Developing Medical Software as a Service Platform
by Przemysław Palemba | Jun 4, 2020
The following case study presents a medical Software as a Service (SaaS) platform. The Pro4People team implemented it for the UK-based startup. The Client had been looking for a technology partner capable of building an innovative software solution, but also familiar with medical device regulations.
Pro4People offered IEC 62304 compliant software development service and subsequently successfully delivered a fully-verified Minimum Viable Project (MVP) version of the platform in less than one year.
The Client turned to Pro4People with a vision of an innovative web-based medical Software as a Service platform. The platform would then provide Medical Device product teams with support in building medical Internet of Things products. The idea of the solution wasn’t trivial and definitely required strong technical as well as regulatory expertise. Time to market and the ability to start the project promptly were similarly crucial.
The Client wanted to control the vision of the product, with limited engagement on their own part, and thus needed a versatile technology partner capable of delivering the solution efficiently. Consequently, Pro4People, as a Certified AWS Consulting Partner, was selected as the best candidate to build the platform.
We launched the project with a short Pre-Development phase to initiate the Software as a Medical Device project. The team spent this initial period on preparation for the The Design and Development phase. The team collected all the initial Design Inputs. They included Intended Use, Product Requirements, Regulatory Strategy as well as the outcomes from the usability studies conducted by a third party company.
Pro4People’s Project Manager prepared a Software Development Plan, initial project schedule together with a test strategy. The project team created a technology stack for the solution as well as its initial architecture. Finally, the team prepared the project backlog. In effect, when a larger Design and Development team joined, they could start efficient software development. The completion of all these activities together with a milestone review meeting enabled starting Design and Development phase.
The client did not plan to setup an in-house engineering team at this stage, since they wanted to focus more on business and product development. Pro4People was thus expected to deliver a full project team capable of implementing the solution efficiently. From the Client’s side, there was just a Product Owner, a Risk Manager together with Regulatory Experts participating in the project.
Pro4People setup a self-managed project team with all the necessary project roles delivered. The primary role responsible for leading project execution was the Project Manager. He managed the project scope, performance, schedule and compliance. Business Analyst was working closely with the Product Owner on turning the product vision into the specifications for the software team. Software Developers not only implemented the solution, but also defined its final technology stack, design and architecture. The UI/UX Designer worked on User Experience of the solution and provided detailed designs of the User Interface, taking into account the outcomes from the Usability studies in line with IEC 62366.
The DevOps role configured development tools and environments necessary to deliver the solution in an effective way. He also documented how the solution should be configured, deployed and maintained. Finally, the Quality Assurance Engineer defined and executed a Test Strategy with all the verification activities included. The Validation and Verification details are described in the later section of this article.
As a result, the Client’s participation in the medical Software as a Service project activities was limited to key areas, including planning, demo meetings, providing feedback to the project team, milestone reviews etc.
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Design and Development
In order to design and develop a non-trivial medical Software as a Service solution and at the same time comply with medical regulations, Pro4People proposed a unique Agile/Maturity approach to the project.
The project Maturity was oriented on fulfilling the stringent regulatory requirements during the development of the solution. The project schedule included several milestones. For each milestone we held a gate review meeting. The Client was thus provided with project control points and ability to approve the delivered milestone results. Particulary, these project reviews aimed at reviewing and assessing the following: project schedule and roadmap implementation, utilization of the budget, fulfilment of regulatory requirements, the alignment between Client’s product and Pro4People project teams. In addition to this, the team created and followed an index of the expected documents and records. We could deliver them in a managed way as a result.
On the other hand, the team split the project execution into Sprints, two-week long iterations. Each iteration included detailed planning, execution as well as a demo of the new software features. Such frequent iterations increased the transparency of the project, e.g. prompt and regular access to new features allowed instant feedback from the team. Moreover, the Client was able to adjust the idea of the product and envisioned features along the way based on the delivered implementation results.
The project team decided to focus first on the most complex architectural concepts together with associated research. This helped insuring the key engineering challenges were tackled first. The architecture of the platform was based on Amazon Web Services (AWS) cloud. As a result we could utilize cloud services, minimize upfront investment in IT infrastructure, and create a solution able to scale its resources to the actual needs.
The product itself was not meant to be put on the market as a medical device. The Client however, wanted to develop the product according to the medical device standards such as ISO 13485, IEC 62304, ISO 14971 and IEC 62366. In order to implement this regulatory strategy, the Pro4People team followed relevant parts of Client’s Quality Management System and then its own IEC 62304 compliant Software Development Lifecycle (SDLC).
As a result of the project execution, Pro4People delivered not only working software (in the form of the source code and software binaries), but also various project documents and records, proving that both Pre-Development and Design and Development phases were accomplished in accordance with the regulatory requirements. Currently, Pro4People can deliver such assignment under its own ISO13485 certified quality management system (QMS), or under clients QMS. It is crucial in the light of the incoming Medical Device Regulation requiring the development of medical Software as a Service under certified QMS.
Verification and Validation
We approached the Verification and Validation of the solution from the very beginning. Quality Assurance Engineers prepared a Test Strategy for the solution as well as performed Quality Assurance verification along the whole project. They were also preparing test specifications and performed ongoing tests of new medical Software as a Service features, providing a continuous Quality Assurance evaluation to the Client.
When we reached the Version Released milestone, the team started the final verification of the solution. We thus provided objective evidence that all the software requirements had been met and all software features worked as designed. The verification activities were carefully planned in a Test Plan document and then the test results were summarised in several Test Reports. This final verification was conducted in a dedicated verification environment.
With the tests execution records available and signed, the Client was able to take a positive and informed decision to accept the verification of the released version. As a result, the developed product version was ready to be handled over to the product team from Pro4People. Then the validation of the solution was accomplished by the Client’s team.
We are happy to say that all of the ambitious project objectives were achieved. We managed to complete the project in about 10 months as well as within the planned project budget. Fully functional version of the platform was implemented together with the associated documents and records. That proved in effect that the team had followed the regulatory requirements.
The MVP version of the system let our Client deliver the first version of the solution to the market. The client could consequently get feedback from the end users, pursue business opportunities and start thinking about new versions of the product and enriching it with more sophisticated features. By having come up with a specific approach and then acting on it, the Pro4People team lifted the burden of the project execution from the Client’s shoulders and allowed them to focus on product planning and business development.
For the involved Pro4People team that was another interesting experience of working on cloud-based Software as a Medical Device (SaMD) solution. Our engineers were delighted to work on concepts such as dynamic scaling of system resources, medical Software as a Service model, a User Interface dedicated for health care professionals, architecture patterns for Internet of Medical Things, containerisation and virtualisation, and many others.
Neil Daly - CEO of Skin Analytics
We selected Pro4People as a strategic development partner based on their deep understanding of delivering Software as a Medical Device (SaMD) products. They’ve been engaged, collaborative and an extremely valuable partner.
CEO of Skin Analytics
Dr David Cox - Chief Digital Officer & Co-founder of Closed Loop Medicine Ltd
The team at Pro4People are great to work with. They are professional, flexible and have a huge amount of experience in developing SaMD, so are able to offer a good balance of direction and pragmatism when it comes to developing software under a QMS, whilst holding your hand through the process if it’s not something you’ve done before.
Dr David Cox
Chief Digital Officer & Co-founder of Closed Loop Medicine Ltd
Tash Thirkell, Operations Manager at ARC Microtech
Pro4People independently reviewed, tested and validated our Medical Device Software to IEC 62304. Working to a very tight deadline, Pro4People’s experience was invaluable and their diligent and supportive team a pleasure to work with.
Operations Manager at ARC Microtech
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