Medical Device Development Consulting
Established in Los Angeles, CA in 2003, Portfolio-Engineering began with a focus on project, program, and project portfolio (P3) management consulting. We have recently expanded our offerings to include the development of clinical and regulatory path strategy for new medical devices, along with the preparation of supporting regulatory filings and submissions for studies and approvals.
We have worked with clients including Amgen Biotech, MedImmune Global Biologics, DuPont Pioneer Bioengineering, and Edwards Lifesciences to bring innovative medical and biological products to market. We apply management tools and techniques to address improved scope management, stakeholder and team communications, prioritization and resource management, faster time-to-market, and risk and cost reduction.
As president of Portfolio-Engineering, Glenn acts as the senior or sole consultant on most engagements. With a Fortune 100 and large consulting-house background, he intentionally keeps Portfolio-Engineering's overhead minimal to be able to provide excellent, cost-effective services, so you get "Big 5" results without the Big 5 overhead.
Glenn is a long-standing member of PMI, maintaining and helping others gain its PMP certification for over a decade.
His partnership with Microsoft dates to 1999 and the introduction of their first enterprise-class project management suite. Glenn has implemented complex customizations of the Microsoft EPM / PPM suite as Project Server, SharePoint Services, and Project Online for dozens of clients, often integrated with the implementation of a governance PMO. He is MCTS certified for Microsoft's PM suite.
For clients, Glenn has implemented project and program management offices (PMOs) and executive project portfolio management systems, performed targeted project management training and culture assessment and development, and lead the initial strategy and planning phases of complex corporate programs.
Joining our team in 2018, Mark brings decades of experience in developing regulatory and clinical strategies that have been successful in bringing numerous new medical devices to market.
His experience covers a wide range of Class I and Class II cardiovascular, orthopaedic, ophthalmic, and neurological devices, including implantable and active implantable devices.
Among his accomplishments are the preparation of a pre-market application that gained US approval of the world's first retinal implant and preparation of an investigational device exception application that enabled clinical evaluation of a first-of-its-kind visual cortical prosthesis. He has also authored several international regulatory filings, obtaining approval of products in the European Economic Area, Canada, South Korea, Taiwan, Saudi Arabia, and Russia.