MedTech Venture Studio

The reason for our focus on clinical innovators is because of their deep understanding of the standard of care and unmet medical needs.

If you have a deep understanding of these areas and have met the other requirements of the program, then we would be open to exploring possibilities with you.

Filed IP and a prototype are basic building blocks that are essential for this program.

If you have not yet completed these activities, then Archimedic may be able to support you with a fee-for-service development program. After you secure patent protection and a proof-of-concept prototype, we would be happy to explore our MedTech Venture Studio program if it is of interest.

The MedTech Venture Studio program is targeting Class I and Class II medical devices. Devices from all clinical areas are considered for the program.

The reason that Class III devices are not targeted for this program is due to the clinical trials and related expenses that are required for these types of devices. 

If you have a Class III device and still believe it would be a suitable fit for this program, we would welcome the opportunity to explore possibilities together.

To get started with the program, we need to first invest time and effort in developing a commercial strategy. This commercial strategy program costs $15,000 with 50% due on initiation and the balance due on completion.

This initial engagement is a way for us to work together on a small project that provides value and addresses critical business factors that are essential for fundraising.

Yes, both Founders and Archimedic are free to opt-out of further partnership discussions if the fit doesn't seem right following the commercial strategy engagement.

Archimedic takes the lead on the SBIR application process. We will leverage our team member credentials, facilities, equipment, supply chain, ISO 13485 certified QMS, and track record to bolster the application.

We do need the Founders to support the Specific Aims and Research Plan sections, clarifying the clinical unmet needs and addressing any clinical outcomes and strategies that are components of the development process. Additionally, we will need Biosketches of Founding team members that will play a role in the development processes.

If grants are not awarded, the Archimedic may reapply for grants. Often, valuable reviewer feedback is provided, which allows subsequent grant applications to be improved with greater chances of success. 

If Archimedic opts to not pursue additional grants or alternative sources of funding, then the partnership agreement is terminated and the founders are free to pursue alternative options.

Archimedic qualifies as a "small business entity" which is a requirement of the SBIR program. Additionally, Archimedic's expert team members, facilities, equipment, supply chain, ISO 13485 certification, and track record in medical device development will contribute positively to the application.

If the SBIR grant was to be routed through a separate NewCo, then there are limits on the amount of proceeds that could be subcontracted to Archimedic. These limits are 33% for Phase I SBIRs and 50% for Phase II SBIRs. Since Archimedic will be facilitating the majority of the development work pertaining to the grant, then the majority of the grant proceeds must be allocated accordingly.

Archimedic's equity in a future NewCo will be vested only after milestones have been achieved. Below is the boilerplate vesting schedule as it pertains to milestone completion:

• $250k Raised - 20%
• Specific Aims Achieved - 40%
• Additional $1.5M Raised - 60%
• Regulatory Clearance - 80%

The percentages above are for total company stock from the time of the partnership agreement. If a new company is formed at any point following the partnership agreement, the vesting schedule will be used to calculate the amounts of stock that will be allocated to Archimedic and the Company founder(s). 

If investment is secured following new company formation, then dilution will be applied to both Archimedic and the company founders, based on the percent ownership at the time of investment. These details will be clarified in the partnership agreement.

The partnership agreement will specify the terms to be defined in a future new company that is formed. This includes equity amounts, vesting schedules, and other critical terms related to the new company. Prior to new company formation, founder IP will be retained by the founding team, and Archimedic IP will be retained by Archimedic. This IP will be assigned to the new company after it has been formed. 

Yes, outside investment may be secured in lieu of, or in addition to, SBIR funding. If outside investment is sought, then a new company will be formed at that point in time. This new company will serve as the capital structure for assigning equity to founders, Archimedic, investors, and any other involved parties. 

We are happy to get a non-disclosure agreement (NDA) in-place at the right time. For our first call together, we prefer to keep discussions high-level and non-confidential. The objective of our first call is to explain the structure of our MedTech Studio Venture model, learn more about your goals, and determine if there is a suitable fit to continue conversations. If the fit is there, we will get an NDA in-place right afterward.