What challenges does your organization currently face related to managing product design controls?

Global IT & R&D leader and multi-patent-holding innovator with over 20-year career transforming technology into a business-aligned source of competitive advantage for leading Life Sciences/MedTech organizations. Extensive experience spans vascular, endovascular, renal, endoscopy, and orthopedics.

Recently Sri was the Vice President Global, IT (Quality, Regulatory, R&D, Clinical & Medical Affairs) at Smith and Nephew where he led digital transformation across R&D, Quality, Regulatory, Clinical, and Validation functions. He was responsible for strategic decision making in the selection, installation, consolidation retirement and operations of enterprise-wide Software applications/tools and technology used across the enterprise.

Previously he was the Vice President of Software Quality Engineering and Program Management Office at Fresenius Medical Care, North America where he was responsible for architecting and implementing a Networked Quality Solution (NQS) framework.

Over the years he has led the development of disposables and implantable products such as Aortic, Peripheral Vascular GI stents, in addition he has led the development of imaging devices at leading medical device manufactures such as Boston Scientific, Medtronic, C R Bard etc. He has graduate degrees in Applied Chemistry from India, Materials Engineering from Drexel University, and an MBA from Boston University.

Jim Weber is currently the Head of CMC Biologics at NGT BioPharma Consultants. Jim is a high-performing R&D leader with significant experience developing biologics and small molecules into successful drug candidates. As an accomplished scientific leader and functional manager in areas of Analytical and Pharmaceutical Development, Jim has led teams in the development of several new biologic and chemical entities that are now marketed drugs. He has a proven track record of building and optimizing organizations, managing cross-functional projects, and applying essential technologies and data strategies to achieve business objectives while minimizing risk. Click here to learn more about Jim’s expertise.

Michael Hess currently consults on the Medical Device industry. Before this, he was employed at Medtronic for over three decades, holding various positions at the company (01/1991 – 05/2023). Medtronic develops, manufactures, and sells device-based medical therapies to healthcare systems, physicians, clinicians, and patients worldwide. Most recently he served as Vice President Corporate Technology and Innovation at Medtronic (05/2020 – 05/2023).

As Vice President Corporate Technology, he led center-based technology org focused on platform technologies, preclinical research, knowledge and collaboration, quality in R&D design, enterprise technology initiatives and product stewardship. He has also served as Vice President Engineering and Medtronic Fellow (09/2019 – 05/2020); Vice President and General Manager, MCS Business (03/2018 – 09/2019); Vice President Heart Failure R & D, CRHF Division (07/2017 – 03/2018); Vice President Bradycardia Research & Development, CRDM Divison (04/2012 – 07/2016); as well as a variety of other corporate facing positions at Medtronic.

Currently Mike Hess is a an adjunct professor in Biomedical Engineering at the University of Minnesota, and Editor in Chief of the IEEE EMBS Pulse magazine, focused on advances in biomedical technology.

Jeff is a founding partner of Spring Lake Equity Partners. Prior to founding Spring Lake, Jeff served as a Partner in Tudor Investment Corporation’s private equity group, the predecessor to Spring Lake, since 1999. He has focused on investments in the software, internet infrastructure, cybersecurity and healthcare IT sectors. Jeff currently serves on the boards of InsideView, Forefront Telecare, and is a board observer for Illusive Networks. Prior investments where Jeff served as a director or was actively involved include Remedy Partners, ObserveIT, Sqrrl, Dorado Systems, Plated, NetProspex, Single Digits, Thorne Research, TractManager, Crossbeam Systems, Intelligrated, and Velocity Technology Solutions. Prior to joining Spring Lake Equity Partners he was an associate with Downer & Company, an international mergers and acquisitions firm. Jeff was also a strategic consultant to Oplab, a start-up medical device company. Previous to that he was a financial analyst in the Corporate Finance Department of Fox-Pitt, Kelton Ltd. Jeff earned a Masters in Business Administration from the MIT Sloan School of Management and a Bachelor of Arts in History, cum laude, from Yale University.

Bob is a founding partner of Spring Lake Equity Partners. Prior to founding Spring Lake, Bob served as Managing Partner of Tudor Investment Corporation’s private equity group, the predecessor to Spring Lake, for nearly two decades. He has served on the Board of Directors of numerous companies including Art Technology Group, Classic Sports Network, Wired, and Intelligrated. He is currently serving on the Board of Directors of Professional Trading Solutions (PTS), SmarterHQ and PhoenixET. Prior to joining Tudor, he was a Vice President at Carlisle Capital, a leveraged buyout firm based in Boston where he played a key role in the acquisition and management of several plastics companies which were consolidated to form Carlisle Plastics, a diversified plastics company that was taken public on the New York Stock Exchange.

Bob was also an executive with the American Management Company, a start-up software company which developed and marketed systems management software for mini-computers. Bob initially served as Chief Financial Officer and was later appointed Chief Executive Officer and led a successful effort to sell the company to a strategic acquirer. Bob was also a management consultant with Bain & Company at which he worked in a variety of industries including communications services, financial services and information technology. Bob earned a Masters in Business Administration from Harvard Business School and a Bachelor of Science in Accounting and Business Administration from Washington and Lee University.

Dale Gallaher is President of Cognition Corporation. Cognition Corporation has been offering solutions for product and process development for more than twenty years. During his time at Cognition, Dale has consulted with many product development companies to help in implementing specific parts of the product development process. Dale has also been the technical lead in the design and development for several of Cognition’s software tools.

Prior to Cognition, Dale was a product development engineer at General Electric. He has over 25 years of product development experience, most of which was focused on implementing leading edge product development tools. Dale holds a B.S.M.E from Bucknell University and M.S.M.E from MIT.

David Cronin, Founder at Cognition Corporation, has worked for over 30 years in the life sciences industry, with the last 25 years improving IT data science models that combine internally structured data items, connections, and deliverables for pharmaceutical and medical device submissions. David brings a knowledge of systems engineering with industry standards and regulations to improve data integrity and chain of custody for complex reports and traces in product development and commercialization.

David also serves as the Co-Chair for the International Council on Systems Engineering (INCOSE) Healthcare Working Group. David holds a BS in Electrical Engineering and an MBA, both from Northeastern University in Boston, MA.

As Chairman and CEO, Gerald is responsible for setting the strategic direction of Cognition Corporation and ensuring that the company is operating ethically, efficiently, and transparently while fulfilling the board’s responsibilities to the company and its shareholders. In addition, as CEO, Gerald is responsible for setting and executing organizational strategy, allocating capital, and building and overseeing the executive team.

Gerald is a deeply accomplished, high-energy executive passionate about propelling innovative, disruptive technology companies to next level success.

In previous positions such as President, CEO, GM, Chairman, Executive Chairman and CRO, Gerald has built a reputation as a high-energy, dedicated, transformational leader who delivers unquestionable transparency and trust with boards, investors, customers, and management teams. Gerald’s strengths are in identifying and harnessing the winning formulas for game-changing growth and strategic exits that maximize shareholder returns, no matter the challenge: startups, turnarounds, and rapid growth.

Gerald’s record includes 7 startups and 4 large enterprises in VC-backed and established companies, consistently scaling and dependably steering each to a strategic exit – delivering the best possible returns for shareholders time after time. Gerald has never left a business he has joined before the exit.

Gerald was named Ernst & Young “Entrepreneur of the Year, New England Finalist” and has been quoted in the Wall Street Journal, Fortune, and has appeared on MSNBC.

Gerald holds A.S. degrees in Materials Engineering and Electrical Engineering, is a graduate of Boston University with a B.S., Business, and an MBA from Babson College.