For companies that outsource their product development, several partnering options are available. The company could choose to work with an industrial design firm or contract manufacturing firm, each of whom may offer a “one-stop-shop” option to take the product from design to manufacturing. As we’ve often discussed, with the complex products in the medical device and life sciences markets, that option can be risky. For product development, companies should choose an outsourced product development partner focused on that aspect of the product life cycle. There are several benefits to working with a product development services partner.
- Wide array of Product Development expertise: Modern medical devices are wonders of technology, often incorporating advanced imaging technology with embedded hardware and software, and utilizing advanced devices such as field-programmable gate arrays (FPGA). Often, a one-stop-shop will lack the expertise to develop in these technologies. A company like Resolution brings skills across hardware, embedded programming, mechanical design, software development and FPGA development. They ensure that the solution delivered maximizes the technology platform with optimal efficiency and safety.
- Detailed understanding of regulatory requirements: A medical device is subject to deep levels of oversight to ensure it is safe and effective for use. The medical device requires design inputs, design outputs, verification, clinical trials and validation before submittal to the FDA for clearance. A successful outsourced product development partner for medical devices must have a deep level of understanding of what’s required for compliance with IEC 60601, IEC 62304, ISO 13485 and know how to ensure products will pass emission and various agency testing for UL and CE marking.
- Singular focus on Product Development: Contract manufacturers are focused primarily on contract manufacturing. Any product development work performed is done with the main purpose of acquiring the company as a contract manufacturing customer. While experts in manufacturing, contract manufacturers fall short with complex development projects. Product development services companies like Resolution focus on only on product development: taking a design and developing a manufacturable solution.
- Skills managing trade-offs: Product development is often about managing trade-offs. Products need to be as efficient to manufacture as possible, must meet regulatory standards, be high quality, and within cost constraints. Product development is where these tough decisions need to be made. A partner like Resolution helps to guide customers through this process, making the best decisions within the constraints.
- Ability to engage other partners as needed: Product development is one critical component in the overall product life cycle. Product development takes the industrial design and creates a manufacturable product. Companies like Resolution will partner with best in class industrial designers and contract manufacturers, engaging those partners at the appropriate point to do what they do best.
When considering outsourced product development options, look to a partner like Resolution to guide you through the process.
Learn more about our breadth of capabilities on our services page.