MedTech True Quality Stories

This is MedTech True Quality Stories, hosted by Jon Speer, founder and VP of QA/RA at Greenlight Guru. Each week, we embark on a new storytelling journey with different MedTech executives as they share real-world, actionable best practices for medical device leaders. Listeners will gain invaluable insights into how these industry pioneers are successfully imagining, implementing, and improving True Quality medical devices.

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Episodes

Improving Outcomes and Reducing Costs with an Intelligent Surgical Medical Device

Surgery can be a challenging experience, not only for patients, but their clinicians and caregivers, as well. The lack of innovative medical devices with intelligent software following cardiothoracic surgery provided an opportunity for one MedTech company in particular. Today’s guest is Evan Luxon, co-founder and CEO at Centese. The early stage company achieved 510(k) clearance from the FDA for its intelligent surgical drainage product called, Thoraguard. Centese followed a deliberate and dilige...

Oct 11, 2019•35 min•Season 1Ep. 10

Elevating True Quality with SaMD for Early Cancer Detection and Treatment

In the U.S. alone, over 80% of the 5,000 biopsies conducted daily come back either falsely negative, or falsely positive. More than 350 breast cancer cases evade early detection because of misdiagnosis. Many of those errors can be avoided. There's one company in particular that is leading the charge with a truly innovative solution to this problem, Koios Medical. Koios is proprietary software that has the power to meaningfully elevate the quality of medical care and support accurate decision-mak...

Aug 09, 2019•36 min•Season 1Ep. 9

A Firsthand Account of the Origins and Outcomes of FDA's Case For Quality and MDDAP

Patients, providers, and companies are already experiencing the benefits of FDA’s Case for Quality Program and CMMI Institute’s Medical Device Discovery Appraisal Program (MDDAP). Today’s guest is Becky Fitzgerald, principal and co-founder of Two Harbors Consulting. She’s passionate about her involvement with Case for Quality and being a lead appraiser for MDDAP. In this episode, Becky gives listeners an inside look into her instrumental work and involvement with FDA's Case for Quality and MDDAP...

Jul 26, 2019•49 min•Season 1Ep. 8

Eliminating Subjectivity And Guesswork With A Modernized Solution To Detecting Ear Infections

If you or your child have ever experienced ear infections, you know how difficult (and painful) they can be to diagnose and treat with prescribed medicines and procedures. Today’s guest is Ryan Shelton, CEO and founder of PhotoniCare, whose team has developed TOMi Scope, a non-invasive handheld imaging platform that uses light to see through ear tissue. PhotoniCare’s TOMi Scope looks directly at the disease, not the eardrum. Some of the highlights of the show include: ● Middle ear infection is t...

Jul 12, 2019•35 min•Season 1Ep. 7

Creating a Culture of Quality at your MedTech Company

Is creating a culture of quality a top priority at your MedTech company? But you’re not sure how or when to start? Today’s guest is Devon Campbell, founder of Prodct LLC, a MedTech company helping to establish and implement holistic, efficient, and practical product development and manufacturing strategies. In this episode, Devon shares valuable insight with listeners on the topic of quality culture within companies. His proven approach has helped a wide range of medical device professionals ach...

Jun 21, 2019•31 min•Season 1Ep. 6

Advancing MRI Technology As We Know It Today

The field of radiology is constantly changing and evolving overtime. One MedTech innovator who's leading that charge is Schelte Post. He’s a quality manager at MR Coils, a company that has successfully developed specialized and innovative Magnetic Resonance Coils for MRI systems. In this episode of MedTech True Quality Stories, Schelte Post shares the fascinating story of MR Coils’ journey in discovering powerful new MRI visible biomarkers, a non-invasive technology can be developed for dynamica...

May 10, 2019•23 min•Season 1Ep. 4

How a Shift in Mindset Resulted in a Higher Quality IQ for this Industry Veteran

Within the medical device industry, there’s a right way and a wrong way to address quality and compliance. Today, our guest is Daniel Powell, CEO of Spark Biomedical, a startup building non-invasive neurostimulation systems. Daniel’s been working in the medical device industry for almost 20 years and shares stories that led him to shift his mindset and focus more on quality. Some of the highlights of the show include: - From FDA warning letters to lots of changes, companies face challenges when ...

Apr 26, 2019•27 min•Season 1Ep. 3

How Sonavex Went from Concept to FDA Clearance in Just 3 Years

How do medical device companies approach the “scaries” related to quality and guidance regulations without breaking the bank? Today’s guest is David Narrow, CEO and founder of Sonavex, a medical device company that offers automated ultrasound solutions. David played a key role in helping Sonavex grow by going from a startup to developing an idea to launching a product in just three years. David shares how to successfully fundraise for seed and Series A rounds, implement a quality management syst...

Apr 07, 2019•27 min•Season 1Ep. 1

Improving the Quality of Life in the Most Delicate Patient Group: Preterm Infants

Premature birth is the number one cause of infant mortality in the United States. Improving the quality of life matters, especially from the moment the most delicate patient is born. Today’s guest is Dr. Amir Fassihi, CEO and founder of Amnion Life. He has been spearheading the company's efforts in developing AmnioBed, a True Quality medical device that aims to save the lives of thousands preterm babies born every year and. Some of the highlights of the show include: - Any minor insult or trauma...

Apr 07, 2019•34 min•Season 1Ep. 2

Improving the Colon Cancer Screening Experience

Preparation for a colonoscopy is not a pleasant or positive experience. From laxatives to the invasiveness and sedation involved, preparing for a colonoscopy is something most patients dread and try to avoid. Fortunately, clinicians and patients can look forward to colonoscopy and colon cancer screening modalities that require no preparation. Today’s guest is Alex Ovadia, CEO of Check-Cap. The company is developing a capsule called, C-Scan, for colon cancer screening, and a U.S. clinical trial h...

Jan 01, 0400•28 min•Season 1Ep. 5

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