Guest Columns

  1. New Wound Closure Technology Set To Triple In Value By 2025, Cannibalize Competitors

    Traditionally, surgical wounds have been closed with sutures, staples, Steri-strips, Mastisol, or some combination thereof. There are multiple benefits to using these technologies, but new products are expected to significantly improve the way surgeons close wounds. Ethicon’s Dermabond Prineo mesh and cyanoacrylate-based skin closure systems, as well as Zipline Medical’s Zip Surgical Skin Closure, are new products that recently have become popular for surgical wound closure. This rise in popularity is cannibalizing older forms of wound closure, such as sutures, staplers, and skin closure strips.

  2. Data Integrity, Startups, & Cloud Storage: Don’t Let This Happen To You!

    Data integrity is of paramount importance to ensure patient health and safety and to improve shareholder value, particularly for virtual companies. Startups finding themselves in the throes of managing complex drug development programs realize they may face great risk if they do not begin with the end in mind and integrate data integrity practices early on.

  3. Digital Health Companies Chasing US, EU Markets Need To Move With The Regulatory Pendulum

    By addressing four areas of common requirement, medical device companies will be in a stronger position to secure authorization and maintain products on both the US and EU markets.

  4. Dos And Don’ts Of Assessing Usage Risk

    Effectively conducting a uFMEA not only facilitates correct identification of existing usage risk, it aids in the generation of crucial design updates for risk reduction or elimination.

  5. Understanding FDA’s Quality In 510(k) “Quik” Review Program Pilot

    On Sept. 6, 2018, FDA announced the launch of a new pilot 510(k) program. This initiative, the Quality in 510(k) “Quik” Review Program Pilot, proposes an alternate pathway to regulatory submission and approval for medical devices. Quik is in its early stages and is therefore limited in scope, but it nonetheless offers another approach to premarket notification. This article examines what makes Quik different from traditional 510(k) submissions, plus its benefits and challenges for medical device manufacturers.

  6. Advanced Auditing Strategies To Detect Data Integrity Risks

    Data integrity is essential in the pharma, biologics, and medical device manufacturing industries. Not only is complete, accurate, and reliable data necessary to assure drug safety and quality, the growing reliance on increasingly sophisticated digital systems means that issues relating to data integrity are increasingly complex.

  7. Four Ways MedTech Can Thrive In Emerging Markets

    Just two percent of the revenues generated by the top 200 medical device companies arise from emerging markets. To achieve greater success, medtech must look beyond the legacy approaches that led to success serving the billion richest patients in the world.

  8. The World’s Scariest — And Most Promising — Medical Device Market

    Despite a labyrinth of risks to overcome, the Mexican medical device market is primed for growth, and presents tremendous opportunity to medtechs that can navigate its pitfalls.

  9. Fault Tree Analysis: Uncover The Root Causes Of More Complex Problems

    A refreshed approach to fault tree analysis can be an incredibly helpful addition to your problem-solving armamentarium. Having the confidence to begin using it — or begin using it more often — is the first step toward getting more comfortable with it and mastering its effects and nuances.

  10. Understanding Clinical Evaluation Reports Under The EU MDR

    Despite the CER being a critical compliance element for medtechs doing business in the EU, there continues to be significant lack of clarity regarding key requirements and best practices for creating these reports.