This process starts with developing efficient methods to address key risk factors early. Through this risk-focused development approach, we help our clients achieve their milestones and build value in their enterprise.
We partner with clients in three types of business relationships to accelerate the growth of new medical technologies. Our primary model is Fee-for-Service.
Read more about our business models in the FAQ section below.
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.
Archimedic is committed to assisting clients with the development of safe and effective medical devices. Our commitment to excellence is reflected in a robust Quality Management System compliant with 21 CFR 820 FDA Quality System Regulation and ISO 13485:2016.
For details, please read our Quality Statement.
From proof-of-concept builds to ergonomic mockups, functional breadboards, Alphas and Betas, functional prototypes are the most common outputs sought by our clients. We adopt a prototyping mindset to address common risk factors, such as usability, adoption, adherence, functionality, and preclinical efficacy.
For most of our clients, a clinical study will be necessary to prove efficacy or comparable improvements over the standard of care. Depending on the requirements of the clinical build, we produce devices for an array of investigational studies.
Breadboards (or electronic test beds) are often generated early in the development process to evaluate functionality of key components. Additionally, these early breadboards can be a platform on which to load firmare. For clinical and production-focused builds, our team creates Printed Circuit Boards (PCBs) that address system performance and safety requirements. Our medical electronics are developed in compliance with IEC 60601, 3rd Ed. and our hardware is verified to ensure safety and consistency in performance.
Software is developed at varying levels of maturity depending on the risks being address. For proof-of-concept prototypes, we rapidly generate prototype code that can demonstrate system functionality. For clinical and commercial builds, we develop software using robust risk management and quality focus to ensure that software meets user, technical, and design requirements. In these clinical and commercial builds, our team ensures safety and efficacy through full software validation and documentation in compliance with IEC 62304.
We develop ergonomic models to evaluate use cases and to optimize human factors for new medical devices. Ergonomic models are produced early and iteratively during the concept development phases to gain feedback addressing adoption, adherence, and safety concerns. Testing ergonomic models can be a low-cost, highly-effective method to gain critical stakeholder feedback before committing to a design direction.
We consider a design ready for transfer to production when it meets not only manufacturing requirements, but also those of functionality, human factors, marketability, and cost. The final design output is captured in a robust 3D engineering database with all components and assemblies designed with their specific manufacturing processes in-mind.
After the design is complete, we generate comprehensive product specifications for the client to ensure quality and repeatability are maintained in manufacturing. These specifications include toleranced component and assembly drawings, material specifications, manufacturing work instructions, and Bills-Of-Materials (BOM).
Nearly all of our customers require Design History Files (DHFs) for quality management and regulatory filings. We utilize a flexible quality system to meet the needs of Class I, II, and III medical products. Read more about our QMS here.
Our engineering expertise may attract new clients, but our program management capabilities and process provide the basis for long-term relationships and client referrals. We place strong emphasis on tracking timelines, budgets, issues, and other project details to ensure that we are lockstep with our clients throughout the development process.
Our ultimate goal is to help client companies enter manufacturing with a well-vetted design that meets commercial requirements. Throughout development, we engage strategic suppliers for component fabrication, contract manufacturing, packaging, sterilization, and other processes to ensure a smooth and comprehensive transfer to production.
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Typically, our business model is fee-for-service. In these projects, we are contracted for product development services and we operate on either a fixed-fee or a time-and-materials basis.
With select clients seeking additional funding support beyond our initial engagement, SBIR/STTR funds are often pursued. If our clients secure these grants and list Archimedic as a subcontractor, we continue on a fee-for-service basis. There may be often restrictions on the portions of grants funds that can be subcontracted, limiting our scope of work. If Archimedic secures SBIR/STTR funds directly as the prime contractor, we receive these funds directly from the agency and are able to apply the full amounts toward the activities that most efficiently advance a product toward commercialization.
In select cases, we license assets and incubate them within Archimedic. This can be an efficient model, since our team already has in place the full capabilities and infrastructure needed to accelerate new medical technologies. For incubated technologies, our team may seek sources of funding from grants and investors. Under this model, Archimedic is responsible for securing the funding and advancing the product toward a future financial transaction, which may be in the form of a sublicense or an asset sale. Agreements are put in place with the asset licensors to share in future financial successes.
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.
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.