Providing ultimate value to stakeholders remains key to the new style of development.
The relatively rapid development of vaccines to combat the COVID-19 virus has highlighted the intense pressure the biopharmaceutical industry is under to get products to market quickly.
But many healthcare organizations and drugmakers know that traditional software development practices can get in the way of this process. Instead, agile software development allows companies to bring their products to market faster, at lower cost, and with fewer errors along the way. While traditional development projects have often been measured in years, an agile approach can often reduce that to months and produce higher quality products.
The need for speed in the development of digital health is well known. Regulatory requirements change frequently and software must be flexible to meet changing demands. Any approach that takes years to complete will simply not suffice.
The sad reality is that technology and software are generally not core competencies in biopharma.
At the PODD 2021 (Partnering Opportunities in Drug Delivery) virtual conference, Jim Collins, Vice President, Device Development Unit at Sanofi, noted that biopharma is culturally and in terms of clock speed different from technology. He told attendees that biopharmaceutical companies must be nimble, persistent and strive to be a learning organization.
To achieve this goal, as biopharmaceutical companies develop digital solutions, they must consider the ultimate value for patients, providers and payers and make this the starting point for development. Agile development makes this goal more achievable.
How agile development differs from traditional practices
Traditional software development is often referred to as a “waterfall approach” and is very sequential in nature. First, a software developer determines the requirements, then maps the architecture, then writes the code, and finally performs testing on the program or application.
In agile development, the entire cycle of requirements, design, implementation, and testing is done in small batches iteratively. This is important in healthcare today, due to rapidly changing demands placed on the pharmaceutical industry. Quite simply, a new way of approaching software development is needed, and agile practices can deliver value to customers or end users more quickly and efficiently.
Unfortunately, many people believe that agile practices don’t work in healthcare product development because there are specific processes to follow and documentation to produce. But even the FDA endorses a standard created by the Association for the Advancement of Medical Instrumentation (AAMI), which provides guidance on how to apply agility in a regulated or medical device setting.
Main factors driving the need for an agile approach
There are three main factors driving the need for agile development in the biopharmaceutical sector. 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 as a recent survey of biopharmaceutical executives conducted by BrightInsight revealed that more than 90% of them believe that digital will be at the heart of their business in the next three to five years. That means more technology investment, more software development, and more reliance on the capabilities of both.
While SaMD is still a nascent category for many biopharmaceutical 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 CEO Kal Patel, MD, noted several of the most impactful:
- Pricing pressure is on the pharmaceutical industry with increased demand for real-world evidence.
- Algorithms can help you better identify patients and provide personalized care.
- SaMD goes through regulatory approvals, so it needs to be validated.
- Benefits: More accurate and efficient patient identification and better medical compliance can increase market share.
Agile helps in these areas because it enables more efficient software development, which speeds time to market.
Benefits to be drawn from agile practices
With agile, since each iteration involves testing, software quality issues are identified and resolved much earlier in the process before releasing a demonstrable product.
- Developers will know much sooner if there is a problem, and they will also get user feedback earlier in the process. This allows developers to fix any issues before substantial work needs to be redone. There is significant pressure to accelerate the development and commercialization of SaMD products. But organizations obviously cannot compromise on product security and reliability. So the combination of these two factors then really leads to the need to adopt agile practices.
- The second factor is predictability. In typical medical device development, even for software, the process typically 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 later stages of development. Since the waterfall method is very sequential, if something unexpected or undesirable happens near the end of the project, developers may have to go back to the beginning to make the necessary changes to the architecture and start the process over again. process.
- The third factor relates to end users and customer satisfaction. We are all health care consumers. A key goal of agile development is to deliver greater value to the end user based on a prioritized feature backlog. This in turn leads to greater satisfaction for end users, be they patients or physicians.
Obtain key support for the adoption of agile practices
Agile development support really needs to start at the top. Organizational leaders should encourage staff to adopt this collaborative approach. Agile also requires a willingness to embrace change and be open to experimentation. It may not be the culture of the organization, but it’s necessary to really drive innovation.
Agile is a more collaborative development process because it solicits feedback from stakeholders at every stage. This is particularly useful for bringing sales and research and development closer together. Although these groups within an organization have not always worked closely together, agile practices give different departments a common goal to work towards: developing a product that achieves greater user adoption and, therefore, , higher incomes. This is one of the key principles of agility.
Another aspect of agile development that promotes collaboration and employee satisfaction is speed to market. As noted, with the waterfall development method, it typically takes three to seven years before a product can be launched. When products are developed with agile practices, employees can see how these products actually benefit end users in a shorter time frame. This promotes positive energy and motivation.
Agile practices require cultural changes in most organizations
A few years ago, adopting agile practices would have been a major cultural challenge for pharma. But there is a change happening in the industry. Executives are realizing that this approach is necessary and, from a competitive advantage perspective, biopharmaceutical companies need to be more flexible in their operations and product development.
A significant challenge for many organizations is having the skills and resources to make this change. Many don’t. Biopharmaceutical companies are known for developing life-changing medical therapies, not high-end software applications.
For many biopharmaceutical companies, success depends on selecting a partner that is right for them and that will help achieve their desired goals. If the goal is to create meaningful products, this should be one of the key criteria when looking for a partner. For example, has a potential partner demonstrated support for other biopharmaceutical companies in bringing products to market quickly?
The second criterion is to find a partner who fully understands what matters to the organization’s end users, including patients and physicians. Digital products are meant to impact and improve people’s lives. Look for partners who share this mission.
As biopharmaceutical companies tackle new digital health development initiatives, they must 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 to different parts of the organization. These employees can then help the organization monitor the implementation.
Change agents can share success stories that various departments are seeing, to help keep staff motivated. They can also track challenges faced by a particular department and then report that information to executives for action.
Finally, biopharmaceutical organizations should not be afraid to join this journey towards agile development. This is a new approach for many biopharmaceutical companies and I know from working with our biopharmaceutical customers that having a team of expert engineers specializing in the agile development of regulated software ensures that digital health and software products can be developed more quickly and cost effectively. The result will be better products that improve patient care and outcomes.
Tamtoro ferry, Co-Founder and CTO, BrightInsight