Why Manufacturing is Part of Product Development with Mike Dolphin

June 22, 2026 ░░░░░░

#461 Why Manufacturing is Part of Product Development with Mike Dolphin

The traditional approach to medical device commercialization often treats manufacturing as a distinct, isolated step executed after the design phase is completed. In this episode, Mike Dolphin, CEO of GuideStar Medical Devices, challenges this linear mindset by arguing that manufacturing process development is fundamentally an extension of product development itself. Drawing from his unique background spanning aerospace engineering at JPL, scientific research, and medical device ventures, Dolphin shares how upfront constraints shape a more predictable path to market.

The conversation centers heavily around the engineering and clinical challenges of epidural anesthesia delivery, a high-consequence procedure historically reliant entirely on a physician's tactile sense. Dolphin details how his company approached this clinical risk profile by designing a closed-loop system capable of automatically stopping a needle upon sensing the epidural space. By establishing critical manufacturing constraints—such as choosing injection-molded plastics and radiation sterilization from day one—the design team avoided the common trap of engineering a prototype that cannot be scaled.

Additionally, the episode dives into the practical friction between tight physical tolerances and production realities, showcasing a creative approach to mold development that bypasses typical vendor limitations. Dolphin also shares his perspective on balancing rigorous documentation with early-stage agility, warning founders against premature lock-down of design controls within a Quality Management System (QMS). Ultimately, the discussion underscores that true commercial readiness requires a unified view where the final product and the manufacturing pipeline are developed in parallel.

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Key Timestamps

00:41 – Guest introduction: Mike Dolphin’s transition from aerospace engineering at JPL to MedTech leadership.
02:02 – Cross-industry lessons: How regulatory oversight, documentation, and system thinking in aerospace translate directly to medical device design.
03:02 – The clinical problem: Demystifying the high-consequence risks of epidural anesthesia, including accidental dural puncture and nerve damage.
05:14 – Engineering an actuator: Shifting from the clinical request for "better sensors" to building a closed-loop mechanical system.
07:34 – Epidural procedure metrics: The market scale of labor, delivery, and chronic pain injections in the US and globally.
09:47 – Integrating manufacturing early: Why sterilization and material choices must be established during initial requirements gathering.
12:02 – Common founder pitfalls: The danger of designing a product looking for a problem versus evaluating cost, market size, and manufacturability from the start.
13:58 – The documentation vs. QMS overhead balance: Knowing when to record choices and when to formally lock down design controls to preserve startup capital.
16:47 – Overcoming injection molding tolerance limitations: A case study on utilizing first principles physics and progressive mold variations to achieve a 10-micron output consistency.
21:04 – Managing manufacturing consistency: Dealing with brittle plastic runs, operator variances, and securing lines against unauthorized process shortcuts.
22:25 – Impact on the 510(k) pathway: Defining commercial readiness as manufacturing readiness for final finished product submissions.

Top takeaways from this episode

Integrate Manufacturing Into R&D: Do not treat manufacturing as a post-development handoff. Developing the manufacturing pipeline is a core engineering activity required to establish a fully validated, commercial-ready device.
Establish Production Constraints Early: Define your sterilization methods, primary materials, and fabrication methods (e.g., injection molding) during initial requirement generation to restrict the design space and eliminate unproducable prototypes.
Leverage First Principles for Tolerances: When manufacturing vendors claim tight tolerances are impossible due to material shrinkage, analyze the underlying physical limitations. Strategies like building progressive progressive molds can deliver highly consistent micro-level outputs.
Audit Process Consistency: Component quality depends entirely on process parameters. Even with identical raw materials, minor adjustments to cycle times or cooling rates by different operators can alter material properties like brittleness.
De-risk the 510(k) With Finished Production Runs: Because a 510(k) submission requires testing on the final finished product, achieving manufacturing readiness is the critical path to compiling compliant regulatory submissions.

References:

GuideStar Medical Devices: The med-tech start-up developing safety solutions for epidural space placement to eliminate accidental dural punctures.
EpiZact: GuideStar’s flagship closed-loop epidural device referenced contextually during the design and tolerance discussion.
Connect with the Host: Etienne Nichols on LinkedIn

MedTech 101 Section

Actuator (vs. Sensor)

In engineering, a sensor is a component that detects a physical change in the environment (like a thermometer reading a drop in temperature) and turns it into a signal. An actuator is the component responsible for moving or controlling a mechanism based on a signal (like a switch turning an air conditioner on or off). In the context of this episode, instead of just giving doctors a sensor to show them where the needle is, the team built an actuator that physically stops the forward motion of the needle automatically, closing the loop between detection and mechanical action.

DFM (Design for Manufacturing)

Design for Manufacturing is the practice of designing physical products in a way that makes them easy, cost-effective, and consistent to produce at scale. Think of it like baking cookies: if you design a cookie shape that requires intricate, hand-carved detailing on every piece, it will take hours to make a single batch. If you design it to be stamped out cleanly by a cookie cutter, you can make thousands of identical units per hour with minimal errors.

Memorable quotes from this episode

"Having worked in aerospace and in medical device, I can say that this is harder than launching rockets." — Mike Dolphin

"Manufacturing is part of development in medical devices. You develop your product, you develop a prototype that works. Now you need to develop your manufacturing process. That takes time, that takes real engineering and real know-how." — Mike Dolphin

Feedback Call-to-Action

We want to hear from you. Do you agree that manufacturing is an inseparable part of the development phase, or do you prefer a distinct handoff? Share your thoughts, leave us a review on your favorite podcast platform, or suggest a topic you want uncovered next. Send an email directly to podcast@greenlight.guru—we read every message and look forward to delivering the personalized insights you need to build compliant, high-quality medical technology.

Transcript

Etienne Nichols: Hey, everyone. Welcome back to the Global Medical Device Podcast. My name is Etienne Nichols. I'm the host for today's episode. Today we're going to be talking about what it actually takes to get from idea to commercial ready 510(k) path, some of the lessons physician entrepreneurs learned the hard way and why manufacturing might be one of the best teachers that you'll ever have when it comes to MedTech.

And the guy to talk to us about this today is Mike Dolphin. He's the CEO of GuideStar Medical Devices and he's building something that for epidurals, for safety. And one someone who's building something like that, you might not think of having the career start that they had.

But we'll just get into his, his background. Before GuideStar, he engineered at JPL, he ran scientific research and experimental design for Ernst and Young and spent years in the trenches of management and technical leadership across a handful of ventures.

He's one of those rare blends that is has deep technical chops, real commercialization instinct and, and a knack for translating big system thinking into a device that has to clear the FDA and survivor real market.

And he's bringing an epidural safety to market. And so that's very important because when we were trying to record this the first time, I had endoscopy and I am so sorry to have that mixed up, but glad to have you with us today, Mike.

Mike Dolphin: Yeah, thank you. Etienne, thank you for the introduction. Glad to be here and excited to talk about some of the challenges that we have in this industry.

You know, I having worked in aerospace and in medical device, I can say that this is harder than launching rockets.

Etienne Nichols: Oh, man. Well, it's like that joke that the rocket. The rocket scientist walks into the bar, and the brain surgeon says, well, it's not exactly brain surgery. Well, it's not exactly rocket scientist.

So anyway, I'm sure, you know, whoever listens to this, I want to talk a little bit about your background you've had. I mean, as we've already talked a little bit, it's kind of an unusual Runway into MedTech, JPL, game production, scientific research and design.

What from those earlier lives actually shows up in how you build a device company? If anything, I'm curious.

Mike Dolphin: Yeah, it's an interesting sort of meandering path. You know, I also did also lifeguarding, which is, which is a healthcare type adjacent industry as well. So, I have a first aid training and very deep interest in space.

And so, I got into the aerospace engineering and did some work at JPL and Stanford on some projects that went into space that actually set me up fairly well for the medical device industry because there's a lot of regulatory oversight, documentation, justification, and really deep thinking on like, why are we doing this? What's the reason fundamentally, why are we making these decisions?

And I think that in medical devices in particular, you want to be asking that question all the time so that you're not just making, oh, I think this will work or this will be slightly better. You're actually saying, is this needed or why do we have this?

And it starts right with, you know, when you're building out the requirements from the very beginning, you want to have that sort of entire process laid out in your head. So, you're, you're thinking, okay, like we're eventually going to be manufacturing this.

Our requirements should be aligned with that right from the very beginning.

Etienne Nichols: Yeah.

And the specific problem you're working on with epidural safety, I mean that's, I can imagine some of the problems that it has. Just, I've always heard that it's something like guesswork, where they're trying to target that space.

But I'm curious what convinced you that this is worth building a company around?

Mike Dolphin: Yeah, that's a really good question.

So just to talk a little bit about the epidural safety aspect. So, the, the challenges that they're inserting this needle, it's a fairly large needle, 17-gauge boat, 9 centimeters long, and they're inserting it into the patient's back towards their spine.

So, the challenge is they're actually trying to get all the way to their spinal cord without touching the spinal cord. There's a little space between this ligament between the vertebrae and the spinal cord itself that's called the epidural space.

EPI being above dura is the protective layer around the spinal cord. So above the dura epidural space is that little gap. It's about 2 to 5 millimeters wide.

And they're trying to place this fairly large needle right there.

Precision is the name of the game. And the way that you're right, the way they do it, it's not quite guesswork per se, but they do need to feel. So, they have a syringe and they're feeling and you're really relying on the doctor's skill and ability to Feel and their skill in advancing the needle to place it correctly.

If someone moves quickly or something happens, you can slip and cause an injury. The injury being if the needle goes into the dura, it will puncture the dura, create a hole, and then spinal fluid leaks out. Patient experiences massive headaches. So, it's quite devastating.

You can also sever a nerve and cause nerve damage, permanent nerve damage, or paralysis. So, these are the. Those are the risks.

It's one of those.

It's one of those procedures that has, in terms of risk, it has a very high consequence value.

So, risks are broken out into probability and consequence.

The probability is considered low. I mean, the probability of paralysis is very low. One in 50,000 patients, roughly the probability of puncturing the dura is somewhat low. It's about 2 to 5%, depending on who you talk to and what kind of data you're looking at.

We think it's closer to 5 or 6%, but that's considered low. Ish.

It's still relatively high. I mean, you're talking 1 in 20 patients. So, it's not super low, but it is low enough.

It depends on how you value consequence. So, if you think the consequence of having a headache that lays you flat on your back for two weeks is a high consequence, then that's, that's pretty bad.

Up until recently, doctors would just say, oh, it's a headache. It goes away. Don't worry about it.

Now they're realizing that these headaches can last months or years. And so the consequence value has been creeping up, and the probability hasn't moved down because people aren't any better at this procedure.

So, what got me into this? So, we were talking to anesthesiologist about this procedure, and he was telling us about. About the risks.

And I looked at it and I said, there's got to be a better way. There's got to be a way we can do this.

When we talk to doctors, they always said, we need a better sensor.

If we can get a better sensor, that sensor will tell us when to stop the needle and we'll do a better job.

And my question was, well, what are you using now for sensing? And their answer was, well, we use the syringe and we feel it. And I said, okay, well, does that work reliably? Oh, yeah, it's very reliable.

My answer was like; you don't need a better sensor. You need a better actuator in engineering speak. So, you need something that controls the needle better.

And then really, we had the idea of just closing the loop.

So, kind of like the difference between putting a thermometer on your wall and having a switch to turn your air conditioning on and off, you can put a thermostat on your wall. And then so when the temperature hits a certain number, it closes the loop and it turns thermostat on that turns the air conditioning on.

So that closed loop type system, I, you know, I was like, why can't we build a closed loop system for the needle? So, then it, it, we have a device, it senses when you're in the epidural space. It stops needle from going any further and places it precisely.

If we can build that, that would be revolutionary. And what really got me into this was, you know, we, we were looking at this procedure and we said, is anyone doing that solution?

Is anyone doing a solution where it's a closed loop product?

And when we looked around, we looked at all the patents, we looked at all the products, there was nothing on the market that was doing this.

And so, you know, at the time, I knew a little bit about how hard it was to make a medical device company, but I honestly started this company because I felt like this was a problem that was worth solving.

So, there's, you know, there's two. Two reasons to start a company, really.

One is to make a lot of money, and the other is to do something that you think is worth doing.

And, you know, whether it's opening a restaurant or creating a new product, if you think what you're doing is worth doing, then that will get you a lot further than just wanting to make a lot of money.

And in, in healthcare and in MedTech in particular, you have to really want to solve the problem that you're solving because it is a very, very difficult journey.

Etienne Nichols: Yeah, that's. How many epidurals are performed every day? Do you have any idea?

Mike Dolphin: Oh, on a daily basis. Oh, geez.

Or any metric. I mean, there's, there's, there's four and a half epidurals performed in hospitals every year in the US Four and a half million.

Those are for labor and delivery, which is both 6% of that, and then for surgeries, the other 40%.

So, there's about two and a half million procedures done for labor and delivery every year in the USA.

There's also another.

It's a harder number to track down, but we think it's around 9 million procedures. 9 million epidural procedures done for epidural steroid injection. Epidural steroid injection, which is pain in the back.

So, people who have Chronic back pain will go in and get an epidural steroid injection.

That's another 9 million. So, we're looking at about 13 to 15 million procedures in the US alone every year.

So, I don't know what the number is on a daily basis from that, but we can do the math.

Etienne Nichols: Well, either way. So, two.

So, the number that stands out to me is 260 if there are 13 million epidurals performed every year. And you said that because we talked about risk probability and severity.

Probability, consequence, your word. But that severity, the specific one of paralysis which says pretty rare, 1 in 50,000. Okay, well that's 260 a year are likely going to experience that, if that's accurate.

And that's a big deal, I think.

Mike Dolphin: Yeah. Now I should specify that the pain guys, they do the procedure a little differently. They typically use an X ray machine while they're doing it, so they have a little bit over chance of getting the paralysis.

But still. Yeah, we're looking at hundreds of people getting paralyzed every year in the US alone.

And then you look at around the world where this procedure is being done, maybe with less skill or less training or less equipment available.

And you know, we estimate there's at least 40 million procedures being done every year around the world.

There's probably more than that. As more countries, you know, become. Yeah. More advanced technologically, there'll be even more.

So yeah, it's. This is a very, very, very common procedure. It's being done literally tens of thousands of times every day.

Etienne Nichols: The other thing that's interesting to me is the, they're doing it by feel. And I suppose if they train well enough, that's fine.

Early on I, I had a surgery once where the, the guy had 13 surgeries. It was on a hand doctor. And I said, and during the follow up, I said, well, tell me, doc, really, do you want to be that 13th guy? It's like, no, you don't really want to be that 13th guy.

So anyway, it's just, you know, it's a spectrum of quality.

You had mentioned something early when you're describing it or describing the problem that you experienced or when first hearing about it. And after talking some doctors, it sounds like you'd gone down the path a little bit because you had an idea for a closed loop system. You looked around, didn't see that on the market.

Two questions. So, I mean, I guess this, I'm breaking the rules. You should only ask one. But when did manufacturing come into your mind and how did you get to that I'm going to turn around.

How did you get that far, first of all, to where you're.

You have an idea in your mind.

And now we're going to build a company about this. And then, and then when did manufacturing come into your mind?

Mike Dolphin: So, we were doing another medical device at the time. So, this wasn't my, my first.

Etienne Nichols: Okay.

Mike Dolphin: Company. We did a. We created another medical device, a very simple device for a knee injection. It was basically a kind of like a.

A really easy stopcock. So, it's a, it's a syringe switching device. You can switch from one syringe to the other. It keeps them in line. It's. It's really good for that procedure.

But in terms of, like, technologically speaking, it was a very simple device. And, but however, even though it was simple, we had to go through all the same steps. And so, we knew how to make a medical device product, and we knew how to get from concept to design to manufacturing and to FDA clearance.

That was all very well established through that process.

So, we were in the very later stages of that. You know, we were in the FDA clearance stage of that while we were conceiving this other idea. So.

So, your question is, you know, when did we start thinking about manufacturing?

Very early. I mean, I think that.

And, and it is, it's interesting if you talk to people about making a medical device. So, like, for example, if you talk to someone about FDA clearance, you say, when should we start thinking about FDA clearance for our medical device?

And the answer will be right away.

Because if you don't, you're going to do a bunch of things wrong, and it's way more expensive to fix it later.

The same is for marketing and sales. Eventually, start thinking about marketing and sales of your product right away. Because if you don't have a market, why are you building a product?

Yeah. So, you need to start thinking about these things right away. And I think the same is true for manufacturing. So. You know, I remember my first.

When I first got into medical devices, the very first meeting I had was with a consultant. And he said, okay, what's your sterilization technique?

And I was like; I don't even have a product. I don't even know what I'm doing. I don't even know what I'm building. How could I possibly answer what my sterilization technique is going to be?

And I was kind of upset, you know, by his question in a way. But in some respects, he was right. You have to think about all these things, everything like Are you going to be sterilizing this through radiation?

Are you going to be sterilizing this through EtO? There are problems with both of those and benefits. So, you need to think about all of these things right from the very get go.

What kind of materials might you be making this out of? Now these things will change, obviously, but for the most part you want it perfectly, pretty much, you know, established very, very quickly. So, we knew from the start that this would be an injection molded plastic device.

We knew from the start that it might have some other components like O rings and springs, and we knew that it would be.

We knew that we were going to choose radiation as our form of sterilization as an example.

And there's some other things too, but like, we kind of knew from the start those were the things that we're heading towards.

And because we had a path from the very beginning, it really helped us frame up our design process right from the very start. And the requirements that we're building at.

Etienne Nichols: the very beginning, those restraints or constraints almost make it a little bit easier because you know exactly what you don't have the blue ocean in front of you.

Mike Dolphin: Exactly. Like by saying we're doing an injection molded device because we want to be able to, we want to be able to produce a million of these things a year.

Right. So, this can't be like a CNC product, or a 3D printed product or a, you know, even made out of like metal components of glass or something that's really hard to manufacture.

So, if that's the case, then like it already frames up your entire design process and that really, really gives you clarity.

Etienne Nichols: Why do you think some founders get it wrong when it comes to manufacturing? And if so, why, why is that? Any thoughts?

Mike Dolphin: I, I mean, I don't have any personal stories to, to point to, but I, I think the danger is that, and I've heard this happens where people come up with an idea and they just build the idea.

Right.

Sometimes they're even building something they think is cool and then they start looking for a problem for it to solve. Which of course is the worst way to go about it.

Yeah, but I do think it happens where people will say, oh, this is, this would be great.

This will solve a problem that I would like to solve.

Turns out that only like 100 people a year have this problem. So, your market is nothing. Okay, well, that was, that was dead in the water. You should never have developed that.

Or it turns out that like, yeah, it's a great solution, but it's going to cost you $20,000 to make it.

So, are you really going to be able to sell this thing for $150,000? And if not, you don't have a market either. So. So you really need to think about all those things from the start, because you need to know what your cost, you know, your market, and that that also frames up your manufacturing as well.

I. I think that the trap for a lot of founders is that they don't think about the FDA clearance, they don't think about the market, they don't think about the manufacturing.

They're just thinking about the design of the product. Like, if I can figure this out, then I'll worry about those other things later.

But in the medical device industry, you need to worry about all of the things now.

Whatever time it is, now is the time to think about it.

Etienne Nichols: Now. There's one thing that I remember you having an opinion on too, though, about quality, like the, the quality management.

And it might be a little bit controversial, especially where we come from. You know, Greenlight Guru. We are an eQMS software provider. But I definitely want to hear your personal opinion and experience.

So, tell me, tell me about that.

Mike Dolphin: Yeah, so there's two sides of this coin. One is you need to have good documentation right from the very start.

So, day one, you do design. Write it down, put in a document, say, I did this design, I made these choices, and this is why.

Or we did this test and we got this result, and that informs us into our design choices later.

That is really, really valuable because it just gives you a really good framework of where your design came from, why you made your choices.

If for some horrible reason your device, you know, failed and someone died and you get audited, you can say, we made all these choices. This was actually the best choice. Yes, someone died, but we, you know, had we made another choice, 100 people would have died. Something like that.

So, you want to be making that kind of documentation right from the very beginning. That's not hard. It just takes a little bit of effort.

Where I, where I think you're going with your question is, you know, when should you start signing off on documents? When should you start doing quality control management?

And is there a place where there's too much of that? And I think that, yeah, there is. I think you can. You don't really need to lock things in until things need to be locked in.

So, for us, we started locking things in during the early manufacturing process, and I, I think that was too early. So, I think kind of the theme of this, this podcast, if you will. Is manufacturing a step you complete after development or is it actually part of development?

Yeah, and I contend that manufacturing is part of development in medical devices.

You develop your product; you develop a prototype that works.

Now you need to develop your manufacturing process.

That takes time, that takes real engineering and real know how.

And at the end of that process, you'll have a fully developed product, which includes the method and, you know, manufacturing pipeline.

That manufacturer product then gets validated through a series of tests. Those test results then get submitted to the FDA, that gets cleared for sale and marketing in the U.S.

now you have a fully developed product.

Now you sign off on everything and now you make it very hard to make changes because it's, it's really important that you don't. But until you have FDA clearance, there's actually no, in my opinion, no real need to have signed off documents other than maybe like a design review where you say, we've done this review and here's all our things and here are the people that were there and the choices that we made and the things that we said about it.

You sign up on those reviews, but I don't think you need to be signing off on design documents. And like, we did a lot of QA overhead during that manufacturing process while we were still changing things.

And, and so it just ended up costing us, especially as a startup, a lot of extra time and money.

And, and so again, you definitely, absolutely need to document this stuff. You need to be keeping track of it and recording your choices, but you do not need to be going through that extra step of like having a QMS system and, you know, all the design control that goes with it, in my opinion.

Etienne Nichols: Yeah, all the lockdown.

When you treat manufacturing as part of the product development, then when it's part of the product development design process, what are some decisions that you feel like that kind of already makes for you or. I mean, we talked a little bit about some. If you already know you're going to be doing injection molding, obviously that's going to dictate quite a bit to the design.

What are some of the things that.

Any other thoughts that you have that.

Well, both that can be affected, but also ways to get there where you are incorporating manufacturing into your design.

Mike Dolphin: Yeah, I think, you know, one of the challenges that we had is we have a very, very precise dimensions on our parts.

So, when you, when we're designing stuff on a CNC machine, you can cut something to, you know, two or three thousandths of an inch, accurate, accurately Pretty. Pretty consistently, or you just build up, like, five parts and pick the one that is camera the best.

Right.

So, when.

Now, 2000ths of an inch is 50 microns, if I have my math correct.

When we went to our injection molding people, we said, we'd like to hit these dimensions. And they said, we can't guarantee anything tighter than 100-micron tolerance.

And we said, we. We need it to be within, you know, 30 to 50 microns of our spec.

And they said, we can't do that.

And so, I pushed back and said, okay, look, when you build a mold, you're building a metal mold. Okay? Now, I know when I'm cutting metal, I can get 50-micron tolerance on that.

Now, the reason why they can't get the part to have that tolerance is because there's shrinkage and there's things that change, and you don't know what's going to happen. Exactly.

So, I'm like, great, fine, build. Build three molds.

Build three molds that are all slightly different or even just try to hit the same target three times and see what you get.

And then.

And we actually ended up doing that on one of our parts. We couldn't get the. We couldn't get the dimensions right. So, we said, okay, fine, build three molds, each of them, you know, 20 microns bigger than the next one.

And then we just picked the one that worked the best, which ended up being the middle one, of course, Goldilocks. And so, once they've built the mold, you can. You can pump out a hundred thousand, a million units, and they'll be almost identical. They'll be within 10 microns of each other.

Every single one of them.

Etienne Nichols: Yeah.

Mike Dolphin: So that was a really interesting manufacturing process where, if you really understand the whole process of what's happening and why things are being built, the way they're being built and how they're being built.

You can get what you want, but you have to also understand, like, so, you know, for whatever reasons, our product has these tight tolerances, and we chose to go down that path.

You know, is that always the best choice? No, but, like, it can be. You know, there's a lot of things where you're going to need that and want that, and there's ways to get there. You just got to be creative a little bit.

Etienne Nichols: Yeah. And I think knowing what's critical to quality and critical to that for that tolerance is important. You know, early in your career, you'll probably say, oh, let's make them all plus or minus, whatever. But I learned somewhere along the way that what's the best tolerance for a device? It's the loosest one where you still have a quality device.

Yeah, yeah. And I think we forget that sometimes.

Mike Dolphin: And also, this kind of goes to like, you know, to bring up Lon Moth's sort of idea of ology of things is like first principles of like physics. So, like, is there a physical reason why the tolerance can't be something?

Etienne Nichols: Yeah.

Mike Dolphin: And so, you know, I know because I've seen test results on multiple parts that were measured.

I know that we're going to get a consistency of 10 to 20 microns on every single part that comes off the mold.

So, if that's the case, then I, then that's the tolerance we can hit.

Right. Not, not 100 microns. 100 microns is just you saying, if I build a mold, I don't know what's going to be exactly.

Okay, fine. But the, but we can get a 10, 10-micron tolerance on our output if we just look at it in a different way.

And from the first principle sort of point of view of like, what is the actual physical limitation.

And I think that that was, that's a really powerful thing. When you start looking at it from that perspective. You're not looking at, you know, what the people are telling you. You're looking at. Well, you're understanding the process and you're understanding what's involved and then you can actually develop your product to be the way you want it to be.

Etienne Nichols: Yeah, I think that's a really good way to look at it because sometimes there's no reason for the challenges that are put on. I remember one product I was working on; it was a, it was a powder coated product and, and it was just, it was just how you gripped it and there was no reason. It was in a size constraint. It wasn't mating with another part.

But we had a profilometer, you know, surface finish requirement that was.

We started having things fail.

Years went by and then suddenly we changed the process slightly and it started failing. We get looked at the toler…why is the tolerance even that way? There's no reason for it necessarily.

So.

Mike Dolphin: Yeah, yeah. And yeah, and you got to be careful. You got to make sure that, you know, your manufacturer is not taking shortcuts.

Etienne Nichols: Yeah.

Mike Dolphin: You know, we, we had one run of plastic that was. Came out really brittle.

We have. What is happening. It's the exact same plastic. Why is it brittle? It was, it was breaking in our hands.

Wow.

And so, it turned out that, that they Had a different operator run the, run the line. And I guess that operator decided to, you know, save some time and, and run it at a shorter cycle time or something.

And so, it can't, you know, the plastic cooled in a different way, and it came out more brittle. So, you got to be really careful about making sure your manufacturing process is done the same way.

Again, this goes back to the development of manufacturing that it's not, it's not just cookie cutter like, oh, if I order, you know, plastic and it's going to be Easton Triton, that is going to be exactly the same parameters every time they make it. No, they might not be. It depends on how they do it.

And you have to have those, those, that entire process needs to be well defined and consistent.

Etienne Nichols: So, when it comes to that, you know, some people call it DFM designed for manufacturing. And we're, you know, we're, we're rolling it into all of design. So really. And I, I agree with that. I think your manufacturing should be DFM from the beginning.

How does that change your 510(k) story? Does it make the submission?

Does it impact it very much? Or are you saying, I mean, I'm, I'm, I'm, I would guess that as a company you want to be, have as many things going in parallel as possible, including your submission. Granted, it, it, you know, it has to lag a certain amount of time. But how does that impact your submission? Any thoughts?

Mike Dolphin: Well, I mean, the 510(k) submission is supposed to be done on your final finished product.

Etienne Nichols: Right?

Mike Dolphin: Right. So, you really can't submit until you have your manufacturing fully developed and you've actually produced parts. Right.

So, you know, we did our full manufacturing development, and we ran 500 parts through it, 500 units. And then we took probably 200 of those units and put them up for testing, if not more.

So, yeah, I mean like that, that is a requirement. So, I think that it really is part and parcel. Like if you want to get 510(k) clearance, you have to have your manufacturing fully developed.

Etienne Nichols: And so sometimes some people would call what you just described, commercial readiness. But how much would you say that commercial readiness is really manufacturing readiness from a product development point of view?

Mike Dolphin: I don't think there's any difference. I think you, you have to have a commercially ready product. Product to submit to the FDA.

In my opinion, yeah, from a marketing and sales perspective, it's a completely different equation. And that's a discussion for another podcast because, yeah, marketing and sales, again, when should you start your marketing and sales efforts? Probably now.

So now it's a little different because you're, you're not going to spend millions of dollars on marketing and sales when you're still in early development.

But you do want to be spending thousands of dollars, tens of thousands of dollars on market research and understanding the market size, understanding that, you know, before you even start building anything, you want to know, do I have a viable market?

That research is really vital. But then after that's done, yeah, you're doing some market prep. But it's, it's, it's going to wait a little bit. Although I did. I, you know, we're a small company and we're limited by my resources.

I listened to one guy, and he said that they launched their product, they had, when they got FDA clearance, they had already done two years of very aggressive marketing for their product, meaning they were spending millions of dollars on marketing for two years.

So that when they launched, they had a really successful launch.

That's awesome. If you have the funding to do that and you have the chops and know how to do marketing and all that stuff and you have the right people on your team, then that's great.

So, marketing can be part of that process too. But so, market ready in terms of. Yeah. In terms of the device itself, market ready and commercial ready or, you know, whatever terms, or you just use.

Etienne Nichols: Yeah, yeah.

Mike Dolphin: I don't, I don't see that any different. Like you have to have the final product.

Etienne Nichols: Yeah. You mentioned funding and I, I'm curious how this impacts funding. So, whether, whether you're at seed series A, does that mindset of manufacturing is part of my production process?

Does it, does it change the equation on how much you should be funding and, and so on?

Mike Dolphin: I think it does.

I think, you know, having gone through this a couple times, I think people underestimate how difficult manufacturing development is and they underestimate how much it will cost.

And there's another part too, which is, we haven't talked about really is, is testing.

So, you know, we spend, you know, we're a small company, we have salaries and everything like that, but in terms of direct costs, and I don't have the numbers on, on hand, but you know, we spend hundreds of thousands of dollars, say on manufacturing development, probably close to a million, if not more.

And plus, all our salaries and everything like that, yeah, we spend another 350, you know, maybe $400,000 on testing.

So that's a real, real cost. And you can't get to FDA clearance Until you have those testing things done.

And that also takes time.

You know, some of the tests took four or five months just because they were back backed up in the queue or they had long, you know, biological times constraints. Yeah.

So, you know, is.

That's also part of the manufacturing development because, you know, you can fail some tests now. What.

Etienne Nichols: It's.

Mike Dolphin: Yeah, now you got to go back to manufacturing and develop it. We. So, on our first product that we did, the previous one, we failed a dimension test.

Just a dimension. Just a lure lock dimension was slightly out of spec.

And the worst part was, is that they were changing the spec.

So, the next year, the spec was going to be different, and we would have. We would have been okay, but the FDA said, no, we're not at the new spec yet.

You must meet the old spec. And we're like, you've got to be kidding me. So, we had to go back to manufacturing and change the mold and hit the spec.

And what year was that? $80,000. 2020.

Etienne Nichols: Wow. I had a similar situation. We were going through something. This exact same situation happened to us. It was lur. Yeah. Wow. That's crazy.

Mike Dolphin: Yeah. The T dimension, if you were into that kind of level of.

Etienne Nichols: Yeah, yeah, I remember the details. I just.

Mike Dolphin: Yes, it was. It was a kind of a stupid dimension. I can't remember the exact parameter that we missed, but it went from a requirement to a recommendation, and they. They took it from a,

I don't know, 100 microns to a millimeter or something. It was a huge difference in terms of requirement.

Etienne Nichols: Yeah. Yeah, that is a really good point. And I think a lot of people, especially, I don't know, engineers, are very, like. In my experience, you know, we've designed this. You know, the. The testing is almost like an afterthought. Okay, yeah, let's go ahead and test it. It'll pass, but that's absolutely right. Any. Any recommendations or thoughts, opinions on the testing process?

Mike Dolphin: Oh, boy, that's a tough one.

Yeah, I think. I think there's a lot of that sort of cross your fingers, like, of course it will pass, or I, you know, I hope this passes.

There are a few things that you can probably knock out earlier and kind of get a sense like, will this pass? Like, you know, we used. We use all materials that we'd used before, so we knew we were going to pass our biological testing. It was just a given.

And in fact, if you're. The FDA even allows for this, if you're using the exact same materials as a previous product with no new materials in it. You don't even need to do biological testing.

You can just point to that other product.

But we were very, very confident we're going to pass the biological test. We had some stainless steel we hadn't worked with before, so that was the only thing that was new.

So, we were highly confident. So having the confidence really, really does help because, you know, you're not gonna have to redo that test.

You know, we, we did all of the dimension testing in house before we send it off to get the expensive dimension testing done.

Etienne Nichols: Yeah.

Mike Dolphin: So, we wanted to make sure we hit those numbers.

What else? I, I think wherever you can, wherever you can do your own testing and, and, and really kind of stress test things in your, on your own bench. Because it doesn't cost very much.

Right. Like when you're doing manufacturing development, you're getting pieces off the line all the time.

So, you take those pieces and you say, okay, great, let's stress test them and see where they land.

And you can do pressure testing, you can do strength testing, you can do a lot of those tests that need to be passed just right there on your bench. And it will cost you almost nothing because you're just doing it yourself.

Whereas if you go and send it off to a lab, you're going to be waiting a month and it's going to cost you $20,000 minimum.

Even if you're doing a small run of four or five and they have to write a report and all that stuff, it's just, you just don't need that. So, I think it goes back to like, do what you need to do, which is just test it yourself.

I mean, I think technically you don't have to send it off to a third party to be tested, but you do need to be qualified. So, I figured third party testing is probably the safer way to go.

When you're doing your final formal testing.

Etienne Nichols: What about manufacturing yourself? Any thoughts or opinions or maybe even the guiding principles that help you make that decision? What, whether to manufacture in house or outsource?

Mike Dolphin: Yeah, this is a tough one.

I have not manufactured ourselves. We've always done contract manufacturers.

So, I'm coming at this with only seeing one side of it.

If I had had sort of the vision and the funding, I think doing more manufacturing in house would have been smart.

And I say that having not done it, and I've been told that manufacturing yourself is a terrible idea. So, I could be very, very wrong on this. I wanted to, you know, caveat that very clearly.

The reason why I Say that is because we have an external manufacturer right now, a contract manufacturer.

Every time we make a change, we change our documents. We have our quality team go through it, we sign it, we review it, our engineers look at it, we send it off to the manufacturing development contractor.

They have their quality people look at it, they have their engineers look at it.

And so now you have two people doing the exact same job.

And worse than that is that I'm paying my people, let's call it a thousand dollars to do the work. I'm paying their people $3,000 to do the work. Yeah, because they're outsourcing. They're outsourcing their costs. They charge us an hourly rate of like, you know, 500 an hour. It might be $10,000. So, so what should have cost me $1,000 to make the change will end up costing five or $10,000 to make the change.

It's probably closer now that I think of it. It's probably closer to $10,000 to make that change for a thousand-dollar change. So, the cost goes off the charts every time you make a change.

Now remember, manufacturing development is a development process.

And if you're signing off on documents and there's a QA involved, those costs are there. And so, you're spending thousands and thousands and thousands of dollars just to repeat work.

Yeah. And it's completely unnecessary.

And you're adding time, which also is a huge cost. So, if it takes me one week to make a change versus two weeks to make a change or three weeks to make a change, that's a huge difference. If I make 10 changes, I've now added 30 weeks to my development time.

So, if you start thinking about this, you go, wait a minute. Okay. Every time I make a change, I'm adding.

If I make 10 changes on the year, it's going to cost me an extra $100,000 minimum.

And it's going to add 30 weeks, which is a year which I have to pay all my payroll on my overhead.

Like it's literally costing us millions of dollars.

Etienne Nichols: Yeah.

Mike Dolphin: So how much does it cost to build my own manufacturing facility? I mean high end for what we're doing for, you know, we just need a clean room, probably $500,000.

So, at the end of the day, it would have been faster and cheaper if I built my own manufacturing facility from the very start.

Now again, I'm going to point to, I mean SpaceX just had the IPO.

So, when I was at, I was at Stanford, a lot of my classmates went and worked with SpaceX. So, I got to go tour their original facility.

And I'll never forget the story. The story stuck in my head and I always remember it. So, I was touring the facility and we're walking around and the guy's like, yeah, this is our shake test table.

And I'm like, you have a shake test table? And I'm like, how often do you use it? He goes like, we've used it three times.

Like we'll probably use it, you know, every once in a while.

And I'm like, how much of the shake test table? They're like, it's like $40,000 to buy them or whatever it is, whatever the number was, I don't know.

And so, he said, so this is what happened. So, we said, we said we got to do a shake test for our product, but there's only three tables in the area that we can get to. Once at JPL and all these other ones and there's like a two month wait time on it, but it's only like a thousand bucks to do the run.

And Elon said, how much of the shake test table? And he's like $40,000 or 100, whatever the number was. He said, great, we'll buy one.

And all the engineers were in the room were like, you're going to just buy a shake test table just because we want to do one test that's going to take us a month to get done, cost us $1,000.

He's like, it's not worth the time to go through someone else and have that done.

That's his philosophy. That's been in the philosophy from the very beginning. This is why SpaceX is the most valuable company in the planet right now.

They do everything. If they can do it in house, they do it in house. Every single thing. They're manufacturing chips now. They're manufacturing their own AI, they're doing their, you know, they make their own heat shields out of their own proprietary heat shield material that they developed because the one that NASA had wasn't quite good enough.

So, you, if you take the philosophy of like, you know, again, it takes more money, you have to have the funding to do it. But if you have the funding to do it up front, if you have the capital, it's generally cheaper. If you're going to be successful anyway and you have to have the floss of, you're going to be successful, if you're going to be successful anyway, it's generally cheaper, faster and better to do it in house.

Etienne Nichols: Yeah, and fast.

Mike Dolphin: I Would say if I had any choice to do differently, I would have done my manufacturing in house.

I'm with the slight caveat on injection molding because I'm not super sure about that one yet. But maybe at higher volumes it makes sense. At low volumes, not so much.

I'm not going to invest in a $300,000 machine to build like 100 units.

Etienne Nichols: Yeah, yeah, that makes sense. Wow, that's interesting. Yeah, that whole philosophy makes sense.

Okay, so we covered a lot of ground in a lot of different areas.

Is there one thing that you're really fired up about at GuideStar over the next 12 months and that people can follow along your journey?

Mike Dolphin: Yeah, I mean, we have a.

I think we have a great product.

You know, we've developed a product that works nearly flawlessly. It does something that no one's ever done before. Like I say, it's a closed loop system.

Think of it as like an automatic braking system on your car.

If you have an automatic braking system on your car and the car in front of you stops suddenly, your car stops and you don't get into an accident. That's what our product does.

Our track record, you know, we're, we don't have tons of data, but our data is sparkling clean. We have very, very, very good results. Over a thousand cases.

The hard part with medical industry is adoption, is that doctors are resistant to change.

They are very well trained. They are very confident in their own abilities.

And so, I think, you know, that's a big challenge for us. How do we break through that? And that's a marketing sales thing.

I'm excited to see where we can get, you know, I, I really think that this is a type of product that could become the standard of care. Or, and if not, this product or product very, very similar to it should be the standard.

Standard of care, in my opinion.

Etienne Nichols: Yeah.

Mike Dolphin: So, you know, in terms of, of where we're going to be, I think, you know, we'll get into hospitals and we'll get more people using it and people will, more people will like it.

At some point we're going to get to that tipping point where people are going to be calling us for it and people will, hospitals will be asking us for it.

Administrators will say, this is, this is something we should adopt. This is clearly better.

We're not there yet.

And I think that that's, that's the big challenge.

So, I mean, does that answer your question? Or there's something.

Etienne Nichols: I think so, yeah. No, that's, that's exciting to see. It's going to be exciting when you reach that tipping point. And I hope I’m; I hope I see that.

Is there anything you need from the audience? Like it's, it's primarily quality, regulatory, product development, a few founders. If you were to ask something from them, I mean, is there anything, you know, that we can do to help?

Mike Dolphin: Oh, gosh, no. I mean, I think obviously go promote our product, but no, I think I, I think in the realm of, you know, we're all developing things to try to help people. Right. In the, in the medical industry again.

Yeah, we're all trying to make money, but primarily every single product is trying to do something good. You know, I've been to a lot of conferences, and a lot of people present, and every single device or product is going to be a better way of doing something with a better outcome for your patients.

Yeah, we're all doing that.

And you have to really, really believe in what you're doing because it's a very, very difficult journey that is not going to go well at times.

And if you believe this is really worth doing and people around you believe it's really worth doing, you'll get the support you need to make it happen.

Yeah, it's hard. I mean, it's hard to, you got to make margins, you got to get funded, you got to, you got know, develop the product.

I would encourage people to really ask the question, is this necessary?

So, in the realm of, of requirements and quality control and quality management, I would say, is this necessary? I, I'll, I'll, I'll sort of end with one last anecdote, which I think is kind of funny.

So, this comes up a lot.

Apparently, people will get audited and they'll say, oh, your documents need to be stored in a fireproof cabinet.

It happens a lot.

Etienne Nichols: Yeah.

Mike Dolphin: There is no such thing as a fireproof cabinet.

First of all, let's just be clear on this. There are fire resistant safes and other products, but there's no such thing as a fireproof filing cabinet. It does not exist.

Etienne Nichols: Yeah.

Mike Dolphin: Second of all, there is no requirement for documentations to be stored in a fireproof cabinet. If you read the requirements, it's not in there. There's no actual language around that. The language is something like it must be stored in two different places or have a backup or something like.

Etienne Nichols: Yeah.

Mike Dolphin: So, this is a really, really good example of requirement creep of where people will start doing things because they think they should or they think, oh, we've always done it this way.

No, just stop Ask the question, what is actually necessary? What does the requirements actually say?

We've had many things where we, you know, when we submitted to the FDA, we said, and they kept pushed back and said, you know, you didn't meet this thing. And we said, we don't have to meet that thing.

It doesn't say that. For example, say you need to test your packaging 60 times. I say, no, we don't.

That's not what it says. It says you need to test your packaging such that you feel the risk has been mitigated enough that you're comfortable with it. That's what the requirement says.

Etienne Nichols: Yeah, yeah.

Mike Dolphin: I'm like, I've done this kind of packaging before. This packaging is used on thousands of products.

Why do we need to test it 60 times when 30 gives us enough confidence, our opinion, unless, you know, you can justify the reason.

So, things like that or the other, the other one that comes up a lot is you must test your device prior to aging and after aging.

No, that's not in the requirements. Read the requirements. So again, the requirements state the device must be tested. In the worst-case scenario, which is a fully aged device, you do not need to test at zero age timing.

But people will tell you have to because it's a good idea.

Yeah, good idea is fine. Great. If there's something you're concerned about, you should do it.

But the requirements state. With the requirements state. And, and I think that that's a real thing for us in terms of just the industry in general.

I would say look at what's needed.

Stop doing things that aren't needed. This business is hard enough as it is.

Don't make it harder.

Etienne Nichols: I think that's great. Yeah, no, no. The requirements. And fulfill the requirements. Do what you feel like actually concerns you. That makes sense.

Mike Dolphin: Yeah. Don't make it harder than it needs to be. It's already hard.

Etienne Nichols: Yeah.

Awesome. I really appreciate it, Mike. I look forward to the next time our paths cross. But until then, really appreciate this conversation. Those who've been listening, thank you so much for listening to the Global Medical Device Podcast.

We'll put in the show notes places where you can find Mike and see what he's doing at GuideStar and see more about the product.

But thanks so much. We'll let you all get back to the rest of your day. Take care.

Etienne Nichols: Thanks for tuning in to the Global Medical Device Podcast. If you found value in today's conversation, please take a moment to rate, review and subscribe on your favorite podcast platform. If you've got thoughts or questions we'd love to hear from you.

Email us at podcast@greenlight.guru.

Stay connected for more insights into the future of MedTech innovation. And if you're ready to take your product development to the next level. Visit us at www.greenlight.guru. Until next time, keep innovating and improving the quality of life.

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Etienne Nichols

Etienne Nichols is the Head of Industry Insights & Education at Greenlight Guru. As a Mechanical Engineer and Medical Device Guru, he specializes in simplifying complex ideas, teaching system integration, and connecting industry leaders. While hosting the Global Medical Device Podcast, Etienne has led over 200...