Toolbox Medical Innovations
Ideation to Product Execution

The global In-Vitro Diagnostics (IVD) industry is in the cusp of a paradigm shift. Blazing the trail is the proliferation of point-of-care technologies offering solutions that promise improved outcomes and reduced costs for personalized healthcare. Nevertheless, turning the technology into cost-effective, accurate, clinically validated commercial products, that can be operated without much technical training is challenging.

Tuned to meet the demanding needs of the IVD industry, ISO 13485 certified life science and diagnostic product development firm Toolbox Medical Innovations helps customers turn their innovative ideas into functional products through their revolutionary ‘Toolboxes.’ These Toolboxes provide a wide range of services from product design and fabrication, prototyping, usability testing, and clinical research, to scaling up the manufacturing process. “Our mission is to offer exceptional product development services that in turn help our customers improve personal wellness,” states John K. Zeis, president of Toolbox Medical Innovations.

In the early design stage, the Toolbox team conceptualizes the product based on the customer, end-user and market requirements, product functionality, and regulations. “Our resources and expertise underpin the Toolboxes providing undivided focus on developing the product, considering factors such as design for manufacturability, user interface, and regulatory barriers while prioritizing customer requirements,” remarks Zeis.

For successful regulatory approval and launch of the product, the Toolboxes follow a systematic approach to attain the required functionality. The Design and Development Toolbox ensures that the internal processes of the device function with limited or without any end-user intervention.

Our mission is to provide exceptional product development services that in turn help our customers improve personal wellness

The team comprising of engineers from different disciplines combine their expertise in polymers, biochemistry, microfluidics, and high-volume manufacturing to integrate the complex functions associated with the device to optimize the product. “We understand how to solve difficult challenges in an efficient and optimized fashion,” states Paul Ryan, VP of Business Development. The Usability Toolbox runs tests on the product throughout the process to determine whether it is intuitive and easy to use for the end user. The team innovates, improves, and modifies the design based on the customer feedback to obtain the desired product features. The Manufacturing Toolbox, on the other hand, provides the complete design for manufacturing and facilitates the successful transformation of the prototype to final product design to transfer.

Toolbox Medical Innovations, as a full clinical research organization (CRO), provides services all the way from developing clinical plans to obtaining the FDA clearance. Focused solely on IVD, a few feathers to Toolbox’s cap include attaining successful CLIA waivers and 510(k) clearance for some of the leading IVD companies in the industry.

Explaining the value proposition of Toolbox’s several success stories, Zeis describes one of their clients who had a concept that exceeded the Cost of Goods Sold (COGS) target. The point-of-care IVD company reached out to Toolbox Medical to re-design their product and reduce the projected cost. The Toolbox team innovatively restructured the assay protocol and simplified the cartridge design which brought down the cost of the product from over $20 to below $5. The organization obtained a design that was not only cost-effective in high-volume manufacturing but also within their budget.

The year ahead looks promising, as the company focuses on providing exceptional services using their enhanced Toolboxes. In their new 18,000 square foot facility with additional test labs for usability and a clean room for pilot assembly, Toolbox plans to roll out new fabrication capabilities to foster continuous innovation.