Medical Device Development - Prototype Through Production

Have you ever been part of a medical device development project where the software limitations prevented a smooth transition from prototype to production? As a manufacturer, you want to do everything you can to reduce the risk, cost, and time it will take to get your product to market. 

Prototyping can consume an immense portion of product development time. Potential solutions need to be tried, tested and tuned to ensure correct system operation.  These critical experiments and trials often require specific (and expensive) tools to enable flexibility and rapid development. Additionally, these tools typically require specifically trained (and expensive) resources to manage and operate. Although these tools can be useful for prototyping the device, completely new implementations are required when transitioning from prototype to production. Unless you have a tool that can seamlessly manage both the prototype and production phases of development you are wastefully throwing away the work done in prototyping phase and recreating an entirely new solution to address the production phase.

Promenade’s solution to avoid the wasted time and effort when transitioning from prototype to production is called “Parlay”. 

 Parlay is a collection of ready-made tools, libraries, and a codebase uniquely designed for the needs of the medical device life cycle starting from prototype and taking you all the way through to production. The self-instrumenting architecture provides complete transparency to the software and device behavior. An intuitive diagnostic user interface allows for full visualization and manipulation of the system. The advanced python scripting capability enables engineers and scientists to experiment, modify, test, and tune configurations and models with little to no embedded software changes (at a fraction of the cost). These capabilities make Parlay especially well suited for the prototyping environment.

 The Parlay framework effectively bridges the gap between prototype and production, enabling the reuse of prototype solutions in your production device. Production medical devices require quality, security, and reliability. Parlay was designed and built with our certified ISO 13485 quality management system and compliant with IEC 62304 software for medical devices and is pre-verified for the needs of production medical devices.  Parlay’s secure embedded core and extensive, robust, libraries allows for straightforward connections of several devices and subsystems, seamlessly managed through the Parlay user interface. Quick and easy integration is executed under a single controlling application reducing the effort to get your device to market. Additionally the Parlay system affords your instrument comprehensive verification capabilities such as, auto regression tests, simulated hardware failures, and manufacturing subsystem testing.

 By incorporating the Parlay framework at the start of your project, you are able to transition seamlessly from prototype through production with minimal changes and less risk to your solution. De-risking medical device innovation was the foundational concept behind the creation of Promenade Software’s Parlay framework.

 Please contact our team of U.S. based medical device software experts to learn more about how our Parlay framework can help you with rapid device development.


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John Morton

John joins Promenade Software with vast experience in a range of safety-critical products.  From consumer to industrial, including industrial internet of things (iiot), medical devices and aerospace, John has been instrumental in seeing multitudes of products get to market. His experience as a lead engineer, program manager, and technical sales make him uniquely qualified to understand customer needs throughout the entire product lifecycle.

I have had the unique opportunity to work with Promenade from a customer standpoint. This team’s vast capabilities, framework, and offerings were beyond measure. The partnership I was able to build as a customer led me to join this dynamic team and organization. I look forward to building similar relationships with our customers going forward.

-- John

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Promenade Software, Inc. specializes in software development for medical devices and other safety-critical applications.
Promenade is ISO 13485 and 9001 certified.

American Systems registrar