Medical device Design Reviews are critical steps within your design and development process. They provide a systematic assessment of the current state within your product development process.It's a necessary forum that allows your team to evaluate the designs, voice and resolve concerns, provide feedback, and assess the overall progress of the project itself.
The Design Reviews process serves a gatekeeper, a checkpoint, where your team decides to move forward, or go back, or stop all together."
Okay, that much is pretty straight forward.
But what is not nearly as clear are questions like…
- When should Design Reviews take place?
- How often?
- Do you need to have an independent reviewer?
- If so, how do you find one?
- And make sure she’s truly independent?
- Aren't there any tips or best practices to improve this process?
These are all tough, but extremely important, questions that your project development team needs to address.
With nearly half a century of combine experience performing medical device Design Reviews between them; Michael Drues Ph.D., Jason McKibbin, and Jon Speer have the battle scars they want to help you to avoid.
In this episode, our experts really get down to sharing actionable tips and advice that your team can start using today to help improve your Design Reviews. They peel back the lens on what has worked for them over the years and share how you can implement their proven strategies at your organization.
Design Reviews are clearly a topic that this group has some strong, and at times, counter intuitive thoughts on.
Some Highlights of this Episode include:
• Why Design Reviews are important?
• How do Design Reviews fit within Design Controls?
• Explain the concept of an “independent reviewer” and why this is necessary?
• When should Design Reviews take place? And how often?
• What should not be included within a Design Review?
• How are Design Reviews the same (or different) from a Phase Review?
• What actionable tips & advice do you have to improve Design Reviews?
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.
Jason McKibbin’s medtech experiences spans more than 15+ years and in his more recent past played an integral role as COO of MEDISISS which was acquired by Medline Inc. Jason’s currently COO at Greenlight Guru.
Bill Loss has spent the last 20 years in the startup world and actively invests and advises in the medtech space.
Announcer: Welcome to the Global Medical Device podcast where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
Bill: Hello and welcome to today's podcast. How can your design reviews improve? It's the third in our podcast series focused on design controls and related topics within the medical device industry. During today's podcast, we're gonna touch on some interesting aspects of design reviews that are sometimes controversial and other times simply overlooked. My name is Bill Loss. I've spent the last 20 years in the startup world and actively invest and advise in the medtech space. Thanks for listening in. Before we get into the heart of today's discussion, let me quickly introduce the three industry veterans joining us today.
Bill: First up, Jason McKibbin. Jason's experience spans more than 15 plus years in the medtech field, including a key role at COO for MEDISSIS. Jason is currently Chief Operating Officer at Greenlight.guru. We also have with us Mike Drues, President of Vascular Sciences. Mike is an internationally recognized expert and featured keynote speaker on cutting edge medical technologies and regulatory affairs. I actually had the chance to catch up with Mike first hand at the recent MD&M East Show in New York. Also joining us is Jon Speer. Jon is one of the co-founders of Greenlight.guru. After kicking around his vision of changing the way medical device companies think about bringing devices to market, Jon launched Greenlight.guru and EQMS solutions built exclusively for the medical device community. Guys, thanks for spending some time with us today. Are the three of you ready to roll your sleeves up and get at it?
Jason: Yes we are Bill.
Jon: Let's go for it.
Mike: Looking forward to it Bill. Thanks for the opportunity to join the conversation.
Bill: Good deal, let's have some fun. So Jason, to kick things off a little. I understand your team has taken a pretty unique approach to facilitating design reviews. I wanted to start out by asking you, how does design reviews fit with design controls?
Jason: Design reviews are a critical step in your design and development process, and one in which your team are really inclusive of all the representatives, from all the functions I.e. Marketing, engineering production and clinical, provide a systematic assessment of the current state within your product development process. It's a necessary forum that allows the team to evaluate the design, voice and resolve concerns, provide feedback and assess the overall progress of the project itself. The design review process, it serves really as a gatekeeper, a checkpoint for when the team decides to move forward, or to go back or to stop altogether. I have personally believed in having more frequent design reviews to ensure your evaluations are more timely and the amount of data information you are trying to digest is more manageable.
Bill: So, Jon, kinda listening to Jason and obviously others throughout your career in the industry describe design reviews as really, I guess, more or less a set of intended checkpoints, what else do you have to offer in terms of how design review should also be, I guess, a way to measure or ensure design controls are being captured?
Jon: Design reviews are, if you ever refer to that wonderful design control process and waterfall diagram defined by the FDA, you see that there are design review arrows that come in at several points in the process. And I think that that's... And Jason kinda said some things that I believe in as well. More is better, I think, when it comes to design review. And I think a lot of times there's kind of the opposite tendency from design review or from product development is that they wanna have less design reviews because they feel as though having another meeting, is gonna slow things down. But that's kind of the problem I think with the product development process, at times, is we think it's gonna slow things down by having a design review and actually the opposite could be true. Design review is a way to communicate with your team what's happening.
Bill: Yeah, it's one of those things where sometimes the extra step actually saves you a bunch of steps. So that makes a lot of sense. Mike, I hear people in the industry referring to the concept of an independent reviewer. Can you explain a bit further what this is and kinda why it's necessary as far as the design reviews?
Mike: Well, that's a great question, Bill. As we just heard Jason and Jon both did a nice job of explaining what the design review is. I'd like to delve into a little bit about why it's important, because quite frankly, I see a lot of companies get in trouble when they simply try to meet the regulatory requirements; that is tick off the boxes on the form, but they don't really understand or make an attempt as to why it's there. So the concept of an independent design review is actually quite simple. Asking an engineer to critique their own design is very much akin to asking a parent to critique their child. It's just simply not realistic. It's gonna be inherently biased. So the design control regulation reminds us to have an independent review. And I do agree with Jason in the sense that more frequent is better than less frequent. But the question becomes, "What does independent mean?" So in many companies, especially larger companies, typically what they'll do is they'll take an engineer from a different group and ask them to review a particular device. But the question is, is that really independent? After all, they're part of the same company. Their paycheck is coming from the same organization.
Mike: Other times companies will hire an outside consultant, like perhaps me, to do an independent design review. But once again, is that really independent? Because the consultant is getting paid by the company. So I can't speak for other people, but what I do when I do these independent design reviews is I want essentially an ironclad consulting agreement basically saying that no matter what I say, I'm gonna get paid. Because if you have somebody come in and just basically tell you that you're doing a great job, your device is wonderful and everything is good to go, then yes, you are meeting the regulatory requirement. But you're not really meeting the intent of what the regulation is trying to accomplish.
Bill: So again, not necessarily being the expert on the podcast here, I do understand that as it relates to FDA and ISO, they're very similar on the topic of design reviews. But the one notable difference is really that the FDA specifies the need for this independent reviewer, so to speak, as part of the design review process, and specifically, as you just shared Mike, really an attendee in that process. Jason, picking at that a little bit further, it's easy to have a consulting agreement kind of in place to define objectively that this person is independent. Is there any other view that you have in terms of really making sure that the independent review is what it is? And to your perspective or vantage point, how independent does the review really have to be?
Jason: Thanks, Bill. It's a really complicated question really. At the end of the day in a small company this can be very difficult. You have a small group of individuals within your organization and therefore really, truly getting independents, as Mike indicated, is difficult. Bringing outside consultation is probably, at least to have a seat at the table, if it's affordable by a small company, and even a large company is probably your best venue or avenue. Really what your objective is, is really selecting an independent reviewer to ensure that there's a fresh perspective; new set of eyes. Someone who hadn't been involved or participated within the particular design and development stage.
Jason: And really the intent is to look at the information objectively and make sure that you're identifying potential issues or critical factors that aren't being addressed or identified, and that at the particular stage that you're at, whether you're in the planning stage or design and development or the development stage, verification, validation, whatever stage you might be, that somebody is reviewing that data with a critical eye that isn't biased or influenced by outside factors. And I think, as Mike said, that's basically very difficult to do. But, at the end of the day, just like you would hire an independent reviewer or independent auditor to come in and audit your facility, whether it'd be manufacturing, quality management system, you have to rely on some of those relationships, and if you can't, if you're a small company and you can't afford an outside consultant, definitely you need to be very cautious and wary about making sure that you have identified the right person to fulfill that role.
Bill: Jon, kind of threading off that a little bit. I know you like to publish a lot of content out there in the industry and give you a chance to maybe back up some of your written comments with some verbal response here. So, in one of your recent blog posts you talked about design controls being objective evidence that really helps prove a device is appropriate, safe and effective. If we look at design reviews as more of a way to define stages or gates, kind of like what we've been talking about, when specifically should design reviews happen? Let's dive into that a little bit deeper.
Jon: Yeah, It's a really... It's kind of a loaded question and I can give you the old cliche response that you hear often when these complicated questions are asked specifically around design controls, and that cliche response is, it depends. When design reviews happen there's a few factors that are at play. One is, what is the project? What are you developing? Are you developing a new implant device or are you developing a line extension to a Class I product or a temporal catheter or some sort of Class II device? So you gotta consider that. The other thing you have to consider, I think, is, who is on the team? Is this team... Are they new? Have they worked together as a team before? Do they have some sort of experience? That sort of chemistry working on previous projects? So those are two important factors. And even with those factors, as I said earlier, if you look at design review as something that's gonna slow you down, well, you've got the wrong approach altogether when it comes to design review. Design reviews should more frequent.
Jon: I look at... If you look at things like user needs and design inputs and design outputs and design verification and design validation as sort of the major chunks or phases or stages, or whatever way you wanna describe that as part of your product development process. I look at having a design review when you've "completed", and I'm using quotes here, user needs and when you've completed the inputs and outputs and when you've completed verification, and when you've completed validation. So very key touch points throughout the product development process.
Bill: So Mike, kind of taking a slightly different stance. So, all of our conversation has been around the benefits of design reviews. I gather Mike from the years of consulting work that you've done, you've probably heard people say things like or at least feel like design reviews seem like a waste of time or maybe they're only held to satisfy a checkbox as it relates to the FDA. How do you respond to comments like that?
Mike: Well, Bill, for folks that see design reviews is a waste of time, it would seem to me that either that A, did not go to engineering school or if they did, they were probably asleep the day that they were teaching this. [chuckle] Because like much of the design controls, it's just... All of this to me is just what I call prudent engineering or common sense. These are things that we should be doing anyway, regardless if the regulation requires us to do it or not. And at the end of the day as we've discussed in previous podcasts, we are dealing with people's lives here. And so the simple reality is that, the vast majority of problems that companies run into, are preventable and in most cases are predictable. And so the design review process is an integral part of that. And that's something that we should be doing as both Jason and Jon have already said more frequently as part of our process, as opposed to less frequently. Bottom line, the better we do in terms of design review the fewer problems we're gonna be having in the future.
Bill: And listening to you guys talk about the subject of design reviews and how it's tied into design controls, also sometimes you hear out there in the space, how are design reviews maybe the same or different from what's maybe referred to as, phase review? Not pointed to anyone in particular, let's see who jumps on it first. So again, is it the same or different? Design reviews and phase reviews?
Mike: I'll get it started and then Jon or Jason please feel free to chime in. Look, at the end of the day, I don't really care what we call these things. Shakespeare said a rose by any other name name still smells as sweet. So as long as we're doing design reviews, as long as we're doing phase reviews as long as we're doing them more frequently as opposed to less frequently; how frequently you wanna do them, that's up to the organization to decide, as Jon alluded to earlier it depends on the nature of the product. If you're working on a device that's essentially a me too device where it's using established technology, and there are already 200 devices out in the market that are like it, then perhaps a more frequent design review is not necessary. On the other hand, if you're working on a Class III, truly life-sustaining or life-supporting implant using a totally new technology that has never been used before, where if somebody uses your device, they live and if they don't, they die. Obviously, in a situation like that, design reviews should be done more frequently. But the short answer to your question is, as long as we're doing it, I don't really care what we call it.
Jon: Yeah, it's a good way to look at it, Mike. I've been, I guess kind of back and forth on this. My view point over the course of my career, and I remember very early on, there was some people who were very, very, very adamant that the design control process including design reviews, was a very special thing that only focused on design controls, and we had this whole other thing, that we called our product development process, that covered more of the business aspects, and we'd have a different thing called a phase review. And if you consider some of the comments that I've made earlier, the project teams already think design reviews are a waste of time. Why muddy it and require them to have a design review for the design control stuff and then have a separate meeting called a phase review to cover all the other stuff. They don't wanna have meetings now. So maybe you should combine it into one single thing and call it design review, because guess what, the people who are involved in that phase review, are probably the same people who need to be involved in that designer review discussion.
Jon: So have one meaningful discussion about what's important, about your product development efforts. Call it a design review, document it, create a record and keep going to that next phase or stage or that designer review milestone of your project.
Bill: Jason kinda tailing end here of our podcast, it'd be great to give the people listening in maybe some tips or a few things that can improve their design review. So, Jason I'd like to start with you. What thoughts do you have to share that are... We can provide tangible objective steps or things people can include as part of really amping up their design reviews and making them more effective?
Jason: Yeah thanks Bill. Really, I think... As I looked at it, I think there's probably three key barriers. One is one size does not fit all in meeting, whether it be the frequency, inside of the team. Really, there's no, I guess, perfect answer. Then they have to look at the design of the device, had to look at its intended use, you have to look at your existing infrastructure and really identify what works best. As I said before, I like the more frequent. It keeps the amount of information, smaller and more manageable, and also gives you more inflection points along the project itself. I think secondly is make sure you have the right people at the table. When people think about design reviews, they typically think about just encompassing engineering. But engineering can represent the technical aspect of this. But you definitely wanna have marketing involved, clinical involved; you wanna have different members of the business, your quality team, regulatory team.
Jason: So, really making sure you have the right people at the table. 'Cause really, the intent of a design review is really for open dialogue, and discussion, and review of the design, and the project itself, to make sure that the path that you're headed is producing a safe, and effective device. And lastly, I think, it's really to make sure to create an environment, or a culture within your organization, where you build trust. Trust is a crucial factor in determining whether or not your design reviews really get to the heart of central problems and concerns. Or do you just have your team rubber-stamp the design review to move it along to avoid conflict. Trust will [19:00] ____ your team's ability to engage in healthy dialogues, and conflicts. I think, it is really important to really get the true intent out of design reviews.
Bill: Thanks Jason. Mike, what would you like to add?
Mike: So, I would like to just leave the audience with a couple of final thoughts. I think both Jason and Jon did a great job of describing briefly the purpose, the objective of the design reviews, and the flexibility that we need in the system to do what makes sense, given the particular device that we're working on. I just want to reiterate what we also discussed in terms of why design reviews are important. Remember asking a child to... I'm sorry. Asking a parent to critique their own child is inherently biased. So, asking an engineer to critique their own design is equally, inherently biased. I would encourage everyone in the audience when they're thinking about the design review, to truly do what they can to foster an environment, whether you do it with a employee of your organization, or an outside consultant. But you wanna really make sure that you encourage them, to say to them, "Look, we want you to be brutally honest. We want you to really bash the heck out of this thing, 'cause we wanna understand where the weak point points are."
Mike: And as a matter of fact, I would love to see the industry take this even a step further. One of my favorite adages is, "Answers are only as good as the questions that you ask." Answers are only as good as the questions that you ask. So, in other words, what good is getting the right answer if you're asking the wrong question? And unfortunately, in medicine this happens frequently. So, I would love to see as part of the design review, not simply to critique the actual design, but ask, "Are we design... " I'm sorry. "Are we solving the right problem? Are we designing the right device?" If you work as an independent design reviewer for a bare-metal coronary stent, what would be wrong with asking the question, "Gee, is a stent really what we want to do?" This is a natural extension of the V & V aspect of the design controls, which is about designing the device right, versus designing the right device. And those two things are very different as we've talked about in other podcasts. But it's not something that, at least in my experience, the industry really focuses on very much. I think, we could do a much better job in those lines. And this is something that I work really hard to try to get people to think about.
Bill: Interesting perspective, Mike. Jon, why don't you wrap us up with a few tips of your own?
Jon: [chuckle] Yeah, this is gonna seem counterintuitive to a lot of product development teams out there. But I'll say it, "Slow down." I think, some times we're in such a rush that we make a ton of mistakes. And we're so hell-bent on getting from beginning to end that there are a lot of mistakes that are made. And I think, as teams there's... I used to be a project manager, and there's a couple of theories about project management. From a business standpoint, the least risky approach to project management is to do things in serial. Do step A. Then step B. Then step C. But project teams aren't generally wired that way. Because often times we're given the due date for our product development efforts before we even start. So, then, there's this crazy effort to try to figure out if I can do A, B, and C, all at the same time. And when I do so, I multitask, and make a lot of mistakes. And I think, that the same needs to be said with design reviews.
Jon: You asked me earlier about how many design reviews should you have? And I'm gonna say, "Have one after your user needs are done. Have one after your design inputs are done. Have one after your design outputs are done. Have one after design verification, after design validation, and when you go to market." Just slow down, and be deliberate about what you're doing.
Bill: Gentlemen, thanks so much for spending time with us. Your comments and points of views are always very interesting, and thought-provoking. To those of you listening in, thank you, and please continue to share your feedback. If you like to stay in touch with Mike, you can check out more of what he has to say on his guest column at Medical Device Online Magazine or connect with him on LinkedIn. You can check out more of Jon's, as well as Jason's writings at greenlight.guru/blog or ping either of them on LinkedIn. Till next time, let's continue working towards improving the quality of life on this great planet of ours.
About the 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.