Medical Device Design and Development

medical device design with precision mechanism

What is crucial to your medical device’s success?

Does the safety and effectiveness of your medical device depend on precision motion, optics, or fluidics?

Does patient experience and outcome depend on ergonomics or careful interaction between device and anatomy?

Does FDA approval – and ultimately success in the marketplace – depend on the coordination of multiple components and functions in a complex, highly integrated system?

We can help.

Contributing to your success, by doing what we do best

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, optics, and fluidics to achieve breakthrough results.

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.

Ergonomics and the device/anatomy interface

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

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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