Dr. Jack Risdahl has over 30 years of experience in medical product development and testing. Dr. Risdahl has both Doctor of Veterinary Medicine (DVM) and Doctor of Philosophy (Ph.D.) degrees, and began his career in academia at the Medical and Veterinary Schools at the University of Minnesota. Following, he served in a Global Director role at Baxter while also holding a faculty position at the Mayo Clinic.
Prior to joining NAMSA in 2012 through acquisition, Dr. Risdahl was an entrepreneur, co-owner and managing partner of the Integra Group. While at NAMSA, Jack was the Director of Preclinical and Functional Studies with global oversite before joining the Product Development Strategy Consulting Group in 2017. His expertise in preclinical studies and safety evaluations allows him to work with innovative medical device companies looking to accelerate the development of their technology, and to also address regulatory agency expectations and responses to those studies. As a former entrepreneur, he is also able to understand and assist in product development strategies for accelerating product development testing that meet specific business goals. He has a broad experience across the medical device spectrum of products for devices, biologics and combination products.
- Oversees and performs preclinical studies and safety evaluations for medical devices, biological drugs and combination products for worldwide regulatory submissions
- Evaluates and prepares business and scientific analysis for new product testing plans necessary for medical product development
- Assists in the development, design and execution of medical product testing plans for a wide range of medical devices from concept to final product
- Performs and oversees gross pathology evaluations for wide range of studies and regularly consults with study pathologists
- Serves as expert in the area of preclinical model development and applications for medical products
- Supports multiple U.S. Food and Drug Administration (FDA) pre-submission meetings to assist in answering preclinical study design questions
- Acts as expert in the areas of preclinical study design for regulatory submission for multiple device and combination product types, including but not limited to: regenerative medicine, cell therapy and transplantation, neurostimulation and cardiovascular devices
- Serves as an experienced leader for medical device testing plan development, covering both efficacy and safety testing as required by regulatory agencies
- Former managing partner of a preclinical testing business which was responsible for the design and build of facilities, programs for preclinical testing and evaluation of medical devices, and marketing and business operations
- Responsible for the implementation and application of standards and guidelines to meet the requirements for U.S. FDA Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) device and tissue regulations. Dr. Risdahl has designed and developed several animal testing facilities, implemented programs and obtained American Association for Accreditation of Laboratory Animal Care (AAALAC) certifications for these operations.
- Oversight of Notified Body non-conformance of animal studies related to recent MDR changes: successful outcome with acceptance of response
- Management of FDA acceptance of animal testing plans for numerous U.S. FDA pre-submission meetings: response and follow-up to FDA deficiencies with successful outcomes to avoid re-testing requirements
- Worked with numerous companies to assist in developing product development testing plans to successfully meet investor, company board, regulatory and marketing goals