Biocompatibility can be challenging and frustrating when developing a medical device. Why do you have to spend time and money to do the same testing, if the materials used in your device have already been tested, approved, and put in medical devices on the market? Biocompatibility impacts the majority of medical devices.
Today’s guest is Josh Crist, a biocompatibility expert who used to work for the FDA and is now with Biologics Consulting and he and Jon discuss the nuances of biocompatibility.
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Some highlights of this episode include:
- Best practices for biocompatibility include using the ISO 10993 test matrix for evaluating tissue, duration, and other factors.
- A common misconception about the test matrix is how the FDA determines and considers cumulative contact.
- Are all tests absolutely necessary? Are there other ways to reduce testing requirements? Consider chemical characterization and risk assessments.
- Josh describes challenges he experienced as both a biocompatibility consultant and FDA reviewer.
- What the FDA expects with chemical characterization: Master file, testing on final finished device, and more.
- Start with FDA’s biocompatibility guidance documents, interact early on with FDA during pre-submission process, and conduct quantitative and qualitative tests.
- “I promise…” days are gone. Other options for 510(k) to avoid getting additional information (AI) letter or not substantially equivalent (NSE) decision.
- Most common mistake made by companies when it comes to biocompatibility is not testing.
Josh Crist on LinkedIn
ISO 10993 Standard
Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
ISO 10993-1 Evaluation and Testing Matrix
Special Considerations: Biocompatibility
510(k) Premarket Notification - FDA
MedTech True Quality Stories Podcast
Memorable Quotes by Joshua Crist:
“The chart (matrix) is definitely your friend.”
“It can be a lot of testing, especially if you think your device isn’t particularly risky. Companies are looking for ways to do a reduced panel or justify not doing certain tests.”
“Is there something in there that’s not supposed to be in there?”
“The most common mistake is...not doing testing…that you would know that you’d have to do. There’s some things you can’t get away with.”
Announcer: Welcome to the Global Medical Device Podcast where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge direct from some of the world's leading medical device experts and companies.
Jon Speer: In my history as a medical device professional, one of the more challenging and at times, frustrating topics to deal with is biocompatibility. You might be working on a device that has a material that you know for certain has been used in other products that are already on the market and there's probably already a whole body of testing that has been done somewhere that you don't have access to and you can't leverage and you're wondering, "Why do I have to go through the same testing that somebody else has already done on this material that has already been used?" I mean, It's tricky. It's challenging and there's lots of nuances on this topic of biocompatibility. On this episode of the Global Medical Device Podcast, we have an expert, a guy who used to work for FDA and now works for a company called Biologics Consulting. This expert is Josh Crist, he knows biocompatibility inside and out, and we barely skim the surface today on the topic of biocompatibility, but it is one that you should check out and learn more about.
Jon Speer: Hello and welcome to the Global Medical Device Podcast, this is your host, founder and VP of Quality and Regulatory at Greenlight Guru, Jon Speer. Folks, there's a topic that I don't want to say plagues a lot of medical device companies, but it does challenge a lot of medical device companies especially those types of devices that have some sort of patient contact in some way, shape or form. Yep, you guessed it. We're gonna talk about biocompatibility today. And with me is frankly an expert in the topic of biocompatibility. I have Josh Crist with Biologics Consulting. So Josh, welcome.
Josh Crist: Thanks. It's nice to be here and it's an interesting topic.
Jon Speer: Well, Josh, you know a lot about biocompatibility. I remember back in the day I used to work on a lot of catheter devices. 10-993, the ISO standard was my friend. I recall fondly this chart that I would go through and I would determine the duration and type of body contact, and I kinda go through that table and figure out what types of tests I needed to do, and so on and so forth. So, is that... I mean, I guess in lightness a little bit, is this still the best practice of, from a biocompatibility standpoint, or are there are some other tips and pointers that you might share with folks?
Josh Crist: Yeah, well, so the chart is definitely your friend. And apart from... It can be a little confusing sometimes figuring exactly where your device is in terms of which tissue and which duration, but if you stick to the chart and do all the testing in the row that you've identified, if you've identified the right row, you should be in good shape. The problem for a lot of companies is, and more so with the 2016 guidance doctrine, is that there's a lot of columns in that row and it can be a lot of testing especially if you think your device isn't particularly risky. So a lot of companies that I've talked to, they're looking for ways to do a reduced panel or justify not doing certain tests. Just a side note for that table in terms of duration, a common misconception is how FDA determines that the contact duration and they really do consider cumulative contact. I see this a lot with like wound dressings that are supposed to be used multiple times. It's not just the 12 hours for one use or something. It's if you're using this daily, they really do total up all that contact. That's another thing to keep in mind for that table.
Jon Speer: Really interesting, and I think that's really a valuable point to consider. This is, folks, if you have done any sort of biocompatibility for a device that you're working on, you know that it can be expensive, you know that it can be time-consuming. You know there's a lot of nuances to that. So I would say, oftentimes, I remember when I worked on projects, I was trying to figure out, Okay, is this test absolutely necessary? Are there other avenues that I can go? Can I leverage things that I've done before? And those are all things I wanna dive into a little bit today. I know these are... This is a very, very deep topic, folks. We're gonna just skim the surface today, but let's talk a little bit about some of those things that you might be able to do to kinda reduce your testing requirements. One of the things that comes to mind is chemical characterization. Can you talk a little bit about the benefits, the pros and cons of chemical characterization?
Josh Crist: Yeah, so a big part of the 2016 Guidance is a risk-based approach in deciding what tests you're gonna conduct. So FDA outlines, you can perform chemical characterization techniques and identify what's really in your device? Something that's good to do, just from a quality standpoint, anyway. But if you do a good job, you can also kind of quantify and identify any potential toxicity, you can use that to guide your biocompatibility testing. Whether it may be a additional evaluation or whether it comes out really clean and supports that maybe you don't have to do some. So take a step back. So it's a risk-based approach, there's a couple of things that it's not that I see a lot. And so one of those is history of use, and so FDA kind of states it in the guidance, and companies will come in with this argument, but it really doesn't hold any water when you get to FDA with biocompatibility except for maybe some specific situations. And so, that's simply stating that polypropylene has been used in medical devices for 20 years. It really doesn't answer any questions for FDA. Because, you know just the name polypropylene really isn't a good description of a polymer.
Jon Speer: I mean, it's so generic, right? There's...
Josh Crist: Yeah. It's like saying, you know, chocolate cake. You don't know what else is in there that you're eating. It could be a lot of things. So some of these polymers have different ways you can synthesize them, different additives and plasticizers and try to put into a manufacturing process where you have potential chemicals just using the processing to make the device. By the time you get the final device, FDA really wants to know what might be in there that you don't expect or that is a side product of the reaction, and not just what the base material is. Polymers can have big molecular weight ranges and it's really just a poor description. So that's not an argument that you can really come in with, except maybe for a skin contacting device for a brief period. I don't think FDA is in general overly concerned.
Josh Crist: But yeah, like polypropylene or AVS are common contacting plastics coming in transient contact, you can maybe get away with that justification, but not necessarily. So that's generally not an argument that applies. A step closer is doing a risk assessment of... From a toxicology perspective, of the polymer chain. It monomers any ingredients you include in your process and evaluate what you know is gonna be in there, and that can be helpful, particularly if you know... For example, if you're using silver nanoparticles in your device. You know that's gonna be something that you have to be careful with going forward in your evaluations and are probably gonna need to use your genotox testing and...
Jon Speer: Yeah.
Josh Crist: It can help guide, but that still doesn't answer FDA's questions of: Is there something in there that's not supposed to be in there? On purity problems with the supplied polymers or resins or side reactions during the manufacturing process or polymerization process depending on if you're making it. And so that's when we get to real chemical characterization and figuring out what is exactly in there. It can be used... It's particularly helpful for the toxicity endpoint, as the subchronic carcinogenicity and chronic toxicity. Not necessarily as helpful for implantation. Implantation, FDA is often looking for the effects of the physical form of the device. So particularly if it has a specific surface geometry or features that could influence the compatibility with the body, chemical characterization doesn't really provide any insight into that.
Jon Speer: So what I'm hearing you say about chemical characterization, correct me if I'm wrong, but what I'm kinda picking up on this is that this is potentially a good screening tool that a company should think about when they're identifying potential materials to use in their product. It's an early type of test that can be done to see if there's any sort of gotchas or potential issues. Am I thinking about this the right way?
Josh Crist: I think that's one way it can be used, and definitely, if you're looking at potential suppliers and if they have chemical characterization data available, that can certainly help you select materials for your device that have a good chance of passing a biocompatibility screening or coming up with good chemical characterization on your final device when you perform it. If you're looking at suppliers that have good clean data, it's more likely that when you finish up, you'll have a good, clean product. But yeah, also, I'm talking about chemical characterization on your final device when you're doing...
Jon Speer: Yeah, okay.
Josh Crist: Biocompatibility testing, but maybe before you do your biocompatibility testing, you can do the characterization to guide your selected battery of tests if you... Particularly for a permanent implant, when you're faced with chronic toxicity and carcinogenicity on the table, potentially, long and expensive tests and if you know that there's nothing really potentially toxic or carcinogenic in your device, you potentially get out of having to, or it probably wouldn't be justified to do those tests, and FDA would be inclined to agree, I think.
Jon Speer: Right. Okay, so folks we're talking with Josh Crist. Josh is with Biologics Consulting. And folks, I'm telling you, we're getting down and nerdy, down into the details of biocompatibility, and it's important to have an expert like Josh on your team, frankly. Especially when you're venturing into this because biocompatibility is one of those topics that it impacts a large, large majority of medical devices. Any simple patient contact, implant, something that's going into the vascular system, into the airway, if it's gonna contact a patient or user in some way, shape or form, these are all things that you need to factor in and make sure that you're addressing biocompatibility. In fact, a lot of regulatory submissions, they have a section that is dedicated just to this particular topic all by itself. So make sure that you have your act together and one more plug for Josh at the moment, Josh has experience both from... From a consulting, from an industry perspective, but he also used to be with FDA and focused on this topic with FDA. Josh, talk a little bit about some of the challenges that you've seen on both sides of the fence, both from an FDA as well as working in industry.
Josh Crist: Yeah, so yeah, I was definitely a FDA reviewer in the plastic and reconstructive surgery branch for about seven years and we dealt with a lot of implantable devices that needed on the... Thorough end of the biocompatibility testing battery. And so it's challenging from an FDA perspective, looking at new devices, or normal materials and at the same time having industry providing wide variety of justifications for tests that they don't wanna do or don't think they have to do and trying to evaluate that from a regulatory perspective. And so on the FDA side, I would see a lot of the chemical characterization approaches and some of them just aren't as helpful, as others. And so, one example is... We should probably talk a little bit about what I mean, or what FDA wants to see when we say chemical characterization.
Jon Speer: Yeah, and if it's okay Josh...
Josh Crist: And there's a lot of ways that characterize...
Jon Speer: I was just gonna say I can lead us into that conversation. I wanna use a personal story from a few years ago that I think will dive into that topic and maybe a couple of others on this, a bigger topic of biocompatibility. So a few years ago, I was working on a device, it was actually a wound dressing, it was a polyurethane foam material, all the specific details escape me at the moment. But we... For those in the wound foam business, there's three manufacturers literally in the world who make this raw material. And there was nothing frankly new about this material. It was, we were purchasing it from a distributor who purchased it from a supplier, and that supplier supplied many, many other wound dressing companies. And so there was definitely a proven track record of biocompatibility for this particular material and we did some chemical characterization, we did some cytotoxicity and a few other tests to be able to show that this material that we're buying is exactly the same as other wound foams that were out there. We even had access granted to us by the supplier for FDA to leverage the master file for that particular material.
Jon Speer: So, but let's just say that the experience at the end of the day, we were not able to really leverage chemical characterization or that master file, instead we were led down the path of actually having to conduct the full battery of biocompatibility tests for that particular material, duration and so on and so forth. So that was an experience that I had. So, maybe this can help us dive into what's a master file and how chemical characterization could be good or how it can be bad, and some of the challenges with that.
Josh Crist: Yeah, so for those of you who don't know, a master file is basically a file that a supplier can submit to FDA that contains a lot of information about their material, physical properties, biocompatibility testing that they've done, chemical properties, etcetera. And then they can provide permission for FDA to look at that master file when reviewing your device, but you don't necessarily get to look at the master file, unless they send it to you, and a lot of them won't. It's kind of a third party. "FDA can look at this, but this is our proprietary information." And so that can make it real challenging going in trying to justify using it if you don't know exactly what's in there. And so, FDA's biocompatibility document talks about master files and if they could be useful, but there's some challenges with using them. One is the FDA's desire to have testing on the final finished device and so the... At baseline, the master file information isn't going to be on your device, your final finished device.
Josh Crist: And so then it becomes a point of comparability and figuring out if there's anything that you can provide to FDA that would justify the similarity of your device, the test articles that were tested in the master file in terms of processing and sterilization. So the narrow path in which it might be useful is if you have a simple device, is pretty simple molded from one plastic or it's just a wound foam. But also that, you know that the way you process it and sterilize it is exactly the same as the way it was done in the master file and then you can provide... FDA has a statement that you can quote the biocompatibility equivalence, this is the same as the test article in its form, it's chemicals added. There's a list of all the ways that it can be the same. If you can state that you're in good shape.
Josh Crist: The problem is you don't always know that that information or the master files didn't have it available, or it wasn't sterilized? Or it wasn't treated in the same way yours was. So it can provide some information, but on its own it's not necessarily going to get you there, but what could be done is if you conduct your own chemical characterization and can demonstrate that there's nothing new coming out of your device and that you don't add any processing agents or additional cleaning chemicals. You could increase the case to FDA that you're similar to what's in the master file. Particularly if they have chemical characterization data, as well, you could line them up and show that yours is the same as this material that's already had testing done on it.
Jon Speer: Okay. And I... Josh I assume that...
Josh Crist: That was a lot but...
Jon Speer: No, it's a lot, but it's good stuff. And, like I said, folks we're getting very detailed here, and I wanna try to pull us up a little bit higher level I wanna focus maybe the rest of the conversation today on things that those in industry, steps that they should take things they should consider. I wanna remind folks that of course you're listening to the Global Medical Device Podcast, did you know that Greenlight Guru recently launched a brand new podcast? Yep, that's right, you'll have to go search for MedTech True Quality Stories, find it on the Greenlight Guru website, simply go to www.greenlight.guru.
Jon Speer: And you can find that MedTech True Quality Stories podcast. You could search for it in SoundCloud, and iTunes, and anywhere else that you're consuming, and listening, to podcast, but it's exciting. We're sharing stories from med device executives from the trenches, things that they're challenged with, faced with, and how they attain true quality with their products and processes. So, really awesome podcast. I'm excited about it. It's some of the most fun that I get to have is to talk to folks like Josh and MedTech professionals about what they're trying to do to improve the quality of life. So, be sure to go check out MedTech True Quality Stories. We gotta wanna remind you I'm talking with Josh Crist. Josh is with Biologics Consulting. He is a biocompatibility expert. So, Josh, let's bring it... Like I said, bring it up a level. Let's give folks some tips and pointers, some things that they can do, today, to take action to put themselves in a good position from a biocompatibility standpoint.
Jon Speer: One of the things that seems obvious to me is, I need to reach out to somebody like you. Aside from that, what are some tips and pointers that you could advise those listening to... From a biocompatibility standpoint?
Josh Crist: Yeah. So, one is the FDA biocompatibility guidance. It's really a great place to start if you are not familiar with the topic and you're looking to figure out what testing you need to do. So, definitely, start there, as well as, your device type might have a device-specific guidance document that mentions some specific tests. There's the different devices like respirators that have more specific biocompatibility requests from the agency, or this particular branch or division. So, definitely check out the guidance documents.
Jon Speer: And let me just remind folks... Sorry, Josh. Let me just remind folks, it's obvious to you and me, but what is that standard that people should be going to from a bio-compatibility standpoint?
Josh Crist: Yeah. It's the ISO 10993 standard. You can also look upon FDA's website, the most recent recognized version. And any issues they have with their standard. FDA recognizes a lot of standards, but certain parts either conflict with their guidance, some where they disagree with. And so, they'll have a note on the extent of recognition on their website. You can get Google FDA recognized standards then it should come up as one of the first search results. I generally use Google to navigate FDA at this point. [chuckle] It's better than navigating it.
Jon Speer: It's easier, right?
Josh Crist: It is. Yeah. Just do fda.gov. [chuckle] There'll always will be better, better information.
Jon Speer: Yeah. And on the... On that ISO 10993, it's a series of standards. Remind me how many parts there are to that overall 10993 series?
Josh Crist: So, the chemical characterization is a part 18, so it has at least, 18.
Jon Speer: Yeah. I was thinking it was around 20. So. Yeah. Okay.
Josh Crist: Yeah. Yeah. Another thing you can do is interact with FDA early. Your pre-submission, if you have a complicated device, some topics get really complicated like in situ polymerizing devices. I have experience with those, and is definitely something that you wanna run by FDA [chuckle] before you get to your point of the final submission. You don't wanna have to redo everything when you're trying to get over the final hurdles of it. The pre-set process could be a good idea, especially if you're early on in the process. And another...
Jon Speer: And folks we've talked to... I was just gonna remind folks, there are previous episodes of The Global Medical Device podcast where we've talked about the benefits of a pre-submission. A pre-submission to FDA has a lot of value of... Based on your... If you have a novel technology, indications, certain things that you're planning to do from a development standpoint, that is very, very important, very helpful on this topic of biocompatibility as well. Go ahead Josh.
Josh Crist: And I also wanted to touch a little more on what I mean when I saw, or what FDA, will find is useful for chemical characterization. We've talked a lot about, kind of, why and why not. There's some tests that are more useful than others. And so, when we're talking about standards, ISO 10993-18. This different test you can use and what they might be useful for. And so, what FDA really likes to see is several tests that can give you both quantitative and qualitative information, and most useful I think, is GCMS to look at volatiles and semi-volatiles, LCMS to look at non-volatiles, and ICTMS, which can trace metal impurities if you have metallic catalysts, or just their quality in general. Those were abbreviation for gas chromatography, but yeah. Those are what you're gonna wanna take a look at when you're considering chemical characterization. Some companies come in with an FTIR spectra and just map it on that of a supplier and say, "Oh, look. All the pieces are the same. So, we're the same as this cleared material." That's, generally, not the detail that is gonna get you through the chemical characterization process. Yeah. And so, there's definitely some additional points to those methods that can get you tripped up. So, I think, it's a good idea to run those protocols by either a consultant, like me, or by the FDA, before you do the testing as you have time.
Jon Speer: Yeah. And, you know, it just seems like this topic can be a Pandora's box at times and...
Jon Speer: And it is important, and I'll share one other story from my past. I was... Early in my career, the 10993 standard, I don't remember its origin, but let's just say it's been around for a long, long time and it makes sense, right? Because medical devices oftentimes interact with people and humans, and you wanna make sure that those materials that you're using are safe. But anyway, I was... We were working on a device, it was gonna be a 510(k) submission, and we were about a week away from doing the 510(k) or submitting the 510(k). I was going through and I had created a traceability matrix and folks, this is about 20 years ago, so this is long before Greenlight Guru existed to help you with traceability. But I was going through my traceability matrix and I had realized that there was a gap, there was something that I had forgotten to do something that had fallen through the cracks and it was bio-compatibility. And the first response or reaction was, "We could just submit that with the 510(k) and assume that we might get a question about it, but we can run the test in parallel."
Jon Speer: And I think once upon a time, that used to be kind of the case where companies could do a submission and they might provide an "I promise" statement on some different bio-compatibility test, but it's my belief today that that's not really the case. I mean, you're setting yourselves up for failure if you submit your 510(k) or other type of regulatory submission, and that biocompatibility topic has not been thoroughly and comprehensively addressed. Can you speak to that a little bit Josh, maybe as both the recipient from the FDA perspective, as well as in your industry experience. What would you advise companies to do there? Can they do "I promise" things or are those days gone?
Josh Crist: Those days are gone. I don't think you'd even get past RTA if you came in with nothing nowadays, and certainly, a statement that you're currently conducting them would not help with that. If you're really trying to move things along, you might get away with doing a subset like the cytotoxicity irritation. Well, you start on one of the more mid-length tests like intramuscular implantation if you need it and then, have that ready knowing that a question in AI letter, you could consider an approach like that, but you're not gonna get to the end of the road without having an explanation for every single box in that table that's appropriate for your contact classification. FDA is definitely gonna ask about it.
Josh Crist: And so, yeah, it's a good idea to think about that ahead of time. Again, if you're not familiar, seek expertise from someone like me 'cause there's a lot of places to trip up even for the simple test when you get into the details. Cytotoxicity for example is one of the more ubiquitous test. You'll probably do that if your device contacts a patient. For some devices where there's some branches, they might want to see a direct contact cytotoxicity instead of an overlay or they'll want to see an illusion instead of one of the other options. There's some depth to each of these sections of the standard with different options and if you don't do the right one, you'll have to redo it. FDA, they will do NSE over a cytotoxicity test. It can happen.
Jon Speer: Yeah, absolutely. And Josh, just remind folks, you listed a couple of acronyms. AI, remind folks what's AI.
Josh Crist: So AI, additional information is the whole process in the 510(k). FDA will review your submission for about 60 days and then, send it back to you with a big list of questions, and you'll have one shot to answer them in that 510(k).
Jon Speer: Yeah. It's not a situation that... You try to anticipate what is expected from or what is gonna be required from an FDA reviewer standpoint 'cause you don't want the AI letter frankly. I mean, it happens. It's okay if it happens. But to Josh's point, you have one shot. And there are some no-brainer activities that... Things like sterilization, things like electro-mechanical testing if your device has electronics, things like bio-compatibility. These are gonna be sections of your submission that are gonna be reviewed with a fine level of detail and you have access to the standard or need to have access to the standard, and in this case, ISO 10993. So, there's really no excuse for having some deficiency on this particular topic. So this is a no-brainer one, this is not a reason to get AI, so be prepared. You have tools, you have folks like Josh, you have the pre-submission, you have the standard, there are guidances, and so and so forth that you can use and leverage to prepare a thorough and complete submission. Josh, you mentioned another acronym, NSE. This is not the one that anyone ever wants, but remind folks what is NSE.
Josh Crist: NSE is not substantially equivalent decision. It's basically a rejection of your 510(k). Honestly though, it's not the end of the world for performance data reasons. It's essentially another hold that you have to pay for, to submit again. It used to be that the FDA will put the device on hold multiple times if they had additional questions. But then that changed with one of the more recent, MEDUSA negotiation, it's down to one hold now, so you get one shot to answer questions, and then the NSE, and then you kinda have to regroup and resubmit, which is a little different from getting rejected...
Jon Speer: Well, that's true.
Josh Crist: Intended use, and getting kicked out of the 510(k) flowchart. Yeah. So what it costs you mostly is time, and that can really hurt your company if you're a startup with a burn rate and try to get things done if you have to go through another three months FDA submission process or more, I think I find things that starts get clogged down when FDA is asking a bunch of questions. The cleaner submission you can have, the smoother things go and you'll get things done a lot quicker. If you try and hedge and get a bunch of questions, it really slows things down and 510(k) turns into two 510Ks, it takes 12 months to complete 'cause you're not just doing a pyrogenicity test or something that you could have just done costing you more and costing you lots the time.
Jon Speer: Sure. So Josh, as we wrap up conversation today and like I said, folks, we're just very barely skimming the surface about compatibility, it's a deep topic, it's not one that you should be afraid of, but at the same time don't assume you're gonna become an expert just because you read some of these standards. Josh, how long you've been dealing with biocompatibility? A long time now, right?
Josh Crist: Yeah, probably about a decade now, specifically, yeah.
Jon Speer: And biologics consulting, you have a whole team of folks that this is what you do all day every day so these are some of the experts.
Josh Crist: Yeah, so Biologics Consulting, we've been around as a firm for about three decades, and we have consultants across biomedical devices and biologics, so we can handle pretty much everything including a combination product, a lot of us have previous experience working at the FDA, and we work with very early companies as well as large companies and so we can help wherever you're at in the process, if you're just starting out and need some strategy and help developing testing protocols or if you're ready to submit and you need someone to handle drafting the submission and interacting with FDA on your behalf, we can help out. And our device team is great, we have about 10 people. I'm probably on the low end of experience to be honest, a lot of us are 25-30 years of industry experience consultants that can definitely put you in good hands. So definitely recommend...
Jon Speer: Yeah, reach out. And folks, it's real easy just biologicsconsulting.com, you can go check out the services and how they might be able to help you. So Josh, last question for today's episode, what is the most common mistake that you've seen companies make when it comes to biocompatibility?
Josh Crist: The most common mistake is quite frankly not doing testing, if you had talked to anyone who is kind of familiar that you would know that you'd have to do, there are some things you can't get away with, you can't get away with coming up with no testing, you can't get away with for a permanent implant not doing some evaluation. So, yeah just underestimating or not doing the biocompatibility testing, it really sets you back, it puts you back at square one a lot of times.
Jon Speer: Alright. Well folks, I know there might be a temptation to try to figure out ways to "cut corners" when it comes to biocompatibility for a lot of reasons, I mean, it's expensive, some device types you could easily spend six figures on your total biocompatibility testing, and that's a lot of money. Also, another temptation might be well, it takes a lot of time, yeah, some of these studies takes weeks and weeks, some of them take months to do, but this is... You gotta consider that at the end of the day, your product is gonna be used to improve quality of life and you wanna make sure that the materials that you're using, the processes to make your device that they result in a product that is deemed safe, and because we're trying to improve life not create issues and challenges for humans. So do your due diligence do your homework make sure that you're crossing every T and dotting every I and being very thorough when it comes to biocompatibility, and make sure you're building your case with risk-based approaches as well as chemical characterization as well as the testing that is required for your type of product for your type of duration so, be thorough that's my advice to you, it is a very very important for those patients who will be receiving your product. Josh, I wanna thank you so much for being a guest on The Global Medical Device Podcast.
Josh Crist: Yeah, thanks so much for having me it was a pleasure.
Jon Speer: Alright folks, once again been talking with Josh Crist, he's with biologics consulting, reach out to him, you can find him on LinkedIn, you can find his information on biologicsconsulting.com, he is a resource that that is ready and willing to help you navigate these challenging biocompatibility topic, so be sure to reach out to him. Folks, you've been listening to The Global Medical Device Podcast, this is your host the founder and VP of Quality and Regulatory Jon Speer. Thank you.
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