Industry Perspectives - Design & Development

  1. Clear And Present Danger: Act Now On Medical Device Cybersecurity

    Medical device interconnectivity has obvious benefits, but it also introduces new cyber-attack vectors for hackers to insert malware, compromise connected technologies, steal patient data, or even jeopardize patient health. The current state of medical device cyber readiness and compliance requires an immediate, industrywide call to action

  2. 6 Indispensable Tools To Drive Effective User-Centered Design

    With every research touchpoint, it’s important to start by concisely defining the purpose of the effort (what do we need to learn?) and, from there, determining the tools most likely to fulfill the need.

  3. 6 Strategies To Obtain Genuine Feedback For Products That Require Behavior Change

    When no existing product addresses a problem customers may have, adoption — and, presumably, regular use — of a new product requires behavior change, and attempting to address behavior change through a survey leads to highly unreliable data. 

  4. Usability’s Importance In Combination Products: The Mylan Citizen Petition Case Study

    Citizen petitions often are submitted to question or persuade FDA to examine product safety issues, but they also have been abused to prevent products from reaching market. Sharp attention to usability and human factors can give you the upper hand, though, if your company is targeted by this underhanded strategy.

  5. Plastics Selection For Medical Wearables: Getting Personal

    Just as our clothes and our shoes and our sense of fashion define who we are as individuals, a wearable device becomes an extension of our identity. As such, the appearance of a device, and its size, weight, and overall feel are just as important as the communication requirements.  

  6. Scientists And Engineers – Why The Divide?

    It is time to discard the old thinking of “drug and/or device,” and to begin focusing on the goal of developing complete therapeutic systems.

  7. Patient-Centered Design Begins At Home

    A home visit presents a unique opportunity to discover how a patient or caregiver manages medications, supplies, and everyday device use. 

  8. The Case For Formative Human Factors Testing

    Because the validation test is required human factors testing, it can be tempting to skip over preliminary human factors activities during the development process. However, this approach is problematic from both a device usability and a safety standpoint.

  9. TAVR: Will It Render Open-Heart Valve Replacement Surgery Obsolete?

    I spoke with Craig Thompson, MD, SVP/CMO of Boston Scientific’s Interventional Cardiology unit, about TAVR costs, benefits, and market drivers, as well as Boston Scientific’s Lotus valve system.

  10. Plastics Selection For Medical Wearables: An Overview

    This article begins a multi-chapter discussion exploring plastic material selection for medical devices, primarily wearables. First, we will discuss the use of rigid materials, followed by a discussion covering the use of elastomeric materials.