M4 Lab Collaborative (CDME) is a core service available under the CCTS Voucher Program. Engineering and clinical experts work collaboratively to find innovative solutions for real-world needs in clinical medicine.
M4 offers engineering services to assist clinicians in translating their needs into healthcare solutions. The team of biomedical, mechanical, materials, electrical, software and quality engineers support the design, testing and fabrication of medical products for user, animal and cadaver studies. M4 works with customers to advance their research tool, medical device, diagnostic, therapeutic and other medically based innovations to drive outcomes that change clinical practice, enhance patient care and improve patient health. They design with the regulatory pathway in mind and are familiar with the clinical trial process, thus leading to outcomes that take innovations from “bench-to-bedside” to improve health outcomes. M4 has a diverse portfolio of projects supporting clients with a wide spectrum of healthcare product types, including surgical tools, implantable electromechanical devices, wound care, diagnostic testing devices, therapeutic devices and surgical training/pre-planning tools.
Visualization of a healthcare product design using applicable design tools for translation into a prototype is a key step in the product development cycle. Customers bring projects to M4 in various development stages (idea, sketch, non-functional prototype or unrefined alpha prototype) for the development and refinement of that design. M4 offers design tools such as artistic renderings, computer-aided-design (CAD) images, functional and non-functional prototypes via additive manufacturing (also known as 3D printing) and other agile fabrication methods. Their additive manufacturing equipment can produce items using polymers, biomaterials, continuous fiber composite and metals and they have full machining capability to work with nearly any material required.
The scope of CDME capabilities in medical product development includes:
- Translation of user requirements and proving feasibility with fabrication of demonstration units
- Design refinement for functionality, manufacturability and assembly
- Design of injection molded, machined and additive prototype units to prove out the design and manufacturing methods
- Prototype fabrication for user demonstrations or animal and cadaver studies
New product and process functional prototyping is a core competency of M4. CDME houses or has access to resources required to create fully operational prototypes. In addition to design and fabrication, CDME houses several mechanical and electrical testing systems which are utilized in testing of client projects. They also have access to testing systems throughout the university to support prototype testing.
Julie Johnson, PharmD, is the Director and Principal Investigator at The Ohio State University Clinical and Translational Science Institute.