Industry Perspectives - Design & Development

1. Closing The Perception-Vs.-Reality Gap In CGMP Quality Culture And Compliance 9/16/2020

   This article is the first in a two-part series on how to demonstrate a high level of current good manufacturing practice (CGMP) compliance during inspections by implementing a strong quality culture; driving the open, transparent communication of risks; and establishing effective quality risk management and quality management review.

2. An Overview Of Bioresorbable Polymers Now Available For 3D Printing Medical Device Applications 9/9/2020

   In this interview with Balaji Prabhu, from Evonik’s Medical Device Competence Center in the U.S, we review how medical device companies can best evaluate current biomaterial options for the four leading 3D printing technologies.

3. How To Design Medical Device Test Fixtures For Maximum Repeatability 9/9/2020

   Test fixtures and inspection equipment are only useful to the extent that they produce accurate, repeatable data. In fact, flawed test fixtures that don’t produce such data can be more harmful to the program than if the test hadn’t been performed at all.

4. Ask The Expert With Christian M. Kelly – Corporate Vice President Of Quality At B. Braun Medical Inc. 9/8/2020

   This article asks Corporate Vice President of Quality at B. Braun Medical Inc. about how quality is impacted in medical device companies by FDA regulations, collected data, and more.

5. Incorporating Privacy By Design & Security By Design Into Medtech Development 9/2/2020

   Medical device companies need to act now to demonstrate their products' cyber resilience and privacy capabilities, not simply to address the myriad of compliance and data privacy regulations but also to establish patient and caregiver confidence in their products.

6. Making FMEA More Robust With HACCP 8/27/2020

   Risk priority number scores and criticality analysis are frequently used to quantify risks for users, designs, and processes. However, these traditional failure mode and effects analysis (FMEA) techniques often fail to fully document risks associated with contamination. To complement FMEA, consider borrowing a risk-management technique from the food industry.

7. Risk Mitigation For Homecare Devices: 4 Tips For Anticipating The Unanticipated 8/24/2020

   With the surge in home healthcare these days, designers must approach risk very differently than when devices were being designed solely for use by clinical personnel. This rise in home healthcare is driving the need for increased risk scrutiny for several reasons.

8. Environmental Monitoring And Sterility Assurance Control For Medical Devices And Combination Products 8/11/2020

   The establishment of an environmental monitoring and microbiological control program for sterile medicinal devices is necessary to ensure microbiological safety and finished product quality. The level of environmental control is primarily dependent on the method of product sterilization.

9. How To Drive Powerful CAPAs With Lean Six Sigma 7/10/2020

   Corrective and preventive actions (CAPAs) are an important and integral part of any quality system for a life sciences company. And yet, strangely, CAPAs rank among the top reasons why companies get 483s and warning letters from the FDA. This article explains how Lean Six Sigma tools and techniques can be applied to improve the CAPA process.

10. What Happens To ISO 13485 When Annex L Is Adopted? 9/16/2019

    Although the structure of ISO 13485 will expand from the current eight main clauses to ten, most of the QMS requirements should essentially remain the same.