Streamlining Optical Medical Device Development, Validation, and Manufacturing

Practical Precision specializes in the development of complex, highly integrated optical medical devices and optical subsystems for startup and established medical device companies, often as an expert partner to a client with its own deep focus or to a more broadly focused medical device development company.

This exclusive focus has allowed us to develop highly-relevant experience and deep expertise solving optical device engineering challenges within the regulatory constraints and market demands of the medical device industry. Coupled with our advanced analysis, modeling, prototyping, and testing techniques, this helps our client companies to:

• Realize and enhance the value of their technology, device, and company at every stage of development, preserving and securing capital along the way.

• Deliver a safe, effective device that provides the best possible experience and outcomes for patients and providers alike.
• Streamline the transfer of complex optical medical devices from engineering labs to a scalable manufacturing process.

Imagination, Expertise, Execution

Proving Novel Technologies, Producing Viable Products

Optical medical devices use light to detect, diagnose, or treat disease or injury. Often, these devices also involve coordinated motion – focusing or scanning the light, for example, while squeezing or stretching tissue. The safety, efficacy, and reliability of these devices requires specialized and careful design, construction, and alignment. Ergonomic and clinical considerations that constrain the size and shape of the device can further complicate the design and manufacturing process.

There are many hurdles on the way from concept to commercially successful medical device. They can be either milestone achievements that add value to the device and the enterprise (often in the form of investment that allows continued development) or stumbling blocks. The same experience and expertise with medical optical systems that is vital to the safety and efficacy of the device is also vital to the success of the product development effort as a whole:

• Early on, speed of development is critical as the basic science and technology are proven out and refined. But even then, fragile or unstable test devices can delay progress and confuse results.
• As more prototypes are developed and tested, stability and consistency from unit-to-unit becomes more important. Also, design decisions made at this time are increasingly difficult to change later and have a more significant impact on the viability of the eventual device.
• Most of these innovative and sensitive devices will require clinical trials for validation, which will hinge on the stability and reliability of the optics and mechanisms when exposed to shipping and handling; a less controlled environment; and extended use for the first time.
• In production, an optical medical device that was not designed with alignment, fixturing, and tooling in mind will be difficult for non-specialists to build, align, and test. The device will have already been through verification and validation, so only marginal improvements can be made using external tooling and fixtures without invalidating the design. Yield may suffer and it will be difficult to scale production.

With focused expertise in developing optical systems for volume production and highly relevant experience applying it to a wide array of medical devices, Practical Precision can help you streamline this process and develop a successful product that can both create and meet growing demand.