MedTech True Quality Stories

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 diligent approach to design and development, while right-sizing its quality management system (QMS). Listen to the full episode as this MedTech executive shares key insights, tips and best practices to help other MedTech leaders achieve similar success. Some of the episode highlights include: - Proactive vs. Reactive: Thoraguard’s core principles are safety, intelligence, and efficacy. - No Rest for the Weary: Thoraguard automatically monitors patients without needing to rely on nurses to routinely check on patients. - MedTech Space: Start by addressing a clinical problem that people are willing to pay for to solve clinical needs. - Proof of Concept Prototypes: Reach out to as many surgeons and others early on to optimize lean launchpad methodology for relevant and reliable feedback. - Quality Role and Regulations: Feedback helps medical device companies avoid feature creep and change scope to meet fundamental and required functionality. - How to right-size your QMS: Build out the QMS as the project and company progress by knowing what’s needed at each phase of development.

Surgery can be a challenging experience, not only…

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-making by ‘seeing’ what humans can’t. Koios Medical offers accurate ultrasound results through artificial intelligence (AI) and machine learning (ML) algorithms that patients need and physicians find valuable to support early detection and accurate treatment of breast cancer and other diseases. Today’s episode features three guests from Koios Medical offering valuable insight to listeners on how they've been successful in imagining, implementing and innovating a true quality medical device that aims to redefine cancer diagnosis as we know it today, and how other medical device professionals can follow in their footsteps. Some of the highlights of the show include: ● Word Origin and Why: Koios is Titan God of Wisdom, Foresight, and Intellect. ● Regulatory Success: Koios Medical’s DS Breast 2.0 received FDA clearance to assist physicians with AI-based software. ● Koios engineers started using AI/ML algorithms to do face-recognition work for a U.S. defense contractor, and transitioned to adapt AI/ML to do more global good. ● Why now? AI has existed for decades, but only recently has computing power allowed massive amounts of data to become useable in a practical sense. ● Competitive Edge: Koios is doing everything possible to maintain its market lead by building an efficient and expedient processing engine and software. ● Design and Development Direction: Koios’ path to clearance commercialization involves behavioral, technical, and financial challenges/opportunities. ● Reason for Regulations: Koios’ mission is to improve decision making for diagnosing cancer and Reason for Regulations: Quality makes us better.

In the U.S. alone, over 80% of the 5,000 biopsies…

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 programs, including how these initiatives were started and have evolved since, as well as lessons learned along the way. ● Case for Quality: Originated due to auditing issue that revealed problems with the quality of medical devices from fully vs. non-fully compliant organizations. ● Capability Maturity Model Integration (CMMI): FDA selected model to help companies improve the quality of medical devices without more regulations. ● Multiple medical device entities produced proof of concept and pilot program to show benefits, effectiveness, and value of Case for Quality and MDDAP. ● Compliance vs. Quality: Medical device industry’s checkbox and compliance mindset can create direct and indirect impact on quality. ● MDDAP focuses on conversations with people; the intent and goals for documenting or recording are different. ● Processes vs. Attributes: Is there a way to predict if a project will succeed? ● Lessons Learned: Medical device industry isn’t great at estimating work, project management, and handling changes to non-functional requirements. ● Minor Changes, Major Impact: Ask for input, receive it, and make changes to build momentum for quality.