Industry Perspectives - Design & Development

1. Why Pharmaceutical And Medical Device Risks Must Be Analyzed By Their Risk Mechanisms 9/16/2025

   Current risk analysis methods focus on the possibility and severity of bad events instead of focusing directly on analyzing and improving the performance of systems and processes producing the bad events. 

2. Improving Drug-Device Combination Product Co-Development 8/8/2025

   Early recognition and mitigation of drug and device integration difficulties are critical to the success of combination products. The collaborative effort in development cannot be overstated. 

3. Minimizing The Impact Of Human Errors Using Relational Risk Analysis 8/4/2025

   This article describes how a mechanism-based risk analysis approach can provide two complementary opportunities for minimizing the likelihood of a human error impacting pharmaceutical and medical device risks.

4. Process Validation: Optimizing Operational Excellence In Pharma And Medical Devices 7/3/2025

   Process validation is often viewed as a costly regulatory formality. However, it is actually a strategic investment that, when integrated into business planning, delivers measurable outcomes in productivity, compliance, speed-to-market, and profitability.

5. Expanding A Bow Tie Risk Analysis Model Using Relational Risk Analysis 6/2/2025

   Relational risk analysis can be used to enhance and expand a bow tie analysis in the pharma and medical device industries to more effectively analyze risks as relationships between mechanisms and events.

6. Tips From A Biomedical Engineer For Medical Device Innovation And Compliance 5/20/2025

   Every new medical device feature must live within a quality management system that tracks design control, risk management, and post-market performance. Waiting until design freeze to loop in your quality and regulatory experts invites costly rework and setbacks.

7. Understanding The Impact Of An RMP On Patient Risks Using Relational Risk Analysis 5/5/2025

   Using relational risk analysis, let's take a closer look at risk management plans for identifying and managing adverse reactions for administering a new therapy to a patient.

8. AI In Medical Devices: Meeting The Regulatory Challenge Around The World, Part 1 5/1/2025

   This article explores the global regulatory landscape, examining how leading authorities in the U.S., EU, U.K., Canada, China, Brazil, Australia, and South Korea are approaching AI in medical devices. 

9. A Proactive 6-Point Approach To Security For Neurotech Developers 4/17/2025

   There are several key security concerns neurotech developers must address from the outset to ensure both medical and ethical compliance, as well as commercial success. 

10. How AI Is A Game-Changer For Auditing Compliance And Efficiency 4/9/2025

    In the life sciences, audits have long been bogged down by repetitive tasks. AI is changing the way auditors operate, making compliance more seamless than ever.