Guest Columns

  1. Writing Compliant IQ/OQ/PQ Protocols — Meeting FDA Expectations

    Writing effective IQ/OQ/PQ protocols is a must for following the regulations required by the FDA for equipment, systems, and utilities to demonstrate suitability for the intended use.

  2. Create A Business Development Plan That Works

    Executives throughout business often misunderstand the meaning of developing business. Business development is about the “long game.” It’s about developing opportunities and collaborations over the longer term, while solidifying and expanding current customer relationships.

  3. What In The World Is The “Fuzzy Front End” Of Innovation?

    The “messy, getting started” period in pre-product development can make many development teams and life science organizations uncomfortable – until you recognize “fuzzy” as less of a warning, and more of an invitation.

  4. MDSAP's Effect On The Internal Audit Process

    The Medical Device Single Audit Program (MDSAP) is recognized by officially approved Auditing Organizations (ISO Registrars) to conduct a single regulatory audit, of a medical device manufacturer, that satisfies relevant requirements of the regulatory authorities participating in the program.

  5. Succeeding In The Latin American Medtech Market: Three Tips, Five Trends

    Latin America is developing into a sizable, predictable part of the global medical device market, allowing foreign manufacturers to have sustainable commercial operations.

  6. Intracranial Stenting Market: Assessment And Growth Opportunities

    This article explores the adoption of intracranial stenting across three major markets (U.S., Germany, South Korea) and projects the overall market opportunity according to currently approved indications. 

  7. Massive Insurance Plan In India Will Open New Markets For Medical Devices

    India’s federal government recently announced a plan to offer free medical insurance to over 500 million of its poorest citizens. Astute medical device companies can leverage this opportunity to build new businesses while transforming the lives of millions of families who presently lack access to the most basic procedures.

  8. AI In Medical Imaging: Opportunities And Hurdles

    The propulsive force driving AI development is the developed world’s aging population, facing growing incidences of chronic illness and morbidity, combined with unsustainable healthcare spending in dire need of curtailing.

  9. Data Integrity, Deviations, And Shop Floor Quality

    Continuous improvement in data integrity can advance a firm on the journey toward a mature culture of quality, particularly through the implementation of QA on the shop floor. Batch record review (BRR) and product disposition are often complicated by data integrity issues and poor data quality.

  10. Challenges Implementing New Advanced HFE testing Methods

    Part one of this series presented neuroscience-based HFE data capture methods that are beginning to penetrate HFE testing programs. This installment will discuss the challenges of utilizing advanced data capture systems in real world HFE testing programs.