MedTech True Quality Stories

Oct 11 2019 23

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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Improving Outcomes and Reducing Costs with an Intelligent Surgical Medical Device

Oct 11 2019 34 mins

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 f

Elevating True Quality with SaMD for Early Cancer Detection and Treatment

Aug 09 2019 35 mins

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 proprieta

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

Jul 26 2019 48 mins

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 ep

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

Jul 12 2019 34 mins

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

Creating a Culture of Quality at your MedTech Company

Jun 21 2019 31 mins

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 to

Advancing MRI Technology As We Know It Today

May 10 2019 22 mins

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 Coil

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

Apr 26 2019 27 mins

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. So

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

Apr 07 2019 33 mins

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

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

Apr 07 2019 27 mins

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

Improving the Colon Cancer Screening Experience

Dec 31 1969 27 mins

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