Industry Insights

  1. Building The Right Team for FDA Approval of Your Innovative Medtech 1/17/2022

    Navigating the complexities of the FDA’s approval and regulatory process for medical devices can be daunting for all companies and particularly stressful for new technologies with disruptive innovation. However, the FDA is best regarded as a partner and not an obstruction. If your device development team does their homework, you'll have a successful product.

  2. Harmonious Harmonization: How To Get Quality System Alignment Right 4/8/2020

    This article is the second in a two-part series explaining how to successfully harmonize disparate quality systems when two companies combine. Part 1 shared horror stories — drawn from the author’s experiences — illustrating what NOT to do during each phase of QMS harmonization. Here in Part 2, we look at case studies in which companies got it right, bringing together parallel quality systems in a way that increased the probability of success.

  3. The Identification Of A MicroRNA With A Key Role In Parkinson's Disease 7/14/2022

    Learn more about the potential of microRNAs as therapeutic targets being investigated for a number of different disease states.

  4. Tales From The Trenches: Developing Potency Assays Outside Big Pharma 7/18/2025

    Lessons learned from developing potency assays to detect activity and variation for cell- and receptor-mediated products — beyond the comforts of a well-heeled company.

  5. Design Verification Testing Of Combination Products 7/12/2024

    Developing a combination product and seeking a list of tests to complete design verification testing? Review the details for planning, design inputs, design outputs, and design verification.

  6. Pharma 4.0 Software Methodologies In Biopharma And Medical Devices 10/10/2022

    The life sciences industry has been using computer software testing methodology to validate software that is categorized to be GxP in alignment with the principles of good automated manufacturing practices and Industry 4.0 standards. This article discusses the methodologies of computerized system validation, computer software assurance, and the Agile approach.

  7. Medtech Innovation: 3 Strategies For Leveraging Agile Methodologies 7/14/2021

    While medtech firms have had proven success with scaling and short bursts of innovation from special projects and acquisitions, many firms have struggled to achieve a steady stream of disruptive innovation. This article provides three strategies for leveraging agile methodologies for better innovation.

  8. Comparability Considerations For mRNA Product Development 2/28/2024

    Given the mRNA-based products' variability and unique challenges, you may need to modify the standard comparability approach. Let’s discuss strategies for any development stage.

  9. Keep Your Eye On The Apple: Apple Makes A Move On The Watch Market—Could Pharma Be Next? 2/18/2015

    CEO of Rolex sounds like a pretty desirable job title and it might have been fun a year ago, when Dufour took the job. Back then, rumors of the Apple Watch were just rumors, and the idea of a tiny computer on the back of your wrist seemed a touch ridiculous.  

  10. The Technologies Propelling GLP-1 Analogues 3/18/2025

    This article delves into the manufacturing and synthesizing technologies used to manufacture GLP-1 drugs as well as the novel drug delivery technologies being used.