Europe
+33 (0)1 42 68 51 79
Japan
+81 (0)3 6260 6688
United States
+1 972 480 9554
Europe
+33 (0)1 42 68 51 79
Japan
+81 (0)3 6260 6688
United States
+1 972 480 9554
For many years, numerous professional organizations and publications within the medical device industry (both print and online) have reached out to Ken Block Consulting (KBC), requesting interesting content for their target audiences. In response, we have authored over 20 original articles across a broad spectrum of topics, from software validation and FDA submissions to usability and regulatory due diligence. Readers are typically regulatory and quality professionals, medtech executives, engineers and others. Internationally recognized for our regulatory and quality expertise (and consistent with our office locations in the US, Asia and Europe), original KBC industry articles have been published around the globe in the English, Japanese and French languages. Unlike "pay to play" publications (where articles by other consultants may appear), KBC content has always been invited by the relevant editorial management, with compensation never paid by KBC or received by KBC. Some of these invited articles are shown on this page, including any links to any content available online.
Testing times, Medical Plastics News
Highlights of the multiple Enforcement Policy documents and Emergency Use Authorization (EUA) documents for PPE issued by the FDA – including respirators, face masks, face shields, gowns, and gloves.
Breakthrough Device Program: A Shortcut to the US Market, DeviceMed (French Edition)
Explanation of the FDA Breakthrough Device Program and two successful KBC client examples.
Considering CAPA: Maybe It’s Not a Monster After All, MedTech Intelligence
Basic guidelines to follow to ensure that your CAPA is valid and can be used as an effective tool to easily assess new issues (including a handy CAPA checklist).
https://www.medtechintelligence.com/column/considering-capa-maybe-its-not-a-monster-after-all/
How a UK company navigated the FDA Breakthrough Devices Program, Med-Tech Innovation News
Step-by-step example of how KBC met the FDA’s Breakthrough Device criteria for a software-only device oriented toward prediction of Alzheimer’s disease (for patients already diagnosed with mild cognitive impairment).
Knock Knock: When merger and acquisition due diligence teams come knocking, Medical Plastics News (European Edition)
Explanation of the regulatory scrutiny that medical device companies undergo when they are targeted for a merger or acquisition.
Mergers and acquisitions: What you need to know, Medical Plastics News (North American Edition)
Explanation of the regulatory scrutiny that medical device companies undergo when they are targeted for a merger or acquisition.
https://issuu.com/mpnmagazine/docs/mpn_na_oct_dec_final
Robust robots? Artificial intelligence wearables and healthcare devices in the US explained, Medical Plastics News
Examples of the integration of artificial intelligence into various medical devices, along with an introduction to the concept of “explainability” of such regulated AI.
https://www.medicalplasticsnews.com/news/robust-robots/
FDA Usability Testing Trends: 510(k) Submission Insights, MEDTEC Japan Online
Review of 510(k) Summary documents demonstrating an increase of human factors and usability as a factor in FDA medical device regulatory clearances.
http://www.medtecjapan.com/ja/news/2015/08/18/1268
FDA evaluation of usability and human factors, DeviceMed (French Edition)
Explanation of FDA regulatory requirements and expectations regarding human factors and usability, within the context of medical device regulatory clearances.
https://www.devicemed.fr/wp-content/uploads/archives/pdf/devicemed-mai-juin-2016.pdf
FDA Will See You Now!, European Medical Device Technology
Introduction of a newly finalized FDA guidance document, outlining the regulatory process for discussing new medical device technologies with an FDA review team.
Dynamic tissue phantoms and their use in assessment of a noninvasive optical plethysmography imaging device, Proceedings of SPIE (International Society for Optics and Photonics)
Explanation of the scientific approach used to validate a new medical device imaging technology, as part of the 510(k) submission effort for a KBC startup client.
New FDA “Q-Sub” Guidance Document: Pre-submission Programs and FDA Meetings, Medical Device Magazine Japan
Introduction of the new FDA guidance document on Q-Submissions, outlining the regulatory process for discussing new medical device technologies with an FDA review team.
New FDA “Q-Sub” Guidance Document: Pre-submission Programs and FDA Meetings, MEDTEC Japan Online
Introduction of the new FDA guidance document on Q-Submissions, outlining the regulatory process for discussing new medical device technologies with an FDA review team.
http://www.medtecjapan.com/en/node/1027
FDA Goes Mobile: Regulation of Medical Apps, European Medical Device technology
Explanation of the evolving FDA regulatory approach to medical device mobile apps, such as mobile phone and tablet software applications.
FDA Update: New Changes to Medical Device Submissions, MEDTEC Japan Online
Review of recently finalized FDA guidance documents, and implications on 510(k), De Novo and PMA device applications.
http://www.medtecjapan.com/en/node/767
FDA Update: Recent Medical Device Application Changes, Medical Device Magazine Japan
Review of recently finalized FDA guidance documents, and implications on 510(k), De Novo and PMA device applications.
FDA Regulation of Mobile App Devices, MEDTEC Japan Online
Explanation of the evolving FDA regulatory approach to medical device mobile apps, such as mobile phone and tablet software applications.