigate risk, but not so much so necessarily from a product perspective, but more from a business perspective. So you've got to look at risk from a lot of different angles, product, business, go to market, manufacturability, scalability, all of these sorts of things are risks that if you don't think about them and then spend the right amount of time and effort on these sorts of things, they can definitely trip up a company that's trying to be successful in the marketplace.

Devon Campbell: I love it. That's a great fifth lesson learned there, Jon. I think that's perfect and very sage advice for any early stage entrepreneur or early stage startup listening to this, thinking about, you know asking themselves, how do I move forward with this idea that I have. I think that's great feedback for them to consider.

Jon Speer: Absolutely Devon, this has been a great conversation and folks, I hope those of you that are listening certainly, hopefully we get some RADx program participants to chime in and listen to this. But certainly all of these tips and pointers and actions, these are applicable... Originally I thought applicable to startups, but man, this is sage advice even if you're a well-established company that's been doing this for decades. These are just some really core, basic foundational fundamentals that every company designing, developing products should embrace as part of their daily practice. Don't you think?

Devon Campbell: Yeah, I think the challenge for larger, more established organizations is overcoming the inertia of their own systems. So what I mean by that is they've already got really large, complicated maybe it's still a very efficient but larger, more mature. Mature is a better word than complicated. Larger, more mature quality systems or product development processes and sometimes that carries so much inertia it's hard to break free from that. And say, how can I do something different and faster? So I think it's definitely applicable. I think the challenge for a larger team is to really be humble and question their processes and wonder if, is there a way that we can behave like a startup to enable us to move so quickly while still capturing the information that we need in piecemeal and kind of building out, so that you're moving toward a fully-controlled system toward the end of your product development process. So yeah, hopefully it's applicable across the board.

Jon Speer: Absolutely. And folks, we're going to wrap up this episode on that, to Devon's point whether you're new to this, whether you're a startup, whether you're a much more mature or experienced organization, there's ways to be quicker and more nimble through this process and do so in a way that is perfectly fine and passes muster with FDA and other regulatory agencies. These tips and pointers that Devon and I have shared with you today, these are all legitimate compliant, well-recognized, well-accepted approaches. So keep that in mind. And if you're working in a system or under an approach that maybe could use a little bit of fine tuning, maybe looking at ways to improve some efficiency and some throughput, well, that's what Devon and Prodct does for a living. So reach out to Devon Campbell. You can learn more by visiting Devon's website. Devon, what is the best way for folks to reach out to you?

Devon Campbell: The website is just Prodct, prodct.dev like product development. You can reach me through there.

Jon Speer: Yeah. And you can fill out the form and he will respond. I've done it, even though I knew him. And then the other thing to keep in mind is at Greenlight, we're here to help too. So, as Devon mentioned a little bit earlier, we've got workflows to help you with document management if you're trying to document your protocols and route those for review and approval, well, we've got workflows for that. We've also got workflows to help you manage your design control activities, even if it's very, very early it's very flexible to accommodate whatever stage of development you're in. And I mentioned risk management, product risk management we have workflows for that. And then certainly as you get to market and you need a more robust quality management system and all the quality event and post-market workflows, we've got those covered within the Greenlight Guru medical device quality management system as well. So if you'd like to learn more about that, go to www.greenlight.guru and we'd be thrilled to have a conversation to understand what your needs are and see if we might be a fit to help you get your products to market and help you improve quality of life of the patients that are going to be benefiting from your technologies. Devon, I always enjoy these conversations so once again, thank you so much. Look forward to future conversations about, I don't know, whatever else comes to our minds in the future. So thank you again so much.

Devon Campbell: Yeah, no problem. Happy to have had this time with you.

Jon Speer: And folks, thank you for continuing to keep the Global Medical Device Podcast at the top of the podcast in the medical device industry. It's because of you, our loyal listeners that we can continue to be that number one spot. So be sure to share more with your friends and colleagues about the Global Medical Device Podcast. Do you have thoughts and ideas on things that you like Devon and I, or others to talk about on the podcast? Shoot me a note, and we'd love to get your feedback and continue to make this amazing and an awesome venue for you to get some tips and pointers to be successful medical device professionals. As always, this is your host and founder at Greenlight Guru, Jon Speer and you have been listening to the Global Medical Device Podcast.


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