Custom Medical Optical Device Development

Custom Class 4 Therapeutic Laser

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.

Challenges of Developing Optical Medical Devices

Optical medical devices use light to detect, measure, diagnose, or treat biological phenomena, 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 as well as the enterprise – often in the form of investment that allows continued development – or stumbling blocks.

  • 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

Ergonomics and Miniaturization of Optical Medical Devices

Ergonomic study of hand held, non-invasive medical device design
The user and patient experience, their perception of your device, and its efficacy often depend on:

  • A comfortable, natural feel in the hand
  • Intuitive and simple interface and operation that produces consistent, reliable results
  • A lightweight, well-balanced package that is easy to control and does not induce fatigue
  • Proper fit and interaction with the anatomy at the distal end

To achieve these qualities in your device, we use a combination of virtual prototyping, rapid prototyping, and user experience techniques:

  • Three dimensional models of male and female operators and patients – scalable according to statistical distributions and with realistic ranges of motion – enable a wide range of concepts to be explored quickly and inexpensively
  • Rapid prototypes of the most promising medical device designs are produced to allow engineers, operators, and patients to evaluate them and provide real world feedback
  • Rapid prototypes of anatomy with realistic feel and response add a new level of realism to the discovery and evaluation process
  • We hold and record focus groups and simulations of real operators and patients using the prototypes

Expertise

ergonomics and medical device design interface and interaction with anatomyPractical Precision specializes in helping companies develop complex, highly integrated medical devices and life sciences equipment that depend on precision motion and optics to achieve breakthrough results, including:

  • Therapeutic laser systems
  • Imaging systems for diagnosis as well as automation and optimization of treatment
  • Full-body scanners as well as compact, multi-axis scanning systems that fit within a handpiece
  • Egronomic and stable patient interfaces, including handpieces and headpieces, that enable controlled and effective treatment and diagnosis using light in all its forms

We honed our expertise in developing lightweight, ergonomic packages by working on both medical devices and hand-held optical devices for soldiers. The advanced materials and construction techniques developed for one cross over and inform designs for the other.

Requirements for sterilization can be a challenge for medical device designs involving precision motion and optics. Practical Precision has helped clients to develop products that can withstand high temperatures and aggressive wash down while maintaining performance over time and enabling reuse.

We have incorporated micro-fluidic systems in both medical devices and life sciences equipment, for precision dispensing and extraction of liquids, sometimes coupled with motion and optics for mixing and measurement.

Easing your compliance burden, not adding to it

Practical Precision interfaces with your documentation control and compliance system while simultaneously maintaining our own systems and processes for traceability and control, to smooth audits and reduce the burden of ensuring compliance for you and your device.

We use a cloud-based product lifecycle management (PLM) system from Arena Solutions to manage the device master record (DMR) and design history file (DHF) for your product. These records are complex and highly relational. Our system ensures that all revisions of all product data (specifications, drawings, etc.), test data, reviews, and approvals are properly linked and tracked.

Design Control for Medical Device Development-FDA-DMR-DHF

This same PLM system improves collaboration and communication between your team and ours, ensuring that you have access to the latest design data for review, interfacing with your own development efforts, and procurement.

Once prototyping or production is underway, the system enables you and your key vendors to participate in the release, quoting, and change control processes in a secure, controlled fashion.

It streamlines procurement and supply chain management by allowing vendors and manufacturers to access the latest released design data for the components they supply, and to be involved in the change control process, ensuring clarity and smooth implementation, so that your project is protected from unnecessary scrap and rework costs and schedule delays.

The first step toward a solution is easy

To discuss your medical device product or idea, or if you just want to learn more about how we might be able to help and the capabilities we can provide you:

Or use the contact form below.

– Rob Campbell, PE
Practical Precision

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