medical_device_pocast_3.5

Medical device design reviews - are more or less better?

What about independent reviews? Are they necessary? How do you get one done?

These are a few of the topics we touched upon in episode 3 of the Global Medical Device Podcast, How To Improve Your Medical Device Design Reviews

And they seem to have struck a nerve

That’s why today, we’re excited to release our first bonus episode, 3.5, so that we could expand upon these topics for you. 

One area deals with getting those independent reviews of your product done and the other concerns comments about slowing down during the product development process. 

Jon Speer and Michael Drues Ph.D. felt they owed it to you to explore these topics on a deeper level in this bonus episode of the Global Medical Device Podcast.

LISTEN NOW:

Like this episode? Subscribe today on iTunes or SoundCloud. 

As we said, Medical Device Design Reviews are critical steps within your design and development process. 

If you’re a startup strapped for cash it may be difficult to have an independent review done. Getting that review can be challenging, but it still needs to be part of the process.  

One way to do so may be to have somebody who is part of a medical device incubator/accelerator that shares the same physical space as you assist in doing the review.  

Although it’s easy to say, but sometimes hard to do, medical device design reviews need to be a part of your planning.

The second thing we wanted to further explore is Jon’s comment about slowing down during the product development process.  

That can be difficult when you are dealing with expectations from senior management or investors.  

Jon clarifies that his intent is to say, be more deliberate. Don’t be in such a hurry to get to the next milestone.  

Start with a project mission and keep the end goal in mind. Follow the structured process so that you can find problems early and often and correct them.  

Eighty percent of medical device companies have fewer than eighty employees. Depending on the nature of your failure, if your product fails, then your company fails, so it’s better to find problems sooner with a deliberate approach.  

Now grab some pen and paper because you’re going to want to take some notes in this 18 minute bonus episode where Jon & Mike really dive deep on a topic they brought back by your popular demand. 


 

About Our Guests:

Michael Drues, Ph.D., is a prolific speaker and consultant to the medical device industry as well as being the President of Vascular Sciences.

Jon Speer is co-founder and resident “Guru” at greenlight.guru, making waves with his innovative approach to QMS software being built exclusively for the medical device community.


Transcription: 

Jon Speer:

Hi, this is Jon Speer again, with greenlight.guru. Mike and I decided that ... Mike Drew is President of Vascular Scientist. Mike and I decided to ... We had a little bit more to say about a couple of the topics that we discussed during the designer view podcast for greenlight.guru, and a couple of the things that Mike and I [pre-patched 00:00:22] about the product development process, but there's two things that we wanted to hit on, on this bonus content.

 

 

First thing is, delve a little bit deeper into this concept of an independent review, what did that mean, and how can you manage that? Then, the other thing we hope to dive into a little bit is, I made a comment on that last podcast, something about slowing down, and that seems maybe a little counter intuitive to the way we've all been wired with product development.

 

 

So, without further ado, Mike, are you ready to [spar 00:00:56] a little bit about that couple of points on designer view?

 

Mike:

Absolutely ready, John. I look forward to this.

 

Jon Speer:

Now, you've raised some point about independent review, or about the need to have true independence, and to make sure that companies structure that in some way. I think you even offered that, sometimes you're hired as a consultant to be that independent reviewer. Yeah, I guess in theory it all makes great sense, but what do you, the start up companies is already strapped for cash. So, maybe have two to three people on their team who are all wearing mini hats on the project. I mean, how in the world can they possibly pull off hiring an independent reviewer, when they don't have cash necessary to built a prototype? How can that happen?

 

Mike:

Well, that's obviously a big challenge, John, and we both work with companies that are the smallest of the small, the start-ups in people's basements or garages, all the way through to the largest of the large, and although, big companies have obviously a lot of money, I find similar challenges, because oftentimes they're not keen on parting with their money.

 

 

So, whether you're talking about a start-up or a really, really big company, I think that many of the challenges are the same. Bottom line, I think it is a real challenge. Although the regulation just says, we need an independent design review. What the heck does that mean?

 

 

One of the suggestions that I made in the previous podcast was, we want to try to create an environment, where that independent reviewer truly feels independent. That in other words, they feel comfortable doing a real critique of the design, and even taking it further, asking the question, "Hey, you're designing this kind of device, but is the real device that you want to design? Is this the real problem that you're trying to solve?"

 

 

So John, you've been in this situation in the past as well. What advice would you have to give to companies, to try to encourage that sort of an environment?

 

Jon Speer:

Well, I mean it's ... If I'm the start-up that has three people and limited cash, and I'm making progress with my product development efforts, and I recognize that I need to have a designer view, I'm not going to fret whether or not I have that independent reviewer. I know I need to have a designer view, and I'm trying to track down somebody that is truly independent might be a bigger challenge for me, and it might be less productive for me actually, than if I actually get my team together and have a designer view.

 

 

So, that would be one thing if push came to shove, I'm going to have the designer view, and I'm going to worry less about whether or not there is an objective third party that's being an independent reviewer, as part of that process. That's one thing that I would do.

 

Mike:

You're right, John. Actually, there's an edge, be careful what you wish for, or you might just get it. But what if you're working in that very smaller start-up company of only two or three people, and you do get somebody like you or I to come in that can offer a truly independent review, and say, "You know what? Quite frankly, your device is pretty bad." You know? What do you do in that situation?

 

Jon Speer:

Well, I mean ... I guess, well, the same adage, careful what you wish for. I think sometimes people are developing products that frankly, they shouldn't be developing, because there's no clinical need, or it's a solution looking for a problem, and sometimes maybe they're afraid to bring in that third party reviewer, because that person is going to tell them, "Why are you doing this?"

 

 

I think the other interesting thing is if that three person start-up, and I realize I need to have a designer view, chances are they know somebody in their network. Right? Or a friend, or a neighbor, or a colleague, or maybe they know of another start-up. Even though I said earlier, I should have a designer view, and not worry about the independence, if I care about what I'm doing.

 

 

You raised a good point. I probably should find somebody to critique what I'm doing, to be objective, and to come in and be part of that designer view process, even if they're not squally trained or qualified per se, but somebody who's going to come in and look at it. Frankly, let them call me out when I'm doing something that doesn't make sense. That's going to be more meaningful to me, right?

 

Mike:

Yeah, and John, let me offer the audience another pragmatic piece of advice. Both you and I both work with very small start-ups that are part of medical device incubators, and oftentimes these incubators work out of shared spaces. I was just in one in California last month, where there's probably about six or eight medical device companies, all working in different areas, but six or eight medical device companies in the same physical space, a great big conference room. If you're working in that kind of an environment, it would seem to me you can just go to the next cubby hole over and knock and say, "Hey, can one of you folks give us a review of our design?"

 

 

So, you're right. You can use networking, you can identify people, but we all have to keep in mind that regulation here, like in most areas, it's very easy to just treat it as a check box, independent review, done. But the question is, is that enough? Is that really what we want to do?

 

Jon Speer:

Right.

 

Mike:

Any final thoughts on this particular topic, John?

 

Jon Speer:

No, I don't think so. It's tough. Of course, it's tough, and trying to sit down and say when and how, and if to do a designer view, can be challenging. The regulations are also pretty clear that it should be a part of planning, and of course, that's easy to say and hard to do, knowing when you're ready for a designer view, it's a bit of an art, and if you don't have that, if you're not quite proficient with the art, sort to speak, I would say, it's going to be clumsy. Especially if it's your first time doing a designer view. It will feel a little, maybe awkward and unnatural, and I guess that's where having somebody like you or me participate in those tests of events, or somebody who's done them before, can help be a guide and facilitate that process a little bit better.

 

Mike:

I agree. Well said, and to your point about not knowing when to do it. I guess I would just deal the, I think it was the Nike commercial, Just Do It. Pardon me, just do it. I don't think it really matters, what the right time is, and I don't think we should need a regulation to tell us that. I think doing it, is the most important, and doing it frequently.

 

 

Again, as we talked about in the podcast, I think it depends on the nature of your device, if you're working on a device with established technology that's been around for a long time, which is 2ME2 to 510(k), and there's already 200 of them out there, then maybe doing a design review on a weekly or monthly basis, might not be necessary. But on the other hand, if you're working on something that is truly cutting edge technology that's never been used before, it's a class 3-PMA, where it's really life sustaining, or life supporting, then maybe doing it more frequently makes more sense, and at least in my opinion, the regulation should not tell us how frequently to do it. That should be up to us, based on things that we've discussed.

 

 

Alright, John. Let's move on to the second point, which I thought was terrific. One of the suggestions that you made in our previous podcast, was simply to slow down and make sure that we're doing the things that we need to do. But John, I don't know about you, I live in the real world, and that's not an easy argument to win, when you say to your senior management, that we need more time, simply because we want to make sure that we're doing a good job. How do we sell that kind of a ... I'm not saying I disagree with you, but how do we sell that kind of argument or logic, to the senior management of an existing medical device company, or to the investors of a very smaller start-up company?

 

Jon Speer:

Yeah, I knew once the words were out of my mouth, I could see them floating in the air, and I couldn't put them back in, and we had already moved on. So, I'm glad we had a chance to kind of revisit this topic.

 

 

Yeah, I do live in the real world and yeah, I can appreciate the pressure, especially from a schedule standpoint. I mean, every project that I've ever worked on was late before I even started. I can imagine that, that's a pressure that our audience feels every single day. So, when I tell them to slow down, I mean, I can imagine that, that was probably ... A matter of people throwing through at their computer screen listening to that. I'm not really sure that ... I think what I intent meant to say, with the intent behind those words, was probably better stated, be more deliberate. Don't be in such a hurry to get to that next milestone, without insuring that you're ready for it.

 

 

That's what I mean by slowing down. Be critical of what you're doing. We're designing medical devices. We should be pretty deliberate and intentional about that, and I think that even though there are all those timed pressures and constraints, we can do things in a way, structure our work in a way that if we kind of have the end in mind, and we are mindful of things like verification and validation when we're developing, using these inputs, that allows us to kind of look into the future, and can also be a way for us to structure our process in a way that allows us to slow down and be more deliberate.

 

 

What do you think, Mike? I mean-

 

Mike:

I agree with you, and one of the arguments that I've heard frequently, not just in the medical device world, but in the drug world as well, is it better to find a problem earlier, rather than later? Many people will say that it's better if there is a problem with a device, with a design of a device, or the manufacturing process, or whatever it is, better to find out about it sooner, rather than later.

 

 

That's easy to say, not always easy to do. The simply reality is that argument might work in a larger established device company, that has a number of products already on the market, but that logic doesn't work as well in that start-up or small company that you described, two or three people working in their garage or basement. They don't have any product on the market yet, and the simply reality is, their investors are looking for a liquidity event, you know, an exit strategy.

 

 

As a matter of fact, in many cases, because of that we've created incentives not to look for problems. I see this in clinical trials all the time. Because if the company or the technology is licensed or acquired by somebody else and a problem is discovered later, it's now somebody else's problem. The folks that started in that company are now probably off starting the next company. So John, what are your thoughts on the simple realities of it's better to sell to find a problem sooner, rather than later? I hear a lot of people make that argument, but is it really as simple as that?

 

Jon Speer:

I think it can be as simple as that. I think when I talk to veteran entrepreneurs, one of the pieces of advice that I often offer is fail fast, and I think that's a similar mindset as finding problems early, and find them often sort of thing. Actually, I think when I say slow down, I think that all of those things can be accomplished in this approach. Being more deliberate, I think is really about an attempt to try to find the problems earlier, and if I'm asking for a strategy or a plan of what I hope to accomplish in my product development effort, then I'm not talking. Most people here plan, and they think schedule, they think answer. I'm not talking about a schedule [inaudible 00:13:45]. I'm talking about some sort of narrative that becomes a critical piece or record for your project, but also a way to communicate to your team. What you're doing and why you're doing it, and defines things like the scope, the description of your product, the intended use, and a number of other critical pieces of information that like I said, just communicate with your team.

 

 

I think if we can start a project with some sort of ... Some would call it a project chart, or a project mission, or what have you. There's lots of different terms that they use, but if you can start with something like that, and keep the end in mind, and kind of rapidly iterate, I guess, and come up with the user needs and design inputs, and think about all the ways that we're going to try to test this thing, and verify this thing, and prove that this device works, then I think that allows us to make new mistakes along the way, and allows us to be much more deliberate in the process.

 

Mike:

Well, John I think those are excellent points, and we need to wrap this up. I'll just dovetail on what you just said, and then I'll give you the final word. So, you mentioned the phrase, fail fast, and again, I've heard this phrase used many times, but in the context of a very small medical device company, and keep in mind, here's an interesting statistic for the audience, 80% of medical device companies have 80 or fewer employees. So, unlike big [farmer 00:15:10], most of the medical device industry is not the Boston Scientifics and Medtronics of the world. It's the tiny companies of the world. They might have a couple of products, or they might not even have any products on the market yet.

 

 

So, depending on what the nature of your failure is, if the product fails, the company can fail, and that means that the people that are working in the company are out of the job. That means that the investors have lost their money. So, once again, I'm not trying to justify the mindset. I'm simply trying to understand why some people would make that argument, that it is in fact not better to find problems sooner, rather to not look for them.

 

 

One of my favorite adages is, there's no better way to avoid finding a problem, than not to look for one. If you achieve the regulatory requirement of an independent design review, by just simply picking off the form. You know, "Hey, we hired somebody to do it. They told us we're doing a wonderful job." You've achieved that regulatory requirement, but have you really fulfilled your, dare I say it, your ethical objective as an engineer, wanting to design a quality product?  Your turn John, and then we'll wrap this up.

 

Jon Speer:

Yeah, great comments, Mike. It's the audience. You're designing, developing, and manufacturing medical devices. I know Mike has from previous conversations. I know that Mike, you share some similar views as me. I'm passionate about this and what I do, and working on the med device space, because I know that what I do impacts the quality of life in a good way, and I think that you all developing med devices are in that same space.

 

 

You have a tremendous opportunity to change lives forever, and I think if you're intentional and deliberate about your product development efforts, you will change the world. You will make it a better place. So, keep doing what you're doing, and enjoy having these conversations with Mike, and listen in next time when there will be another topic that has a ton of tips and advice for you, going through the medical device product development process. Thank you.

 

Mike:

Thank you, John, and thank you to the audience, and we would love to hear from any of you that would like to share your comments, agree or disagree, some of your challenges. If you have topics that you would like to hear us discuss in the future, please feel free to contact us directly. Thanks again for your time.

 


About the Global Medical Device Podcast:

global medical device podcast

The Global Medical Device Podcast powered by greenlight.guru is 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.

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