Meet Our Team

Andrea Agree is a Regulatory Scientist at MED Institute. As a graduate research associate, Andrea was awarded a Pre‑Doctoral Fellowship from the American Heart Association for her research focusing on understanding the mechanisms by which the body protects itself from heart disease. At MED, she has developed and implemented regulatory strategies and supported submissions to health authorities globally. She holds a BS in Biochemistry from Iowa State University and a PhD in Biochemistry from the University of Illinois at Urbana-Champaign where she also earned her Certificate in Business Administration. Andrea completed her postdoctoral training at the Dwight Look College of Engineering at Texas A&M University, College Station.

Dr. Charlebois began his professional career focusing on projects involving advanced biomaterial selection, characterization and optimization for orthopedic implant design. He has held various positions within the Cook organization over the last several years, ranging from product discovery to cell and regenerative therapies. Steve holds a BS in Metallurgy, Mechanics, and Material Science from Michigan State, a MS in Biomedical Engineering from University of Minnesota, and a PhD in Mechanical Engineering from the University of Memphis.

Brooke has over 7 years’ of experience in the medical device industry. She has held various positions within the Cook organization. She began her career focusing on clinical research and patient recruitment. Brooke’s primary role is to promote MED’s mission and services to raise brand awareness. Brooke graduated from Indiana University with a BA in Communications.

Dan has over 30 years’ experience in Regulatory Affairs with exposure to a wide variety of medical technologies, submissions types, and regulatory agencies. He has extensive work in developing non-clinical and clinical protocols and experience in interpreting the results of those studies. He holds a BS in Chemical Engineering from Rose-Hulman Institute of Technology and MS in Applied Statistics from Purdue University.

Trish Dine is an Engineer at MED Institute. As a graduate student, Trish earned first place at 2018 BMEidea, the leading nationwide biomedical technology competition for her work on a novel ureteroscope. She was also awarded Best Pediatric Innovation at the 2018 International Meeting for Simulation in Healthcare conference, for her work on a silicone model simulating developmental dysplasia of the hip. Trish graduated from the University of Michigan with a BS in Biomedical Engineering and an MSE in Biomedical Engineering, Medical Product Development.

Dr. Fearnot has served as the founding President of MED Institute (1983), Cook Biotech (1995) and Cook Advanced Technologies (2009). He has lead development for commercialization of over 40 breakthrough medical products, involving engineering design, non-clinical testing, clinical studies, quality systems statistics, and a variety of regulatory submissions in several countries. Dr. Fearnot has authored over 150 scientific journal articles and abstracts, and has invented over 100 U.S. and foreign patents. Neal holds a PhD in Electrical/Biomedical Engineering from Purdue University.

Jonathan has worked on a variety of medical devices in various stages of medical device development. These experiences span the device development cycle, including concept generation, test protocol development, and manufacturing plan analysis. Jon received his MS in Biomedical Engineering from Cleveland State University.

Rob has 10 years of experience in Quality Assurance and Quality Control having previously held roles as a QC Lab Technician and GLP QA Auditor. He holds a BS in Biology from John Brown University and a MBA from the University of Saint Francis.

David Gross, PhD, PE, leads the MRI safety and computational modeling and simulation (CM&S) groups at MED Institute. Dr. Gross was awarded a Pre-Doctoral Fellowship from the American Heart Association (AHA) for his research focusing on improving the MRI safety of patients. He received the Magna Cum Laude Merit Award at the 2016 ISMRM Annual Conference. Dr. Gross holds a BS in Biomedical Engineering and MSE in Interdisciplinary Engineering from Purdue University, MS and PhD degrees in Biomedical Engineering from Ohio State University, and is a licensed Professional Engineer.

Brandon has worked in the medical device industry for 9 years and has experience in all phases of medical development, spanning from early concept generation and feasibility phases through the successful regulatory submissions. He has provided post-market engineering support on a wide range of product lines. He graduated from Michigan State University with a B.S. and M.S in Mechanical Engineering.

Dr. Heise has over 25 years of industry experience developing scientifically robust regulatory and clinical study strategies and is active in developing processes to generate real world evidence for medical devices. He participates in projects within MDEpiNet and Harmonization by Doing and leads several committees. Ted graduated Magna Cum Laude with a BS in chemistry from the University of Nebraska at Omaha and a PhD in analytical chemistry from Iowa State University.

Eric spent several years working in the Engineering industry, then transitioned into the Information Technology department. Eric uses his Engineering background to ensure that the team is fully equipped to handle the projects that come our way.  Eric graduated from Purdue University with a BA in Aerospace Engineering.

Pratik has over 8 years’ experience coordinating and managing multiple clinical trials in various therapeutic areas. He has published over 15 journal articles, has reviewed over 25 articles for international journals, and is an Associate Editor for the International Journal of the Cardiovascular Academy. Pratik holds a BS in Biotechnology from University of Mumbai, a MS in Biology from Indiana State University, and is a certified Clinical Research Professional from SOCRA.

Amy works in the MRI safety evaluations and computational modeling and simulation groups. She is active in the field as a member of the International Society for Magnetic Resonance in Medicine (ISMRM), the Biomedical Engineering Society (BMES), and the American Society for Mechanical Engineers (ASME). Amy graduated Magna Cum Laude with a BS in Mechanical Engineering from The Ohio State University.

Dr. Kim has over 38 years of experience in CM&S starting with his undergraduate research. For the last 13 years, he has analyzed and designed many medical devices and has in-depth knowledge and analysis skills in multiple disciplines such as non-linear structural, vibration control, impact, CFD, FSI, fatigue, and MRI safety. Stephen holds MS and PhD degrees in Mechanical Engineering from the University of Minnesota.

Kimberly is responsible for maintaining the documentation systems for business procedures and providing administrative support to MED staff. She has focused on dedication to customer service and quality throughout her professional career.

Dr. Alan Leewood is the Director of Advanced Engineering at MED Institute. After earning a Ph.D. in Aerospace Engineering at Purdue University in 1985, Dr. Leewood co-founded AC Engineering Inc., a consulting company that used the nonlinear FEA software, ABAQUS, to solve a wide variety of challenging engineering problems. Since joining MED Institute in 2004, Alan started a Discovery Engineering group, a Computer Aided Engineering team and, most recently, an MRI team that evaluates the safe use of implantable medical devices.

Alex has been involved in global medical device research and development for over 6 years. She has worked on a variety of devices across many stages of the medical device development process. Alex holds a BS in Biomedical Engineering from Purdue University, is the inventor or co-inventor of several patents, and has an authored publication in the medical device development field.

Justin has worked on many Class II and Class III medical devices over the last 19 years. He has worked with regulatory bodies around the globe, has submitted several patents, worked with various physician specialties in both the engineering lab and the operating room, and participated on standardization committees. Justin holds a BS and MS in Engineering from Purdue University.

Brian has over 20 years’ of experience in web development, graphic design, and project management.  His analytical, creative, and perceptive skills enable him to design, develop, and maintain various database solutions. Brian studied Architectural Design and Project Management at Ivy Tech State College and Architecture at Ball State University.

Lori Nolte, PhD, RAC is the Director, Regulatory and Clinical Services for MED Institute.  Lori has 19 years of industry experience with clinical trials and regulatory work.  Her most recent experience was as the director of regulatory affairs for a major medical device company, leading a team of over 60 employees responsible for global regulatory submissions and approvals for 8,000+ products.  Prior to moving to industry, Lori was an Assistant Professor at Washington University School of Medicine in St Louis, Missouri.  She is an author on 40 published scientific articles.  Lori has a Ph.D. in Clinical Physiology from the Karolinska Institute in Stockholm, Sweden.

Joe graduated from Purdue University with a Master of Science Degree in Mechanical Engineering and served in Purdue’s Hillenbrand Biomedical Engineering Center as a post-graduate research associate until joining COOK Medical in 1999. He has been active in developing medical products in the field of regenerative medicine for applications in wound care, G.I., cardiac and neurosurgical therapies, and has obtained over 40 U.S. and foreign patents. Joe has also assisted with developing COOK’s design control and medical device risk management processes and procedures.

Michael is an expert in clinical research, focused on designing and executing well-considered and efficient studies.  He managed successful clinical trials for five years, ranging from small pilot studies to multi-site pivotal (phase III) trials with hundreds of subjects that spanned three continents.  For the past eight years, he has designed clinical trials for medical devices and cell therapies in a variety of disciplines, including surgery; cardiology; wound care; urology; and pulmonology.  Michael holds a Bachelor of Science degree in Engineering (Biomedical focus) and a Master of Science degree in Physiology, both from Purdue University.

Justin has over 15 years’ experience and is an industry leader in product development, engineering, regulatory affairs, and clinical trial services. He has held various positions within the Cook organization ranging from clinical research to contracts. As a patented inventor, he is well versed in early concept development and has spent his career focusing on working with physicians and inventors to innovate from the lab to the marketplace. Justin graduated magna cum laude from Indiana State University with a BS in Exercise Science.

Erick Smith is a Research Engineer in the MRI safety and computational modeling and simulation (CM&S) groups at MED institute. He graduated from Purdue University with a BS in Aeronautical & Astronautical Engineering. During his time at Purdue, Erick was on many research teams including working on Project Escalator and lead designer for the PREFER2 Project (Purdue Research & Educational Facility for Exos Rockets).

Hayley specializes in the field of regenerative medicine. She has 6 years of experience as a biologist in research and development and has worked on projects ranging from concept development to process optimization. She has developed and executed methods to evaluate the cytocompatibility of medical devices. Hayley’s work has contributed to poster abstracts and peer-reviewed manuscripts. Hayley holds a BS in biology from Purdue University.

Colleen currently leads quality system efforts and serves as the Management Representative for MED Institute.  She has over 36 years of experience in quality assurance, quality systems and quality control at MED Institute.  Colleen has experience with vendor audits and has provided quality system and internal auditing services to sister and client companies.  She has also assisted with revisions to Quality Systems for clients who are remediating or improving their Quality Systems. Colleen also serves as the company Treasurer and provides guidance and assistance with financial reporting and business system processes.