Industry Perspectives - Design & Development

1. How To Build An Exceptional Medical Device Biocompatibility Program 9/17/2021

   In recent years, biocompatibility and compliance with the ISO 10993 family of standards have been an area of significant attention. Demonstrating biocompatibility is an integral part of any device development. This article explains how to integrate a biocompatibility toxicologist into your team and his/her role within the development process.

2. How Do We Achieve The Promise Of Using Digital Health Measurement? DATAcc Leads The Way 9/15/2021

   Digital health measures are redefining our understanding of health and disease by changing what we measure and how we measure it. It is the perfect time for the field to build the digital health measurement toolbox with intention – and build it right. The Digital Health Measurement Collaborative Community is a new pre-competitive collaboration dedicated to this, and you can get involved!

3. 5 Misconceptions About Data Integrity In Pharmaceutical And Device Development & Operations 9/15/2021

   Data integrity (DI) issues in pharma and medical devices have always been there, but in my experience as a consultant, these issues have increased in frequency more recently, thus moving them to the forefront. In this article, I explain five misconceptions about data integrity in our industry.

4. What’s The Role Of Interim Consultants In The Life Sciences & How Do We Use Them Effectively? 9/3/2021

   When life sciences companies need new talent, they typically have two options: bring in a consultant or hire a full-time employee. Usually, this decision is dictated by the permanence of the role, but sometimes, timelines complicate things. In this situation, an interim consultant can be the solution. But what is the interim consultant's role, really, and how do we use them effectively?

5. Digital Health Apps & SaMD: Incorporating Privacy In Design & Development 9/1/2021

   Some digital health apps are regulated by the FDA and other regulatory bodies, and some are not. But all software as a medical device (SaMD) and digital health apps have a common expectation: privacy. This article delves into the related regulations and how to go about developing your app or SaMD using the 7 principles of privacy by design.

6. How One Company Developed The Next-Generation Electronic Stethoscope 8/23/2021

   A pressing issue driving improvement in stethoscope technology is the change in modern-day healthcare. There has been a greater need to provide a diagnostic tool that goes beyond amplified sound with the ability to change the way medicine is practiced. This is the story of how HD Medical developed the next-generation electronic stethoscope.

7. The 5-Step Checklist For A More Mature, Robust Quality Management System 8/20/2021

   Whether you are preparing for a pre-approval inspection, have the corporate desire for continuous inspection readiness, or are engaged in a LEAN initiative to clean up and strengthen your quality management system (QMS), further maturing your QMS can be helpful to ensuring a robust, comprehensive, and compliant QMS.

8. Medical Device Packaging Considerations For Product Developers: Begin With The End In Mind 8/11/2021

   By incorporating packaging early in the process, medical device developers can alleviate stress, minimize risk, create a more effective product, and eliminate cost surprises. This article shares best practices for how to do so.

9. CMS Takes Aim At Medical Device Cybersecurity – How To Ensure Continuous Medicare/Medicaid Coverage 8/4/2021

   In its June 2021 report, the U.S. Office of Inspector General declared that Medicare lacks consistent oversight of cybersecurity for networked medical devices in hospitals. The Centers for Medicare & Medicaid Services (CMS) is now considering additional ways to highlight the importance of medical device cybersecurity, in conjunction with the FDA and the Office for Civil Rights.

10. EMA Publishes Guideline On Quality Documentation For Medicinal Products 8/2/2021

    This new EMA guideline will become effective on January 1, 2022. It describes the information that should be presented in the quality part of a marketing authorization dossier for a medicinal product when it is used with a medical device and/or as part of a medical device. Medicinal products are similar to "combination products" referred to by the US FDA.