#412: How to Build a QMS That Actually Works: From Startup to Scale in MedTech

Ashkon Rasooli: 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.

Etienne Nichols: In the medtech world, success hinges on seamlessly integrating product development, quality management and clinical investigation. Because, let's face it, one of the most important parts of being a medical device company is maintaining traceability.

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Etienne Nichols: Hey everybody, how's it going out there? We're in California at the LSI conference and I'm with Ashkan Rasooli, who he has an interesting approach to building that quality management system. So when we talk about medical device companies, obviously they have to have a quality management system.

What I'm curious about though, from your perspective, Ashkahn,

when a medical device company starts and finishes, that quality management system has gone through something of an evolution. So what does it look like at the beginning? Maybe the beginning, middle and end?

And what are your thoughts about what it takes to build those things out appropriately?

Ashkon Rasooli: Yeah, so you know, my manifesto is that you got to take the BS being burdensome out of qms. And so what I'm really getting at is the qms, if effectively implemented, it is a powerful project management tool.

And if you do it right, meaning you balance the short term burden with the long term burden, you're actually going to have an optimal product development process.

So I'm going to first talk about like what generally looks like and then talk about the ways that it typically goes wrong and then how to do it optimally.

So ideally, you know, the evolution of the QMS kind of follows your business needs and your product development process.

And if you think about just the general steps in the product development process, we typically have a phased approach to that. But every phase has an objective, which is pretty intuitive.

Right. There's that initial phase we call feasibility.

You don't even have your problem you're trying to solve quite defined yet, so you're trying to define the problem and then see if there is a product solution to that.

This phase typically involves a lot of iterations,

a lot of changes that is not a phase you want to implement QMS control on. And so I typically call that phase zero.

But after you kind of nail down your problem you want to solve and the product that solves it, then you get into, okay, I have a feasible solution.

And now let's plan on how we make this a product.

That becomes your planning phase. And you got to talk to different stakeholders, different swim lanes, different. That becomes your phase one. At the end of phase one, you've got a product defined, you've got a plan to make it a reality.

And there's different paths that you gotta go in that. And you get to phase two. And so phase two ends up being executing on that plan to get to a final design.

So phase two, the objective really is I got a final product design.

Then you get into testing. Right. We call that phase three or verification of net devices. The point of testing is, does the product I design meet the product I defined?

Etienne Nichols: Yeah.

Ashkon Rasooli: Right. And so it's just going back to my product definition from phase one, possibly updated in phase two and making sure that it meets that definition after that. The product I defined, did it actually solve the problem I was trying to solve?

Etienne Nichols: Yeah.

Ashkon Rasooli: So that becomes validation. So that's phase four. And then once you validate it, you're like, yes, it does solve that problem. Then you get into, okay, getting ready to sell. So everything that goes into that, we call it design transfer and phase five.

But that would be your regulatory clearance. That would be things like manufacturing scale up, getting your suppliers in line, all of that ready to go to market, sell and scale up.

And then after that you got your post market maintenance, updating the product sustainability activities, that kind of stuff.

So I just outlined phases zero to six, all the way from, you know, scrambling to we got product and selling market. And so those are the typical phases.

Now ideally you would have your quality management system at every phase getting ready to support the next phase. Because the quality management system is a system of procedures that assigns roles and responsibilities to people according to which then people need to act and create records as objective evidence of following the procedure,

ultimately to show the objective of the procedure we're meeting, right?

Etienne Nichols: Yeah.

Ashkon Rasooli: And so you want to be ready for that next phase one phase in advance.

What actually happens though, often is people implement QMS according to the enforcement points. And so one of the realities of medtech development is the enforcement points of having a QMS come later.

Typically app product launches. When people think of.

Etienne Nichols: I like that. Yeah,

that's a good. I actually like that Phase a Lot. Or that phrase a lot enforcement points. Because some, one of the things that I think about, and I don't mean, I don't mean to cut you off necessarily, I'd love to get back into this.

But if we go outside Medtech, there are words that we use like protocol and procedure and different things, and they can be a little bit intimidating. I'll just use an example for like a,

for a, let's say a fitness regime. Maybe you're talking about this certain protocol for this certain goal that you want to have for a fitness regime. Well, you call it a workout plan that makes it easier for me to metabolize.

You know, you call it a protocol, I think, okay, you know, and actually somebody, a doctor sent me a, A protocol for a certain,

for certain reducing a certain type of infection or something. And I'm thinking you're going to send me a protocol. You know, as a friend of mine, actually, he's like, yeah, let me send you that protocol.

It was just a sheet of instructions. It. And I think sometimes we scare ourselves with these, you know, quality management system. But like you said, it's the set of procedures or the plans that you're going to put in place for these different activities and then there are different enforcement points.

I love that.

Ashkon Rasooli: Yeah. You know, one of the first principles in the Agile Manifesto is quality over proceduralism. And what I'm trying to get at is exactly what you just said. Proceduralism is having procedures for the sake of procedures, but quality is understanding the objective that the procedure is about to achieve and understanding your role in that.

Right. So, you know, if you've got a risk management procedure. It sounds scary, right? But the goal of a risk management procedure is something we do every day, which is making sure the risk is acceptable for what it is we're about to do, given the benefits.

Etienne Nichols: Yeah.

Ashkon Rasooli: That's all.

Etienne Nichols: How bad is this thing going to hurt somebody? And can we fix that?

Ashkon Rasooli: Prevent it from happening? And if not, if there's some residual risk, it's possible. Is it worth it?

Etienne Nichols: Yeah, let's take that into account. Absolutely.

Ashkon Rasooli: Because that's a decision every day. When you step outside, when you drive a car, you're accepting, you're assuming a certain level of risk, but it's worth the benefit. So that's an assessment you're doing every day.

We just call it the risk management procedure and we make it structured in.

Etienne Nichols: Medical device development so the enforcement points make sense. And maybe, maybe it would be worth talking about those different enforcement points because I would expect a heightened Sense of formalization at each one of those points.

So in the early stages, let's say feasibility,

what procedures? Or official, unofficial enforce, not enforced, you know, audited, not audited. You know, we can talk about all the different things. I don't want to go necessarily into that depth, but what do you recommend a company at that level have?

And then maybe we can go on to the just kind of outline the different enforcement points that you're talking about here.

Ashkon Rasooli: Yeah. So the feasibility being the early stage with a lot of rapid iteration, where the problem and product are not yet defined completely, is actually one that least benefits from having structure.

The quality management system is about control of different objectives you're trying to achieve. One of the first things we do, we define a quality manual, quality policy, quality objectives, right?

Yeah. And so we got objectives. How do we achieve them? We keep controlling. And control necessarily does have a burden associated with it. It does necessarily slow you down a bit.

But also if you know that what you have is a prototype to be changed 25 other times, the control immediately becomes invalid and therefore you get no benefits. You just get the burden.

Etienne Nichols: Yeah.

Ashkon Rasooli: And so in phase zero, I would actually argue that you don't want any formal procedures. What I would actually start thinking about in phase zero is building a quality culture, which is more making sure the team's on the same page about the heavy responsibility of developing a medical device, making sure everyone's aligned about patient safety.

That is kind of what we're focusing on. And you kind of build that culture just to set yourself up for success in the following phases. Right.

Etienne Nichols: I can almost see,

because I agree with you, sometimes the chaos is necessary to get things. Yes, and chaos is a too extreme of a word. But like you said, the formal controls, you might not benefit that from that at the very beginning.

However, and I'm curious what you think about this is when you go through and start developing that early stage feasibility, defining the problem, defining all those things, those aren't necessarily, they shouldn't necessarily be controlled by your quality management system, but they should be inputs to how your quality management system is going to function later on or how your design controls your risk management is going to.

Would you agree that 100%, which that's also going to go well.

Ashkon Rasooli: So actually when you're talking about product definition in phase one planning,

I would argue that a QMS implemented effectively at that stage starts working on the quality manual, but also the quality policy.

And the question you're trying to answer with a quality policy really is what role does quality Play in my product presentation,

is it only going to be the bare minimum necessary to check a box and be allowed into the markets? That's the one end of the range because you can't be less than the bare minimum, you just won't be granted access.

hing worth noting Here is the: 1345

And ultimately the goal of: 9001

And you get to define customer requirements.

Etienne Nichols: Yeah.

Ashkon Rasooli: And so this is part of why I say a quality management system effectively implemented is just good project management. This is how you consistently build quality systems. And so in phase one in your product definition, the executive management must make a decision of what role does quality play in my go to market strategy?

Etienne Nichols: Yeah. Okay, let's talk about the enforcement point.

Ashkon Rasooli: Yes.

Etienne Nichols: When does it start needing to be enforced and controlled?

Ashkon Rasooli: So there are two enforcement points that are typically driving activities in a startup. You see startups for the most part with scarce resources try to postpone that which is not immediately necessary.

There's obviously the regulatory enforcement of if you're in the states, the fda, if you're in the eu, your notified body. However, those typically come at product launch that basically gates your product launch.

If you're a pma, you know you're gated by an inspection.

If you are a Class 2 or Class 1, you're still supposed to have it at product launch.

Etienne Nichols: Right.

Ashkon Rasooli: Even though there's no inspection.

The other category of external enforcement points typically ends up coming from investors, investors as a part of their due diligence, depending on the stage of the company. And long term actually require that you have some sort of a regulatory strategy, some sort of equality strategy and show them how far down the road you are.

And so typically startups start thinking of this stuff when one of those external enforcement points arrive. Right, right.

I would argue that this ends up typically being a case of short term gains sacrificing long term efficiency. And in fact it is one of the primary contributors to what I call BS in a qms, you know, a burdensome approach.

Etienne Nichols: A burdensome approach. Ye, yeah.

Ashkon Rasooli: Because what really happens is you end up having spent a long amount of time, sometimes years. You know, the average time from inception to pma for class three devices is 13 years.

So that's obviously class two devices shorter. But like that's the kind of timeline we're talking about. Sometimes you spend years iterating on the design, testing and all that. And then you're like, I gotta establish a qms.

You gotta go retrospectively.

Yeah, remediate all that. The quality is not going to be great, it's going to feel burdensome, it's going to be all at the same time and it is not necessarily going to be value added.

And so ideally you would prep for the stage after the form with your procedures. So you know, I talked about how if you're in phase one, you're defining product. That's a great time to start thinking.

Quality policy, quality manual, quality objectives, management review. Get the management position on where does quality stand. But also prep yourself for phase two, which is going to be product design.

And so that's going to be things like the PDP process, the product development process. If you got software, software development, life cycle. How are we going to go about designing this thing?

The risk management process. Because risk management is a part of your product design. It gives you inputs in the design. You don't want to be thinking you're done with the design, only for quality to last minute come in with five mitigations you need to build in that take you five months.

Right, right, yeah.

Etienne Nichols: Or cybersecurity. I mean there's lots of different inputs there.

Ashkon Rasooli: Exactly.

Etienne Nichols: Makes total sense.

Ashkon Rasooli: There's a lot of different inputs that if not implemented early on is going to just delay whatever target launch you have later on. Yeah, yeah. And so in the same vein, you know, getting ready for testing verification in phase two, then you want to make sure you've thought of your software VMV procedures,

your product VMV procedures, your sampling plans.

How is usability going to look? Do we need to do any formative testing? Do we need to do summative testing? What does that look like? What is the scope of that?

use, basically and you need a: 14155

Or if you're going to, you know, outsource to a CRO, those are decisions to be made. So get yourself set up for what user validation and clinical validation looks like.

Then in phase four, get yourself set up for phase five, which is going to be all the manufacturing procedures, IQO Q PQ process validations, the equipment manufacturing, the maintenance suppliers, the clearance and then get yourself ready for post market surveillance in phase five.

Etienne Nichols: If you could just give one piece of advice to startups and I don't know, early stage companies who are thinking about, well, do I need a qms, I don't need QMS right now, or do I need a QMS right now?

What would be the piece of advice that you could give them? And just to kind of close this conversation out, I would say start small.

Ashkon Rasooli: And do a little bit of time and it's going to not seem like a burden. It is. Often I see it become a burden because it is not thought of early.

And so what happens is what could have been just like maybe hours a month, maybe like four hours a month for everyone over a period ends up being a huge milestone to drive to.

Etienne Nichols: Yeah, I think it's good advice. Well, cool. Thanks so much, Ashkan.

Ashkon Rasooli: Thank you.

Etienne Nichols: Hope you enjoy the rest of the conference.

Ashkon Rasooli: Thank you. You too.

Etienne Nichols: Thanks for tuning in to the Global Medical Advice 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 podcastreenlight 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.