Guest Columns

  1. Brexit Finalization: How Will Medical Device Compliance Change In Europe In Jan. 2021? 11/23/2020

    The UK's transition period in leaving the European Union ends on December 31, 2020. The Medicines and Healthcare products Regulatory Agency (MHRA), which regulates medical devices marketed in the UK, released new guidelines in September 2020 detailing how devices will be regulated beginning January 1, 2021, with varied compliance dates for different device classes.

  2. ISO TR 24971:2020 — Bringing Clarity To Risk Acceptability In ISO 14971 11/19/2020

    With ISO TR 24971:2020, the technical committee responsible for the medical device risk management standard has finally addressed the confusion around the policy for risk acceptability criteria and the difference between that and the criteria themselves.

  3. System Impact Assessment: A Risk Management Framework For A COVID World 11/18/2020

    Infusing risk management is essential to an organization, especially in terms of facility, utility, and equipment qualification. Although qualification is usually the last step before moving to process characterization and validation, integrating a risk management approach is an effective way to ensure qualification activities are focusing on what matters most — that equipment performs as expected.

  4. Advanced Computing In Pharma & Medtech: How Cognitive Biases Can Cost You Millions 11/11/2020

    In their race to leverage sophisticated computing technologies (particularly artificial intelligence, robotics, augmented/virtual reality, and IoT), life science companies face a hidden, insidious challenge — avoiding the cognitive biases that can cause them to unwittingly exacerbate already business-threatening cyber risks.

  5. Digital Health Apps In Europe — The Road To Reimbursement Goes Through Security 11/9/2020

    In September, Spain’s National Cryptologic Center issued a road map to minimum security requirements for digital health applications and e-health mobile apps. This article highlights important recommendations from the 11 sections of the publication, serving as a preliminary checklist when preparing for market entry in Germany and/or Spain.

  6. Pandemic Accelerates Expanding Role Of Real-World Evidence In FDA Medical Device Submissions 11/4/2020

    By forcing the FDA to become comfortable with the use of real-world data in order to authorize COVID-19 diagnostic tests, the pandemic may have unintentionally forced the agency to reflect in a more pragmatic way on what characteristics of real-world evidence (RWE) it believes are essential for data integrity and what level of uncertainty it can tolerate in connection with RWE.

  7. Best Practices For Selecting & Implementing New Technology In The Life Sciences 11/2/2020

    Software tools and their supporting hardware can undoubtedly enable greater performance within your medical device, pharmaceutical, or biotech business. Regardless of the type of technology implementation, how you select technology and how you implement it are two critical factors for any organization.

  8. Peripherally Inserted Central Catheter Vascular Access Market: Competitive Factors And Strategies 11/2/2020

    While COVID-19 has negatively impacted some competitive strategies, PICC makers can anticipate continued long-term demand amid a pivot to new or reprioritized strategy areas.

  9. How To Implement Continuous Process Monitoring Of Validated Processes 10/28/2020

    It is time to consider augmenting your validated pharmaceutical, medical device, and tissue production processes, including processing, packaging, and labeling, with continuous process monitoring to ensure continued compliance with established specifications and requirements if you do not want to be cited by the FDA.

     

  10. Forecasting The Extracorporeal Membrane Oxygenation (ECMO) Market In The Wake Of COVID-19 10/26/2020

    This article will explore how COVID-19, along with key clinical trials, will ultimately change the ECMO market in future years through an assessment of high-, mid-, and low-level adoption scenarios, and how this market will change for pandemics in the future.