Articles by Bob Marshall

  1. Evolving To Meet The Medical Device Outsourcing Boom 3/19/2018

    The global medical device outsourcing market is expected to reach $88.2 billion by 2025. I spoke with Steve Cottrell, president of global life sciences consulting firm Maetrics, to learn about some of his approaches to serving the medical device market and planning for this growth.

  2. Empowering Women’s Healthcare With Data Science And AI 3/14/2018

    The Centers for Medicare and Medicaid Services published statistics on U.S. personal healthcare spending by age and gender in 2012. The key difference that drives these numbers for women between the ages of 19 and 44 is the cost of maternity care. One company focused on supporting women in this space and looking to capitalize on this market opportunity is Ava Science, Inc.

  3. Frequently Asked (Regulatory) Questions 3/1/2018

    The pivot from 25 years as a medical device practitioner to the chief editor’s chair at Med Device Online has been fun, but not devoid of challenges. My initial fear – that stepping out of the hands-on device development and manufacturing trenches would inhibit my ability to make a tangible difference for device users – has given way to satisfaction in the knowledge that my experience can help to inform and guide others in the industry.

  4. Medtronic Fighting For Minutes…While Losing Hours 2/26/2018

    We’ve all seen or heard commercials from the American Stroke Association (ASA) encouraging people who suspect they might be having a stroke to call 9-1-1 right away, because “time lost is brain lost.”. Stroke is the No. 5 cause of death in the United States, killing nearly 130,000 people a year. That’s one in every 20 deaths, according to the ASA. But even if you survive a stroke, you are not even close to being out of the woods.

  5. “We Are Only Diabetes” 2/21/2018

    Medical device companies often face difficult choices regarding their products, from design tweaks and regulatory red tape to determining whether to solve needs in-house or outsource.One uniquely difficult decision, though, is whether to diversify — and how much — or to specialize.

  6. CAPA Should Not Be Cruel And Punitive Action 2/9/2018

    In a recent guest column on Med Device Online, FDA inspectional observations were summarized for the most recent fiscal year indicating 400 of the 1,030 inspectional observations written by CDRH investigators pertained to procedures for corrective and preventive action (CAPA) not being adequately established (and followed). At 39 percent of all device-related 483s in FY 2017, CAPA was the most prevalent observation.

  7. The Medical Device Excise Tax Is A Disaster! 2/2/2018

    Mark Leahey, President and CEO of the Medical Device Manufacturers Association (MDMA), recently issued a statement in response to President Trump’s State of the Union Address, "While the passage of an additional two-year suspension of the medical device tax is a recognition of how important it is to bolster America’s leadership position in this industry, Congress must permanently repeal this disastrous policy in order to fully realize the long-term investments in patient care and job creation that are critical to growth.” Did he really say – disastrous? Oh yes he did!

  8. Are Wearables Improving Outcomes? 1/26/2018

    To all of you who take health and fitness seriously, I say “hang in there.” It’s almost February and you will have your gyms, swimming pools, and fitness centers back very soon. The January influx of people who made losing weight or getting into shape one of their New Year resolutions will soon recede. Lines will diminish for exercise machines and swimming lanes as the lazy side of human nature lures these well-intentioned newbies back to their comfy couches.

  9. A Cure For A Broken Heart 1/23/2018

    A talk with Steven Morris, founding partner, CEO, president, and board member of BIOLIFE4D. His company is leveraging advances in life sciences and tissue engineering to 3D bioprint a viable human heart suitable for transplant.

  10. I Said “No.” Management Said “Yes.” FDA Said “Recall.” 1/22/2018

    At most medical device companies, mere utterance of the word recall is akin to mentioning the Dark Lord’s name in the Harry Potter series of novels: it’s simply not done, unless one wishes to invite misfortune upon oneself. In Harry Potter’s world, the Dark Lord (Voldemort) is referred to as “He-Who-Must-Not-Be-Named,” a moniker easily coopted by “recall”-averse medical device companies into “That-Which-Must-Not-Be-Said.”