DeviceAdvisors, LLP
Medical Device Consulting Services
Quality/Regulatory Product Development Intellectual Property
Roger R. Alm is an intellectual property specialist with expertise in polymer and surface chemistry. He has a BChE in chemical engineering, a MS in chemistry, and is a Registered Agent with the U.S. Patent and Trademark Office. His most recent position was Patent Liaison Specialist for SurModics, Inc., where he provided intellectual property guidance and support for their drug-eluting coatings technology. Previously, Mr. Alm was employed at 3M Company where he developed or co-developed many fluorochemical and polymer-based industrial products, and later became Patent Liaison, managing the interactions between various 3M divisions and patent counsel. Mr. Alm also has worked as an independent patent agent, drafting patent applications for a local patent law firm. He is listed as co-inventor on 7 issued U.S. patents and has authored numerous technical papers and articles.
Mr. Alm provides patent searching and analysis expertise, especially useful for startup medical device firms and related investors. Patentability assessments are of key importance, as well as the evaluation of freedom-to-operate in light of potential dominating patent art. Through the development of patent landscapes, he can assess intellectual property strengths and weaknesses, and create strategies and recommendations to insure the client’s IP strategy is congruent with overall business plan. Contact Mr. Alm directly at 651-226-9710 or
ralm@deviceadvisors.com.
Marie J. Versen is an ASQ Certified Quality Manager, with over 20 years experience in establishing quality systems and controls for medical device coatings and related chemical materials. She most recently served as Vice President of Quality Management & Regulatory Compliance at SurModics, Inc. Her responsibilities included quality system development and maintenance, quality engineering for new product introduction, and quality control for production. At SurModics, Ms. Versen worked with a large number of small-to-large medical device companies to establish quality control systems consistent with their products. She has strong knowledge of FDA/ISO and OUS governmental regulations for medical devices, pharmaceuticals, combination products, and biologics. In addition, she has extensive experience with both federal and local regulations governing chemical manufacturers and processors, including those of USDA, OSHA, MNOSHA, EPA/MPCA, DOT, ATF. Contact Ms. Versen directly at 612-616-2229 or mversen@deviceadvisors.com.
Ronald F. Ofstead is a chemistry and polymer materials specialist, with a BSci in Chemistry, and MS and PhD in Organic Chemistry. His most recent position was as Vice President, Chemical Materials Development, for SurModics, Inc., where he provided technical and managerial leadership in new chemicals and polymers development, materials characterization and testing laboratories, and surface analysis laboratories. Dr. Ofstead also served on an internal project management team, providing oversight of all new product development programs and mentoring of all development teams and leaders. Previously Dr. Ofstead held the position of Director of Laboratories at Science, Inc., a privately-held startup medical device company, with responsibility for product development, performance testing, manufacturing process development, and pilot production. Prior to that, he held numerous positions at 3M Company, most recently directing research and product development in 3M’s biotechnology and bioseparations business areas. Dr. Ofstead has over 30 patents issued or applied for, 25 of which relate to polymer materials for environmental or medical uses. He also has authored numerous publications and presentations, the most recent of which was “Surface Modification of Medical Devices” at a USFDA Surfaces in Biomaterials course in Rockville, MD. Contact Dr. Ofstead directly at 651-774-0252 or rofstead@deviceadvisors.com.
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