A common hurdle to achieving agile benefits

Agile” remains a hot topic in general, and “compliant agile” is a goal in many medical (and other regulated) companies.

However, “agile” also remains difficult and elusive for many.

This article will examine one of the most common hurdles to achieving agile benefits from well-intentioned initiatives.

First, let’s address agile and medical device development in general. The most common questions we get regarding agile are:

  • Can we use agile in medical device software development?
  • Can it be compliant?
  • Can it be safe?
  • Is it a wise thing for us to do?

The short answer is “yes.”

“We find that many agile methods, when implemented properly, are not only compliant with regulatory law & guidance, but are better than traditional methods for ensuring safety and effectiveness.”  – Alan Kusinitz, Founder SoftwareCPR®

The next most common question we get is “Can’t we just change part of our process and succeed with agile?”

The short answer is “no, in most cases.”


Every organization, and every level in an organization, effectiveness can be evaluated across four factors illustrated in the quadrants of the diagram below.

Optimal Business Performance Model

Optimal business model

As the name implies, optimal business performance occurs when all four quadrants or factors are functioning optimally.  The four factors also interact and are dependent on each other, so a major change in one area can affect one or more of the others.

Using the model as a foundation, the question can be rephrased as “Can we just change a part of the Processes & Systems factor? The answer is “no” because agile if more than just a process change.

common hurdle to achieving agile benefits

Transitioning to agile has many challenging aspects … an “off the shelf” “plug and play” is unlikely to work for most medical device companies.  While agile does imply development process changes, there are also changes usually needed around:

  • culture (agile is very different from deterministic approaches like waterfall or pure stage-gate development)
  • people (e.g., different competencies, roles)
  • other processes beyond device development (e.g., financial planning, performance management, marketing)
  • strategy (e.g., product release cycles)

Therefore, your agile success and how you achieve it will necessarily involve other parts of your organization.   We have found that the most successful implementations have one or more of these key attributes:

  • Senior executive sponsorship and commitment
  • Critical mass culture change across three or more functional groups
  • Desperation – general knowledge that company will fail without change
  • Hopelessly committed to customer satisfaction

The benefits associated with agile are clear and have been demonstrated in both regulated and non-regulated environments. Unfortunately, the hurdles are also clear and have been encountered by those struggling to achieve the benefits.

If you or your organization has been struggling, look at what changes you are making. Have you sufficiently addressed all four optimal business performance factors?

About the author

Succeeding despite relentless change is the goal of 21st century organizations. Mike helps achieve those successes by working with leaders of start-ups to Fortune 20 companies and national governments. His aim is to help them re-imagine and create adaptive, innovative enterprises that increase profitability and value across the quadruple bottom line: customers, employees, owners/shareholders, and communities.

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Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for scheduling!

  • Agile principles that align well with medical
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

2-days onsite (4 days virtual) with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

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This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

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