12 PM CDT | 10 AM PDT | 1 PM EDT
The Chicago Booth Angels Network of Chicago is hosting Rob Packard, the Founder and President of Medical Device Academy, a regulatory consulting firm for medical device startups
Rob Packard will speak on FDA regulatory process to get medical devices approved for indications of use from an investors point of view. He will address the process, systems, testing, costs, risks, time line and any related items that an investor should be aware of before investing in these companies.
Registration priority will be given to CBAN Chicago members. Zoom link will be send out a day before the event.
Rob V. Packard (Speaker), Medical Device Academy
I am a regulatory consultant that specializes in the device industry, but I started in the biotech and pharma industries in 1990. My specialty was the scale-up of new products from lab quantities to commercialization. During the 10 years, I was involved in that work, I scaled up a lot of different products. In 2000 I switched to the medical device industry. In 2004 I started my own medical device company as CEO, and in 2005 we had already completed the development of our first product. Ever since I have been specializing in quality and regulatory requirements for medical devices.
Amalesh Sanku (Moderator) '99
Amalesh is currently President & CEO at Sagertech Communications- a strategic marketing consulting company. He leads strategy and marketing engagements for telecommunications and medical technology companies with engagements in strategic planning, corporate strategy, marketing and sales strategies. He has identified potential acquisition targets, negotiated strategic global alliances, evaluated M&A prospects, led due diligence teams for organic and inorganic growth and portfolio management process both within and across business units at several companies.
Amalesh has worked at or partnered with some of the top technology companies in US such as Sprint, AT&T Bell Laboratories, Lucent technologies, Ciena, E.F. Johnson and Mpower communication. He has led marketing teams at several of these companies and has extensive experience in formulating marketing strategies, product management, market intelligence, competitive positioning, channel management, creating value propositions that resonate in the market, life cycle management of products, pricing and brand strategy development.
Amalesh is currently serving as a Director and an Officer on the Board of Gateway Foundation- a $110M non-profit drug and alcohol addiction counseling service- largest in the state of Illinois. He also serves on the board of the Chicago Booth Angels Network of Chicago. He has recently served on the advisory board of Feed My Starving Children-a non-profit organization dedicated to eradicating global hunger among children. Also served as an advisory board member at Johnson County Community College, KS to develop and offer a Data Science certified course.
Amalesh has an MBA from the University of Chicago Booth School of business, a M.S. in Computer Science from Oklahoma State University and a B. Engineering in Electronics and Communications from University of Madras, India. He holds a US Patent in multimedia performance of open systems.