Industry Insights

91. 3 Lessons Learned In Optimizing Medtech Product Innovation 12/10/2021

    Even a vision, a top-notch development team, and the money raised to make your medical device happen can all be for naught if you don’t take the right actions. You may create the most astounding innovation using cutting-edge technology, but it’s important to first validate the marketplace opportunity.

92. Pros And Cons Of Outsourcing To Taiwan: What You Need To Know 2/14/2024

    Businesses adopt outsourcing to Asia as a pivotal strategy. While this entails both benefits and drawbacks, explore why teams should first necessitate careful consideration before making a decision.

93. From Chips To Genes: The New Era Of Animal Models Transforming Drug Testing And Research 8/16/2023

    The U.S. is at the forefront of the AI-based research trend surge to elevate the understanding of human physiology, testing potential therapies, and identifying disease mechanisms. Let's examine the five most promising innovative advancements in animal models, as well as key considerations for those working in the field.

94. Cell And Gene Therapy Manufacturing As Large-Scale Biology 8/20/2020

    Scaling the production of a few million living cells in the lab to manufacturing the billions of cells needed to treat patients comes with its own unique array of complexities. 

95. Risk Intelligence And Risk-Based Decision-Making: Combining Strategic Risk Management With Safety Risk Management 2/17/2021

    You’re familiar with ISO 14971, the “Application of Risk Management to Medical Devices” standard. Upon closer inspection, you’ll learn that this standard is in fact a standard for medical device safety risk management. However, risk management goes beyond the product safety aspects and includes strategic and operational elements. This article discusses how risk managed at one level allows for opportunities for value creation at other levels.

96. Is The SDV In Risk-Based Monitoring Misunderstood?

    What’s in a name?  Not much according to Shakespeare.  But the man who penned “A rose by any other name would smell as sweet” was a 16^th century poet and playwright, not a 21^st century clinical research professional.  For us, names matter.  Despite recent efforts to standardize the definition of Source Data Verification (SDV), the term still means different things to different people, and that needs to be navigated very carefully. By Laurie Meehan, Polaris Compliance Consultants

     

97. The Complex Regulatory Landscape Of Flow Cytometry For Cell Therapy 11/8/2024

    Flow experiments must be controlled to produce consistent data. With a gush of new technology, regulators have put more scrutiny on flow cytometry-based approaches.

98. Analytical Instrumentation – Advancing A CDMO's Capabilities 8/12/2020

    To serve client needs as pharma tech advances, a CDMO must know when to acquire new tech, increase overall instrument capacity, and maintain existing validated instrumentation.

99. How To Achieve Precise And Flexible Dosing With Multiparticulates 6/22/2021

    For orally delivered medicines, developers often must balance a drug’s “curb appeal” — its specific delivery mechanism, taste, ease of administration, and convenience — with safety and efficacy.

100. Overcoming The Challenges Of Patient-Centric Specification Setting 9/30/2020

     The revolution in scientific knowledge that is bringing hope to patients with devastating diseases is also setting the stage for modernizing our approach to specifications and process control. Updating our approach to specification setting will accelerate the delivery of breakthroughs to patients.