In an ideal world, no one would have a catheter, but the reality is that 100M patients worldwide rely on an indwelling urinary catheter. Catheterized patients often experience problems, such as catheter-associated urinary tract infections (CAUTI), catheter blockages, leaking and bladder spasms. FLUME estimates the healthcare burden of Foley catheter complications to be equivalent to $80 on average, for each of the 28m placed annually in the US – a total burden of around $2.2bn – and close to $60 even for short-term placement.
William Curtis: Driving Diagnostic Excellence | Ep.50
In Episode 50, we speak with CEO of nRichDX, William Curtis. nRichDX’s patented IVD-labeled platform is the result of an intensive technology development effort that commenced in 2016 and was commercially launched in November 2019. It’s a patented sample prep system that in its current state already provides up to 10x more genetic targets for liquid biopsy testing. It’s commercial stage with some highly regarded customers that cost-effectively improves test sensitivity, earlier detection and earlier intervention leading to superior outcomes. They have been supporting themselves with some angel money and contracts as they have developed both manual and semi-automated systems and data to support performance. The company is raising $20 mm to (1) develop a fully automated system using the exact same scalable technology and (2) to finally be able to invest in Sales and Marketing and commercialize their products.
Join us as we discuss the $5.53 billion liquid biopsy market, the evolution of early cancer detection, the rising importance for liquid biopsy abilities to find information about cancer diseases with the use of blood samples, William’s MedTech entrepreneurial insights into launching companies tackling today’s unmet clinical needs..
Ramin Mousavi: Innovation Leadership Mindset | Ep.48
Ramin Mousavi is the CEO, President, and Board of Directors for Cathworks; a medical technology company focused on applying its advanced computational science platform to optimize Coronary Artery Disease (CAD) therapy decisions and elevate coronary angiography from visual assessment to an objective FFR-based decision-making tool for physicians. Ramin has executive leadership and operational experience
in general management, marketing, strategy, product development, and commercialization across multiple market segments and was responsible for developing the clinical and commercial strategy for CathWorks. He helped with the regulatory clearance of the product in Europe, United States and Japan. He also led the company’s Global Health Economic & Reimbursement strategy where the company was successful in receiving reimbursements in the US and Japan. He is leading the way in building an innovative and community-based organization with a mission to provide clinicians with objective data, so they can make the best decisions for their patients.
Axis Research & Technologies: Medtech Training Camp | Ep.46
AXIS Research & Technologies, Inc. was an idea that originally started from a non-profit created by Founder and CEO Nick Moran to educate youth about the negative effects of diabetes and being overweight. That nonprofit morphed into a broader opportunity to create a Bio Skills Company to provide facilities, medical equipment and tele-training services for surgeons, medical professionals and medical device companies to practice surgical techniques, develop and perfect medical devices and provide education to audiences worldwide. Now in 2021 AXIS is rapidly creating and deploying new technology and IP that is advancing how medical device companies, hospital systems and researchers develop, evaluate and improve medical procedures, devices and outcomes that are reducing risks, and saving lives.
Join us as we discuss how Axis is helping to solve current Medtech challenges with its medical skills training platform, how it’s state-of-the-art labs across America are allowing surgeons, educators and researchers to impact the training sphere, and much more!
Scott Pantel: The Endless Data Challenge | Ep.39
COVID-19 has put the Medtech industry at center stage with unparalleled demand for diagnostic tests, personal protective equipment (PPE), ventilators, and other critical medical supplies. In addition to the extraordinary measures underway to rapidly ramp up manufacturing capacity and capabilities, Medtech companies are also looking outside their normal sector boundaries to explore creative solutions to strategize how they will supplement capacity, open-source equipment design, and address deployment of medically trained employees to support public-health needs. Forward-thinking firms will need data to respond with new products, services, and operating models that can optimize the shifting landscape of healthcare and Medtech development.
Join us as talk with the CEO & Founder of LSI, Scott Pantel. In this episode, we discuss the challenges of living in an era of an overabundance of Medtech data and how unique market insights remain an industry challenge. We explore why it’s more important than ever for startups and large corporations to make their key strategic decisions based on unique and timely insights. Learn about Covid’s impact permanently changing the Medtech landscape, and the new considerations the industry must face to address unmet clinical needs.
Stan Rowe: The Three Legged Stool | Ep.36
Deerfield Management and Stan Rowe created a therapeutic device incubator, NXT Biomedical. NXT Biomedical expects to invest up to $25 million in cutting edge technologies over the next 5 years. Deerfield has allotted up to an additional $250 million for the formation and development of five to eight startup companies that emerge from the incubator. NXT Biomedical provides an exciting new pathway for exceptional science to be incubated with the world-renowned leadership while continuing to address major unmet needs with next-generation medical technologies.
In this episode of DeviceAlliance’s Medtech Radio, we speak with the Co-Founder & CEO of NXT Biomedical, Stan Rowe. Stan recently retired from Edwards Lifesciences where he was Chief Scientific Officer since 2008 and also served as Corporate Vice President, Advanced Technology. He joined in 2004 when Edwards acquired Percutaneous Valve Technologies, a company he helped to found in 1999 and served as President and CEO. Join us as we discuss Stan’s life lessons learned in the Medtech industry, including…
– What are the biggest mistakes R&D makes
– Growing a company in his bedroom to being acquired
– Biggest strategic considerations for innovation
– Different types of accelerators
– Addressing the future of unmet clinical needs
PRO-TECH: Designing Workflow | Ep.33
Accurate medical device labeling is a critical component to any quality control system. Often though, labeling is only considered at the end of the packaging process, which in itself, is often at the end of medical device design and production. Typically, product engineers develop a device, and only then start to think about how they are going to package and sterilize it. And, then after all that work is done, and typically only after that, do OEMs (original equipment manufacturers) and their contract packaging partners consider the labeling requirements. Yet, many downstream quality issues are the result of incorrect labeling and/or ill-conceived quality controls that do not provide the proper monitoring at each stage. These can result in drastic consequences from the US and/or EU regulatory bodies, and more importantly to the health of the patient. If the wrong components are incorrectly labeled or not labeled at all, the negative downstream effects can be considerable.
In this episode of DeviceAlliance’s Medtech Radio, we speak with CEO of Pro-Tech Design and Manufacturing, Pam McMaster, and her son Aaron Swanson President of Pro-Tech Design & manufacturing. PRO-TECH is a family-owned, full-service FDA and ISO 13485 registered medical device contract manufacturer who specializes in medical device assembly and packaging, laboratory services and custom sewn products. Join us as we discuss what most medical device companies forget about, defining and optimizing workflow, the importance of your sterilization method to materials selection, how to navigate an audit during a pandemic, and what opportunities have arisen in this new Medtech environment.
Dr. Keith McCrea: Fighting the Cytokine Storm | Ep.31
In June, the Department of Defense announced it was funding a clinical trial of the device because it showed encouraging preliminary results in critically ill COVID-19 patients at a military hospital in the U.S. and 14 other hospitals in Europe. ExThera Medical’s Seraph 100 extracorporeal blood filter could go a long way in helping COVID-19 patients. In a release about DoD’s funding, it was stated that it appears as if the Seraph 100 helps improve patient outcomes by providing additional time for supportive care while reducing the sources of inflammation and possibly preventing further damage by reducing SARS-CoV-2 virus/RNA in the bloodstream.
In this episode of DeviceAlliance’s Medtech Radio, we speak with ExThera Vice President of Research and Development, and Chief Science Officer Dr. Keith McCrea. He also serves on the scientific advisory board of NESAC/BIO, an NIH-sponsored program at the University of Washington. Dr. McCrea holds 15+ years of demonstrated experience working in the medical device industry, with skills in materials science, polymer science, and surface modification. Join us as we discuss the biology of the “Cytokine Storm”, and how Seraph 100 was used to treat sepsis and drug-resistant bloodstream infections in the prevention of septic shock but is now being used in the fight against COVID-19.
Taylor McPartland: Entrepreneurial Recipes for Success | Ep. 30
ScaleHealth is an innovation ecosystem focused on connecting great innovators in the health/wellness space, with the strategic resources and partnerships with the goal to impact communities in need. On April 7th ScaleLA formally announced that it will be renamed ScaleHealth, a move which coincides with the announcement to open a 2nd location in Orange County. This location will be launched in partnership with The Innovation Institute, a nationwide leader in healthcare provider innovation, and will be housed at the Innovation Lab in Newport Beach.
In this episode of DeviceAlliance’s Medtech Radio, we speak with CEO of ScaleHealth Taylor McPartland. Join us as we discuss his unique background into entrepreneurship, ScaleHealth’s mission to build a global health innovation ecosystem, why Orange County was the perfect next step for their strategic growth, and much more!
Marinela Gombosev: Developing Soft Skills in Leadership | Ep.29
To celebrate our 4th Annual Women in OC Medtech Event, we will be doing an interview with event panelist Marinela Gombosev. Marinela is CEO of Evoke Neuroscience, a data and diagnostics company focused on reducing the number of people living with treatable cognitive impairment. After immigrating into the United States as a war refugee from Bosnia at the age of 14, she went on to complete her undergraduate studies in Electrical Engineering at the University of California, Irvine and received an MBA from Pepperdine University where she was recognized as a “Top 40 under 40” alumna. In 2015, Marinela was inducted into the University of California, Irvine School of Engineering Hall of Fame as the youngest recipient of this award. She has spent her entire 15 year career in regulated industries, the most recent 10 of which have been in medical devices.
In this episode of DeviceAlliance’s Medtech Radio, we discuss her experience coming to the US, the importance of why soft skills in leadership are essential in these times, the impact of Alzhimers’s Disease and Evoke Neuroscience’s solution for cognitive impairment, what women can do to prepare themselves for success during these times, and much more!