Articles By Doug Roe

  1. Insiders’ Guide To Winning In the Drug Delivery Device Market — Part 3: Quality Systems 2/9/2016

    I recently sat down with Christopher Eustace of Hospira, who has over 27 years of quality experience in both the pharmaceutical and medical device industries, to discuss how a combined QS program is necessary for life science companies striving to capture their piece of the delivery device market.

  2. Insiders’ Guide To Winning In the Drug Delivery Device Market — Part 2: Regulatory Compliance 1/26/2016

    I recently sat down with David Amor, managing partner at MEDgineering, Inc., to discuss the challenges associated with bringing drug delivery devices to market, as well as emerging therapeutic areas and technologies. David’s background is in mechanical and biomedical engineering, with expertise in regulatory systems and compliance. 

  3. Insiders’ Guide To Winning In the Drug Delivery Device Market — Part 1: Design 1/12/2016

    As challenges continue to mount in the med device industry, many companies are looking to drug delivery as a new revenue stream. Here, Neil Cammish, technical director, International Device Solutions, discusses the drug delivery technologies poised to have a market impact in 2016 and beyond.

  4. Secrets Of Micra: How Medtronic Reinvented The Pacemaker 1/4/2016

    The concept and the required technology of the Micra Transcatheter Pacing System (TPS) may end up in Webster’s Dictionary as a true example of disruptive innovation. I sat down with Mike Hess, VP, Bradycardia R&D CRHF Division at Medtronic, to discuss the origin and development of this device.

  5. Navigating The Post-Affordable Care Act Storm 12/11/2015

    Profit margins are thinner. Reimbursement is more complicated. Innovation must be more finely tuned. How will the medtech industry survive the storms of a post-Affordable Care Act (ACA) world?

     

  6. 5 Things We Learned From ‘UDI, Wave One’ 9/1/2015

    Most of the unique device identifier (UDI) wave one rollout is behind Class III med device companies, so what did we learn to avoid getting washed away by waves two and three? I spoke with Jay Crowley —  formerly CDRH’s Senior Advisor at the FDA and one of UDI's progenitors — about the lessons med device manufacturers can take from ‘UDI, Wave One.’

  7. Stryker’s MAKO Surgical Acquisition: A Second Look 8/18/2015

    At a time everyone was playing follow-the-leader in consolidation, Stryker took a different approach. With the MAKO acquisition, Stryker was bold enough to sacrifice short-term profit for long-term gain. I talked with Stuart Simpson, VP and GM of Stryker Reconstructive Business, about how that gamble could pay off.

  8. Philips Healthcare: A New Approach To Innovation 8/4/2015

    How can well-established med device companies overcome the internal hurdles that prevent disruptive innovation? It is not a complete lack of structure that promotes optimal innovation. Just loosen the reins. I had the chance to discuss this topic with Ken Berta of Philips Healthcare. Berta works under the Philips Group Innovation umbrella and is the Head of Commercial Operations, North America.

  9. New Insights On Med Device Market Consolidation 7/17/2015

    If your company is considering M&A as a solution to the med device market pressures, you need to understand the challenges ahead. I sat down recently with Steve Cottrell, the new president of Maetrics Life Sciences Consulting, to discuss his thoughts on the issue.