In this episode of the Global Medical Device Podcast, Jon Speer talks to Herschel “Buzz” Peddicord, founder and CEO of InControl Medical, which designs and manufactures patented devices for the control of incontinence.

Listen to Herschel share his valuable insights from spending four decades in the medical device industry, developing products that address and improve quality of life and truly make a difference in patient lives.

 

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Some highlights of this episode include:

  • Guard Cash: It takes some medical device startups to raise additional rounds of funding and capital, but don’t give up or be ashamed to ask for advice about designing and developing devices to get them to market.
  • Anytime you develop a medical device product, you must test, maybe redesign, connect with target customers, and overcome the FDA’s regulatory challenges.
  • More than 60 million women experience female urinary incontinence and another 17 million deal with fecal incontinence. Yet, treatments such as medications and surgery don’t work.
  • The two types of female incontinence are stress urinary incontinence due to weak pelvic floor muscles caused by childbirth or high-impact exercise and urge incontinence caused by the overactive detrusor bladder muscle.
  • Herschel decided to develop a device that treats both types of incontinence. Attain is a transvaginal device that delivers dual stimulation signals to all muscles involved in causing incontinence.
  • No woman has ever died from urinary incontinence, but it dramatically changes their lifestyle. Attain allows women to get away from using pads and diapers to stay dry and avoid leakage.

 

Links:

InControl Medical

Keiretsu Capital, LLC

FDA - 510(k) Clearances

Affordable Care Act

Greenlight Guru Academy

The Greenlight Guru True Quality Virtual Summit

MedTech True Quality Stories Podcast

Greenlight Guru YouTube Channel

Greenlight Guru

 

Memorable quotes from Herschel Peddicord: 

“Female urinary incontinence - it is an absolutely huge market. More than 60 million women deal with urinary incontinence and another 17 million deal with fecal incontinence.”

“Incontinence in 90% of the cases is a muscle issue.”

“We have about a 93% success rate at stopping urinary incontinence.”

“As far as we know, no woman has ever died from urinary incontinence, but it dramatically changes their lifestyle.”

 

Transcription:

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: I had an opportunity to catch up with the president and CEO of InControl Medical, Herschel" Buzz" Peddicord today. It was a great conversation for a couple of reasons. First and foremost, anytime I get a chance to chat with somebody who's been in the medical device industry for 40 years and had several successful ventures and serial entrepreneurship along the way. I always find that fascinating, but I think the thing that sticks out the most to me is very clear that Buzz is 100% focused on developing products that address and improve quality of life, that truly make a difference. He focused and emphasized on the importance of quality. So, I hope you enjoy this episode of the Global Medical Device Podcast, and thank you so much for continuing to be fans and listening to the Global Medical Device Podcast. Hello and welcome to the Global Medical Device Podcast. This is your host and founder at Greenlight Guru, Jon Speer and joining me today is Herschel Peddicord. Herschel is the founder and CEO of InControl Medical. So Herschel, welcome.

Herschel Peddicord: Thank you very much, I'm happy to be here, Jon.

Jon Speer: So Herschel, a great place to start is, tell us a little bit about who you are and the origins of InControl Medical and things of that nature, and then we'll dive into some details and talk more about your journey. But first and foremost, who is Herschel Peddicord?

Herschel Peddicord: Oh, he's a character I'm telling you. I wouldn't loan him any money. I've been in the medical device business for about 40 years. My last company was a telemedicine company called HomMed and sold that to Honeywell, and then I retired, did what you're supposed to do, went and bought the condo on the beach in Florida. Then I went to visit my mom and dad, who were both professors in the University of Mississippi. My mother says," Well, if you're so damn smart, why don't you come up with something that'll stop me from having to get up five or six times in the middle of the night to go to the bathroom?" My first thought was," Too much information, mom." But I went down in the basement and looked up female urinary and continents and it is an absolutely huge market. More than 60 million women deal with urinary incontinence and another 17 million deal with fecal incontinence, which is a whole different level. So, I started looking at what was available for treatment and mostly it was medications that don't work, or surgery that I think, surgeries dropped a lot after 108, 000 liability lawsuits against sling manufacturers. There was not anything really designed to treat... There are two basic types of incontinence. One is stress urinary incontinence, which is weak pelvic floor muscles caused usually after childbirth or high impact exercise. The other is called urge incontinence. You've probably heard of overactive bladder. The bladder is not really overactive. It's just a vessel, that collects urine. There's a muscle that sits on top of that bladder called a detrusor muscle and somewhere around the time of menopause or pre- menopause, it loses its communication with the brain and it starts squeezing whenever it wants to. So, imagine you're going 70 miles an hour down the interstate and your detrusor muscle says," Hey, it's time to go to the bathroom." Well, that's a problem. It's not just a inaudible to stress urinary incontinence, it empties the bladder.

Jon Speer: Wow.

Herschel Peddicord: Essentially when you boil it down, incontinence in 90% of the cases is a muscle issue, either weak pelvic floor muscles, or an overactive detrusor muscle, but there was nothing out there that really treated both. You had some devices that were designed for urge, some that were designed for stress and nobody addressed both issues in one device. I spent a couple of years talking to doctors, scientists, physical therapist, engineers, and told them what I wanted. Some told me it wasn't possible, but we did it anyway. We developed a device that uses electrical muscle stimulation and there's a neuro component to it. We also use the pudendal nerve to get to the detrusor muscle. It's a trans- vaginal device because that's where the muscles are. We send out two different signals, one to the pelvic floor muscles to strengthen them and another signal to the detrusor muscle to calm it down. It's been refined several times, improved. We have our own specific algorithms that we designed to address these issues, and we have about a 93% success rate at stopping urinary incontinence.

Jon Speer: Wow, that's amazing. Here you thought you were going to go to the beach to retire and you speak to a loved one and she says," Hershel, there's a need out there." I guess, obviously, helping those that we loved is a great motivator to start a whole new company again. I mean, that had to be a really interesting journey, to start it all over again?

Herschel Peddicord: Well, yeah. And you can only play so much golf. I am not very good at golf. I can hit the ball, don't ask me where it's going to go, I can hit it. You didn't see me in the Ryder Cup over the weekend. I guess I'm a sucker for stress or addicted to stress, I don't know. I got together with the guys that made money on HomMed and said," I want to do another company." And they said," How much you need?" So we started InControl Medical.

Jon Speer: Wow, and that was what? 11 years ago, if I remember?

Herschel Peddicord: I think it's 10 years ago.

Jon Speer: 10 years ago. Okay, very cool. I think the first product that you developed, I think it was called InTone. I think you mentioned before we started today-

Herschel Peddicord: Correct.

Jon Speer: ...that that product is no longer on the market. But when you were developing the InTone device, you mentioned that there was nothing on the market that combined both of these needs.

Herschel Peddicord: Correct.

Jon Speer: How challenging was it to not only design and develop, but get through all of the regulatory obstacles and hurdles and things of that nature?

Herschel Peddicord: Well fortunately, it's something I've done a few times before for other companies, but yeah, anytime you develop a product, you have to test it. Of course, we did a lot of testing in- house, some humorous stories, someday we'll have a beer and I'll fill you in on those. At any rate, we did our clinical trials, proved that it worked, then submitted to the FDA. It's was a 5, 10K device. We basically used e- stim devices as the predicate, though they're to be honest, not close to each other, but it worked. So anyway, and the InTone product required the use of a physician, and it was done that way intentionally so that the patient would go in to the physician's office, he would set the stimulation algorithms for the patient and they'd go home, they'd come back two weeks later, he'd test," How are things going?" Make any adjustment necessary. It was really designed to be sold through physician offices but right after Obamacare, or the Affordable Care Act, came into effect, insurance reimbursement dropped from essentially retail price to about a quarter of that and that made it... and then of course everybody's deductibles went up. So, that business model of selling through physicians no longer worked, it was not economically feasible for us or the physician, or the patient. So, we basically took 18, 24 months off, not off, we redesigned the whole product line, back to the FDA and got clearance for over- the- counter. We still have physicians that recommend the product, don't get me wrong. Patient can now order from our website as well. When you look at the market, 70% of women never tell their physician they have the problem because they're embarrassed about it. They don't tell their husbands, they just quiet, but they will order something delivered on a plain brown box with no signs on it screaming you have incontinence and use it at home and have success with it.

Jon Speer: Well, I mean, I think that's a real interesting challenge. I mean, you've got a market need for sure. Yeah, how do you reach those? When you were working directly with physicians and the product was basically prescribed and placed by the physician, I mean, you had to pivot that, now you have to reach the audience through marketing and other places. How did you go about finding how to connect with the women who could benefit from these products?

Herschel Peddicord: I got to tell you, I had never done direct to consumer before. I had built sales forces for numerous companies to call on physicians and sell products. That's what I did for most of my career. Now I'm trying to reach people out there in the netherworld and convince them that they should spend several hundred dollars to buy our product and use it. We went through a couple of ad agencies. All the ad agencies, by the way, will tell you they know exactly how to do this. Sometimes that's true, most times it's not. But at any rate, I took the Google tutorials, the Facebook tutorials, and I had to reinvent myself a little bit, but we found an agency that was good at putting up ads on Facebook, and Google, and Bing, and Pinterest and Instagram marketing today is considerably different than it was 20 years ago.

Jon Speer: Oh absolutely.

Herschel Peddicord: When you bought an ad in a magazine, a newspaper and ran a TV spot or two, and you were done. Well, it's a lot more involved today. So it was a case of we had a product that worked and we knew it worked. So, after Obamacare, we had a choice. Close the doors and go home, or find another way to sell it. You ask about advice to other entrepreneurs. Don't quit, don't give up. You're not dead until you're dead, got to keep fighting. Find another way to skin that cat.

Jon Speer: Absolutely, absolutely. Folks, I want to remind you, I'm speaking with Hershel Peddicord. Herschel is the CEO of InControl Medical, and you can find a lot more about InControl Medical. Very simple, go to their website incontrolmedical. com. All one word, no spaces, no hyphens, anything inaudible, incontrolmedical. com. While I'm taking this break, want to remind folks about Greenlight Guru. Greenlight Guru has the only medical device success platform on the market today, designed specifically and only for medical device companies by actual medical device professionals. Within the success platform, there are workflows to help you manage and maintain your design control information, design history file, your risk management, workflows, helps you with document and record management, as well as post- market quality events, things like CAPAs, and complaints, and nonconformances, and it's all in a single platform, a single source of truth. So, if you'd like to learn more about the Greenlight Guru medical device success platform, very simple, go to www. greenlightguru, you'll learn a lot more about that product that I mentioned, and we'd be happy to have a conversation with you and understand your needs and requirements, and see if we have solutions that can help you. So, reach out to us, we'd be happy to help. All right, so Herschel, getting back to the conversation, I mean, obviously InControl has had to pivot a time or two from that first product InTone, to going direct- to- physician, now direct- to- consumer and figuring out how to continue to pivot and evolve to address the need. Obviously, you've got quite an array of products in your portfolio today. So, give us a little bit more information about InControl Medical and the types of products and how you've continued to build out that product line?

Herschel Peddicord: Premier product is called Attain, as in attain quality of life, attain freedom. Jon, as far as we know, no woman has ever died from urinary incontinence, but it dramatically changes their lifestyle.

Jon Speer: For sure.

Herschel Peddicord: There are grandmothers that won't go visit, see their grandkids because they're afraid they're going to have an accident in the bed of their daughter or son. They don't want to do that. They won't go on vacations because they can't drive more than an hour before they have to stop. Women in their 50s who are getting back into the dating pool, afraid to be intimate with a partner because they might have an accident. I mean, these are lifestyle changes that affect the inaudible. So, if you can get away from pads and diapers and not leak anymore, why wouldn't you do that?

Jon Speer: Right.

Herschel Peddicord: So, we wanted to develop a product to fix the muscles, rehabilitate the pelvic floor muscles, rehabilitate the detrusor muscle. Now you don't need to pads or diapers anymore. So, this is the Attain device. It uses a trans- vaginal probe, it's inserted, and then it can be inflated. It's inflated so that the electrodes that put out the neuromuscular stimulation are up against the walls of the vagina. It also acts as active resistance. So when they squeeze on it, obviously, it's air so it's pushing back. So, it gives you an exercise and strengthens muscles quickly. There's also a pressure sensor inside this balloon that measure the pressure inside the balloon. So now, when the woman squeezes on the balloon, it registers a change in pressure, which is also a sign of muscle strength. So, it measures pressure down to one one- hundredths of a pound per square inch. So, when she squeezes, she might squeeze at 1. 2 pounds today, tomorrow it might be 1. 3. She can literally see her muscle strength is going up. We're using a bar graph, and each one of these bars represents so many pounds per square inch. The next version, Attain Plus, actually has an app attached to it that plots a graph showing those exact digital... The woman can now see actual clinical data on her muscle strength as it goes up every day and then it trends ut over seven days, 14 days, 30 days, and the physician can also see, if she does it go to her physician, that she's making progress inaudible. So, our goal is to give the woman a real medical device, FDA cleared, we build them right here in Brookfield, Wisconsin, and we've got every quality standard known to man, and she can then do her exercises and get well and get treated. Now, once she reaches dryness, she uses it once or twice a week to maintain her gains. It's very similar to going to the gym. You go to the gym now, you're going to build muscle. Quit going to the gym, the muscle will get weak again. But if you go once or twice a week, you can maintain your gains. The good news is, for Medicare patients, we became Medicare direct, we can bill Medicare direct. So, Medicare patients can basically get this for a little or nothing, and there are about 17 million women on Medicare with incontinence. So, we bill Medicare and we ship the product.

Jon Speer: Yeah, very cool. I mean, I love the solving for a real need to improve the quality of life. I mean, it's a mission that we believe in 100%. It's my own personal North Star. I mean, I've been in the medical device industry not quite as long as you, but long enough to realize, fortunately very early in my career, that the things that I am involved with as a medical device professional, the products that I design, have a huge impact on that quality of life. I want that to be a positive impact and I'm just thrilled to have an opportunity to chat with you and hear about your journey and how you're focused on improving the quality of life for women with this huge need. Herschel, as we start to wrap things up a little bit today, I mean, obviously you're a serial entrepreneur. You've done this quite a few times now. You've understood when to pivot and how to pivot and adjust and evolve your business. You mentioned a moment ago that one piece of advice that you give to other inventors and entrepreneurs is don't give up, keep going. What other tips, pointers, advice, suggestions, could you offer those listening today about being successful in a journey to bring products to market that solves real needs?

Herschel Peddicord: Actually, a couple of friends of mine and I started a consulting company to work with entrepreneurs. We finally gave up because it was so frustrating because nobody would listen. First of all, don't think that you raised a million bucks and you deserve a quarter of a million dollar salary. You're not going to make big bucks, not in the beginning. Cash is king, have to conserve as much cash as you can. If you think you're going to need$ 2 million to launch your business, get$ 4, because you're going to be wrong. Something will happen that will come up, that will eat up that cash faster than you can move. So, always start with a little more than you think you will need, because there are a lot of cow patties out in the pasture and you're going to step in one or two, whether you like it or not. I know, my shoes are filled. So, don't give up and don't be afraid to take advice. Don't be afraid to ask for advice. There are plenty of smart people in this world that maybe have already done something you want to do. Maybe not the same product or whatever, but the same market. Don't feel ashamed to ask for advice, there's nothing wrong with that. Those would be my number one pointers. Guard your cash, watch it carefully, spend it like it was the last penny you're ever going to have, and stay focused, don't give up.

Jon Speer: Yeah, I love that. I mean, I've seen unfortunately so many medical device startups that seem to get enamored and almost fall in love with raising additional rounds of funding. It's concerning to me because my focus has always been about, okay, yes, it does take some capital to design and develop devices and get them through regulatory, through FDA and what have you, but get them to market. But my focus is always about trying to minimize, to get from point A to point B as quickly as possible, try to get that product into the hands of the physicians and the patients who can benefit from those products as quickly as possible. But so many startups seem to be allured by this... they get in this fundraising trap, to your point, maybe," Oh, I'm going to raise$ 2 million." They get into it, they realize," Oh my goodness, I stepped in a cow patty or two, and now we're on fumes so we don't have enough cash to get to that next point." So, then they have to go raise another round, and another round, and another round. Any practical tips, or pointers, or thoughts that you can share with folks that might be stuck in that trap of fundraising?

Herschel Peddicord: I've always worked with angel investors and I have nothing against venture capital or private equity. They tend to be, let's just say, a little bit greedy and they want a big chunk. Obviously if you're going to sell equity, you're going to be diluted and that's something else you can expect to happen. If you're going to go raise capital, you're going to get diluted, you're not going to own 100% of your company anymore, but be sure you have a good board of directors that stays with you and supports you what you're doing. So, there are angel groups out there. There's one called Keiretsu that's very effective, it's nationwide. Most of their investors are in the$ 25,000 to$50, 000 range, but there's a lot of them and they give you access to them. You present your product to them and the idea and the concept and people that like it participate and you don't give away the whole farm unless, if you're going to go raise$ 20 million, then yeah, you're going to probably need a VC group or private equity, but you need a couple of$ 2 or$ 3 million to get going, keiretsu is a good example of a group to do that.

Jon Speer: Okay and folks will find the link to that organization and provide that in the show notes that accompany the podcast. Well, Herschel, I've enjoyed an opportunity to learn a little bit more about who you are, a little bit more about InControl medical, any final thoughts that you want to share before we wrap up this episode of the Global Medical Device Podcast?

Herschel Peddicord: Well, I think it's important like you said, Jon, that people understand that you're not just trying to sell a product. If you're just trying to sell a product. Well, good luck. You really need to focus on what you can do for society as well. Individuals stand behind your product. First of all, focus on quality. Make sure you have the best quality product you possibly can and give excellent customer service. If you do those two things, you'll be successful. There's two rules about customers. Rule number one is the customer is always right. Number two, if the customer is wrong, refer to rule number one.

Jon Speer: Yeah, it's true, that's sage advice. Well, Herschel, thank you so much. I appreciate the opportunity to chat with you. And folks, again, check it out incontrolmedical. com. You can check out the products that they have, the Attain device and others in their portfolio. If you or someone you know who could benefit from this type of solution to help with incontinence challenges, well, you can order those products directly from InControl Medical, so check that out. As always, thank you for listening to the Global Medical Device Podcast. It's because of you that the Global Medical Device Podcast continues to be the top podcast in the medical device industry. So, thank you so much for that. Continue to spread the word and share this with your friends and colleagues. We love learning about new listeners and folks that are finding and discovering the Global Medical Device Podcast for the first time. As always, this is your host and founder at Greenlight Guru, Jon Speer, and thank you so much.




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