Organize development for a startup

Situation

A USA-based startup, consisting of an owner and two consultants, was developing a new medical product. However, the team faced significant difficulties finishing the development phase. The main challenge was a lack of organizational structure and formal processes. Therefore, the startup needed support to complete the medical device development process and bring the product to market.

Capabilities

The collaboration required a partner with a proven end-to-end process for developing medical devices. This process needed to cover the journey from the initial concept to final approval. BAAT provided the infrastructure for the startup’s consultants to work within an established system. In addition, BAAT provided the resources needed to fill expertise gaps. BAAT also had the ability to formally act as the Legal Manufacturer for the company. This provided the startup with access to an established quality and development structure.

Solution

BAAT took over all existing development results and integrated them into the BAAT document management system. A dedicated BAAT project manager was assigned to drive the project forward. By following BAAT’s established procedures, the team identified the remaining gaps. They then defined the necessary next steps and strategically divided the workload between the startup’s consultants and BAAT’s internal team. This structured approach created a clear path for the remaining medical device development activities. It also allowed the consultants and BAAT team to focus on their respective areas of expertise.

Result

This structured approach led to the successful achievement of 510(k) approval. A complete manufacturing line was established, with the consultants managing day-to-day manufacturing. Meanwhile, BAAT maintained all inspection records and ensured full traceability throughout the manufacturing process. With the product now officially on the market, the company is positioned to work towards its ultimate goal of a successful exit. The project demonstrates how an experienced medical device partner can provide the structure, expertise and infrastructure needed to move a product from development to market.