Quality Insights from a 40+ Year Veteran of the Medical Device Industry

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Зроблено Greenlight Guru's Jon Speer + Medical Device Entrepreneurs, Executives, Inventors & Consultants; R&D, Quality, Regulatory, Greenlight Guru's Jon Speer + Medical Device Entrepreneurs, and Consultants; R і знайдено завдяки Player FM та нашій спільноті. Авторські права належать видавцю, а не Player FM, і аудіоматеріали транслюються безпосередньо з сервера видавця. Натисніть на кнопку Підписатися, щоб слідкувати за оновленнями в Player FM або скопіюйте і вставте посилання на канал до іншої програми для подкастів.

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 Buzz 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.

Some of the 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 aren't effective.
  • 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.

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.”

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

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