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Guest Contributor: Richard Dolman, Certified Enterprise Coach, Agile Velocity

Contrary to popular belief, Agile isn’t the Wild Wild West. Adopting an Agile approach to bringing your medical device to market will not result in undocumented chaos, product delays, FDA warning letters, lost revenue, or any other worst-case scenario.

Rather, adopting an Agile mindset prepares your medtech company for the inevitable changes of today’s fast-moving business environment.

Many people assume that Agile is only relevant to software development. You may even believe that Agile is in conflict with quality assurance and regulatory compliance best practices for medical device product development, which has traditionally employed linear waterfall methods and frameworks.

The key to implementing Agile effectively is to identify what has worked for the software development industry and apply the principles within the context of device design and development.

Agile principles have been used to dramatically reduce medical device product delivery cycles by months, simply by breaking down the requirements into smaller deliverables, in order to get faster feedback loops throughout the product life cycle. This can help you identify and address potential hazards earlier in the process and help accelerate your go-to-market timeline.

Read on to explore seven ways Agile can help medical device manufacturers like you bring safe and effective products to market.

What is Agile?

With roots in lean thinking, Agile is a set of values and principles that acknowledge the realities of change and emphasize the need for collaboration and a focus on value in response to change.

At its core, with its emphasis on iterative and incremental processes, Agile enables organizations and teams to break down complex problems into smaller units, making it easier to identify and solve issues that can impede value delivery.

Agile originated in 2001 when 17 individuals met, seeking common ground on ways to improve software development, issued the Agile Manifesto that detailed four core values and 12 principles.

While the values and principles are universal, the methods, frameworks, and practices that may be applied are dependent on the context. You’re not following a framework for the sake of following a framework. When it comes to Agile, understanding the context in which you operate is essential.

Seven Ways Agile Can Help Medical Device Manufacturers Achieve Their Goals

Applying the right Agile strategy can help medical device manufacturers deliver products faster without sacrificing quality or increasing risk. Agile medical device development built around iterative and incremental delivery can help manufacturers ensure the way in which they bring their products to market is as innovative as the products themselves.

Following are seven reasons medical device manufacturers should consider an Agile approach.

  1. Faster feedback loops. The best way to deal with complex problems is to iteratively remove uncertainty and risk. Traditional methods and processes were often built on predicting every detail up-front with long, stage-gated phases, which makes responding to change more expensive and painful. The shorter the iteration, the shorter the feedback cycle, which enables us to learn and respond to changes faster and more effectively.
  2. Focus on value. Most organizations have more demand than capacity and an unintended consequence can be that teams are just trying to get everything done rather than prioritizing tasks based on value. Agile encourages a relentless focus on value delivery to help ensure that precious resources – people, time, and money – are invested wisely.
  3. Growth mindset. A core tenant of Agile is to accept the inevitability of change. Better yet, to anticipate it and build change into our planning. A key to fostering sustainable Agile is for leaders to be open to new ways of thinking and working. I encourage conducting frequent retrospectives at all levels, in order to inspect and adapt regularly, to help shift from a fixed to a growth mindset.
  4. Space for innovation. The pace of change is greater than ever, and meeting customer and market demands requires a relentless pursuit for innovation. Creating space for innovation is not just about processes or technology. It’s also about creating a culture of learning that includes safe-to-fail experimentation. Make it safe to experiment within the lifecycle, so that the product delivered meets safety guidelines and market demands effectively.
  5. Increased transparency and collaboration. Making work visible and creating transparency can dramatically improve collaboration, decision making, and process flow. Transparency also helps reduce risk and the cost of delivery. Missed requirements or changes are much harder to resolve and more expensive when they’re hidden in silos or unnecessary process controls. We also need to bring teams together, combining design, development, testing, and other functions, to create shared ownership, instead of hand-offs that can create delays and additional costs.
  6. Attention on continuous improvement. With its foundations in lean thinking, Agile encourages teams to seek continuous improvement. One hallmark of lean and Agile is to start with what you know and make iterative and incremental improvements. This sounds obvious, but many organizations and teams are simply overwhelmed by the volume of demand they face, so the desire to improve often gets pushed aside to just “get stuff done”.  Leaders need to foster a culture of learning and improvement, so teams and individual contributors know they can allocate time and energy to actually making improvements that will last, and benefit the product and the customer.
  7. Accelerate go-to-market timelines. All of the benefits listed here ultimately translate into   the ability to get products to market faster, without sacrificing quality or increasing risk. Market responsiveness is enabled, by getting teams aligned to value, reducing complexity, shortening cycle times and feedback loops, and increasing decision agility.  Taking a balanced approach to align and learn where Agile may provide benefits, and working with a coach to help build Agile capabilities that are right for your organization, can help you realize these goals.
Apply Agile Across Your Quality and Regulatory Functions

Medical device manufacturers are always seeking ways to reduce costs and accelerate timelines. Agile is one way to achieve those goals. As M&A activity ticks up and competition for funding and resources becomes scarce, every minute and every dollar saved makes a difference.

Finding a trusted thought partner who understands the nuances of applying Agile while maintaining ISO 13485 compliance is an opportunity to set your organization apart from the competition.

Ready to explore how Agile can help your organization meet its quality assurance and regulatory compliance goals? Contact QA Consulting or Agile Velocity to get started.

About Agile Velocity

Agile Velocity, a trusted referral partner of QA Consulting, helps organizations accelerate agility by providing whole organization coaching, leadership and team coaching, and Agile training. By leveraging their Path to Agility® transformation framework, they advise clients on the best way to avoid failure and achieve business outcomes as quickly as possible.