Traditionally viewed as too unstructured for highly-regulated environments, Agile can keep organisations compliant while driving innovation.

Accelerating innovation, costs and competition are forcing companies in the health and life sciences (HLS) sector to seek new ways to enhance delivery, speed and customer experience. Many industries are turning to Agile to rebuild their operating models around multiple self-directing, high-performing teams, with more than half of respondents in the 15th Annual State of Agile Report revealing that either a majority or all of their company’s teams have adopted Agile.

However, the fluidity and responsiveness to change that characterises Agile methodology has prompted some in the HLS sector to believe that Agile is incompatible with the technology and processes involved in highly regulated industries such as theirs. They assume that Agile is just not workable for any organisation building products under regulatory compliance.

In this article, we outline the benefits that Agile methodologies can bring to the HLS sector and offer some guidelines on how to leverage these benefits. But first, what makes some organisations reluctant to adopt Agile?

Agile hesitancy

When the Agile movement emerged in software development two decades ago, it transformed not just the way software companies operated but also businesses in other industries that recognised the benefits of more frequent delivery, early feedback and continuous improvement. Companies adopted Agile as a way to respond faster to competitive pressure, customer demand and market changes. Since then, Agile has become the standard for businesses seeking to outperform competitors.

The shift to Agile has not been as pronounced in more highly regulated industries. In pharma, clinical research and medical devices, for example, the constraints of detailed documentation, strict processes and stringent regulations have made companies in these industries wary of Agile.

With its emphasis on multiple smaller teams working autonomously, Agile worries some operators in the HLS sector concerned about governance and control. Regulated industries such as these naturally operate under strict standards of scrutiny, and companies that do not comply with constantly changing regulations risk huge fines, legal penalties and reputational damage.

When it comes to adopting Agile, pressure to meet compliance and regulatory requirements deters many companies dealing with high-risk projects, restrictive deadlines and requirements that are not always clearly defined. When implemented correctly, however, Agile can actually enable these companies to meet their compliance and regulatory obligations faster and more reliably.

Agile works for HLS

The pressure to perform in ever-shifting market conditions is driving many HLS companies to confront their reluctance to adopt Agile and seriously consider its benefits. With operating models under pressure from increased complexity in the customer landscape, tighter margins and intensifying competition from traditional and new rivals, they are seeking ways to improve their time to market, reduce their development costs and drive greater overall operational efficiency. Internally, unnecessarily complex processes, systems and governance make progress difficult. Employees become frustrated as a result and start to question the point of their efforts.

Agile allows companies to eliminate much unnecessary complexity so that they can focus on what matters — which, in the case of HLS companies, is the patient or user experience. With processes standardised using predetermined KPIs and R&D departments given greater flexibility, quality in care can become the key objective.

Agile means the R&D department can become a HLS company’s engine for competitive advantage. Daily stand-ups and weekly or fortnightly demos of what has been achieved demonstrate incremental progress, as well as providing transparency and understanding of the processes being followed.

Risk is mitigated by taking small steps as fast as possible. You can’t predict the future, but you can manage it with shorter sprints/iterations. Any negative developments can be caught early, with teams able to respond quickly to unexpected changes that arise without prompting the process to collapse.

A cross-functional team structure breaks down silos and boosts the commercial agility of the organisation. Teams are smaller and more defined, giving them the flexibility to iterate faster and accelerate their operational efficiency. Working together, they develop practical ways to speed up and enhance end-to-end processes, reinforce cooperation and diminish hierarchies that don’t serve a purpose. People look beyond their teams and functions to consider the impact of their work on the broader organisation, while maintaining a focus on what the customer needs in all elements of that work.

Agile best practices support continuous testing, an integral feature of DevOps that aligns well with HLS companies. The focus on automated testing streamlines the digital experience for software development in highly regulated industries and dispenses with the need for labour-intensive, error-prone paper-based documentation. Automated documentation details the most current modifications and capabilities. Any error is easily identified and traced back to the code change associated with it and how it was tested.

Agile done right

Agile ways of working can help HLS organisations survive and even leverage the challenges of changing customer landscapes, intensifying competition, accelerating technological change and diminishing margins. However, it is not simply a question of adopting the tools and methodology and expecting teams to pick them up and use them. HLS businesses considering Agile must focus on culture, team structure and processes.

Adopting an Agile approach successfully requires shifts in mind-set and behaviour that must be modelled from the top down. Long before the tools and processes are introduced, organisations need to start thinking about how to structure teams, formulate objectives and ensure customer orientation is correct.

Leaders across the company must deliver coherent, consistent messaging about the new approach and why it is being adopted. They need to engage with different stakeholder groups and address their concerns. Early successes should be celebrated and teams’ experiences broadcast companywide.

Companies need to place a greater focus on trust autonomy, and mutual respect to drive a mind-set shift toward empowerment and accountability. For example, if people are accustomed to thinking that they work on a specific project and report to their direct boss, they need to focus instead on what they need to achieve within a specific timeline and whose input they need to achieve that goal.

HLS businesses considering Agile must focus on culture, team structure and processes.

Product and process design must centre on end users, with team members using preliminary rather than complete information to make decisions earlier in the process and adjusting to the practice of sharing work in progress instead of finished products.

Another aspect of Agile that companies need to consider is team creation. Teams should include only those who need to be on them, and they should be elastic enough to expand and contract as needs evolve. At earlier stages of product development, for example, a team may be weighted in favour of medical and regulatory experts, but the composition may shift to include more digital specialists as the technology progresses.

Process design may also undergo a transformation. A design-thinking approach is a prudent way to re-engineer key processes. By focusing on how best to optimise user experience and quickly testing prototype solutions, agile organisations generally make one team responsible for a process end to end. That team will take input from internal and external stakeholders to create and test an MVP, building on feedback through successive iterations to create a solution.

Agile pilot

Reflecting the incremental nature of Agile, HLS companies prepared to trial Agile should adopt its processes gradually. As teams deliver on small sprints, they build trust among all stakeholders. Regular stand ups and demos illustrate progress and create transparency. Any issues that arise are dealt with immediately rather than compounding and creating insurmountable problems at a later stage. This ongoing incorporation of feedback and regular monitoring of quality means the final product aligns closely with the customer’s needs while maximising patient safety and data integrity.

Engaging an external partner with extensive experience working with the HLS sector also creates peace of mind for organisations hesitant about adopting Agile. NearForm has worked with health services worldwide, on developing Covid-19 tracker apps for international governments and digital transformation for clinical trials, for example.

For areas of the business that must follow a standardised process due to regulations, Agile may not be the answer. However, much of the activity in HLS businesses is not regulated, and the processes are complex simply because they have been made that way. By differentiating between processes that demand specific standards because of regulation and those that don’t, organisations can identify many areas where Agile can be leveraged to great effect. And even if Agile methodology is unsuitable for certain processes, key Agile principles such as customer focus, team empowerment, adaptability and a focus on results are tenets that any organisation can strive to embrace.

By getting the approach right over multiple iterations, companies avoid having to dive into another major transformation initiative a few years later. Adopting Agile in the right way will enable them to transform on a continuous basis.

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