Ken Block Consulting (KBC) has earned our excellent reputation primarily through tackling challenging product-related regulatory submissions and resolving tough company-related regulatory compliance situations. Many new KBC clients have seen those previous successful outcomes for others, and then reached out to us for assistance.

With a goal of helping even more companies learn from our hands-on experience and successful approaches, KBC has also authored a wide variety of published articles on medical device industry topics, given invited speeches at dozens of industry events around the world, and participated in many educational conference panel sessions. In addition, KBC has been referenced or quoted in articles written by others, plus our work has been cited by prestigious universities and law schools. These additional activities and recognitions have helped establish our international reputation as thought leaders within the medical device industry.

In the end, what counts most is the achievement of excellent results for our clients – so we are always excited to apply our capabilities and knowledge to the next project, and always looking forward to meeting new client companies!

Published Articles

Over 20 original articles have been authored by KBC (in multiple languages) at the invitation of various content editors around the world, subsequently appearing in numerous hardcopy publications and online platforms targeting the medical device industry. Unlike pay-to-publish arrangements, KBC only provides articles where the publishing organizations are requesting our pro bono talents to directly benefit their readership. More information can be located here.

Invited Speeches

KBC has given over 50 speeches around the world, at the invitation of respected professional industry associations, educational conference organizers and others. We always create unique content for these international events, focusing on subjects of interest to the targeted audience (e.g., cybersecurity, investigational device studies, software validation, FDA inspections, etc.). Attendees may include executives, engineers, regulatory/quality professionals or others, depending on the speech topic. More information can be located here.

Panel Sessions

KBC has been invited to participate in numerous industry conference panel sessions in the US and Europe, covering topics from wireless device connectivity and 3D printing to US market entry and FDA regulatory strategy. These events include direct interaction with other panelists and audience members, allowing KBC to leverage our deep experience to help others who are seeking guidance. More information can be located here.

Law School Citations

Highly respected centers of educational excellence including Harvard University, Southern Methodist University (Dedman School of Law) and the University of California (Davis) have each used either KBC published articles or KBC website content, which have been cited in law review papers or included within university coursework. More information can be located here.

Article References

Over the years, several published articles written by others have either referenced KBC or included quotes from KBC. These articles are either seeking our viewpoint regarding some focused regulatory topic where KBC has deep experience and knowledge or are covering successful client KBC work involving unique medical device technology. More information can be located here.