Case Study: Proving the Concept - How to Get Started Before You StartOne of the major challenges facing a company wanting to introduce an innovative new software-enabled product is how to be sure it will meet the needs of its intended users. The more pioneering a product idea is, the fewer precedents are available to guide how it should work. Given the cost of releasing new medical instruments and systems, companies need to be sure that the concept will work - to prove the concept - before committing the resources required for full product release.Over the years, Syncro Medical has collaborated with our clients in many successful proof-of-concept projects. As a software engineering company, we have helped prototype not just the desired software component but have also used software to emulate the planned hardware, particularly for user interaction and simulated interfaces. Since this work is done outside of formal design controls, we can make very fast changes without much overhead, letting our clients easily try out various scenarios for user interaction and product behavior.Our approach to rapid prototyping and proof of concept take different forms:
- User-focused: Interaction design, workflow, and the graphical interface are refined via iterative user testing
- Technical Risk Mitigation: Project and technical risk are addressed by prototyping various areas of technical uncertainty
Our client is a large, multinational corporation well known for healthcare products that do not include software. They have determined that a number of their products could become more usable by providing their customers with a mobile app that would assist in planning and monitoring usage of the product. Since they had no experience in product software, and no internal software team, they needed assistance to confirm that this approach was technically feasible and would indeed by useful to the patients using their products. In other words, they needed to prove the concept.
Syncro Medical was able to quickly assemble a software team that got right to work addressing the company's needs.
The proof of concept focused on three primary areas:
- The Mobile App
- Device Interface
- Cloud Interface
QUESTIONS NEEDING ANSWERS
Syncro Medical started working together with our client to outline the basic desired functionality from a user perspective - what will the user need and want at each step of the process? What choices should be available? How should the app guide the user, and when should the user be allowed to override the guidance? How should results be displayed? Answers to these questions and more were incorporated into successive revisions of the prototype mobile application.
DEFINING THE DEVICE INTERFACE
Based on our results from the initial prototype, we were then able to determine the interface between the mobile application and the device itself, both the data/command content, and the protocol. By using Bluetooth Low Energy (BLE), Syncro Medical leveraged our experience in various wireless and Bluetooth protocols, but specifically targeting a device with limited battery capacity.
Our client then asked Syncro Medical to implement the interface on the device side. The company had chosen an Arduino-based platform to prototype the device, so our engineers designed, implemented, and periodically updated BLE support on the prototype device to confirm that the resulting interface and functionality would meet all anticipated product requirements.
USER INTERACTION AND TECHNICAL PROTOTYPING
The proof-of-concept mobile app went through a number of iterations, as our client worked with various visual and workflow concepts provided by Syncro Medical. Our choice of development tools - native Java on Android - ensured that changes could be made quickly and efficiently as our clients refined the user interaction.
The prototype app did more than just simulate the user interaction; it also exchanged data with the device over the BLE interface, stored the results, made the calculations required to display the results, managed the issues involved with a single app supporting multiple devices, and handled user authentication. As a result, the proof of concept contained a rich set of features that confirmed the technical feasibility and desired behavior of the product.
The other concept that needed to be proven was the cloud interface necessary to provide the user with a full mobile experience, including cloud-based data storage that could be replicated across multiple mobile devices. Various cloud providers were considered, and the proof of concept effort prototyped connections to two of them. Each had a different approach to cloud support and therefore different interfaces; the effort helped our client clarify what approach would work best for their product.
The proof of concept effort was completed earlier this year after only four months. The results ensured a solid BLE interface to the device, and the user interaction prototyping provided valuable information for the final graphic and workflow design.
ON TO THE PRODUCT DEVELOPMENT...
The company continued Syncro Medical's engagement by having us move right into formal product development. We are now creating a mobile medical app under full design controls, using Syncro Medical's Quality System to ensure that our client will have a successful 510(k) submission. The project is fully incorporating all the lessons learned and decisions made during the proof of concept phase, while still being flexible enough to accommodate additional changes as requested.
Not every intended product release warrants such a large-scaled proof of concept effort. Many times, Syncro Medical has provided useful and important user and technical prototyping in just a few weeks - a low cost investment to be sure that the formal product development effort gets off to a good start.
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