Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss the use of an FDA pre-sub (or pre-submission) prior to making a formal submission of a 510(k) or PMA to the agency. While a number of companies are taking advantage of this, as of right now, still free opportunity, many others are not. When submissions are being rejected at such...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss the use of human factors (or ergonomics or useability) in medical device design, the FDA’s increased interest in its use, and how different users impact the device development (such as patient/home use versus physican/hospital use). Specifically, the following questions are addre...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss the passage of MDUFA IV and the changes that are associated with it. Further, we discuss the potential impact this law will have on medical device innovation. In an era of politicians calling for greater healthcare technology and a reduction of healthcare costs, stagnating innova...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss many of the concerns and issues involved with the off-label use of a medical device. Further, we talk about the advertising and promotion of such use, what’s permitted, and what will get a company in trouble. Specifically, the following questions are addressed: What is off-label...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss the differences between materials and biomaterials, biocompatibility, biofriendly, biostable, and bioabsorbable. Specifically, the following questions are addressed:   What’s the difference between a material and a biomaterial? What’s the difference between a biocompatible materi...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss the impact 3D printing has made on the current medical device industry, the challenges that are restricting greater use, and a couple of examples of bleeding edge applications that will likely play a substantial role in medtech and healthcare very soon. Always an interesting topi...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss the significance of reimbursement as it relates to product development. Not all medical device designers and engineers make the necessary connections between these two seemingly unrelated topics. In reality, however, the two need to be considered carefully alongside regulatory is...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss a recent Editor's Letter that appeared in the March 2017 issue of MPO. In it, I wrote about a blog Dr. Jeffrey Shuren , director of FDA’s Center for Devices and Radiological Health, authored regarding findings of recent hospital inspections as related to medical device repor...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we discuss the use of real world evidence in the medical device approval process, which has gained much attention lately due to several reasons. It was specifically mentioned in the 21st Century Cures Act and it was also the topic of a recently released FDA Guidance document (PDF). Further,...