Industry Perspectives - Design & Development

  1. Beyond Usability: What It Means To Humanize A Medical Device
    7/5/2017

    When a medical device fits into the user’s life, he or she is more likely to use it as intended. Patients are much more than the disease being treated. They are human beings with full lives, and they don’t always want to be reminded that they are “sick.”

  2. Two Lessons From A Reproductive Health Startup
    7/3/2017

    Company's progressive regulatory strategy and awareness of market, regulator, and consumer concerns hold insights for other medtechs. 

  3. Will Bioresorbable Vascular Stents Overtake Drug-Eluting Stents As The Gold Standard In CAD Treatment?
    6/28/2017

    Despite the success of drug-eluting stents, the cardiology community has long recognized the disadvantages of leaving a metal object in the coronary vasculature.

  4. MedTech Funding: A City Of Two Tales
    6/27/2017

    Medtech investment always has been different, a fact that was on display as I attended two recent regional events showcasing innovation. So how are investors - and the industry itself - meeting ever-evolving innovation, development, and investment challenges?

  5. New “Realities” In The Life Sciences And Health Care Industry
    6/26/2017

    While the public at large tends to think of virtual reality and augmented reality mostly in the context of video games and smartphone applications, no industry has done more to put VR and AR technologies to use - or has more untapped potential - than the life sciences and healthcare.

  6. Navigating The Ethics Of Product Validation
    6/14/2017

    Competing priorities can potentially lead to ethical conflict between consultants and device manufacturers, especially when development is near-complete. The keys to avoiding such conflict are a mutual understanding of shared safety and usability goals, and honest communication.

  7. Creating A Custom Spring Assembly For Medical Devices
    6/12/2017

    Each medical device component needs to meet strict quality and safety standards. One often-overlooked piece of this complex puzzle is springs, whose mechanical function supports much of the innovation in medtech — even as more products depend upon digital features.

  8. Biocompatibility And Material Selection – How To Retain Efficiency In The Design Process
    6/7/2017

    Any device material that could contact the patient at any time must demonstrate biocompatibility. However, there are different biocompatibility requirements (or endpoints) that must be demonstrated, depending on the duration and the nature of patient contact.

  9. Sourcing Fabrics For Medical Wearables
    6/5/2017

    An OEM or startup designing a medical device utilizing soft materials likely has an idea of the textiles and the technology they want to use. Proper sourcing of the most effective fabric ensures that the final product will be affordable enough to mass-produce, suited for tech integration, biocompatible, durable, and crafted from application-specific materials.

  10. From “Approved” To “Covered” — What Medical Device Companies Need to Know
    5/31/2017

    As early as possible, medical device companies need to develop an integrated strategy that identifies a path to broad payer coverage. Companies must align their R&D, clinical, regulatory, reimbursement, and sales and marketing strategies to a common goal, and have a clear understanding of the challenges ahead in order to succeed.