With the new push for faster and faster development prototyping outfits such as Proto labs have been adding a new services. A key new service is overmolding plastic for medical parts. Medical designers can now introduce overmolding early into their design process. But there are challenges. Becky Cater reviews best practices and some of the
The dust up between St. Jude Medical and Muddy Waters is nothing short of a cybersecurity nightmare – even for companies that have a solid security plan in place. The medtech community needs to better understand it and keep a close eye on the developments. Essentially, it represents an ethical gray area on the part of cybersecurity
Adaptive clinical trials are not a new concept, but they are new to medical device technology. The practice of conducting adaptive clinical trials has the potential to save manufacturers time and money, as well as help them get to market quicker. FDA has released guidelines recommending that medical device companies use adaptive designs in clinical
Bundled payments in orthopedics may not directly influence medical technology companies yet, but the smart firms are paying attention. The process will very likely soon be used in procedures beyond hip and knee, such as spine surgeries and neurosurgery, and future iterations of the program could include commercial risk-sharing. It is the future of many
Thomas Bold is the President and CEO of RenovaCare. RenovaCare is developing first-of-their-kind therapies for regenerating human organs by using a patient’s own stem cells. With extensive business experience in biotechnology, device manufacturing, stem cell research and regenerative medicine, Thomas is streamlining RenovaCare’s flagship technology, the SkinGun. The SkinGun is a revolutionary technology that uses
Jonathan Draper is the director of Product Management in the healthcare division at Calgary Scientific. Calgary Scientific provides advanced web-enablement, mobility, and visualization solutions for industries wanting secure access to their data or graphic intensive applications. In this episode Jonathan discusses how mobile devices are gradually being integrated into the health industry.
Walt Murray, ICLA, CSSMBB, is the CEO of ARC Experts and a strategic partner for MasterControl Quality & Compliance Consulting who recently gave a presentation on “Identifying and Conquering Your Design Control Risks Specific to Your Mobile Health Innovation” at MD&M East. His presentation highlighted design and development, along with best practices. Walt joins us
Scott Dodson is the CEO and President of AirXpanders. AirXpanders is an emerging medical device company to watch in the U.S. Based in Palo Alto, AirXpanders has developed a technology that improves the breast cancer reconstruction process for women and is currently under review with the FDA. By employing a revolutionary new tissue expander, the
FDA recently released new guidance documents on 3D printing. These guidelines clarify compliance and technical considerations for additive manufactured devices. Chris Krampitz, a strategy and innovation expert for AM technologies at UL answers questions about the documents and gives overall advice for additive manufacturers in the medtech space in a podcast, Compliance for 3D printed medical devices: What
Dr. Magdalena Sanz Cortes is an associate professor of obstetrics and gynecology at Baylor College of Medicine. She advises senior engineering students at Rice University who have created a prototype of a device to monitor the pulse and oxygen levels of a fetus undergoing endoscopic fetal surgery in a mother’s womb. The WombOx team of
For a man who took a company from $17 million in sales to a $4.5 billion publicly traded juggernaut listed at #307 on Forbes 400 billionaires, John Brown is a remarkably humble man. He’s also, for all intents and purposes, the man who put Stryker on the map during his 32-year tenure as CEO, which
The author of new book, “Mantra Design – Innovate, Buy or Die!,” Dana A. Oliver joins us. Dana has helped grow Medtronic’s Surgical Technologies ENT / NT division from $100 million to approximately $2 billion in annual revenues over fourteen years and will discuss his definitive innovation leadership guide book.
Valeska Schroader is the SVP Product Management at Vital Connect, a leader in the biometric wearables industry. The company is introducing a new wearable for the medical community that will make wearables viable for a doctor¹s office, out-patient care or hospital setting. VitalPatch is the first peel-and-stick, one-time use wearable that delivers clinically accurate measurements
Stephanie Domas, Battelle’s lead medical device security engineer, discusses the cybersecurity climate for medical device technology, and provides some insight into how to painlessly approach your own risk-mitigation plan.
Today we have Eagle Pharmaceuticals President & CEO, Scott Tarriff and Adrian Hepner, M.D., PhD, EVP Clinical Research, Regulatory & Medical Affairs. Eagle Pharmaceuticals recently announced that the FDA granted Fast Track Designation to their product, RYANODEX, for treatment of exertional heat stroke. The Fast Track Designation highlights a serious, unmet medical need that exists