The Smithwise product development process is focused on bringing new medical technologies to market.
Read more about our business models in the FAQ section below.
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.
Our customers are almost always planning to launch a clinical study 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.
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 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 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.
Our engineering expertise may attract new clients, but our program management capabilities and process provide the basis for long-term relationships and client referrals. While we are a team of technical experts, 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 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.
Have a different question? Ask away!
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 Smithwise 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 Smithwise 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 Smithwise. 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, Smithwise 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 Smithwise 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, Smithwise 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 Smithwise 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 Smithwise to operate as the prime contractor in securing the SBIR/STTR funding. Under this mode, Smithwise 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 Smithwise 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 Smithwise 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.
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.
We're distinct from many other product development firms in three key areas.