019 – Insight into IVD device development with John and Jenn Zeis

In this episode I sit down with John and Jenn Zeis from Toolbox Medical Innovations to discuss:

  • How Toolbox came to be [3:14]
  • How Toolbox helped one of their clients take their idea to market [5:25]
  • How John and  balance their family and their business [6:39]
  • How Toolbox helps their clinical and regulatory clients [9:43]
  • Why pre-established relationships are important [10:55]
  • The biggest issues Toolbox clients face [12:55]
  • Why usability is important [15:25]
  • The two main reasons to do usability studies [17:08]
  • John and Jenn’s key piece of advice for device development [18:53]

Take Action:
1. Text TOOLBOX5 to 44222 to get your copy of the ‘Top 5 errors made in clinical studies and how you can avoid them’

Guest:
John K. Zeis is the President of Toolbox Medical Innovations, an entrepreneur, and an expert in diagnostic device development.

Jenn Salzetti Zeis is the VP of Clinical Operations at Toolbox Medical Innovations. She specializes in medical device and diagnostic clinical trials with almost 25 years of clinical research experience in the IVD industry.

Resources:
Visit Toolbox at AACC 
Next Generation Diagnostics Summit
Lab on a Chip

Connect:
Guest: John Zeis
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Guest: Jenn Salzetti Zeis
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Company: Toolbox Medical Innovations
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Host: Meghan Alonso
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Host Company: Imua Services
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All Podcasts:
iTunes: bitly.com/InspiredbyIMUA

Podcast Transcription:

– [Announcer] Are you ready to master the waves of medical device product development? Well, wax up your surfboard because you are listening to Inspired by Imua. And here is your medical device product development expert, that Hawaiian-hearted hostess who will help you hang 10, Meghan Alonso.

– [Meghan] E komo mai and aloha! You’re listening to Inspired by Imua, where we help you master the waves of medical product development. Each week, we interview guests that educate, guide, and inspire to give you the skills you and your product need to hang 10. If this is your first time listening, Imua is spelled I-M-U-A, and it’s a Hawaiian word meaning to advance forward with passion despite rough waves. There are plenty of those in medical product development, but keep listening because we’ve got you covered. So today, I’m specifically gonna talk about IVD in life science product development. So I have the Dynamic Duo, the owners of Toolbox Medical Innovations here with me, and I play a big role in Toolbox as well, so I still work there. I do a fair amount of work there. We have a lot of fun as humans and dogs. Today, there are three dogs in the office, so that was a unique day. Usually, there is not that many at one time. So today we’re gonna talk about just some advice for IVD and life science development, some mistakes to avoid, and just kind of the general flow of how Toolbox works. So to give you a little insight into Toolbox, it’s an integrated company. We provide everything from developing a regulatory plan all the way to manufacturing transfer under one roof. So we have a few different teams that attack product development from lots of angles and specific expertise in IVD and life science development. So without further ado, I will introduce John and Jenn Zeis. And oh, one last thing, so don’t forget today, we have a freebie for you to download. If you text the word TOOLBOX5, that’s all one word, no spaces, toolbox then the number five, to the number 44222… Again, that’s TOOLBOX5, that’s what you’re texting and you’re texting it to 44222. Now what that will get you is the top five errors made in clinical studies and how you can avoid them. So that’s just a little treat from Toolbox today. So, John and Jenn, are you ready to hang 10?

– [John] We’re ready.

– [Meghan] All right, so we touched on a little bit of Toolbox’s background in the intro, but I guess let’s start out with the story of how you, I guess how the Dynamic Duo met way back when and how the idea of Toolbox came into play.

– [John] Yeah, Jenn and I have met a long time ago

– [Jenn] Just a few years ago.

– [John] Back in the early ’90s, actually, and we both worked at Quidel. And then after that, we both went on to start our own separate companies, and I was doing the engineering design and development, and Jenn was doing the clinical research and clinical studies. And then what I found with my company is that we did a really good job at the engineering and the prototyping, but we didn’t really, there was a lot of things that we didn’t get involved with. We didn’t evaluate the user needs and how to ascertain those needs. We didn’t really know that much about the assay and the science behind the device. We didn’t know what it took to go through a clinical study or usability studies or get a product through the FDA. So there was just a very kinda narrow amount of things that we can help with. So Jenn and I decided that we would combine our capabilities together and start Toolbox Medical. And so what we’re able to do now is provide not only the engineering design and the fabrication and the clinical studies, but we also have added usability studies, instrument integration, human factors, and regulatory support and marketing support.

– [Meghan] So with that, is it a model where someone says, “Hey, I need everything done” and they can get everything done with you, or is it more I mean ala carte, or maybe both?

– [Jenn] Yeah, either/or. If we have clients that will just need engineering services and same with clinical or just a usability study, we can divide up those services and you can pick the tools you need.

– [Meghan] Yeah, and then I’m actually gonna skip around a little bit. I had a different question planned, but you brought up a good point in that you were telling me, well, about a client that you’ve helped recently that you did kind of do everything with, and they came to you very early on, and they didn’t necessarily know where they were gonna position their product in the marketplace, so…

– [John] Yeah.

– [Meghan] Tell our listeners more about that.

– [John] Yeah, so we had a client that came to us. They were out of a university here in California, and they were a, very early on, they had a really great technology for detecting antibiotic resistance, but it was really very much a lab, internal tests that they were running, and they didn’t know what it took to get a product to the market. So we just really liked to help them solve their problems, so we were able to put together a team to help them not only with the assay development and then the instrument integration and the cartridge development, but we also were able to bring some experts into this to help them with their marketing strategy and really what is it that they wanna develop and who are their intended users and what are their needs. So we really kind of take the tact of trying to understand what our customers need from us, and if we don’t have, if we need to bring somebody in to help support that, we will.

– [Meghan] Okay. And then my original question that I was gonna ask, so not only are you two in business together but you’re obviously married and have a family. So, how does that work? How do you guys make it work?

– [Jenn] Well, I think Toolbox is our family, and our family is Toolbox, so everyone here is part of our family, and our kids are part of Toolbox as well. I mean from the get go, they were putting chairs together, slapping concrete on the walls, and my dad was building furniture, and our son was putting computers together. So you know, I think we have a really good work-life balance as well, so we’ll throw a little play into work and take a hike and take the dog out and be chatting about work during that time too.

– [John] And it really is reflected in our company’s values, which are to serve, enjoy, prosper, and foster, and I think we really do all of those very well. We’re all here to kind of help serve each other and serve our customers, and I think everybody, all of our employees have got that attitude. We definitely like to have fun. We have, as Jenn mentioned, we have barbecues every Friday. We have Day at the Races. We have happy hours, and we really like to have a good time, and even when we’re working, we’re having fun. And we also like to foster and try to grow ourselves and grow each other and help people out that need it. And I think there is just that attitude throughout the whole company here.

– [Meghan] Mm-hmm. So tell us more about the barbecues. How did that get started?

– [John] You know, the great part about the barbecue was it was nothing that Jenn or I did. It was something that the group here, that the guys all of a sudden, one of the engineers here decided he was gonna bring his barbecue, and they had talked about it here, and he brought it in, and somebody went out and bought some hot dogs and chicken or I don’t know what, and then they started barbecuing. Then they started setting up, “Well, who’s gonna bring in the meat for this Friday?” and then it really turned into something that became a… We do it every single Friday. And now we have a sign-up board, and everybody has, some people bring in sides, some people bring in meats, and it’s worked out really well, and it’s something that just sort of got started here internally.

– [Jenn] And I think our customers actually love to come down for Friday afternoon meetings to join in on the barbecues.

– [John] We just had a fund internally to get a new barbecue because the one that we had was on its last legs

– We’ve worn it out.

– [John] We’ve worn it out, and everybody here pitched in and we got it, and we got the front of it with our Toolbox logo etched into it, so we’re really excited about that.

– [Meghan] Yeah, I think that adds an extra notch on there too.

– [Jenn] The official Toolbox barbecue.

– [Meghan] Yeah, for sure. Okay, so we got a great story on more of the engineering side of the house. So Jenn, tell us more on the clinical and regulatory side. Walk us through a study or a client that you’ve helped recently, just so our listeners have a better idea of how that process works.

– [Jenn] Sure. One of our smaller clients came to us, and they don’t have a clinical research department within their company, so we are their CRO. So we developed a protocol. We got IRB approval. We found them 17 geographically distinct sites throughout the country, and we are in the process of executing that protocol and getting ready for our site initiation visits. And the study is aimed to start this fall, and we will be… once it’s initiated, we’ll be monitoring it throughout the study. Then we’ll be performing our closeout visits, analyzing the data, and getting ready for that 510submission.

– [Meghan] So you mentioned 17 sites, and I know the value of these pre-established relationships, but explain to our listeners why that’s really important, why someone just can’t say, “Hey, I know this doctor down the street “because I take my kids there, “and he’s great, and maybe he can read my clinical study.”

– [Jenn] Right, that’s actually a great question. We have worked with some of our sites for 20-plus years and have this great relationships with them. But not only that, you want a good site. You want a site that has a clinical research department, a clinical research coordinator that knows good clinical practices and a PI that has a vested interest in wanting to do a good job for your study.

– [Meghan] It seemed like a pretty large study, with 17 different sites that…

– [Jenn] Yes, we will be busy traveling around the country.

– [Meghan] So what makes one study demand a high number of sites, whereas another one could just have… Could one have three or four?

– [Jenn] Sure. It really depends what your product is. This particular study is for flu, and we wanna make sure that we hit our number of specified positives, so we need a certain amount of flu A positives, a certain amount of flu B positives, and in order to get that, as you know, every flu year is different, so… We had a really good flu year last year but… And when I say good, good for our clinical and we saw a lot of positives, bad for there was a lot of sick people in the country.

– [Meghan] I was one of those.

– [Jenn] Right. So, we wanna be spread out throughout the country as well because one side of the country might get hit and the other side might not. We might see a higher prevalence of flu B in Texas versus California. And we are also doing a CLIA-waived study, so the FDA wants us to be geographically distinct as well.

– [Meghan] Okay, good. So, John, I’ll take it back to you. Working with clients over the years, what do you see that’s a barrier for people, or where do they tend to get themselves into trouble?

– [John] Yeah, so there’s a couple, I mean there’s several areas, but one common thing that I have seen is that a lot of these diagnostic companies, they’ll start with the technology and they’ll start maybe with developing some sort of maybe a very accurate sensing methodology or some other sort of way that you can detect for the presence of something, but they don’t really have in mind what the final product will be and who the end users are and what they need to do with this product. To me, it’s been the companies that I’ve seen that have been more successful are those that actually start with the user need and start with what is it that people need out of this product and then work to develop it around that. Because what you’ll find, if you go the other way, is you might have a great sensing technology but maybe if some of the sample prep and some of the steps it takes to get the sample to the point where you can put it across your sensor or so burns them that it actually won’t allow you to use that product in the environment that you need to. So I think that’s one of the most common things.

– [Meghan] Mm-hmm, okay. And Jenn, what about on your end, with just the different things, like getting people’s way or problems that…

– [Jenn] Oh yeah, complicated protocols and not really working through your protocol before you go out to do a study. I just was out a couple of sites last week. We’re getting ready to start another study and made special trips to these sites just to work through the protocol logistics. We don’t wanna end up during the site initiation visit with all these unanswered questions delaying the actual start of the study, so we work through the protocol logistics with the investigators and the study staff and actually figured out a bunch of questions that needed to be answered, so those will be answered and ready to go by the time we’re doing the site initiation visits. That makes for a more successful study.

– [Meghan] Okay, good. So one thing that we haven’t touched on yet, which is newer to Toolbox, is the usability testing. And so tell us what, kind of, the infrastructure of our building, what that provides as well as why usability is important.

– [Jenn] I think John touched on a little bit of usability just a few minutes ago, about why it’s important to have the customer’s focus in mind when you’re designing and developing a product. And now, we’re actually doing a more formalized testing throughout the design and development process with formative usability studies all leading up to our summative testing study. And here at Toolbox, we actually do have a usability room where we can facilitate these studies and actually have our clients view in, and we have a… Our room allows for our clients to be in on the other side with a one-way mirror actually watching their potential consumers use their product, which I think is very helpful throughout the design and development process. And it’s one thing to imagine it, but it’s another to see it and to see how people really work and use your product.

– [Meghan] Yeah, and so that you can find out in the formative studies, right?

– [Jenn] Oh yeah.

– [Meghan] You can modify the design based on how they’re interacting?

– [Jenn] Of course, yeah. So formative studies are small in nature, eight to 10 potential targeted users, so whether this… If your product is meant for point-of-care CLIA-waived office, you bring in RNs, LVNs, medical assistants, and you’re doing smaller scale studies with… You can even do prototypes along the way, even paper prototypes, but, you know… I don’t know, what else do you have to say about that, John?

– [John] Yeah, I mean to me, I think Jenn covered it pretty well. There is really two main reasons that you wanna do these usability studies. Number one is because it’s gonna make your product more successful and less likely to have a recall. And number two is that the FDA recognizes that, and they’re really starting to demand that people do those studies. In other parts of the medical device industry, it’s a requirement, and we believe that it potentially will be a requirement in the diagnostic industry very soon. But even if it is not, it’s really the right thing to do during development.

– [Meghan] Mm-hmm. So we can wrap this up by just all of the wisdom that you’ve come across over these year… that you’ve collected over the years of working with different companies and seeing different things, from Quidel where you started, which they pump out lots of products, it’s a very high-volume manufacturing environment, to more of this startup company that they’re gonna have very low-volume products for a few years then hopefully ramp up. What’s some key advice or key takeaways that you want to leave with people? Oh, and I don’t want you guys to forget that if you text the word TOOLBOX5, so it’s all one word, TOOLBOX5, the number five, to 44222, you’ll get the five most common mistakes made in clinical studies and how to avoid them. So don’t forget to download that. So okay, back to those key advice or key takeaways for our listeners.

– [John] Yeah, I think for me, one of the key pieces of advice is to not underestimate what it takes to develop a diagnostic product. I think in some cases, people may think medical devices and pharmaceuticals, they’re very complicated products to develop. But diagnostics have got a lot of complexity as well. I mean if you think about the number of disciplines that are involved, you’ve got the assay, which includes chemistry and biology. You’ve got usability experts that need to be involved. You’ve got microfluidics, surface chemistries, hardware, software, the regulatory aspect of it, and then even trying to design a product, as Meghan mentioned, that can be made in high volume, so many different disciplines that have to work very closely together. And you can have experts in each of those fields and still be unsuccessful because the interactions between those groups don’t work well together. And so I feel, the advice that I would give is realize it’s complex, and make sure that you get those experts, and make sure you have people that can interface between those different areas.

– [Meghan] Good. Okay, well, we will wrap it up there. Thanks for joining me today. And I haven’t mentioned this since the intro, but today, August 2nd, Toolbox is exhibiting at AACC, so you can find us over in booth 4279 in Philadelphia, and if you miss us there, don’t fret because we will also be at the Next Generation Diagnostics Summit in D.C., August 23th through the 26th, and for Lab on a Chip in San Diego, and that’s September 28th through the 30th. So we hope to see you at one of those three events and stop on by, get your freebie, talk to us even more, and see how we can help you with your project.

– [John] Thank you.

– [Announcer] Mahalo for joining us. If you are new to riding the waves of medical device product development or if you’ve been in development for a while already, Inspired by Imua is here to surf with you. Wanna be a master of the waves? Text HANGTEN, that’s all one word, H-A-N-G-T-E-N to 44222. We’ll send you the most common wipeouts companies make in product development so you can avoid them and reach master wave status. Again, that’s HANGTEN to 44222. We publish a new episode every Tuesday, so catch us at inspiredbyimua.com. Imua.

About the Author

Meghan M. Alonso

Meghan M. Alonso, referred to by Shark Tank’s Kevin Harrington as a medical device development expert, is known for her award winning medical device podcast, Inspired by Imua, the chapter she wrote in best selling book “Put a Shark in Your Tank, and her valuable connections in the medical industry. According to the Huffington Post, she helps clients navigate the complicated process of bringing their ideas to the marketplace. She’s a patriotic military wife, pet parent, founder and co-founder of 4 successful companies who thrives on guiding medical device and IVD companies through development and manufacturing.

When she isn’t helping others, Meghan is hard at work on her MBA she is pursuing from Auburn University, staying active with her adorable husky Abby, crossfitting, enjoying great restaurants and fine wine with her husband, and soaking up the sun the nearest beach.

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