How can medical device development companies incorporate the Agile development and still comply with ISO 13485 and Title 21 CFR Part 820? The answer becomes clear when we realize that the goals and values of Agile and medical device development are generally well aligned. The specific practices of Agile development can be tailored to meet the demands of medical device development with its focus on the emergent properties of safety, reliability, and security.

Regulatory goals and values

The traditional approach to medical device development is the Waterfall development process. However, neither ISO 13485 nor 21 CFR 820 require a specific process for development. Instead, the focus of these regulations is on the requirements for the manufacturer’s quality management system (QMS) and the attendant design controls used during development. Regulators are primarily concerned with ensuring that a development process is established, and followed, that ensures the safety, reliability, efficacy, and security of the resulting product.

Regulators have shown a growing acceptance of Agile methodologies in medical device development. Although no guidance is yet available from the FDA, industry groups like the Association for the Advancement of Medical Instrumentation (AAMI) have published guidance documents on this topic [1] showing that the goals and values of Agile and medical device development are more aligned than many people believe.

Agile Goals and Values

As originally conceived in the Agile Manifesto [2], Agile does not constitute a set of practices and processes. Instead, Agile is a statement of values and goals specifically for the software development process. The goal of Agile is to optimize the process of development for quality, productivity, predictability, and effectiveness. However, because the manifesto does not attempt to provide a definition of specific development practices, Agile development in practice is typically drawn from one or more of a number of different Agile frameworks, [3] including Scrum, Extreme Programming, Kanban, and feature-driven development. While the appeal of Agile spans engineering disciplines, no specific frameworks have been published that apply Agile principles to projects outside the software domain. Despite this, all development projects can benefit from a set of practices drawn from various domains intended specifically to meet the goals and values of Agile.

Agile is often misunderstood to promote development practices that are undisciplined. In particular, there appears to be an impression that Agile advocates for the complete absence of documentation. This misunderstanding is likely due in part to the way in which the Agile Manifesto expresses its values, but it is certainly reinforced by the poor implementation of Agile in certain industries. The value statement “Working software over comprehensive documentation” is not intended to mean that documentation has no value, but rather, it is an expression that the quality of the actual product is more important than the volume of the documentation for the product. This statement has been misused to suggest that documentation is not important in an attempt to avoid a task seen as less desirable or exciting.

The true goal of Agile is to promote development efficiency while delivering on a product that meets the needs of the customer. In the case of medical device development, the needs of the customer include providing a product that has a documented ability to meet the regulatory goals of safety, reliability, efficacy, and security.

NOVO Development Process

NOVO’s QMS is designed for our business model and our role in the development phase of the product lifecycle. Our product development process has been refined through many successful projects to meet the needs of the types of multi-disciplinary development projects that we specialize in. The overall PDP includes a phased approach to product development that is consistent with a traditional Waterfall plan for development. However, we tailor the development plan for each phase of development, and we utilize the best practices, including Agile practices, suited to each engineering discipline and to the specific needs of the project. In all cases, NOVO seeks to maximize the value we provide to our clients by optimizing our development process.

We serve many different clients, in different industries and with different needs. It is therefore critical to our business to be able to tailor the development plan for each project. The one need that is common to all clients is the need to deliver a high-quality product as efficiently as possible that satisfies the requirements and needs of all stakeholders. In this sense, the goals of Agile are very well aligned with the needs of our clients, whether the product is a medical device or otherwise.

A blend of the Agile and Waterfall design and development processes

 

[1] AAMI TIR45 Guidance on the use of AGILE practices in the development of medical device software

[2] Agile Manifesto. Retrieved May 24, 2019, from https://agilemanifesto.org/.

[3] https://en.wikipedia.org/wiki/Agile_software_development (probably don’t need this reference)