How Agile Practices Can Enable Faster, Better Digital Health Products

Ferry Tamtoro

The relatively quick development of vaccines to fight the COVID-19 virus has highlighted the intense pressure the biopharma industry is under to get products to market quickly.

But many healthcare organizations and drug manufacturers know that traditional software development practices can impede that process. Instead, agile software development enables companies to get products to market quicker, cheaper, and with fewer missteps along the way. While traditional development projects have frequently been measured in years, an agile approach can often trim that down to months and produce better quality products.

The need for speed in digital health development is well known. Regulatory requirements change frequently and software must be flexible to meet the shifting demands. Any approach that takes years to complete simply won’t do.

The unfortunate reality is that technology and software are generally not core competencies in biopharma.

At the virtual PODD 2021 Conference (Partnering Opportunities in Drug Delivery), Jim Collins, vice president, device development unit at Sanofi, noted that biopharma is culturally and clock speed-wise different from tech. He told attendees that biopharma companies need to be agile, persistent, and strive to be a learning organization.

Toward that goal, as biopharma companies build digital solutions they should consider the ultimate value to patients, providers and payers and make that the starting point in development. Agile development makes that goal more achievable.

How agile development differs from traditional practices

Traditional software development is often referred to as the ‘waterfall approach,’ and is very sequential in nature. First, a software developer determines the requirements, then maps out the architecture, then writes the code, and finally conducts testing on the program or application.

In agile development, the whole cycle of requirements, design, implementation and testing is done in smaller batches in an iterative manner. This is important in healthcare today, due to the rapid changes in demands being placed on pharma. Quite simply, a new way of approaching software development is needed, and agile practices can deliver value to the customers or end users more quickly and efficiently.

Unfortunately, many people believe that agile practices actually don’t work in healthcare product development because there are specific processes that have to be followed and documentation that has to be produced. But even FDA endorses a standard created by The Association for Advancement of Medical Instrumentation (AAMI), which provides guidelines on how to apply agile in a regulated or medical device setting.

Top factors driving the need for an agile approach

There are three top factors driving the need for agile development in biopharma. One of the most important is that, from a Software as a Medical Device (SaMD) perspective, it provides a safer and more effective product.

This is significant since a recent survey of biopharma executives by BrightInsight revealed that more than 90% believe digital will be core to their business within the next three to five years. That means more technology investments, more software development, and more dependence on the capabilities of both.

While SaMD is still a nascent category for many biopharma companies, the reasons for and benefits of this approach were the subject of a panel discussion at DTx East (2021) in Boston. On his blog, “DTx East Panel Recap: Building Regulated Software as a Medical Device,” BrightInsight’s CEO Kal Patel, MD, noted several of the most impactful:

• There’s pricing pressure on pharma with increased demand for real-world evidence.
• Algorithms can allow you to better identify patients and deliver personalized care.
• SaMD goes through regulatory approvals, so it has to be validated.
• Profits: More accurate and efficient patient identification and improved medical adherence can increase market share.

Agile aids in these areas because it enables more efficient software development, which enables faster time to market.

Benefits to be gained from agile practices

With agile, since each iteration involves testing, software quality issues are identified and fixed much earlier in the process before releasing a demonstrable product.

1. Developers will know much earlier if there is a problem, and they’ll also get user feedback sooner in the process. This enables developers to correct any issues before substantial work needs to be redone. There is significant pressure to accelerate the development and release of SaMD products. But organizations obviously can't compromise on the safety and reliability of the product. So the combination of those two factors then really drives the need to adopt agile practices.
2. The second factor is predictability. In typical medical device development, even for software, the process generally takes an average of three to seven years from concept to market. Along the way there are bound to be several delays. These usually involve surprises encountered in the later phases of development. Because the waterfall method is very sequential, if something unexpected or unwanted happens near the end of the project, the developers may have to go back all the way to the beginning to make necessary changes to the architecture, and start the process over.
3. The third factor relates to end users and customer satisfaction. We are all consumers of healthcare. A key focus of agile development is delivering greater value to the end user based on a prioritized backlog of features. That in turn leads to higher satisfaction for end users, whether they be patients or physicians.

Getting key support for agile practice adoption

Support for agile development really needs to start at the top. Leaders in the organization should encourage staff to embrace this collaborative approach. Agile also requires a willingness to adopt change and be open to experimentation. This may not be the culture of the organization, but is needed to truly drive innovation.

Agile is a more collaborative development process because it solicits feedback at each step from stakeholders. This is especially helpful in bringing Commercial and Research & Development together. While these groups within any organization may not historically have worked closely, agile practices give different departments a common goal to work toward–developing a product that gets higher user adoption, and in turn, higher revenue. That's one of the key principles of agile.

Another aspect of agile development that promotes collaboration and employee satisfaction is the speed to market benefit. As noted, with the waterfall method of development, it typically takes three to seven years before a product can be launched. When products are developed with agile practices, employees can see how those products actually benefit end users in a shorter period of time. This promotes positive energy and motivation.

Agile practices require cultural changes in most organizations

Only a few years ago, adopting agile practices would have been a significant cultural challenge for pharma. But there is a shift happening in the industry. Executives are realizing that this approach is needed, and from a competitive advantage standpoint, biopharma companies need to be more flexible in their operations and product development.

A significant challenge for many organizations is having the skills and resources necessary to make this shift. Many don’t. Biopharma firms are known for developing life-changing medical therapies, not top-shelf software applications.

For many biopharma, success depends on selecting a partner that is a good fit, and who will help to achieve the desired goals. If the goal is to create meaningful products, then that should be one of the key criteria when they're looking for a partner. For example, has a potential partner shown evidence of supporting other biopharma companies in releasing products quickly?

The second criteria is finding a partner that fully understands what matters for the organization’s end users, including patients and physicians. Digital products are intended to impact and improve people's lives. Look for partners that share that mission.

As biopharma firms tackle new digital health development initiatives, they should do so from the perspective of the patient and how it fits into the overall picture of care.

Practices for success with agile development

Adopting agile practices is a journey for many organizations. One way to make the journey as smooth as possible is to assign change agents in different parts of the organization. These employees can then help bring the organization along as the implementation takes place.

Change agents can share success stories that various departments are seeing, to help keep staff motivated. They can also track challenges that a particular department is experiencing, and then bring that information back to the executives to be addressed.

Finally, biopharma organizations should not be afraid to partner on this journey to agile development. This is a new approach for many biopharma companies and I know from working with our biopharma clients, that having a team of expert engineers who specialize in developing regulated software in an agile manner ensures that digital health solutions and software products can be developed more quickly and cost effectively. The result will be better products that improve patient care and outcomes.

Ferry Tamtoro, Co-founder and CTO, BrightInsight