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MedDevOps: Streamlining Compliance in Highly Regulated Industries

DevOps has been gaining traction in business for decades and has even recently seen a start in highly regulated industries like medical device development. This begs the question: can DevOps be effectively implemented in safety-critical environments? In short, the answer is yes. Read on to learn how and why you should implement DevOps in MedTech and other regulated industries, and discover key strategies for adopting your golden ticket to faster compliance.

MedDevOps

Agile’s focus on iterative collaboration has taken the software world by storm, leading to faster, better product delivery everywhere it has been correctly implemented. In software development, DevOps (a combination of “Development” and “Operations”) has been heralded as an organic evolution of successful Agile. DevOps focuses on breaking down the silos between departments, bringing QA (quality assurance) into the development process, and overall improving both the speed and accuracy of delivery.

Related reading:

Agile Operations: The Evolution of DevOps

DevOps Part 2: Methods, Practices and Tools

So why shouldn’t this be applied to safety-critical industries like MedTech, where delivering better solutions faster directly correlates with more lives saved? With MedTech regulations expanding and the activation of the EU MDR (European Medical Device Regulation) looming close as May 2021 approaches, it is more important than ever to quickly and reliably deliver quality medical technology.

But Highly Regulated Industries (HRI), including medical device manufacturers, must meet rigorous standards with a strong emphasis on traceability and post-production accountability to ensure public safety. Agile and DevOps are, to some extent, outsiders in these HRI fields, due to an abundance of rigorous safety standards and strict security compliance measures. 

In MedTech particularly, critical changes in the new regulations require a broadening scope of health-related software to achieve high compliance standards. Closely controlled processes, extensive risk management, and a far-sighted emphasis on regulatory approval define the new world of MedTech regulations globally. Medical device manufacturers must also demonstrate critical solutions in their development toolkits (namely, a QMS or Quality Management System). At the same time, increasingly data-driven MedTech is moving towards the Cloud, where DevOps reigns supreme.

Adopting DevOps Practices for Compliance Requirements

The first step to adapting the DevOps framework to your highly-regulated product development lifecycle is treating security as a “first-class citizen.” If you approach development with security and traceability in mind from the first step, compliance should not be a significant challenge. Workarounds and late-stage adjustments are only necessary for teams that have not done the essential groundwork for an industry that operates with extensive compliance requirements. This is the inherent fallacy of the idea that a DevOps approach is unworkable for safety-critical industries: if your team is always focused on achieving compliance, there is no reason a more efficient development lifecycle should negatively impact delivery.

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Once you free yourself from the assumption that DevOps isn’t suitable for your industry, the only step left is adoption. DevOps provides you with a framework to de-silo development, QA, and Operations. This leads to faster delivery times and improved delivery quality by incorporating feedback processes and encouraging more collaboration. Continuous Integration and Deployment (CI/CD) is the name of the game, allowing your team to build, improve, and deploy a working product quickly – without sacrificing traceability or compliance.

Key considerations for implementing MedDevOps

There's a reason MedTech has been slow to adopt Agile and DevOps, despite their significant benefits. With compliance constantly hovering, it can be intimidating to make a change in your current working system. But if you take the time to work out the kinks and approach development with care, the resulting process improvement will provide immeasurable benefits. Incorporating a lifecycle mindset built to improve delivery and traceability may seem daunting today, but tomorrow you'll be glad you did. Read on for a few key considerations you should keep in mind as you begin implementing MedDevOps.

  • Shift Left. "Shifting left" refers to moving away from the traditional and linear approach to the development cycle that isolates requirements, testing, deployment, and operations. When you shift left, you seek out defects earlier in the cycle, running tests and application security practices at every development stage rather than holding them off until the end. This practice improves overall quality and eliminates time-intensive rework that results from end-of-cycle quality testing.
  • Begin with DevSecOps. Short for Development, Security, and Operations, DevSecOps aims to improve security accountability across the organization by approaching security decisions with DevOps speed and scale. This helps create an equilibrium between these critical fields, cutting down errors and adding traceability and accountability throughout the entire development life cycle. DevSecOps is both a framework and a toolkit. It can be built into existing applications to simultaneously secure and streamline sensitive operations, improving compliance measures while reducing both cost and labor. 
  • Commit to (relative) silo-busting. Eliminating silos is one of DevOps' primary characteristics, so this should come as no surprise. Highly regulated development environments are traditionally heavily siloed, placing a considerable impediment on cross-team collaboration. This has challenging implications for deployment and usually leads to longer delivery times. In DevOps theory, no team (or team member) should be completely reliant on another team (or team member) to understand and deliver a task. This is not always achievable, especially in smaller organizations, but every team can achieve a degree of siloes that improves efficiency without sacrificing valuable expertise.
  • Have an abundance of contingency plans. One of the benefits of operating at greater efficiency is the chance to conduct more tests. Take after Netflix and make sure you have a contingency plan in place for every predictable failure. Shifting left will allow you to ask more questions and create more solutions earlier in the development process. The time you save at the back end will let you create a more efficient and workable solution that will save you precious resources when inevitable problems do arise.
  • Automate everything you can. Automation should be incorporated across your development lifecycle, cutting down on both delivery time and human error. Shorten the process by introducing automated infrastructure management, compliance and security, and feedback metrics. By introducing end-to-end DevOps automation, you will free up your team up for both crisis management and development innovation while ensuring that you remain on the right side of compliance.
  • Remember that compliance is king. Disorganized workflows and unreliable traceability measures are the nemeses of compliance. DevOps can be your remedy to this when implemented correctly. By integrating testing into the earliest development stages, you can ensure your path to compliance with greater reliability. But to do so, it is essential to imbue every team and process with the gravity of compliance, encouraging everyone to share accountability for final delivery and promoting a more collaborative environment.

Related reading:

Building Security into DevOps

Convinced about MedDevOps, but not sure where to start? The best way to begin is finding a robust, integrated tool and a clear guideline to help you craft the perfect implementation plan. High-performing teams use Intland’s DevOps Guide on Implementing Continuous Integration & Delivery to ensure they are up to date on fundamental concepts, best practices, and tooling expertise. Break down silos and better align your development by adopting MedDevOps to bridge the gaps in complex software development for your safety-critical product – and make your life easier while you’re at it.

Related resource:

DevOps Guide on Implementing Continuous Integration & Delivery

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