Across industries, the pace to introduce new products is increasing. This puts pressure on companies to shorten the design and development cycles. Medical devices are no exception in this respect.

One key question for medical device business is that because of burdensome regulations and complex business environment, is it possible to get certified, high-quality medical product to the market quickly and smoothly?

Yes, it is. We’ve found that one answer in shortening the development cycle is to apply to medical device design and development three commonly known methodologies: Design Thinking, Lean Start-up, and Agile. According to our studies, when applying these to medical domain, short development cycles with effective feedback can be achieved despite the burdensome regulations and complex business environment.

Short introduction to the methodologies

Design Thinking, Lean Start-Up and Agile are common approaches to develop digital services. There are numerous representations on how these approaches co-exist and how they help in reducing the development times by eliminating waste and focusing on the essentials any given time. You can see one example of the presentation when developing digital services below (picture #1).

Picture #1. Example of Design Thinking, Lean Start-Up and Agile approaches - how they co-exist and how they help in reducing the development times by eliminating waste and focusing on the essentials any given time. Source: Servian / Nordstrom Lean Model.

Design Thinking strongly emphasizes the user or human-centric perspective in the process. Design tools and approaches are systematically used to come up with innovative design solutions satisfying the user expectations.

Lean Start-Up methodology aims to shorten product development cycles by adopting a combination of business-hypothesis-driven experimentation and prototyping, iterative product releases, and validated learning. Lean start-up methodology suggests that if companies invest their time into iteratively building products or services to meet the needs of early customers, they can reduce the market risks and sidestep the need for large initial project funding and expensive product launches and failures.

Agile is an umbrella term borrowed from SW development but having a wider applicability in which cross-functional teams work with users to develop and release Minimum Viable Products (MVP) frequently in short cycles. Agile encourages collaboration and self-organization among multidisciplinary team members.

Design Thinking, Lean Start-Up and Agile methodologies in medical device design and development

According to our studies, medical device development can greatly benefit from these three methodologies. When done properly, they will reduce the time to market of the device by ensuring that right and well specified customer problem will be solved with a feasible solution, which is going to be incrementally developed. The following figure describes how the three approaches interact and how they can be applied in medical device design and development.

Picture #2. Design Thinking, Lean Start-Up and Agile methods in Medical Device Design and Development.

Design Thinking is something that can be utilized especially during the very early idea elaboration phase of the medical device development. It is a powerful approach when defining the design challenge and seeking the answers to the questions: “What problem are we trying to solve?” and “What are the real user needs?” Besides the initial user requirements, understanding the clinical and user environments as well as the intended use are also crucial when developing medical devices.

Lean Start-Up methodology is something that can be utilized especially during the prototyping phase, aiming to shorten product development cycle. Fast prototyping as well as combining insights and skills from various essential domains in medical device development bring additional understanding about the feasibility of different alternatives.

Agile is something that can be utilized especially during the actual design and development phase. Agile is a good approach for incremental development and testing, which both are done in short iterations. The four values of agile (see e.g. Agile Manifesto), are relevant for the medical devices as well. These values are discussed more in our White Paper, which can be downloaded from the end of this post.

If we look closer the figure, we can see that there are some notable differences that must be accounted so that these approaches would work seamlessly together and add business value also in the medical device domain. The imperative need for quality management system, patient safety and risk management must be taken into account. These determine the design and development of medical devices right from the idea phase, with increasing intensity.

Effective medical device design and development requires deep understanding about the users, clinical environments and technologies to be used. The team needs to have a broad spectrum of competences where some of those are specific to the medical domain.

Learn more about Design Thinking, Lean Start-Up and Agile approaches in medical device design and development

The discussion above was only a short introduction to the topic. If you want to learn and read more, we've created a free White Paper, in which we’ll describe in more detail how to get high-quality medical products to the market as quickly as possible by utilizing product development model, which is based on these three methodologies. The illustration above (picture #2) will be also described and discussed from checkpoint to checkpoint.

The following topics are covered in the white paper:

• Mapping of medical device development concepts into the spectrum of the three mutually supporting approaches (Design Thinking, Lean Start-Up and Agile).
• Strong and imperative focus on patient safety and related product risk management
• The role of design controls throughout the development lifecycle
• The challenge related to the concept of Minimum Viable Product (MVP) in a regulated environment.

Collect yours by following the link!