Can a proof of concept (POC) help validate your ideas and ensure that your new medical device meets market needs before full-scale development?
Absolutely. Here are five ways a POC can reduce risk in medical device software development:
A POC enables teams to test specific ideas and technical solutions early in the development process. This helps organizations mitigate potential challenges before they become significant issues. For instance, Syncro Medical validated a Bluetooth Low Energy (BLE) communication system for a cardiac catheter lab device. By testing how the environment and high data rates would interact with the system, they confirmed the feasibility before moving into full development.
POCs allow focused assessment of uncertainties related to technical feasibility, user experience, and market demand. In another case, Syncro Medical worked on a drug delivery system, conducting multiple POCs to assess both technology feasibility and user workflows. These targeted assessments clarified how the device would function in real-world scenarios, reducing the risk of misalignment later.
Because POCs are conducted outside of strict regulatory frameworks, they offer flexibility for rapid iterations. Syncro Medical demonstrated this while working on a mobile app connected to a new drug delivery system. In just a few weeks, they cycled through several iterations to refine the user interface, enabling quicker problem-solving and adapting without the regulatory constraints that would slow down a full product development.
A POC provides a platform for stakeholder and end-user involvement early on, allowing for fast feedback loops and informed decision-making. Additionally, POCs can simulate real-life use scenarios, enabling developers to capture more accurate feedback from end users. For example, during the development of a cardiac instrument, Syncro Medical repeatedly presented POC iterations to users in simulated environments. The feedback helped refine the user interface and workflow until it perfectly aligned with customer expectations, ensuring that the final product would perform well in the field.
POCs promote continuous improvement through short, agile sprints that allow rapid testing and adjustments. Syncro Medical frequently uses one-week sprint cycles in their POCs, compared to the longer three-week sprints used in full development cycles. This quick turnaround helps developers rapidly refine their objectives and outputs, ultimately accelerating the time it takes to bring a product to market.
Keep Reading our POC Series
5 Common Pitfalls to Avoid when Doing a Medical Device Proof of Concept