Biologics Consulting Group, Inc.
is pleased to make the following announcement:

Ian S. Millett, Ph.D., RAC, joined Biologics Consulting Group, Inc. in March 2009, as a Senior Consultant (Medical Devices) on March 15, 2009.  With this addition, BCG provides clients with regulatory expertise on a broad range of medical devices including IVDs.

Ian was a Medical Device Fellow with the FDA.  During his tenure, he drove the reevaluation of the agency’s oversight of software containing devices.   His other accomplishments include panel discussions, review of HDE devices and the review of point-of-care devices.  Working within OIVD at both the 510k and PMA level, Ian brings a strong IVD background to BCG’s clients.

In industry, Dr. Millett directed the regulatory efforts for a broad portfolio of products including stem cell therapies, sterilization, and drug-eluting stents.   He developed a regulatory strategy that doubled the revenue of a pre-amendment device without the need for additional testing.  Ian drove a successful filing that allowed a multi-national company to make a key business milestone, a filing that contributed over 10% to gross revenues.

Ian brings an international perspective to BCG’s clients:   In industry, Ian expedited both U.S. and oU.S. market entry by exploiting data gained in one market to facilitate regulatory filings in subsequent markets. 

Most recently, he directed the regulatory, clinical and quality efforts for a novel oncology therapy.  This electromechanical device spanned several regulatory areas, providing both imaging and treatment to cancer patients.  

Prior to his move to industry, Dr. Millett was a researcher in the Applied Physics department at Stanford where he led key studies in protein and RNA folding.

Ian has received numerous awards including CDRH Medical Device Fellow, Medtronic Medical Device Fellow, recipient of the AFOSR Grant for Basic Research, participation in the forthcoming formulation of CLSI’s EP-15, and RAC certification in both the U.S. and EU.  Dr. Millett has published extensively in scientific journals and is a frequent invited speaker on both scientific and regulatory topics.

Dr. Millett holds a B.S. in Chemistry from the University of California, Berkeley and a Ph.D. in Chemistry from Stanford.

As a Medical Devices Senior Consultant for Biologics Consulting Group, Ian will utilize his broad technical and regulatory expertise to assist clients in the following areas:

• Developing market-specific and global regulatory strategies for bringing medical devices and combination products to market quickly
• Assisting clients with strategy and development of preclinical testing and other product development issues
• Collaborating with clients in building submissions that expedite regulatory review
• Preparing and assisting in the preparation of  pre-IDEs, IDEs, 510(k)s and PMAs
• Representing clients in interactions with FDA
• Assisting clients in preparing for FDA meetings and FDA Advisory Panel meetings
• Providing in-house training on FDA regulatory issues and new policy developments

View Dr. Millett's Curriculum Vitae...

Page Updated March 16, 2009