Mastering Agile Design and Development for NICU Medical Equipment

Written by Kentec Medical

Agile methodologies are flexible design and development processes commonly used by software engineers. Learn how medtech developers can apply agile principles to streamline their work.

Designing advanced medical equipment is a rigorous process that requires a thorough, systematic approach. To keep pace with new technologies and stay competitive, some medtech developers have been rethinking how they approach development by adopting practices from other disciplines to improve their processes. One prime example is the agile method, which was originally developed within the context of software development but maps onto medical device development quite well — especially medical equipment used in NICU wings.

How exactly does the agile method help medtech developers get products to market while meeting regulatory requirements? Here’s what you need to know:

What Is the Agile Method?

The agile method is a framework that provides medical device developers with the flexibility to respond to changes and uncertainty in the design, testing, and verification stages of the development process. Agile methodologies prioritize simplicity and quality in part design, as well as frequent communication between medtech developers and clients, which allows feedback to drive the development and testing cycles. The Agile Manifesto, which lays the groundwork for more efficient and collaborative software development, includes 12 principles, the second of which is: “Welcome changing requirements, even late in development. Agile processes harness change for the customer’s competitive advantage.”

Prior to the advent of agile design, the waterfall development process was the most commonly used approach for developing medical equipment. This model takes a top-down, linear approach, wherein each stage of development — planning, design, fabrication, launch — is separate from the others and must be completed before the next can begin. For instance, users’ needs inform NICU medical equipment product design, design output informs the verification process, and so on. Because the results of each stage are the direct inputs for the next stage, there is little room for unexpected revisions, design changes, or input from end-users or clients.

For teams working on small projects or projects with well-documented, fixed requirements, the waterfall model can still provide a reliable framework with predictable budgetary, timeline, and scope expectations. That said, agile development processes are often more efficient and economical in today’s fast-paced world.

What Are the Advantages of the Agile Method?

Agile techniques take advantage of cutting-edge rapid prototyping technology to develop, deploy, test, and review devices in multiple rounds before the final rollout, while also logging supporting documentation for each iteration of the product. This allows for product designs and features to be updated, tested, and validated as needed, and helps medical device developers easily navigate regulatory regimes.

Additionally, agile methodologies ensure that new products are held to consistent standards. Verification is built into the cyclical structure of agile development, which uses frequent builds, unit tests, regression tests, and other process controls to ensure quality. This helps medical device developers identify defects quickly and often, significantly reducing risk down the line.

These processes also provide visibility into each development cycle for all stakeholders, which makes it easier for teams to incorporate feedback into product designs while increasing their ability to manage and mitigate risk.

Start Leveraging the Benefits of Agile Design Today

An agile development method is key to getting superior medical devices to market faster. However, efficiently implementing this approach can be challenging for medical device developers who aren’t familiar with it, who are just starting out, or who are reluctant to leave behind the waterfall method to which they’ve become accustomed.

Kentec Medical can help! Using our speed-focused model for agile design, we’re able to help aspiring medtech developers bring their devices to market faster and with far less capital investment. We’re committed to providing each of our customers with top-notch customer service because we believe that’s the secret to developing and rolling out high-quality NICU medical devices. Contact us today to learn more about how our team can make your ideas a reality.




Works Referenced

12 Principles Behind the Agile Manifesto. (2019, October 06). Retrieved January 22, 2021, from https://www.agilealliance.org/agile101/12-principles-behind-the-agile-manifesto/

Affairs, O. (n.d.). Production and Process Controls (P&PC). Retrieved January 22, 2021, from https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/production-and-process-controls-ppc

Agile Manifesto for Software Development. (2020, November 12). Retrieved January 22, 2021, from https://www.agilealliance.org/agile101/the-agile-manifesto/