One big gripe about Minnesota’s medical device community is the lack of college graduates ready to hit the ground running.
Speaking at a governor candidates forum last week, Vascular Solutions CEO Howard Root said finding enough workers, including quality engineers and regulatory specialists, is the “number one obstacle” facing his company. He took direct aim at the University of Minnesota.
“There’s not one, single university graduate qualified to do it,” he said.
Perhaps Root should look north to St. Cloud State University. The school recently announced it added a Master’s of Science Degree in Applied Clinical Research, a program that will teach students how to design, conduct, and evaluate clinical trials in medical devices.
“A more comprehensive and well-rounded program is beneficial to both students and future employers,” Dan Schaber, vice president of clinical research for Medtronic Inc.’s (NYSE: MDT) cardiac rhythm disease management unit, said in a statement. “Gaining additional experience about the profession in the educational environment means that these students will be prepared to hit the ground running upon hire. As a hiring manager, if I can spend more time on trial development and execution versus developing and delivering dedicated training programs, the result is enhanced productivity.”
St. Cloud stands out in Minnesota, and indeed the rest of the country, for its devotion to producing workers specifically for the medical device industry. The school’s relatively new Regulatory Affairs and Services Graduate program offers courses like “Regulatory Submission/Application Requirements for Medical Devices, “International Regulatory Affairs: European Union, Canada, Japan, and Australia,” and “Reimbursement for Medical Technology.”
Even more impressive is the faculty. The program is run by Chuck Swanson, Medtronic’s former vice president of corporate regulatory affairs. Others instructors and advisors include Steve de Baca, vice president of quality for Boston Scientific Corp. (NYSE: BSX), Mark Duval, a well known Minneapolis attorney who specializes in the Food and Drug Administration, Felix Friedman, a UnitedHealth Group Inc. (NYSE: UNH) official, and Carla Monacelli, managing partner and co-founder of Argenta Advisors, a healthcare reimbursement consulting firm.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
