mdPACE is a new Program jointly funded by TEDCO and a Federal Department of Commerce EDA i6 Grant. The output of the program will be an increased flow of FDA cleared devices from the Central Maryland region. The desired outcome of this increased flow is heightened visibility among financial and strategic investors, and manufacturers such that the increase is sustainable. A reliable critical mass of medical device clearances in the Central Maryland region will eventually lead to the businesses formed around those devices remaining in the region – once that happens, all the indirect and non-scientific job creation surrounding medical devices (QA/QC, supply chain support, manufacturing, etc.) will flow into the region with attendant economic development benefits.
The core value proposition of this Program is quite simple – by applying the continual expertise of individuals who have successfully navigated the medical device commercialization process, the Program will assist entrepreneurs generate 510(k) cleared technology in 12-18 months less than the 36-42 months needed by an inexperienced, unguided team. It is estimated that the cost of a team going through the Program’s efficient process will be $300-$500K (including modest team salaries) versus $600-$800K for the unguided team. Program experts will focus the team on an early design freeze and on the specific, proven, design control oriented requirements of the 510(k) submittal process. The nuances of these requirements are often apparent only after taking several medical devices through the process; they are certainly not readily apparent to an inexperienced team. As the team moves toward a 510(k) submittal, the following elements of the business will be developed.
- Reimbursement strategy
- Manufacturing strategies
- QMS Regulatory strategy
These elements and a 510(k) clearance will combine to represent a significant value inflection point and create an attractive monetization opportunity.
While there is no expense associated with participation in the mdPACE Program, it is the intention of TEDCO and EDA that the Program be self-sustaining beyond the three-year grant period. TEDCO feels that the future successes of the companies assisted through the mdPACE Program can be a means to this long-term sustainability. Upon acceptance into the Program, each participating company will enter into a deferred compensation success fee agreement (specific terms of the agreement can be found in the Request for Application). Deferred compensation arising out of company successes will be reinvested into the mdPACE Program in future years.
The prospective mdPACE team will be coachable and will have secured some funding, either dilutable or non-dilutable. Ideally, the team will have been through a successful FDA pre-submission meeting. Target technologies with a clear 510(k) regulatory pathway and the following characteristics will be eligible to participate in the Program. Note that criteria may be modified in years 2 and 3.
- Material IP with real roadblocks.
- Either an existing reimbursement code or a clean, quantifiable revenue model.
- A predicate device (i.e. no De Novo applications).
- No requirement for a PMA.
- No requirement for human trials.
Additional selection preferences may include the following.
- Quadrant 4 on cost/value continuum (i.e. low cost, high value).
- Large market (i.e. >$500M) or represent a threat to an existing product line.
- No electronics (i.e. no “plug”).
Candidate companies and entrepreneurs may express their interest in participating in the mdPACE Program by submitting an application as outlined in the Request for Application (RFA). Potential applicants should take care to follow the RFA submittal requirements very carefully. Applications will be accepted on a rolling basis.
Neil Davis Director, Entrepreneurial Development firstname.lastname@example.org 410.715.4164