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Accelerating neurotechnology development using an Agile methodology.

Anil Kumar Thota¹, Ranu Jung^1,2

¹Adaptive Neural Systems Group, The Institute for Integrative and Innovative Research, University of Arkansas, Fayetteville, AR, United States.

Frontiers in Neuroscience

|March 4, 2024

Summary

This summary is machine-generated.

This study advocates for the Agile methodology in developing novel neurotechnologies for medical devices. Adopting Agile can accelerate the delivery of innovative treatments for chronic immune and autonomic disorders.

Keywords:

Agile design controls medical device development neurotechnology peripheral neural interfaces verification and validation waterfall

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Area of Science:

Bioelectronic medical devices
Neurotechnology
Medical device development

Background:

Novel bioelectronic devices targeting neural control of visceral organs and inflammatory pathways represent innovative Class III medical devices.
Current development often uses the Waterfall methodology, which can cause delays and increase costs due to its rigidity.
Agile methodology, successful in software development, faces challenges in hardware-based medical devices due to regulatory hurdles.

Purpose of the Study:

To compare the Waterfall and Agile methodologies for developing medical devices with physical components.
To advocate for the adoption of the Agile methodology in the development of neurotechnologies.
To illustrate the application of the Agile approach using a peripheral nerve interface example.

Main Methods:

Comparative analysis of Waterfall and Agile methodologies in medical device development.
Discussion of regulatory considerations for Agile implementation in hardware-based medical devices.
Case study utilizing a peripheral nerve interface to demonstrate Agile methodology.

Main Results:

The Waterfall methodology's limitations in adapting to changes can lead to significant delays and increased costs in device development.
Agile methodology offers flexibility and efficiency, potentially overcoming the drawbacks of Waterfall for medical device development.
The study highlights the feasibility and benefits of applying Agile principles to neurotechnology development.

Conclusions:

Adopting Agile methodology can accelerate the market entry of life-saving and life-sustaining medical devices.
Agile offers a more adaptive and efficient approach compared to Waterfall for developing complex medical devices.
Implementing Agile for neurotechnologies can benefit patients with autonomic and chronic immune disorders by providing earlier access to innovative treatments.