Regulatory & Compliance Perspectives

  1. Examining CAPAs' Role As A Critical Medtech Management Tool
    3/28/2016

    A CAPA system collects process information across the organization and provides cross-functional intelligence to identify when, why, and where potential compliance issues are occurring. This information, when systematically collected and rigorously analyzed, is a critical element of effective management control of an organization. 

  2. How To Build Strong Medtech Payer Relations
    3/24/2016

    “Payer relations” is a broad term that describes the process of working with payers to obtain, maintain, or expand positive coverage decisions. This article will focus on initiation of that process, and the important aspects of planning and executing this critical component of an overall reimbursement strategy.

  3. New AdvaMed CEO Scott Whitaker Discusses His Vision For Medtech
    3/22/2016

    Part one of our interview with incoming AdvaMed CEO Scott Whitaker reviewed his start in advocacy and his career to this point. Part two of our conversation is a look forward to Whitaker’s plans — both for himself and for the organization — during his first year with the global medtech trade association, and beyond.

  4. 3 Rules For Defensible Compliance: Applying Risk Management To Regulatory Decisions
    3/21/2016

    Defensible compliance is, at its core, the consideration of risk management in every regulatory decision. Simplifying your approach and educating organizational stakeholders are two fo te keys to achieving defensible compliance. 

  5. 4 Shortcomings Of Intellectual Property-Focused Investing
    3/18/2016

    Intellectual property (IP) is pretty foundational to qualifying many health care ventures as “investable.” In theory, this sounds like a good idea. But the unpredictability of patent enforcement, the expense of securing IP, and the X-factor of competition are among the reasons why IP isn't the "whole story" when it comes to launching a new product.

  6. From Biotech To Medtech: A Chat With New AdvaMed CEO Scott Whitaker
    3/15/2016

    I recently interviewed new AdvaMed CEO Scott Whitaker. We discussed his early legislative background with the U.S. Department of Health and Human Services (HHS), as well as how he thinks his 11 years of experience at BIO will apply to his new position. 

  7. Understanding Medical Device QMS Requirements For Combo Products: Pharma Company Edition
    3/14/2016

    In the spirit of reducing the QMS burden on companies developing combination products, FDA acknowledged that there is no need for redundant cGMP requirements that are analogous between drug and device regulations. That said, drug companies should understand the implications of the required 21 CFR 820 subparts, and why they were deemed critical enough to consider for implementation.

  8. CMS Should Follow FDA’s Lead: Adopt Reforms To Facilitate Medtech Innovation
    3/9/2016

    The Centers for Medicare and Medicaid Services (CMS) should take a cue from FDA and implement impactful reforms and efficiencies that will help support investment, innovation, and timely patient access to the best in American medicine. 

  9. 3 Key Sources Of Data-Related Compliance Risk (And How To Fix Them)
    3/7/2016

    Current FDA and U.S. Department of Justice compliance trends reinforce that a company’s ability to accurately and quickly gather, analyze, and manipulate data is the key to avoiding enforcement actions. Here, we will highlight three particular areas of risk and discuss the merits of validated compliance-related data in appropriately designed and controlled systems

  10. Medical Device Single Audit Program (MDSAP) -- What Manufacturers Need To Know
    3/1/2016

    The Medical Device Single Audit Program (MDSAP) pilot is nearing its end and the 2017 MDSAP implementation is looming. While still viewed with a certain degree of suspicion, the program likely will become the new model to follow for most medical device manufacturers selling internationally. Read on to learn how your company can thrive in the new regulatory landscape this program will create.