November 'On the Road' with Stephen Rapundalo
Wednesday, November 26, 2014
The year keeps racing past as we near its end…unbelievable where the time has gone.
When we last left off, I was on my way to the MD&M Chicago 2014 Conference and Exhibition. There I chaired an all-day session on various topics related to “Designing Next Generation Medical Devices”. Morning speakers presented on miniaturization and new power technology, as well as on protecting IP and new design. Two workshops – “Innovation that Matters: Cost & Patient Safety” and “Human Factors” – were delivered in the afternoon. Session speakers were from a cross-section of the industry – Covidien, CareFusion, Medtronic, MicroSystems Engineering, WiTricity, and others.
The following week saw me attend the Open House for SRI International’s new Phase 1 Clinical Trials Facility located at the Michigan Life Sciences Innovation Center in Plymouth. The 9,400 square foot unit includes 13 beds, three infusion chairs, an investigational pharmacy, a lab and overnight rooms for volunteers. SRI will also offer consulting services to local biotech/pharma companies, helping them evaluate market opportunities, refine their business plans, target drug opportunities, apply for federal grants and help them navigate the regulatory process.
The next day I attended the annual Inno-vention Conference hosted by Oakland County’s Medical Main Street. The theme for Inno-vention 2014 focused on technology, innovation, digital business trends and how they are applicable to health care. Krischa Winright, CIO of Priority Health and VP of Information Technology at Spectrum Health, was the keynote speakers who discussed the importance of digital connections in the fast-changing healthcare landscape.
Later that same day, I attended a press conference announcing a NIH award of $21.2 million over five years to a consortium of Marygrove College, University of Detroit Mercy, Wayne County Community College District and Wayne State University. The grant was awarded through the NIH’s Building Infrastructure Leading to Diversity (BUILD) initiative, created to engage minority and economically disadvantaged students to pursue STEM education, expose them to laboratory research and encourage them to follow biomedical careers. The Detroit consortium’s project is called REBUILD (Research Enhancement for Building Infrastructure Leading to Diversity) Detroit and will recruit its first cohort in the second year and begin training.
It was back to airport during the final week in October. First, I headed to Salt Lake City to participate in the Medical Device National Skills Harmonization Meeting sponsored by the Community College Consortium for Bioscience Credentials (C3BC). Representatives from across the medical technology industry met with community college faculty and workforce development staff to review and refine skillset standards for five functional areas: manufacturing, regulatory, quality, instrumentation, engineering and R&D. Such standards are to be utilized by a national network of community colleges to elevate the skills and knowledge base of future entry-level workers. While in Salt Lake City I also sat down with my counterpart, Kimball Thomson with BioUtah, and we compared notes on our respective organizations, operations and programming.
Then it was off to Minnetonka, MN, to attend a Midwest Region Issues Summit sponsored by CropLife America, Biotechnology Industry Organization and Responsible Industry for a Safe Environment (RISE). We gathered at Syngenta’s corporate headquarters to discuss various agricultural biotechnology regulatory and policy issues such as GMO labeling, clean water act, and others.
I took the first week in November off for family matters, but while in Virginia stopped in to visit with my counterpart Jeff Gallagher at VABio. Coincidentally, their offices at the Virginia Biotechnology Technology Park building are on the campus of the Medical College of Virginia (Virginia Commonwealth University) where I pursued my PhD studies in the Department of Physiology. So, for nostalgia reasons, I stopped to see my graduate advisor, and is was great to catch up after so many years and walk the old halls of the Sanger Hall Basic Sciences Building (with vivarium odors still intact).
Once back in Ann Arbor, I met with Joe Listroth at U-M’s WUOM radio station, who’s developing “The Next Idea”, an on-air and online project that will focus on creativity, innovation and ideas to move Michigan forward. The initiative will begin with essays by contributors from across a spectrum of backgrounds and industries. Stay tuned as we’ll post my point of view when it comes available.
On November 13th I attended the annual CEO Summit at the Detroit Westin Book Cadillac hosted by Business Leaders for Michigan). You can find all the fine presentations, panel discussions and videos on the BLM site, including the keynote by Peter Diamandis, M.D., Chairman & CEO, XPRIZE Foundation and Executive Chairman, Singularity University, who spoke on the future of competition (see his new book - Abundance: The Future Is Better Than You Think).
The next day I participated in the bi-annual meeting of the Biotechnology Advisory Board at Henry Ford Community College. Representative from the industry gather with faculty to review curriculum, talent development and training initiatives, and asset needs to support the institution’s mission.
Last week began with the inaugural meeting of the BEST (Broadening Experiences in Scientific Training) Advisory Board at Wayne State University. The institution was one of only 10 academic centers in the nation to receive a NIH grant in fall 2013 to establish enhanced training opportunities to prepare graduate students for careers outside of traditional academic roles. The five-year, $1.8 million grant is supported through the NIH Common Fund's Strengthening the Biomedical Research Workforce program.
Mid-week I met with Mark Sutter, CEO of Terumo Cardiovascular and Jan Stegemann, PhD, Associate Professor, Biomedical Engineering at U-M. I was there to advise and assist Dr. Stegemann and his colleagues in their efforts to better develop curriculum, particularly to be more inclusive of regulatory science principles. We discussed how better to interface directly and align with the FDA’s educational initiatives that seek to build a better understanding of regulatory review processes and policy and their application to biomedical product design and development.
On the way back to the office, I stopped in to meet with Phil Muccio, CEO of Axiobionics. The company moved here from Ohio in 2009. It creates wearable pain management systems for patients with chronic pain resulting from strokes, spinal injuries or neurological disorders. The customized garments, fitted with electrodes, are designed for patients to wear under their clothing and promote stronger muscles, reduce pain, increase function, improve posture and facilitate circulation.
Then Thursday, in the middle of the snowstorm, I trekked to Clinton Township and visited with Jerry Heckendorn at AIM Plastics. He gave me a tour of their facility including a massive clean room where they provide comprehensive services that produce rapid turnaround on highly-complex plastic injection-molds, molded parts and assemblies for biomedical products. Customers can begin working with AIM Plastics at any stage of their project, from the product development phase to prototyping, on through to production manufacturing. It was fascinating to see how the products you encounter in the physician’s office, hospital or home setting are really made with such amazing precision. AIM does a lot of work in the medtech hubs on both coasts, but also has provided its services to start-up and multi-national companies based in Michigan. Check them out…very impressive workmanship and quality.
Lastly, on Friday, I traveled to Lansing to meet separately with Sen. Joe Hune’s (R-Howell) and representatives from the Department of Licensing and Regulatory Affairs (LARA). A number of multi-national and small regional medical device companies have been caught up by unintended consequences of legislation passed to regulate drug compounding in the aftermath of the meningitis outbreak here in Michigan and other states earlier this year. The law imposes significant regulations on compounding pharmacies and pharmacists including criminal sanctions for certain violations. Unfortunately, it also included medical device manufacturers, wholesalers and distributors, and requires them to hire a licensed pharmacist-in-charge to oversee and be responsible for their products sold or distributed in Michigan. MichBio is working aggressively with its company partners to mitigate this regulatory burden – watch our upcoming Advocacy Alert for more information.
So that’s it for now. Have a safe and enjoyable Thanksgiving holiday weekend with family and friends. Talk to you next month.