SUPPLEMENT MEDICAL ELECTRONICS
MEDICAL DEVICE DEVELOPMENT SIMPLIFIED Gerhard Krüger,Perforce Softwareexplores current trends and best practices for medical device development
‘single source of truth’, but the foundation is typically a version control system, which will be familiar to electronics designers using continuous integration (CI) to integrate code and other files into a shared repository. By versioning everything, companies can have confidence of complete real-time and historic visibility of every action. There are a few factors to remember
when choosing a ‘single source of truth’, such as support for all file types (for instance, some systems do not handle binary files well), an immutable history (facts cannot be changed retrospectively) and that a previous version of the software can be rolled back to easily and quickly. Pre-defined workflows help to
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oftware development is now an integral part of many medical device designs, ensuring efficient machine-to- machine communications and on-board instructions. So, it is logical that good software development practices should be at the heart of medical device product development and we are seeing more organisations reviewing the techniques and tools they are using, in the context of strict industry regulation (FDA in the US and local equivalents in Europe), the need to validate software processes as part of audit reporting, and in an increasingly competitive market.
AGILE AND CONTINUOUS DELIVERY Agile continues to gain fans in many organisations, to help bring projects to fruition quickly. Continuous Delivery (CD) takes Agile beyond development to production, helping businesses to introduce products faster. Its’ core tenet is a development pipeline where early feedback, automated build and test are incorporated, so what is deployed is what was tested. It works particularly well for small, frequent releases. DevOps is becoming more common in
the electronics market, including medical device development, particularly to support intensive sequence of releases or enhancements. DevOps introduces better collaboration between development and operations teams, unearthing and addressing problems earlier. Agile and Continuous Delivery are natural partners, because they enhance the transparent working that DevOps requires.
S8 FEBRUARY 2018 | ELECTRONICS Successful DevOps adoption in
electronics product design depends on a few factors, including thinking beyond just managing code to cover all digital assets - such as third-party components, CAD drawings, prototypes, build scripts, test scripts and data, build artefacts and environment configurations– in a unified continuous pipeline that enables automation and testing at every stage.
SINGLE SOURCE OF TRUTH Integral to many DevOps initiatives is the use of a ‘single source of truth’, which addresses the siloed way that most software has been developed in the past, by creating a single place for all the digital assets associated with a product’s development and lifecycle. That information is then available in a highly transparent and collaborative way across all contributors, with traceability of who did what, when, where and how, plus how two different ‘artefacts’ might inter-relate. In medical device development, this
makes a crucial contribution to compliance processes, because the manufacturer must be able to always recreate the exact version used in product deployment. In addition, it becomes easier to automate processes and engender better collaboration between contributors, whether technical or non-technical. It also helps to manage security risks, because breaches in the development process – whether accidental or deliberate – become easier to trace. There are various ways to attempt a
Figure 1:
DevOps is becoming more common in the electronics market, including medical device development, particularly to support intensive sequence of releases or enhancements
regulate processes, but always choose a system that is technology-agnostic and does not enforce new ways of working. For instance, it may be important to have a tool that enables developers to carry on using Git, while still giving the organisation visibility and control over their work. Med-tech developments can scale very rapidly, so the system must accommodate large, complex repositories and users who may be distributed all over the globe. The ‘single source of truth’ should
also cover all lifecycle stages of a digital asset, particularly where DevOps is involved, across ideation, design, development, test, deployment, release and maintenance. After all, ideation and development are only the first steps in how digital assets are maintained and evolved. This is where an increasing volume of all kinds of organisations are revisiting the latest generation of what was traditionally known as application lifecycle management (ALM). In medical and life sciences markets,
ALM has a tangible impact on time to market, due to the contribution of automated traceability for compliance audits and certification testing. Of course, there are many other aspects to successful medical device development, but embracing the best elements of today’s software development trends brings multiple benefits.
Perforce
www.perforce.com T: 08453 450116
/ ELECTRONICS
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