Regulatory & Compliance Perspectives

  1. Failure Analysis 101

    A one percent failure rate should be unacceptable in any industry, especially healthcare. More aggressive and smarter testing will, in essence, cut that current failure rate in half. 

  2. China’s Healthcare Reforms: Medtech Manufacturers Must Remain Cautious

    China’s latest round of healthcare reforms are aimed at ensuring sustainability by reducing costs, so as to create a more efficient healthcare system for China’s people. However, the reforms, if implemented effectively, will have a significant impact on medical device companies.

  3. Lights, Camera, Validation! — Preparing For FDA Prime Time

    In the “validation/manufacturing transfer” stage, we move beyond lab-queen prototypes, small sample sizes, and controlled bench testing to prove that the product will fully satisfy user needs under actual or simulated operating conditions. This is the dress rehearsal for commercialization.

  4. Five Qualities Of A Good Use Risk Assessment (uFMEA)

    Not all use risk assessments are created equal. There absolutely is a right way and a wrong way to complete Use Failure Mode and Effects Analysis (uFMEA) assessments, and decisions made during the process can make or break your regulatory submission.

  5. Unintended Con$equences Of FDA Form 483s

    I talked with Sandra Maddock, president and CEO of IMARC Research, about trends in clinical research for medical devices, and she opened my eyes to a few very sticky situations with the FDA.

  6. To Test Is Human, But Verification Is Divine

    This article is the third in a series exploring some of the important relationships involved in each phase of medical device development. Here, we'll look at key relationships during the verification phase.

  7. Routine FDA Inspections: Lower The Boom On The Back Room

    The FDA's Consumer Safety Officers have a tough job to do inspecting medical device facilities. Are you making it harder for them? And, in doing so, are you making routine inspections harder on your company?

  8. Moving Beyond The Learned Intermediary Doctrine

    In Taylor v. Intuitive Surgical, Inc., the Supreme Court of Washington concluded that the Washington Product Liability Act (WPLA) “impose[d] a separate and distinct duty for the manufacturer to provide warnings to the purchaser of the product.” For device manufacturers, it is of critical importance, going forward, to limit the import of this decision to the factually unique reasons compelling the Court’s decision in this case.

  9. 4 Early-Stage Relationships Vital To Medtech Development

    This article is the first in a series exploring some of the important relationships involved in each phase of medical device development. We'll begin by looking at key relationships during the concept (or conceptual) development phase.

  10. MACRA, Non-Adherence Shaping Medtech Reimbursement — For Now

    The Medicare Access and CHIP (Children’s Health Insurance Program) Reauthorization Act of 2015 established the Quality Payment Model, starting this year. MACRA has been touted as a guide for leading the development of new devices, but can it survive patient non-adherence, spurred by better access to information, and the proposed American Health Care Act?