Regulatory & Compliance Perspectives

  1. Sanmina’s Culture A Template For Medtech Growth

    Having worked for two different device contract manufacturers, and having made decisions to outsource manufacturing to other contract manufacturers, I’ve had both good and bad experiences. Reflecting on one of my best experiences in outsourced medical device manufacturing, I reconnected with Tim McGinnis, VP of quality assurance and regulatory affairs for Sanmina’s medical division, to gain insight from his successes.

  2. The Impact Of U.S. Tax Reform And Trade Policy On The Medtech Industry

    This article - the second in a two-part series - examines the impact of a border adjustment and a border tariff on medical device companies, as well as the dynamics between the U.S., Mexico, and China.

  3. 3 Bad Ideas For FDA Pre-Sub Meetings

    The FDA currently handles about 1,500 pre-subs per year - a number expected to grow to about 2,350 in the next five years. Here I present three sure-fire ways to make your pre-sub meeting stand out for all of the wrong reasons. 

  4. Beyond Validation: How Meeting Only Minimum Usability Requirements Can Affect Devices After FDA Approval

    Because FDA requirements focus heavily on usability issues related to safety, device developers can fall into the trap of assigning less meaning to usability problems that won’t cause harm. But, it is not always possible to catch all unanticipated use errors during validation, and usability problems not directly related to safety risks can still affect purchasing decisions and device acceptance.

  5. Designing Drug Delivery Devices For Usability

    Usability is a critical factor for all medical devices, but drug delivery devices come with their own unique challenges. Designing for usability requires a clear understanding of user needs and limitations, as well as the environment in which the device will be used.

  6. How An ACA Repeal Could Impact Medtech

    Given that Republicans hold only a simple majority in the Senate, it is expected that their power to dismantle the ACA will be limited to those provisions that are tied to the budget. This article — the first in a two-part series — will discuss how repealing certain parts of the ACA will impact the medtech industry.

  7. Medtronic’s CardioInsight, A Nanocoated Stent, And A Hug

    Thinking about flowers, candy, and cards? (If not, your Valentine’s Day may be in jeopardy.) While you’re thinking, why not explore some good news for the traditional Valentine symbol, the heart?

  8. 50 Shades Of FDA: Some 2017 Guidance Documents Will Require Clarity

    Among the dozen "A-List" guidance topics that FDA has slated for finalization in 2017, three already have been released. That's good progress. But, at least three of those guidance initiatives put forth directives that medical device companies may find difficult, if not impossible, to follow.

  9. Missed Diagnosis Motivates Entrepreneurial Response

    In his final year of medical school, Matt Kesinger realized that a clinical examination was never going to be good enough for early stroke detection, and he began to develop the technological solution that would become Forest Devices’ ALPHASTROKE.

  10. Reconditioned Devices: Potential Regulatory Changes Create Tension Between Third-Party Entities, OEMs

    Concerns voiced in the Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers request for comments represent a situation to monitor, affecting product quality and public health issues.