We continue our chat with FlintRehab’s CEO (Dan Zondervan) and Clinical Advisor (Dave Reinkensmeyer) to see what is their secret sauce and can we spread their advice to other entrepreneurs facing clinical trials, the FDA, choosing a business model that works for you and being prepared to fail.
Host: Dr. Mary Goldberg, Co-Director of the IMPACT Center at the University of Pittsburgh
Guests: Dr. Dan Zondervan (VP) and Dr. David Reikensmeyer (Clinical Advisor) of FlintRehab
FlintRehab | Website, Facebook, YouTube, Twitter
Products | FitMi, MusicGlove
IMPACT Center | Website, Facebook, LinkedIn, Twitter
Full Episode Transcript | PDF
Timestamps:
01:18 Clinical Trial Process - Research Perspective
04:14 Clinical Trial Process - Industry Perspective and Communicating the Value of a Product
05:40 FlintRehab’s Consumer Product Mentality
06:31 Including Qualitative Components
07:44 FDA Process and Tips
12:08 Business Models Differ by Product
17:05 Size and Structure of FlintRehab
21:12 Final advice
SPEAKERS
Mary Goldberg, Dan Zondervan, Dave Reinkensmeyer
Mary Goldberg 00:06
The IMPACT Center at the University of Pittsburgh supported by the National Institute of Disability, Independent Living, and Rehabilitation Research proudly present ImpacTech. On today's episode Secret Sauce, we continue our chat with doctors Dan Zondervan, and David Reinkensmeyer, CEO and Clinical Advisor of FlintRehab. Recorded remotely from my soundproof bedroom closet in Pittsburgh, PA, this is your host, Dr. Mary Goldberg, and welcome to our eighth episode of the ImpacTech podcast series. On our last episode, we learned a bit about how Dave and Dan formed FlintRehab, their success in transferring multiple products to market and how they straddle the university in business environments. We're going to kick off today's conversation about FlintRehab products clinical trials. But for our listeners that missed the last episode, could you please reintroduce yourselves Dan and Dave?
Dan Zondervan 01:06
Sure. I'm Dan Zondervan. I'm the CEO and co founder of FlintRehab.
Dave Reinkensmeyer 01:10
And I'm Dave Reinkensmeyer. I'm a professor in mechanical engineering and neuroscience at UC Irvine. I'm a co founder of Flint as well.
Mary Goldberg 01:18
Thanks so much. Welcome back. And we'll start with you, Dave, could you provide just a bit of an overview of the clinical trial process, and perhaps just describe a little bit sequentially about whether you needed to do a clinical trial for both of the products that Flint is currently selling?
Dave Reinkensmeyer 01:38
Yeah, that's an interesting topic. So as we mentioned in the last episode, that our company was funded out of an SBIR grant primarily in the beginning, and National Institutes of Health and CMRR, National Center for Medical and Rehabilitation Research. And these grants are science grants, they're research grants that need to address a scientific topic. And so as we got together and thought, we want to apply this, what's the burning question. And for MusicGlove, it was really, you know, can we get better recovery compared to the conventional thing a person might do at home, if they were trying to continue their hand rehabilitation on their own. And so we hypothesized that the MusicGlove because it would help people be more intense and more motivated, and they'd do more repetitions and be more engaged, that that would produce better results than just getting, you know, following a book of exercises, a paper book of exercises, which is kind of the standard that if you've ever had rehabilitation yourself, you know, that's, that's what you'll get often when you get home. So one of the fun things about that clinical trial, and I have this plot up in my lab, I put up on the wall, because it was such a fun, one of my favorite all time graphs from a study. And I just had a PhD student graduate. And she gave me a set of coasters with pictures from presentations I do, and she gave me that that plots on one of the coasters as well. So but the plot was, it shows how many, how many practice movements people did with the MusicGlove at home, when we gave it to them to take home. And what we what we had is, so the plot shows a diagonal line going from zero up steadily. And that would be what we want you to do over time. So on the x axis is the three weeks of the study. And that line saying this is what we asked you to do the cumulative number of repetitions that we add. So it's just imagine a line growing steadily up. And then when we put what the average person did, it kind of follows the line for the first week and then accelerates up from it. And so they ended up doing more than we asked, which was really rewarding results. And so that kind of was a great validation. And then you know, on average people they'll get, I think Dan can comment on this too. But I would say probably 20% 30%, this is in the chronic phase after stroke, if you're using the glove, you'll get about 20-30% boost and your small hand function with it. There's a lot of variability on that. So some people will benefit, you know, double and some people benefit less than that. But that seems to be if you do say 8,000-10,000 repetitions with the device that you could get that kind of boost.
Mary Goldberg 04:01
So rewarding, I'm sure to see results like that and perfect to report back to the funding agency, get your papers out, but also very convincing right to be able to market the product. Dan, did you want to add anything to that?
Dan Zondervan 04:14
I'll just add a perspective from the industry side, which is something that I have come to learn as we you know, did the clinical studies and put them out there. So you know, I think it's very ethically important to do these studies before you release the product to so that you know you're not selling selling snake oil, right like that. here's a here's a device, we hypothesize that we'll be able to give this to people at home, they'll actually use it and get better. But the surprising thing for me is that when it came to marketing the device that didn't end up being as salient I guess to the potential consumers as we thought it would. So when we were selling the device to clinics, so we have both a clinic and an at home version of the product. They were very interested in the clinical studies. They wanted to see the proof that it worked, but when we were selling it to people to use at home. You know, for us, it was important to know that it worked. But for them, it was way more powerful to hear testimonials to hear other people. You know, it's an anecdote as a as a scientist, you know that that an anecdote is not it's not evidence, but for them, it created a personal connection, that it just seemed to be much more relevant, rather than a graph in a paper. And so that was kind of interesting coming from the scientific side, just, you know, when you get out there, and you have to communicate the value of a product to someone to be able to distill the information that you learn in a clinical trial in a way that's meaningful to them, and that they feel applies to their situation on the ground.
Mary Goldberg 05:37
That's very interesting. Go ahead, Dave.
Dave Reinkensmeyer 05:40
Yeah, and I jump in on that one, too, because I think it relates to this Flint's consumer product mentality. And it also relates to kind of a bigger question in Disability and Rehabilitation. But on the one side, you have maybe like the medical model, and randomized control trial, very controlled, see how it goes the other side, you have just people want independence to do the things that they find that are that are helpful to them, then that matched into that consumer model, because you know, we started selling it on Amazon, and people were leaving reviews there, they and they, you can buy through the website, you can go look at all the reviews there as well. And there's also a Facebook group that Flint started, which grew a lot and people are commenting and talking about, Hey, this is how I used it. This is how I found it. So it's a really interesting, and that's super rewarding to go through and read all the comments on it.
Mary Goldberg 06:31
That's so cool. And so knowing that testimonials are what speak to users, do you include qualitative components in your trials and other evaluations or even your ongoing research?
Dave Reinkensmeyer 06:44
Oh, yeah, yeah, we've always done it, we've tried to make it better and better, we recognize that that user input both from the people who've had a stroke, and then also clinicians is really super important. What's interesting now is with our large data set of anonymized data, you know, we can match up actual usage patterns, potentially with surveys, we haven't done the surveys yet, but we're talking about doing that. So we pick a group of people and say, Hey, would you like to participate in a research study, we're going to survey you about the device. And then we can sort of if, if they allow us, we can match it up to their actual data use, or the usage patterns of the device and kind of see how the team aligned with each other, which is really exciting for me as a, just from a scientific perspective, but then also, it's going to tell us like, what do you do to make the thing better? Or like the, let's call them the hyper users, the one that use it a lot and benefit? What, why, what's going on there? And can we like, get that secret sauce spread out to other people, you know?
Mary Goldberg 07:44
Awesome. And so after the trial was completed, did you start the FDA process? And did those activities primarily occur within the university or within the Flint rehab environment?
Dan Zondervan 07:58
So yeah, the FDA process we, so the products are listed with the FDA. So they're class one devices that we sell, so they don't require what's called a pre market approval from the FDA. But the registration and everything is done through FlintRehab. So when rehab is registered with the FDA as a medical device manufacturer, but we did all that very early days, when we were actually still going through the clinical studies got the registration set up. And honestly, I mean, it's you talked in the last episode about wearing different hats, that was a very different hat that we have to figure out how to wear of navigating the FDA. And really, it just came down to finding helpful resources that that could basically share their knowledge with us, and then taking the time to go through what they shared with us and glean out the actual relevant bits. But at the end of the day, actually, what ended up being most helpful was we just got on a phone call with someone at the FDA explained our product explained the pathway that we had identified for basically, here's the product code, this is where we think it fits under what the FDA regulates. And this is how we think that enables us to market it right, whether we can sell it over the counter, or if it requires a prescription, and just kind of talk that through with with a representative, we, you know, shared our resources, and they were able to give us the green light and say yes, this makes sense and provide us some other tips. So that was very surprising. You know, but, you think of these regulatory bodies as people sitting there with with red tape trying to get you to not proceed. But when we actually started interacting with them, they were eager to help us find a better path forward and find a way to appropriately navigate the FDA.
Mary Goldberg 09:30
It's great to hear that your experience was largely positive. Definitely working with several entrepreneurs through our IMPACT project, it seems to be one of the bigger hurdles or at least most mysterious parts of the innovation process. And so aside from the chat that you had, what other resources stood out to you as being particularly helpful and are there any other tips that you can think of that you would like to share with listeners that have to go through the FDA
Dan Zondervan 10:00
Yeah, it's tough, especially if you have a new product that doesn't fit under something existing that makes it a lot more challenging. You know, it's hard because it all costs funding right, you can find a consultant that's going to help you a lot at but you know, you're gonna have to pay for them, it's, I don't know, it's one of those things, it's just kind of a bullet you have to bite to get through, I guess maybe one tip is that a lot of it is less overwhelming as you go, it's kind of just about learning a new language, you know, that there's a lot of jargon involved. And I think for me, as I just kind of started to understand the definitions, you know, verification and validation, what a 510 K is what premarket approval is, then it starts to become less mysterious, you know, these things that they're, they're not in a normal vocabulary. And so as you start to add them into yours, then it opens up the doors, and you can actually start to see how the lines connect and say, oh, okay, I have to do this. And then I have to find a predicate product that matches mine. And then I have to submit this thing, and I have to have these, you know, standard operating procedures and good manufacturing practices, and then they start to become less mysterious and turn into just work, which is fine, because then you can get a little bit done every day, and it eventually gets there.
Mary Goldberg 11:07
So the learning curve included from start to finish, to when you got the approval about how long was that runway to give people a heads up of what they should expect?
Dan Zondervan 11:19
Well, so for us we're as a class one product, you know that that's in the same vein as like a tongue depressor. So we're just dipping our toe in the FDA process. So we had about the easiest path. We had a predicate device that had a 510 k submission. And the FDA said this is a class one device, we don't need to approve it, you can just list it with us and and sell it under this indication, which is as a tool for doing exercise. I think that process of identifying that and figuring that out, and then talking with the FDA and feeling certain that that was appropriate, it was probably about a year and getting all of our standard operating procedures and everything in place. So that's that's for things of, you know, how do you receive product? How do you validate a vendor for a part, because you know, the FDA cares about all that stuff, they want to make sure that when you're putting your product together, you're checking the right boxes to make sure that it's going to be safe for the end user.
Mary Goldberg 12:08
Thanks for clarifying that. And so yeah, the heads up is that even the easiest path that you may expect about a year to be able to fully operate. So let's pivot a little bit, we very briefly discussed business models, and the ones that that FlintRehab engages in, could we talk a little bit about how the business models may differ for the different products? So for example, the hardware to the software to any other applications?
Dan Zondervan 12:41
Yes, so this, this is one of the things that ended up being most interesting, I think, as we got the product finished, got the FDA stuff done, had the clinical trials wrapped up, we opened the doors on our website, released the product to a resounding chorus of crickets, because we have to do all the marketing to get the word out. And that people, you know, find out about it. And so initially, the business model that we had in mind was a referral model. So that we would sell devices to clinics, patients would come in to do their outpatient therapy at the clinic, use the product there. And then when it came time to be discharged home, you know, you're no longer going to have outpatient visits, they would say, Oh, well, this is available, you can buy it out of pocket, take it home and continue this exact same therapy that you're doing. So it seemed very logical. But the problem is, is that therapists are busy and they're not salespeople, they don't view it as part of their job to sell the product that they're using, they might not even know right? That it's available where where the patient can go and buy, it ended up being a difficult system to scale. We also you know, when you kind of relinquish a lot of control, you can't ramp up the number of referrals that you want therapists to give out very easily, since they're not your employees. And so really what we ended up doing was two things. So first, we reduced the price point of our product. So we initially had a version that sold with a tablet so that if people didn't have to worry about installing software on their computer, it just came as a set, but we developed a version of the software that you could install on your home computer and that let us sell it at a lower price point. So now it seems much more feasible that people could just do a one time purchase instead of some type of payment plan or put it on credit or something. And then the other one was we started to look at people are selling products, modern consumer products. And the way they do it is that they they basically create a website with a technique called search engine optimization. And they generate content so that I'll use our thing you know, we're selling at the stroke rehab product. So we write an article, we put it on our website for something stroke related. So the the best diet for preventing a stroke or good stretching exercises if you've had a stroke. And so then as we start to generate that content when people may ask these questions, that's what you do. You go to the internet, you type it in your favorite search engine, and you click on the top two or three links. And so by generating that content by optimizing our site by doing all of these different things, we are able to become the number one Stroke blog in the US. So when people go and they search for these stroke related terms, they see our articles, and they click on them, and they get basically free educational information. And then there's options, they can sign up for a newsletter, they can navigate through the site to see our products. And it basically gives us a touch point. So we're able to now interact with people on our website, that we know that our product is relevant for them, right? So we know that if they're coming, that they could benefit from what we have to offer. And so then we have email campaign and all these other things to expose them answer those questions. And then we have a basically a shop on our website where they can just enter their credit card information, and we ship it to their house. And so it's much more of just the way that if you wanted to sell like fancy jam, you know, you could have a website with the articles about cooking, and people would come and they'd buy. It's just a very consumer driven type of modern sales model. But it only works because we had a low enough price point. And because there was basically a gap where nobody was writing this type of content. So we were able to it took about 18 months, I would say from when we first made the decision to pursue this business model to when we have generated enough content that our website was actually the one showing up as people were searching these terms. And then of course, developing all of the email marketing and everything that that has to complement it. So it was a long process. But it ended up being the one that that was successful, because you could scale it and you can kind of see the data at each point in that pipeline and optimize it in a way that you need to when you're working with relatively niche market
Mary Goldberg 16:29
Who contribute to and edits your blog. Is that something that you do in house? It is Yeah, so
Dan Zondervan 16:35
It is, yeah. So we have, I'll give a shout out to Kari Dahlgren. She's our VP of Marketing, and has been curating and generating content for the blog and the website since day one, since we basically started down this business model. And we have a couple of in house writers that generate content as well we outsource some of it. So we have therapists that we work with that will actually review the content, make sure that it's appropriate for certain articles that might recommend exercises, for example. So we try and do a good job of getting a lot of eyes on things before they go live.
Mary Goldberg 17:05
Just curious how many people does FlintRehab employ?
Dan Zondervan 17:10
There's 10 of us right now.
Mary Goldberg 17:12
And Could you briefly describe the roles of those 10?
Dan Zondervan 17:16
Sure. So our company, you could kind of think of it as two pillars. So we we mentioned our initial funding was through SBIR mechanisms. And that's something that we've continued to to pursue. So we have essentially a grants division of engineers and grant writers that develop new projects, and then carry them out. And then basically, that funnels into our R&D pipeline. That was actually how we were able to develop our second product FitMi within the company, and we have other products coming up through that pipeline as well. So that's about half the employees. And then the other half are really on the e commerce side. So we have Carrie and the marketing team, we have a salesperson, so if somebody wants to call in and they have questions, fielding those, and then we have a fulfillment and operations team, which manages supply chain, so making sure we're ordering parts, it's going out to our fulfillment centers responding to returns customer service requests.
Mary Goldberg 18:05
Got it. Yeah, thanks for that overview. So you mentioned the email campaigns, the blog, the SEO, the search engine optimization. I'm curious about what role social media has played in the promotion of your products, and how you see that evolving over time, especially with some new products coming down the line?
Dan Zondervan 18:25
Yeah, I mean, in a lot of ways, it's made a business like ours possible. As I mentioned, this, this is a relatively niche market, you know that the need is very high. As Dave mentioned, one in four people will have a stroke, but there's a lot of existing medical infrastructure that they'll go through and so then to come out the other end and be a potential candidate for a home rehab product. So you really need to be able to target your marketing in order to basically get up to enough volume to cover your your overheads and the cost of goods and all that. And so with social media, the secret that everyone knows is that you're trading privacy for convenience. And so when you do that, you're basically sharing information about yourself so that companies that have a product that might be relevant for you can very specifically target it to you, whether that's something that we're all comfortable with is maybe a different conversation. But it does allow a company that has a niche product, to put it in front of the right eyes at a low cost, you can think of the cost if we just had to do TV advertising, we'd have to pay, you know, a really large amount, and we'd have no idea who was looking at it and if they actually came and bought our products because they saw a TV ad, whereas by advertising through Facebook, for example, we know it's going to be somebody in this age demographic, if they end up buying our product we know so we can track Okay, we spent $10 on Facebook ads, and we got $100 back so we know we can scale that up in a way that just wasn't possible 5,10 years ago, I guess. Yeah, 10, 15 years ago. Yeah. And then the other side of that is that outside of even us putting money in and trying to advertise David mentioned that we started a Facebook support group and this was really just way of creating, you know, it kind of went in line with with the blog and generating content for people, we wanted to create a sense of community that was much more user generated, user driven. And so really, we just created the support group. And we notify people of it through the website, I think it's around 10,000 users or something now, and people are interacting daily. And we do very little, we moderate the content to make sure people aren't going in there and to spam people or harass people or anything like that. But we really just let the people interact and has our banner at the top, so people use our products, they'll share their experience with it. And it does a lot to basically validate the the experience of users. And I think, also build a sense that this is a brand that's not looking to just take your money that we're looking to actually provide you with something that that's going to help. So
Mary Goldberg 20:48
thanks so much, Dan, your your knowledge in this space approach and early success are really impressive. And I've learned so much from both of you about the need the path, the role, the scaling up and your business model. I'm interested in what else our listeners should know about being successful in this space. So what is your sage advice, and we'll start with you, Dave, to close out our conversation today.
Dave Reinkensmeyer 21:12
I think we've covered it, I mean, you've got to have a good idea. And then people have to find it useful. And then you got to have a great team. And it's way more than the invention that expands out into things that Dan just talked through with the marketing and the supply chains, and the support and the community and all of that. So they're just if you can clone, Dan Zondervan, and Nizan Friedman, and that that would help too.
Mary Goldberg 21:36
Starting with a compliment. Dan, what is your sage advice to share with our listeners?
Dan Zondervan 21:50
But now I feel obligated to say you need an excellent advisor. Really. Yeah, although in truth that was that was very critical, I think the collaborative environment and Dave's lab is what the fertile ground that allowed Nizan and my working relationship to grow. And then you know, on the on the business side, I guess I would just say, Be prepared to fail. We've had not several product failures, not not only successes, you just don't hear about the failures, because they don't make it the market. And along with that, I guess, be responsive to what people are saying to a point, you get feature requests all the time. But if it comes down to your customers don't want the product that you're selling them, you need to go and try something different. So I think it from the research side, you know, you can have something and you could say, well, I know this will work if you'll just do it. But if people aren't going to do it, you know that that's not going to do much good.
Mary Goldberg 22:38
Thank you for sharing and to our listeners that missed the last episode, could you please one more time share where our listeners can find out more about you and about FlintRehab?
Dan Zondervan 22:49
Sure, yeah, the best place is just to go to our website. So that's Flintrehab.com, it's f as in Frank L I N T rehab dot com and to clarify, that's what we're not affiliated with the city of Flint. It's we make tools to spark recovery. So like a flint creates a spark our tools we hope sparks recovery in the users.
Mary Goldberg 23:08
Thanks so much. It's been such a pleasure and appreciate both of you and your the great work that you're doing. Thanks so much, Dan. Thank you, Dave.
Dave Reinkensmeyer 23:16
Thanks, Mary.
Dan Zondervan 23:17
Thanks.
Mary Goldberg 23:21
If you like ImpacTech, please review us on Apple podcasts or wherever you listen to podcasts. Thank you again for tuning in and continue to make an impact in whatever you do. A quick note from our sponsors. IMPACT initiatives are being developed under a grant from the National Institute on Disability independent living and rehabilitation research. NIDILRR is a center within the Administration for Community Living Department of Health and Human Services. IMPACT initiatives do not necessarily represent the policy of NIDILRR, ACL or HHS and you should not assume endorsement by the federal government and the same goes for the University of Pittsburgh. We would like to thank our ImpacTech guests and our production team led by Dr. Michelle Zorrilla at the University of Pittsburgh Department of Rehabilitation Science and Technology.