Archimedic participates in a number of programs and initiatives to help new companies advance or assist established companies in bringing new medtech products to market.

• J&J Innovation JLABS The premier life science incubator empowering and enabling innovators to deliver life-enhancing health and wellness solutions to people around the globe.

  Archimedic offers a discount to JLABS companies through the vendor Resource Hub.

• Ben Franklin FabNet A partnership for rapid prototyping and fabrication utilizing advanced manufacturing technologies, offered through Ben Franklin Technology Partners of Southeastern Pennsylvania.

  Regional companies may apply for matching funds from FabNet to work with members of the partner network, including Archimedic.

• FDA Pediatric Device Consortia The goal of the FDA’s Pediatric Device Consortia (PDC) Grants Program is to facilitate the development, production, and distribution of pediatric medical devices through funding of nonprofit consortia.

  Archimedic participates as an official design partner of the Pennsylvania Pediatric Medical Device Consortium and the National Capital Consortium of Pediatric Device Innovation.

Our project collaborations often result in new intellectual property that form the foundation for patent filings.

In fee-for-service relationships, we typically assign intellectual property rights to our clients as part of our service agreements. We expect that our team members are listed as inventors on related patent filings in accordance with patent law.

When Archimedic directly secures grants and/or equity investments to facilitate product development and commercialization (see “What is your business model?” question above for more details), we structure joint intellectual property agreements.   

After entering into a business relationship with a client seeking funding to advance their technology and who may be a good candidate for SBIR/STTR programs, Archimedic may support companies in securing additional grant funding. (See “What is your business model?” question above for related details.) There are two ways we collaborate with organizations through the SBIR/STTR process.

The first and most straight-forward collaboration is for Archimedic to operate as a subcontractor. In providing support as a subcontractor, companies leverage our track record of developing successful devices, qualified development team, quality management system, and facilities and equipment. For these types of subcontractor relationships, we provide a letter of support capturing our qualifications and specifying the details (timelines, budgets) for the project.

The second mode of collaboration is for Archimedic to operate as the prime contractor in securing the SBIR/STTR funding. Under this mode, Archimedic files with the agency directly and obtains letters of support from the contributing academic institutions and other organizations part of the grant process. A team member from Archimedic operates as the Principal Investigator (PI) for these types of grants. We collaborate with partnering organizations and institutions to generate many of the grant application components and Archimedic completes the filing and communications with the SBIR/STTR agency. Typically, we pursue this prime contractor route only if a prior fee-for-service engagement with an organization has been completed.

We work with many clinical innovators and academic hospitals that have limited resources to drive business operations, product development, project management, fundraising, and the other functions necessary to build a medical device business. In select cases, Archimedic will license a technology from an academic institution or an individual and incubate the technology internally, leveraging our team members, quality system, supply chain, facilities and equipment. 

Due to the investment of resources required, Archimedic is very selective regarding the technologies we pursue for this incubation program.

Developing even a simple medical device often requires multiple years of dedicated effort. This is due to the many technical, regulatory, clinical, quality management, and manufacturing processes that must be simultaneously managed to achieve market approval. From napkin sketch through regulatory approval, companies can usually anticipate seven- to eight-figure investments. For this reason, we primarily work with organizations that are seeking or have successfully secured external financing.

While the overall funding requirements for commercializing a new medical device are significant, the vast majority of our clients obtain smaller rounds of funding to achieve early technical and clinical milestones. We structure development programs to fit within these smaller rounds of capital, helping companies map out the longer-term development processes, timelines, and budgets needed to unlock future funding rounds.

Yes. Archimedic’s quality system allows for flexibility in our approach to each project. As an alternative to utilizing our internal quality system, our can work within your quality system when requested.

We pride ourselves on flexibility and ensuring our team members are being utilized to their optimal abilities. We often work with clients that drive one disciplinary area. For companies simply seeking a single part to be designed within a much larger system, we are generally not the best fit.

We’re distinct from many other product development firms in three key areas.

• Medtech expertise – this goes beyond product development. Our knowledge of regulatory, clinical, payment, IP, and business factors are leveraged throughout the development process to help our clients determine what product to build and how to optimally structure the development roadmap.
• Technical expertise – our broad array of technical disciplines, including mechanical and electrical engineering, software development, industrial design, and human factors, allows us to deploy the right disciplines on the appropriate tasks. 
• Program management – changes in new medical device projects are inevitable, but our goal in program management is “no surprises.” We work hard to ensure that our internal teams and client teams are in lockstep throughout the development path. 

We typically start each conversation with a high level, 30 minute, non-confidential phone call.  If we both determine that there is a strong fit for collaboration, we put a mutual NDA in place and dive into the project details during a follow-up meeting.