Guest Columns

  1. What To Expect From A Remote Inspection -- & How To Navigate It 7/23/2021

    Regulators have moved toward remote inspections since the pandemic began, and this is likely to continue. This article presents an overview of the remote inspection process and provides advice on how to prepare for and deal with the inspection on the day, as well as how to respond to any concerns raised following the audit.

  2. Selecting The Best Human Factors Method For Your Medical Or Drug Delivery Device Evaluation 7/21/2021

    A robust human factors process has become critical to product optimization and market competitiveness for medical devices and drug delivery devices, but not all companies have the resources, funding, or time to conduct such user studies. This article from Genentech's head of human factors engineering examines the three major categories of evaluation that you should consider, the pros and cons of each, and how to select study participants.

  3. Retro-Validation: 6 Factors To Resolve Validation Deficiencies 7/19/2021

    A retro-validation is a re-execution of the method validation with the method parameters, setup, and everything kept the same as before to retrospectively cover all prior generated data. It is not the same as past validation because you would shore up the validation deficiencies or gaps. This article discusses the 6 important considerations.

     

  4. The 8-Step Checklist To Write Effective Investigation Reports 7/16/2021

    It’s always best to prevent the need to investigate a non-compliance, but if you experience a non-compliance, it’s necessary to quickly and effectively perform an investigation. The investigation report needs to be clearly understandable to anyone reviewing the report, and hopefully you'll also learn enough to make sure the non-compliance doesn't recur.

  5. FDA Releases Guidance On CMC Changes To An Approved Application: Certain Biological Products 7/14/2021

    At the end of June, the FDA released a new guidance to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application. This article summarizes the guidance.

  6. 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.

  7. 4 Lessons For AI In Medtech: Case Studies From Breast Cancer Detection 7/12/2021

    Recent advances in artificial intelligence (AI) and machine learning, especially deep learning, are poised to help further advance many medical fields. One of the physicists involved in helping advance breast health solutions through AI shares his 4 lessons learned in working with AI in mammography technology, and those lessons can be applied to many other medtech fields.

  8. How To Enhance “Operational Learning” In Biopharma 7/9/2021

    According to conventional wisdom in biopharma, operational learning is derived from existing practices, including inspections, audits, deviation investigations, and gemba walks. What is often missing is the necessary understanding of the “how.” This article provides advice, as well as lessons learned from Takeda and Biogen.

  9. The Evolution Of Polymeric Materials In Vision Care & Ophthalmology 7/7/2021

    Synthetic polymers play an essential role in spectacles, rigid gas permeable and soft contact lenses, corneal on-lays/in-lays, corneal scaffolds, intraocular lenses, and vitreous humor replacement in vitrectomy. Biopolymers are critical in the structure and metabolism of the cornea, crystalline lens, and the vitreous. 

  10. How Is Medtech Design Evolving — & Are You Keeping Up? 7/5/2021

    Couple the pandemic with the last decade’s trend toward overhead reduction through distance care and the combination is driving more rapid change to the medical device environment than ever before. This article takes a glimpse at the recent evolution in medical device design and speculates how it might evolve in a post-COVID world.