Medical Device Concept to Commercialization in Seven Steps
Turning an idea for a medical device into a successful commercialized product is no easy task. It requires time, funding, foresight and creative solutions to take these products from concept to commercialization. Gilero has been providing design, development and manufacturing services in the medical and drug delivery device markets for almost 20 years. We know that every device is different and comes with unique challenges and requirements. Below is a general overview of what will take place when trying to develop a medical device and get it to market.
Understand User Needs
Having a solid understanding of user needs is paramount to the success of any medical device. We help our customers define user needs and complete human factors research, but it is beneficial when customers come to us with an awareness of target use population, different device configurations, market size, volume opportunities and cost targets. Is the target market particularly cost-sensitive? Is this device easier to use than competitor devices on the market? Does it fit into the workflow of clinicians? These factors are important in determining whether or not the device will be embraced by the target user and ultimately succeed in the market.
Gilero has worked with doctors, inventors and entrepreneurs at various stages in the design process. Some customers come to us with pieced together prototypes, while others have nothing more than a napkin sketch of their idea. During concept development, these ideas are fleshed out through consideration of technical, regulatory and business requirements. Cross-functional teams, comprised largely of engineers, work together to brainstorm, sketch and render concepts using CAD software.
Design the Device and Packaging
At this point in the process, a solid foundation of user research and early concepts will allow an engineering team to design and develop the device under Design Control procedures. Concepts will be translated into engineering design specifications and become detailed 3D CAD models. Formal documentation will be generated throughout the design process, including Design History Files, detailed requirements documentation, component specifications, software & hardware specs, assembly drawings and materials selection. For medical devices, packaging is often an afterthought, but it is a critical part of design and should be handled in parallel to device design. Throughout the entire design process, design for manufacturability should be top-of-mind. Consider how many parts make up the device and how much labor will be required to build it.
Creating prototypes that look and feel like finished products helps to advance design while evaluating the form, fit and function of the device. It’s valuable to work with a design partner that has in-house equipment to fabricate rapid prototypes, as this can help streamline design iterations and expedite the development process.
Testing will occur throughout the development process and may include physical, biological, electrical, software or performance testing. Formal test methods and protocols specific to each device will need to be generated, including a Design Verification & Validation (DV&V) plan. DV&V happens late in the product development process. Design Verification will determine if the device was designed correctly. Design Validation should demonstrate that the medical device meets user needs and intended uses. Completed reports of testing activities will be used in regulatory submissions.
Plan Regulatory Pathway
Understanding the regulatory landscape and working with a regulatory professional is essential for outlining a clear path to regulatory approval. Different types of devices have different regulatory requirements and clearance timelines. In all cases, certain procedures will need to be followed throughout the design and development process. Design History Files and technical files will need to be maintained through a Quality Management System. Appropriate documentation will need to be compiled and submitted to the FDA for clearance in the US market. If the device will be sold in the European market, technical files will need to be submitted for CE marking. If the device involves a drug, additional device-related documentation will be required to support drug filings.
Once a device has received regulatory approval, it is ready to be manufactured and sold on the market. Having a basic business plan is becoming an increasingly important part of a successful commercialization strategy. Working with a business consultant can be beneficial in determining a reasonable market penetration strategy and schedule. A plan for distribution and how the device will be marketed also needs to be figured out. On the manufacturing side of things, the transfer of knowledge from design to manufacturing should be as seamless as possible. The manufacturing process must be able to scale with demand, and opportunities for cost savings and process improvements should be identified along the way. Ultimately, the products we have seen become most successful in the market are those with a well-thought-out business strategy and strong manufacturing partner.