Medical Device Executive for md PACE Program
The Maryland Technology Development Corporation (TEDCO) is seeking individuals with appropriate medical device product development and commercialization experience (“Medical Device Executives”) to lead and support early-stage commercialization efforts for university-based, medical device technologies as part of the mdPACE program.
The mdPACE program (the “Program”) is a virtual commercialization center that is being created by TEDCO with support from the Department of Commerce and the Economic Development Administration (EDA) through an i6 Challenge grant. The Program will leverage (i) the innovations in medical devices emerging from the Central Maryland/Baltimore/Washington Metropolitan region’s prominent medical and engineering schools including the University of Maryland and Johns Hopkins University, and (ii) the region’s significant entrepreneurial support infrastructure, to significantly increase the number of successful medical device companies in Maryland. This effort will address a key problem in the region – an insufficient number of experienced entrepreneurs – and help the region establish itself as a prominent innovation cluster for medical devices through the creation and success of a critical number of medical device start-ups based on the commercialization of university technologies.
Statement of Services Required:
TEDCO is seeking contracts with up to five Medical Device Executives for the Program. Each Medical Device Executive will be asked to lead the effort on 4 – 5 commercialization projects at a time, but will work collaboratively with other Medical Device Executives on all projects in the Program. TEDCO will seek to build a diverse team of Medical Device Executives each of which will have a specific strength in one of the following areas: regulatory matters, reimbursement, engineering/quality management, or clinical environments.
Medical Device Executives will participate in the selection of companies/projects that will be accepted into the Program. They will work with the inexperienced management of those companies and guide them through a stage-gate product development process that will ultimately lead to a 510(k) clearance from the Food and Drug Administration (FDA) of a commercially viable product at the end of 18 to 24 months.
One goal of the mdPACE program is to develop a commercialization model that can be duplicated in other areas of the country. In addition to working with companies/projects, Medical Device Executives will be expected to help shape the Program itself to best achieve this goal.
Medical Device Executives will be expected to commit up to 20% of their time (8 hours per week) to the mdPACE program.
Medical Device Executives will work with their project companies and participate in monthly Program meetings to make stage-gate decisions and to provide status updates to the other Medical Device Executives and mdPACE staff. Since the Program is new and likely to evolve over time, the roles and responsibilities of the Medical Device Executives are likely to change. Medical Device Executives will be responsible for adapting to these Program changes and performing other tasks necessary to ensure the success of the Program.
Date and Time by which Proposals must be Returned:
TEDCO asks that individuals interested in applying to become a Medical Device Executive for the Program submit a résumé or CV with a cover letter indicating why they are interested in the mdPACE program and why they would be a good candidate. Materials should be submitted via e-mail prior to March 31, 2017 to “Program Manager” at firstname.lastname@example.org; however, candidates will be considered as soon as résumés/CVs are received.
Medical Device Executives must have experience with medical device product development and commercialization – specifically, obtaining an FDA clearance [510(k) pathway] for at least one medical device product. Other evaluation criteria to be considered include: an understanding of medical device markets, experience advising medical device companies, familiarity with the Stage-Gate Product Development process and quality management systems, experience working in a start-up environment, and familiarity with the commercialization of university technologies. Finally, candidates will be selected based on the Program’s need for a diversity of expertise in one of the following areas: regulatory matters, reimbursement, engineering/quality management, or clinical environments.
TEDCO may conduct interviews and reference checks with selected candidates.
Medical Device Executives will be compensated at the rate of $150.00 per hour. Ideally, TEDCO is seeking Medical Device Executives that find value in working with early-stage medical device companies for the opportunity to give back and support promising new entrepreneurs. Such work might also provide an opportunity for the Executives to formally join or otherwise engage with a promising new company after it has completed the mdPACE program.
Applicants are subject to Subpart C of 2 C.F.R. Part 180, “OMB Guidelines to Agencies on Government-wide Debarment and Suspension (Nonprocurement).” Applicants may not be subject to any debarment or suspension with any government agency or otherwise excluded or disqualified from receiving federal funds.