Tim Reynal, Founder of Ingenyx & Sanjiv Prabhakaran, CEO of Bytes | Navigating Risks, Change, & AI-Driven Solutions for Medtech

Sanjiv Prabhakaran, CEO of Bytes, and Tim Reynal, founder of Ingenyx, discuss how medtech teams can de-risk development and accelerate FDA readiness. Sanjiv shares how Bytes helps companies solve complex workflow problems, including using AI to cut QA test script creation from weeks to days and speed the path to approval; Tim explains why startups consistently underestimate time, cost, and regulatory rigor, and how early risk identification prevents runaway budgets. Together they unpack practical guardrails for AI in regulated environments: why humans must govern the work, why FDA won’t accept straight AI outputs, and how multilingual device testing raises hidden safety risks, plus leadership lessons on empowerment, integrity, and listening. 

 

Guest links: https://ingenyx.com/ | https://bytesinc.com/ 

Charity supported: ASPCA

Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com. 

PRODUCTION CREDITS
Host & Editor: Lindsey Dinneen
Producer: Velentium Medical

 

EPISODE TRANSCRIPT
Episode 092 - Tim Reynal & Sanjiv Prabhakaran

Tim Reynal & Sanjiv Prabhakaran

[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.

[00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.

[00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.

[00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.

[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.

[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.

Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I am delighted to welcome Tim and Sanjiv to the podcast. Tim is the founder of Ingenyx and the originator of the human-led AI Fit engineering framework, a forward-leaning model that redefines how complex systems are designed, tested, and brought to market. With nearly three decades of experience in enterprise technology and regulated environments, he has built his career at the intersection of engineering discipline, operational execution, and emerging AI capability.

Sanjiv is the CEO of Bytes. Bytes partners with medical device companies to de-risk development programs, strengthen regulatory readiness, and accelerate the path to m-market. Innovation moves fast, regulatory risk moves faster. Bytes helps medtech companies stay ahead of both. Their consultants combine deep medtech engineering expertise, regulatory and compliance experience, and system-level thinking across hardware, software, and clinical workflows.

All right, Sanjiv and Tim, thank you so much for being here today. I'm really excited to speak with both of you.

[00:01:54] Sanjiv Prabhakaran: Thank you. Yeah. Thanks for hosting us.

[00:01:57] Lindsey Dinneen: Of course. Well, I would love to start by finding out a little bit more about each of you. So we'll start with Sanjiv, but I would love to learn sort of who you are, what your background is, and what led you to medtech.

[00:02:14] Sanjiv Prabhakaran: Good questions. So, well, basically I'm an, you know, by trade, I'm an engineer and an entrepreneur at heart. So I have kind of spent about 20 years plus at the intersection of like complex operations and software and have been kind of helping a lot of small to mid-size companies in their challenges with operations and workflows and, you know, when it comes to medical devices, you know, what are the processes that are involved in getting to FDA approvals and test materials.

So after serving as VP of engineering for an e-business firm, I founded Bytes back in 2002, and since then, the focus, like I said, has been primarily on helping all these small to mid-size companies, especially in medtech and AI. The whole idea is solving their impossible workflow problems. And that's kind of where, you know, we bring in experts like Tim and other engineers who have that. Sp- In addition, I hold nine US patents, which reflects my passion for building things that don't exist yet. So that's, that's the fun part. So that's in a nutshell about what Bytes is all about and how we are excited with this whole medtech industry now.

[00:03:44] Lindsey Dinneen: Yeah. Awesome. Okay, I definitely have things I wanna dive into, but Tim, I'm gonna let you introduce yourself first, and then we'll keep the conversation going.

[00:03:53] Tim Reynal: Sure. So what got me into medtech? Probably like most people, when I graduated from college, I never in a million years thought this is where m-- I would end up. But through the process of organizational evolution and companies that got acquired and so forth, here I am. What draws me to medtech is very much that medtech has real risk, and companies often underestimate the risk upfront. And my goal, my job as a consultant to these medtech companies, is really to help them identify risk early, de-risk, and help cost containment from going out of control, 'cause that's, that's the, the biggest failure point I think in most medtech. It's not a get-rich-quick industry by any means and people lose a lot of money trying to get their product commercialized.

[00:04:48] Lindsey Dinneen: Yeah. Yeah, absolutely. And again, so much to dive into. I love that. So, so Sanjiv, so I'm curious, when you were-- th- and this will go for both of you, honestly, but when you were growing up, did you-- could you have imagined that you'd be where you are now? Have you always been, you know, super curious and wanting to kind of tinker with things and solve problems? Or where did this interest develop from?

[00:05:14] Sanjiv Prabhakaran: Yeah, that's a good point. I mean, the-- in my early days itself, I had this whole thing about, you know, breaking things apart. Like the-- my dad would have some equipment at home, I would break it apart and see what's inside. And so, and, you know, I, I, I get those, those early days punishments for that, you know? But, but that's kind of where the whole interest kind of started. And from that, you know, even in school projects, I would, you know, have the opportunity to build this old type of telephone systems that you, you know, you pick up a string and you talk to the other end and get some electronics into it and things like that. So it was those fun days.

But that's kind of where it evolved and you know, when I was in the industry heading as VP in R&D, VP of Engineering and R&D, things would pop up that would really you know, have clients you know challenged with certain types of solutions. And you know, my whole goal there was, okay, what kind of things can we do to alleviate the clients' problems? And so it was always that of solving things as, as efficiently as possible and which drove me to kind of eventually start Bytes to handle those kinds of issues that clients face.

[00:06:31] Lindsey Dinneen: Yeah. Yeah, absolutely. And so, you know, you, you talked a lot about liking problem-solving and, and designing things or creating things that don't exist, right? And so you're, you're passionate about innovation and where it meets, you know, these engineering solutions to things. And so I'm, I'm wondering if there are any projects that you have undertaken with Bytes that kind of stand out as particularly meaningful or I don't know, revolutionary, something that just kind of stands out as?

[00:07:04] Sanjiv Prabhakaran: Yeah, that's a, that's a good good point there. I would say especially in the recent days when we got involved in the medtech industry, one of the biggest challenges of this particular client was facing was getting QA test scripts built as, as quickly and efficiently as possible. So when our consultant got in there, the initial challenges, they were already six months behind because of all the backlog. And and the, you know, when our s- when our consultant started looking at all the pain points and what could be done, the, the best solution was to utilize some of the AI tools that are out there to kind of see how we can streamline and speed the process, speed up the process.

And so in the end you know, cutting short the story there, it, you know, what used to take three to four weeks, they were able to bring that down to, like, within a day or two. So the amount of manual labor that could, you know, was able to, you know, that we were able to efficiently reduce, saved a lot of time and speeding up their whole you know, process towards, towards FDA approval.

So those kinds of, you know, that was a big, big aha moment kind of thing. Okay, this is really good what we can do to not only save lives, you know, save product development cycles and help teams or even developers understand the power of, you know, ethically and, and correctly using AI so tools. So, so that's, that's kind of the the big moment that, that really started to shape up once, once we got. So that was a good example, a very recent example, I would say. But there are a lot more, you know, from the past which, which are pretty interesting, so.

[00:08:47] Lindsey Dinneen: Yeah.

[00:08:49] Tim Reynal: Can I piggyback to what Sanjiv was saying about this particular project? Because I think your listeners will be fascinated by one of the biggest challenges in the medtech industry is in today's world and with AI, you've got these medical devices that need to be able to translate, it might be as many as 50 different languages, and they have to be right. Right? You can't, you can't have a mistranslation on a device that's hooked up to a patient. And so one of the most fascinating things, again, that AI is really helping us do and move more quickly on is building the multi-langua- multilingual functions into these devices. And that's one of the things that the project that Sanjiv's talking about had to be conquered, and it was one of the reasons they were running so far behind because again, you've got all these multi languages, but you have to test every single one and every single word that these devices depend on and make sure there's no possibility of mistranslation.

[00:09:48] Lindsey Dinneen: Oof, yes. That, yes, and that's...

[00:09:50] Sanjiv Prabhakaran: Very good point. Yes.

[00:09:53] Lindsey Dinneen: Exactly. I mean, the, some of the things that you-- Well, well that in particular is such a great example of a risk that you might not even consider. Like, you might, it might just be one of those things you go, "Oh, shoot," kind of after the fact. And so, you know, that also brings me to, and I'm curious, from when you were a kid, Tim, were, were you constantly, you know, trying to, like, de-risk situations?

[00:10:19] Tim Reynal: Yes. And I just learned something about Sanjiv that we have in common because I was about 12 years old, I took the lawn- the family lawnmower out to the driveway, and I completely tore it apart 'cause I needed to know how it worked. And my father came out and saw the lawnmower in pieces all over the driveway, and he told me, "You have three hours to get that lawnmower back together or you are going to be in your room for weeks." So yes, I, I love technology and I'm the biggest proponent of get the right tool for the job, get the right engineer for the task, do it right the first time and it'll save you a lot of money, but it will also reduce your risk. It's part of the de-risking process, is get the right, the right tools, the right person on the job.

[00:11:10] Lindsey Dinneen: Yeah, and that's great because I wanted to ask you about exactly some of the-- maybe some of the common things you see medtech startups struggle with when they are, you know, really early on and perhaps this is their first time trying to bring a device to market, and you're trying-- you're coming in as the expert and saying, "Hey, here's what I'm seeing. Here's how I can help." But what are some of the common things that maybe trip up medtech startups at the beginning?

[00:11:37] Tim Reynal: That is a great question, and the-- it, it's 100% across the board. The people that have a startup come in with a vision and a product, and it's usually a great concept, it's usually a great prototype, but they have no idea of how long it's gonna take, how much it's gonna cost, and what kind of risk they're gonna encounter. And then there's the whole regulatory compliance side where they really they just have no idea of how rigorous the FDA process is to get through to your 510 approval so that you can go to market. And so they always underestimate that effort.

[00:12:18] Lindsey Dinneen: Hmm. Hmm. Yeah, that's-- Oof. That's, that's-- I'm so glad there are people like you out there helping these, these, you know, companies because, yeah, we want them to succeed. We want those-- that technologies to be brought to market. So yeah, that's, that's wonderful. Now, you know, you mentioned AI. It's obviously a hot topic across all sorts of industries. I'm wondering how-- this is another interesting avenue of de-risking-- how do you balance potentially some of the challenges or potential pitfalls with AI versus obviously it can do an incredible amount of, of good too? So I'm, I'm curious how you kind of balance that.

[00:13:01] Tim Reynal: Well, I balance it with a, a, a slogan that I've coined called "Human-led, AI fed." And the idea is that you never wanna turn AI loose in medtech or any other industry and think that it's going to do the complete job without the human intervention. It's the human intellect that ca- that has to govern what AI can do. And the human thought beforehand, if it's well thought out and what you're asking AI to do, you'll get a very good result. If it's poorly thought out and you ask AI to do it, you're gonna have a lot of human interv-intervention afterwards.

So the human involvement is all the way through the AI cycle, and a lot of companies don't realize that. They, they have, ... In one of my, my, my day job right now, the amount of AI tools at our disposal, I probably have 20 to 30 different AI engines and agents that I can work with. How do I know which one I should use, right? How do I know which one is the best one? And now there's AI agents that will help you make that decision too. But you know. So I, I joke around with some of my coworkers is "My AI agent is gonna speak to your AI agent."

[00:14:20] Lindsey Dinneen: Yeah. Yeah, that's the, the new "My people will call your people" kinda?

[00:14:25] Tim Reynal: Exactly.

[00:14:28] Sanjiv Prabhakaran: That's right. I know there are, there are boardrooms that now are run by AI agents, right? So it's kind of funny. But yeah, Tim, Tim hit the point right there, Lindsey, is you need that human control, human intervention. Even in our development team that we, you know, we-- the teams use the AI tools to, to create some base found-- baseline coding, but to fine-tune it, you need a real well-trained engineer to really go through that. It will save time, but at the same time, you know, it, it definitely needs that correction where, where it's required, so.

[00:15:04] Lindsey Dinneen: Yeah, absolutely.

[00:15:06] Tim Reynal: And for the, for FDA, they don't accept a straight AI response. So, they, they have tools that will detect that something was all driven by AI, and so they will only accept a human submittal. So, that's important to know because again, we get back to that risk. It takes a human mind to make sure that we're not gonna kill a patient or a clinician with a product we put out there.

[00:15:32] Lindsey Dinneen: Yeah. So having those guardrails in place is really helpful and imperative really. Yeah. Okay. Yeah. Okay, so, you know, both of you have had some really incredible careers so far, and I would love if you would share a little bit about your leadership style and philosophy and, and maybe some lessons learned along the way as you've built companies and, and been in these, these leadership roles. That would be awesome.

[00:16:03] Tim Reynal: Sanjiv?

[00:16:04] Sanjiv Prabhakaran: Sure. Yeah. Okay. I mean, mine is very simple. You know, leadership, it's, for me, it's the art of empowerment through clarity. That's kinda what we look at. So, you know, it's, it's not about having all the answers, but it's, you know, about providing the vision and the tools that our team feels confident enough to find those answers themselves, right? So, so at Bytes, you know, I, I view my role primarily as, you know, removing that, that friction layer so the team can basically do the best work. And that way it, it, it kind of motivates the team members, it motivates the developers and, and everybody else in the team to kind of put out their best. So, so that's kind of the way I look at, you know, how, how my style would be and, and my style is and what I like to do.

[00:16:54] Lindsey Dinneen: Awesome. How about you, Tim?

[00:16:59] Tim Reynal: So this is where Sanjiv and I partner very well together. One, we are great collaborators, but I take the approach the older I get, the more I realize people need and want to be heard before they're gonna listen to anything I say. And so I-- in order to solve their problem, I have to hear what their problem is, and I have to hear their perspective on it. So I'm learning to sit back and listen and not feel like I'm the expert that has to speak. And often the more I listen, the more I realize that my initial answer is gonna change based on what I've heard. And I think good leadership, first of all, lead with high integrity and honesty and transparency, but listening is one of the hardest things human beings have to, to learn.

[00:17:48] Lindsey Dinneen: Yeah. It is. But it is such a great skill set, and I, I find that it's kind of fun, because the more curious you are, the more you just learn something new every day. And s- people can teach you so much, you know?

[00:18:04] Tim Reynal: Yes.

[00:18:04] Lindsey Dinneen: Yeah. Yeah. Okay. Yeah. Yeah. So, all right. S- so you, you have these again, really exciting things. I would love to hear more about what excites you about trends in the industry, but also about the company in particular, and just sort of what is, what is driving your next level of, you know, passion for what you're doing?

[00:18:30] Sanjiv Prabhakaran: Hmm.

[00:18:31] Tim Reynal: Oh, for me it's-- that's an easy question to answer because we are now, with the advent of AI, we are able to solve things we never thought the human being would be able to solve when it comes to DNA chains and proteins and all of that. And so to me, I'm just fascinated by how fast the m- medical device community or industry is moving to, to leverage the power of AI and the stuff that we're seeing, I mean, just even in surgical robots that I've been able to have exposure to and, and work on some of those projects, we're able to do things to the human body we just never even imagined we could do, all with a surgeon that's not even, not even in the same room. They can do it from across the world, and that to me is just-- that's fascinating. Think about what that means for going into outer space and being able to take care of astronauts that are, you know, en-en route to Mars. We think, we think that's an impossibility, right? But we're gonna make it happen.

[00:19:34] Lindsey Dinneen: Yeah, there you go. Love it. And how about you, Sanjiv?

[00:19:38] Sanjiv Prabhakaran: Yeah. Yeah. No, that's-- Yeah, no, I think Tim covered most of the points there. That's, that's the excitement in the industry. And for us also, you know, we, you know, I deal with not only with medtech, but other enterprise software also. And so what happens is, you know, now with all these AI tools that are out there, you know, you can, you can cut down a lot of the in efficiency in, in operations between different software systems and be able to tie all those together and provide a much cleaner dashboard that automates a lot of the process.

Like, for example, one of the clients we are dealing with is you know, they deliver what do you call, lubricants to, to and different types of you know, lubricants that they deliver. But many times, you know, the amount ordered is different from the amount that was delivered. And so now, you know, the piece of paper and basically says, you know, asks this, the client to sign off and say, "Hey, I only got one hundred and fifty instead of five hundred." And that, all that bunch of paper comes back, and now the admin has to go put that, all that into the system in a manual process, right? You read through that.

So we are looking at, you know, systems where you can OCR scan that sheet and extract the right number. I mean, it has to obviously read the handwriting and all those things. So it's, it's a, it's a, it's a mundane process, but if you can automate all of those with smart AI tools now, which we are, we, which we are able to do, it, it, it creates a lot of difference in in the, in the overall operation. Yeah. So, so that's, that's kind of where the whole thing is heading.

[00:21:11] Lindsey Dinneen: Yeah. That's, that's-- that is so exciting, and I think, I'd love your perspective too. You know, there's, there's both of you 'cause AI is something that you believe so strongly in, and I think it's really incredible to see the innovation and you both sort of alluded to the speed that which, you know, things can get to market faster perhaps, like, we could just m- be more efficient at our jobs and then create more impact hopefully. And so I'm curious what you would say to anyone who's kind of just still nervous perhaps about the use of AI, whether they're nervous about proprietary information or things like that. What are the, what are the best practices so that, you know, somebody who might be a little concerned feels more at ease?

[00:21:57] Sanjiv Prabhakaran: Right. Right. Yeah, I think, you know, in that situation, it's always, you know, there is always apprehension about anything new, right? When, when banking systems came and said "you can do online banking," nobody wanted to do that, right? It took, it took some time for people to, you know, scan the check and deposit it through your mobile phone. Nobody would do that, right? So, so, so those are the kinds of changes that will evolve. And people right now, the cha- the, the biggest problem is AI is moving at a much rapid pace. So if you don't train yourself or if you don't take that step, it's going to put you behind and, you know, everybody else will be moving forward, right?

So that's, that's a, it's a very, very tough decision for people to make. I know there, there's all this question about privacy, but that's been-- I mean, everybody's privacy is out in the market now. With all the hacks and with all the, you know, things that have happened, there's nothing more to hide, right? So, so how much more can you protect?

But at the same time, you do wanna be careful what you put in there and make sure that your account, you have a valid account that is secured and, you know, take the basic protection steps there. Turn off, you know, you can go into the privacy settings, turn off what you don't like, and, and to use it and and take advantage of these tools. That's the only way to take, you know, take one step at a time. Take one tool, do try it out, you know, learn, learn about it and, you know, figure out what it does and very soon you'll get used to it and, and start exploring more. So that's, that's my take.

[00:23:30] Lindsey Dinneen: Love it. Tim, anything to add to that?

[00:23:33] Tim Reynal: Sure. So for people who have a fear of "AI is gonna take my job away," AI is definitely reducing headcount across all of tech including medtech. What it doesn't take away is the human intellect that keeps pace with AI and that it it-- that people know how to govern AI and put it to good use. So for people who can see how requirements, design, and testing connect and where they disconnect, that's when you become very valuable to companies, especially in a consulting role. So for people coming out of college that are looking, "how do I adapt to this?" Is first of all, understand what AI can do and what it can't do, and then learn how to identify gaps and risks because of AI, and you become very valuable, especially as an engineer.

[00:24:26] Lindsey Dinneen: Yeah. Yeah. That's great. Well, okay, so this has been a great conversation so far, and I really appreciate both of your inputs and just advice and all of those good things. I do wanna pivot the conversation a little bit just for fun. So I'll ask you both the same question. You can decide who goes first, but all right, imagine that you were to be offered a million dollars to teach a master class on anything you want. Can be within your industry, but it doesn't have to be. What would you choose to teach?

[00:25:00] Tim Reynal: I can go. Yeah, very easily it would be how to fail gracefully.

[00:25:05] Lindsey Dinneen: Ah, okay.

[00:25:07] Tim Reynal: Because failure is the only way th-that we learn how to do it better, right? So if you're successful at everything you do, and I certainly have not been, but it's the failure that has always helped me grow and has taught me the most.

[00:25:22] Lindsey Dinneen: I love that. Great masterclass.

[00:25:24] Sanjiv Prabhakaran: Cool. Nice. Yeah. So, for me, I would think, you know, having been running this business for so many years the art of simplifying the complex. That's kinda what I would, I would look at as you know, whether it's explaining a patent pending algorithm or teaching someone how to organize a chaotic business, you know, I love that, that whole translation process. So that's probably what I would teach, how to make any massive, you know, goal or intimidating goal and break it down into logical executable roadmaps.

[00:25:58] Lindsey Dinneen: Yeah. Okay. Love it. Great masterclasses. All right, and then how do you wish to be remembered after you leave this world?

[00:26:09] Sanjiv Prabhakaran: Ah, Tim, you want to go on that?

[00:26:11] Tim Reynal: Sure. I want to be remembered for a person with kindness who helped people feel validated and important.

[00:26:23] Lindsey Dinneen: I love that. Awesome. Sanjiv?

[00:26:26] Sanjiv Prabhakaran: Okay. For me, I would say someone who built bridges. So, you know, specifically bridges between technology and human needs. That could be one of the topics that I would like to be remembered about

[00:26:40] Lindsey Dinneen: Yeah. Excellent. Awesome. Okay, and then final question: What is one thing that makes you smile every time you see or think about it?

[00:26:51] Sanjiv Prabhakaran: That, that would be seeing a complex plan finally click. So I like to see the client's reaction to that. That's, that's what I-- we solve a a challenging problem, whether it's an operational headache or, or something that you know, the team is trying to realize within their organization. When you see something working after what we have built, then that aha moment on their face is, is always the best thing that makes me smile.

[00:27:23] Lindsey Dinneen: Love it.

[00:27:24] Tim Reynal: So Sanjiv is giving you the politically correct answer 'cause it's really his grandkids.

[00:27:30] Lindsey Dinneen: Sure.

[00:27:32] Sanjiv Prabhakaran: Yeah, that is true. They just made me smile this weekend, so that's never, never a bad thing.

[00:27:41] Lindsey Dinneen: Yeah. Awesome. How about you, Tim?

[00:27:45] Tim Reynal: So the one thing professionally that makes me smile is seeing anybody that beats the odds, that goes against the odds and, and gets, gets to where they were hoping to go, attains the goal. I think seeing medic- the evolution of medical technology always makes me smile, and being able to be a part of it makes me smile. Now again, that's my politically correct answer, but as Sanjiv knows, I'm an avid gardener. We, we refer to our backyard or our whole yard as the Reynal Botanical Garden because we have just about every kind of hybrid plant, tree, flower in our yard that we can fit. And so what...

[00:28:25] Sanjiv Prabhakaran: He's got 6,000 bulbs.

[00:28:28] Tim Reynal: Yeah. Bulbs, yep. And when I see something go from a seed to a full-on plant and flower, that makes me smile.

[00:28:37] Lindsey Dinneen: Love it. Oh, that's fantastic. Well, this has been a wonderful conversation. Thank you both so much for joining. And we're so honored to be making a donation on your behalf as a thank you for your time today to the American Society for the Prevention of Cruelty to Animals, which is dedicated to preventing animal cruelty in the United States. So thank you for choosing that organization to support and thank you for, like I said, sharing your expertise and your advice and stories with us, and we just wish you the most continued success as you work to change lives for a better world.

[00:29:13] Tim Reynal: Thank you for having us.

[00:29:14] Sanjiv Prabhakaran: Thank you, Lindsey. Yeah, thanks for having us. It's been fun.

[00:29:18] Lindsey Dinneen: I agree. All right, till next time.

[00:29:21] Tim Reynal: Take care.

[00:29:22] Sanjiv Prabhakaran: Yes.

[00:29:23] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.