DevOps is valuable in many ways, yet some businesses need to be faster to adopt it. Concerns about complexity and security have hindered enterprises in regulated areas, such as medical devices and pharmaceuticals, from adopting the strategy, which emphasizes robust collaboration between development and operations teams to accelerate the deployment of new software and services.

Even the most stringently regulated sectors, with careful adherence to best practices from the start, may reap the benefits of DevOps. Moreover, highly regulated health and life sciences (HLS) companies will need DevOps to comply with regulations while remaining commercially competitive.

What does DevOps do?

The DevOps methodology combines software development (Dev) and IT operations to expedite and improve the overall quality of product delivery while optimizing the SDLC (Ops). DevOps strongly emphasizes collaboration, communication, and automation across the SDLC to bridge the gap between development and operations teams. Here are a few critical duties carried out by DevOps:

Automates manual tasks: DevOps automates manual and repetitive tasks in the software development lifecycle, such as testing, building, and deploying software. This can reduce the risk of human error and increase the speed and efficiency of software delivery.
Emphasizes collaboration and communication: DevOps emphasizes collaboration and communication between different teams involved in the software development lifecycle, including developers, operations, and security teams. This can help improve software quality and reduce the risk of errors and delays.
Facilitates continuous integration and delivery: DevOps enables continuous integration and delivery (CI/CD) by automating the build, testing, and deployment processes. This can help developers quickly and reliably deliver users new software features and updates.
Prioritizes security: DevOps prioritizes security by integrating security measures into the development process from the start, as opposed to considering security as an afterthought. By doing so, you may ensure that software complies with security requirements and reduce the possibility of security lapses.
Promotes a culture of continuous improvement: DevOps encourages teams to continually evaluate and improve their processes to promote a culture of continuous improvement. With the identification and elimination of inefficiencies and bottlenecks in the software development lifecycle, better software may be produced more quickly.

However, with everything DevOps offers, highly regulated companies initially resisted DevOps. 

Let’s find out exactly why.

When DevOps first emerged, the major concerns for companies following strict regulations were to maintain their security controls and governance processes. Deploying changes more frequently was viewed as a risk to security and the governance controls which were firmly in place. Another reason for not moving towards a DevOps way of working was the “segregation of duties” requirement, making it impossible for developers to deploy into production – thereby, unable to “do” DevOps. 

Apart from this, Highly regulated companies initially resisted DevOps for several reasons:

Risk aversion: They are typically risk-averse and may be hesitant to adopt new methodologies that are perceived as risky. DevOps involves changing established processes, which can be seen as a risk.
Compliance concerns: They Operate under strict compliance requirements and may be concerned that DevOps practices may not meet these requirements. There may also be concerns about ensuring compliance when development is happening rapidly.
Siloed culture: In many highly regulated companies, different teams and departments work in silos, making adopting DevOps practices emphasizing collaboration and cross-functional teams challenging.
Lack of expertise: Adopting DevOps requires specific expertise and skills that may need to be more readily available within highly regulated companies. This can make it challenging to implement DevOps practices effectively.
Legacy systems: Highly regulated companies often have legacy systems and processes that are difficult to change. DevOps requires a level of automation and tooling that may not be possible with legacy systems.
Perception of DevOps: Initially, there may have been a perception that DevOps was only suitable for small startups and technology companies and not applicable to highly regulated industries such as finance, healthcare, or government.

But now things are changing as the advantages of DevOps gained more attention, and highly regulated organizations started to adopt the concepts, frequently with tweaks to comply with the regulations of their particular industry. Some businesses have discovered that DevOps may enable them to increase their agility, effectiveness, and compliance while still satisfying the specific needs of their sector.

Why do DevOps principles fit well in highly regulated industries?

DevOps principles can fit well in highly regulated industries because they promote continuous improvement, collaboration, automation, Agile methodology, and faster time-to-market. By adopting DevOps principles, organizations in regulated industries can improve their agility, efficiency, and compliance while still meeting the unique requirements of their industry.
Here are some key reasons why DevOps principles can work successfully in highly regulated businesses.

Continuous improvement: DevOps principles are based on continuous improvement and iterative development. This approach can help organizations quickly adapt to changing regulations and compliance requirements in regulated industries and respond to new risks and threats.
Collaboration: DevOps emphasizes collaboration between different teams, including developers, operations, and security. This can help organizations in regulated industries ensure compliance and security requirements are built into the development process from the outset rather than being addressed as an afterthought.
Automation: DevOps relies heavily on automation, which can help organizations in regulated industries streamline compliance processes and ensure consistency and repeatability. Moreover, automation can offer an auditable trail of compliance actions and lower the risk of human error.
Agile methodology: DevOps is often based on Agile methodology, emphasizing flexibility and adaptability. This can be especially beneficial in regulated industries, where changes to regulations and compliance requirements are standard.
Faster time-to-market: DevOps can help organizations in regulated industries speed up the time-to-market for new products and services while maintaining compliance. This can help these organizations stay competitive and respond quickly to changing market conditions.

Things to consider when adopting DevOps in highly regulated industries

Adopting DevOps in highly regulated industries can be challenging. Still, it is possible with the right approach since DevOps practices have become increasingly popular in software development and can be applied in highly regulated environments. 
However, some unique challenges must be addressed when implementing DevOps in such environments.

Understand the regulatory environment: It is crucial to understand the regulatory environment in which the organization operates. This includes identifying the specific regulations and requirements for the organization and its products or services. This knowledge will help define the scope of the DevOps adoption and identify any compliance risks or concerns.
Develop a compliance strategy: A compliance strategy that considers the specific regulatory requirements and the DevOps approach should be developed. The strategy should address how compliance will be achieved throughout the software development lifecycle, including the planning, development, testing, and deployment phases.
Involve all stakeholders: DevOps adoption in regulated industries requires the involvement of all stakeholders, including developers, quality assurance personnel, compliance personnel, and management. This ensures compliance concerns are addressed from the outset, and everyone is aligned on the goals of the DevOps adoption.
Implement automation: Automation is a crucial aspect of DevOps and can help to ensure compliance by providing consistent and auditable processes. This includes automating compliance checks and tests and incorporating security and compliance requirements into the development pipeline.
Maintain a culture of compliance: Maintaining a culture of compliance throughout the organization is essential. This includes providing ongoing training and education on compliance requirements and ensuring compliance is built into the organizational values and culture.
Establish clear governance: Clear governance is critical in highly regulated industries. This includes establishing clear roles and responsibilities for compliance and implementing controls to ensure compliance with regulations and internal policies.

In conclusion, adopting DevOps in highly regulated industries requires a thoughtful and strategic approach considering the unique regulatory environment. With the right approach and a commitment to compliance, DevOps can help organizations in these industries achieve greater agility and efficiency while maintaining compliance with regulatory requirements.