Can Agile Tools Enhance Stage-Gate Processes?

stage gate processCan you ever make a stage-gate process Agile? Can modern tools and a hybrid approach to Waterfall and Agile bring greater flexibility to developers as they seek to bring higher quality products to market more quickly?

Is Agile freedom?

Developers in strictly regulated sectors sometimes look with envy at the freedom of others who need nothing more than a good idea and Kickstarter funding to begin ideating, prototyping and iterating a new product:

“The problem with med tech is it’s highly traditional. If you look at industries that are user driven, people are getting stuff they like from day one - but medtech has never been that way. What’s more, product development follows a traditional waterfall approach that serves only to exacerbate one of our biggest challenges: lead time from idea to market”

Henrik Norstrom, Brighter

Waterfall, with its linear approach to development and formal requirements for exhaustive initial specification and final verification, therefore, has sometimes been seen as the enemy of speed, creative flexibility and agility.

The advantages of Agile

In Agile, working features are produced fast and frequently throughout development. Verification is a key part of Agile development, but it is realised though frequent builds of product, iteration and ongoing regression testing.

In this way, it is argued, a more responsive system of continuous quality improvement is developed. It speeds up overall development times by identifying defects in ideas and products more quickly and more often, reducing overall project and product failure risk.

As stakeholders in a process see real and tangible features delivered and demonstrated during each sprint it provides extra motivation for completion by the team, as well as the opportunity for early feedback and review.

From NPD to NPI. Agility and control with a stage gate process

Waterfall and the stage gating approach

A traditional waterfall approach, on the other hand, breaks development down into certain phases bounded by stage gates. Ideation and specification happens in the early phases, followed by feasibility studies, then a build against specifications and finally validation and testing. These are:

  1. Scoping
  2. Feasibility (including the creation of a detailed project plan).
  3. Developing
  4. Testing and validation
  5. Launch

At the end of each phase of the project a group of stakeholders from different departments are drawn together to assess progress on the project and decide whether to continue based on various technical and commercial go/kill criteria.

For developers in tightly regulated sectors, breaking a project into well understood and documented phases in this way allows projects to be properly tracked for future auditing and product approval purposes. It also prevents expensive builds commencing without proper inquiry into their feasibility.

A waterfall product development project, then, typically only produces a working product at the end of a process.

In contrast, Agile works on the basis that the quicker you can bring an idea to life for a team and its customers, the faster problems and flaws get identified. The faster this happens, the more quickly workarounds to problems can be found.

Towards a hybrid approach

However, a hybrid approach to NPD (favouring a mix of Waterfall and Agile), now suggests incorporating time limited sprints into phases to create working iterations of products and features throughout a development cycle.

These phases can still be bounded by traditional gate reviews, providing for the capture of documentation and more formal review sessions to track the meeting of specifications, as well as the progress and viability of a project. After all the Agile process does have its own set of ‘gates’ - they’re just called criteria, ‘definitions of done’, ‘minimum viable product’ thresholds and the like.

With these so-called Agile stage gates the benefits of an iterative approach to product development can be folded into a more traditional waterfall system – and can result in a marketable product being produced sooner rather than later in the design cycle.

Cross functional participation and greater project visibility

Full visibility of project progress and more cross functional input are also central tenets of an Agile approach.

The stage gating tools on the market available as part of sophisticated document management systems (DMS), can make these processes much quicker and more seamless - with documents gathered and shared digitally, approval gained and new specifications published automatically.

Digital tools can allow more visibility and input from different functions (including the customer and end user) during all phases of a project. They can allow changes and updates to specifications to be published and tracked by all stakeholders.

Notifications and reminders within a digital document management system (DMS) can help streamline and speed up the review processes that might once have been mired in endless meetings and email exchanges. These tools can more easily facilitate and support a faster ‘do, plan, check, act’ cycle that is at the heart of so much Agile practice.

Tools that enable virtual approval processes and distance collaboration can also make it possible for ‘distributed Agile’ to function more effectively. A document management management system with the right digital tools for sharing, reviewing, editing and alerting engineers to changes as a process continues, can help workers in different locations to contribute to projects and not miss vital changes and updates to a project’s direction.


Modern document management tools deployed within a traditional product development cycle can make them more agile and responsive, overall. They can bring greater visibility of progress to all of a project’s stakeholders, while providing ways for them to feedback, track and contribute to phases more quickly and effectively. At the same time ‘Agile stage gating’ can harness the power of an iterative approach to problem solving, while locating it within a more formal digital governance framework.

The value of DMS for Product Development

Tags: Product Management

Joe Byrne

Written by Joe Byrne

Joe Byrne is the CEO of Cognidox. With a career spanning medical device start-ups and fortune 500 companies, Joe has over 25 years of experience in the medical device and high-tech product development industries. With extensive experience in scaling businesses, process improvement, quality, medical devices and product development, Joe is a regular contributor to the Cognidox DMS Insights blog where he shares expertise on scaling and streamlining the entire product development cycle, empowering enterprises to achieve governance, compliance, and rigour.

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