Articles By Jim Pomager

11. 3 Ways To Gain A Strategic Edge With Your Medical Device Supply Chain 12/22/2014

    Is distribution a core competency for your company? My guess is that you answered “no.” Most medical device manufacturers would cite R&D, design, production, or even sales and marketing as points of strength in the value chain. Far fewer, I’d venture to say, would claim outbound logistics as a strategic advantage — which is completely understandable. Supply chain management for medical device manufacturers is no longer a matter of simply moving products from point A to point B.

12. How Dexcom Plans To Eliminate The Finger-Stick (And Bring CGM To The Masses), Part 2 12/15/2014

    In Part 2 of this Q&A, we continue our conversation with Dexcom CEO Terry Gregg, getting his insights on artificial pancreas technology, how Dexcom competes (and partners) with the major players in the diabetes device space, what startups should do to procure funding, and other topics.

13. How Dexcom Plans To Eliminate The Finger-Stick (And Bring CGM To The Masses), Part 1 12/12/2014

    Continuous glucose monitoring (CGM) has completely transformed the way diabetes is managed. However, the technology is currently approved only as a complement to the good, old-fashioned finger-stick, not a replacement for it. I recently spoke with a man whose company intends to change that — Terry Gregg, CEO of Dexcom, Inc. During our conversation, we discussed Dexcom's current and future plans for CGM, the company's regulatory strategy, how it competes with much larger device makers, artificial pancreas research, and much more.

14. 5 Big Trends Affecting Polymer Material And Process Selection For Medical Devices 11/17/2014

    I recently joined a group of medical device makers, material suppliers, contract manufacturers, and other members of the medical plastics community at a one-day conference called Technology Advances in Plastic Materials and Processing for Medical Devices. The event crammed a whopping 14 technical presentations into eight hours, covering everything from emerging polymer formulations to injection molding challenges to new surface finishing technologies. Throughout the course of the event, several recurring themes emerged during presentations and conversations with attendees. Here are 5 major trends medical device OEMs should take into consideration when selecting plastic materials and manufacturing processes for their designs.

15. Medtech In Motion: Building A Medical Device Business On Actuation 11/7/2014

    When I first met Maureen Mulvihill, Ph.D. — during a tour of her company’s offices and manufacturing facilities earlier this year — I was struck by her down-to-earth yet contagiously positive attitude.

16. Bridging The FDA-CMS Divide: An Optimized Route To Market For Medical Devices, Part 2 10/28/2014

    In the crucible that is today’s healthcare environment, medical device companies can no longer wait until they have regulatory approval or clearance to begin pursuing reimbursement for their products. Nor can they approach regulatory and reimbursement activities as completely independent initiatives. A more tactical, integrated methodology is required.

17. Bridging The FDA-CMS Divide: An Optimized Route To Market For Medical Devices, Part 1 10/21/2014

    When Kevin Conroy joined Exact Sciences as president and CEO in April 2009, the company had a novel, highly accurate, and noninvasive diagnostic technology for the early detection of colorectal cancer — and a potentially huge market. It was also low on capital. Conroy and his team estimated that product development and separate clinical trials to satisfy FDA and CMS requirements would take the better part of a decade to complete, and there was no way to finance the company for that long. Yet here we are, less than six years later, and Exact Sciences’ Cologuard test has obtained both FDA approval and a CMS coverage. How did the company's prospects shift so dramatically? It all began with one fateful meeting.

18. Making Breast Cancer Screening Available Worldwide — Without Radiation Or Pain 10/1/2014

    In honor of Breast Cancer Awareness Month, this month’s CEO Corner profiles the founder of a breast cancer diagnostics company whose mission is to provide less-expensive, easy-to-use screening tools to the developing world — and radiation- and pain-free options to specific patient groups in the U.S. Mihir Shah, CEO of UE LifeSciences, recently told me the story about how his company began, the struggles it faced in bringing its products to market, and the strategies it used to overcome those challenges.

19. 5 Keys To Protecting Your Medical Device From Cybersecurity Threats 10/1/2014

    In this nascent era of connected healthcare, medical devices must be evaluated in a much broader context than simply a series of discrete patient engagements. They should be viewed as the basic building blocks of a massive national biomedical device network, one that undergirds our nation’s entire healthcare infrastructure. Unfortunately, they are also the most vulnerable components of that system. Learn how to protect your devices, the national network, and patients from malware and hackers.

20. The DOJ & cGMP Enforcement: What The Medtech Industry Can Learn From Pharma's Folly 9/23/2014

    What would you say if I told you that failure to comply with FDA Current Good Manufacturing Practices (cGMPs) could soon cost your company millions — as much as $505 million, or even $750 million? Those are the amounts paid by pharmaceutical manufacturers in recent years to settle allegations of manufacturing adulterated product that eventually ended up in Medicaid and other government healthcare programs. If you think these examples don’t apply to you because you’re a medical device manufacturer, then think again.