WHILL Delivers FDA-Approved & IEC 62304-Compliant Smart Mobility Vehicles

The Challenges

WHILL produces all of the software related to the controls of its own products with a goal of developing convenient and safe products. Its team of engineers works in a system where they can internally produce both hardware and software, making it faster and easier to deliver enhancements for existing functionality and develop new functionality including integrating features with smartphone apps.

In addition to building a product that WHILL’s customers will fully enjoy, it’s crucial that the team build software that operates reliably and meets medical device safety requirements per regulations in each country.

Achieving IEC 62304 compliance and obtaining FDA Class II medical device approval for WHILL Model C2 enables physicians to prescribe it as a medical device to mobility-impaired consumers with a broader range of medical conditions in the U.S. healthcare system.

The team faced the following challenges in trying to achieve their goals.

• Creating an efficient system to improve product quality.
• Ensuring the functional safety of embedded software for smart mobility.
• Establishing a process to efficiently reuse legacy code assets and ensure their quality.

The Approach

With code quality top of mind, WHILL considered multiple static analysis tools, including commercial and open source software (OSS). The tool they selected had to meet the following five points:

• Provide guidance for quality and standards compliance such as IEC 62304.
• Offer scalable licensing and affordable pricing for WHILL’s needs.
• Opportunity to expand and continually improve code quality.
• Provide exceptional maintenance and support.
• Compatible with the IDE used in development with low learning cost

The Solution

Based on WHILL’s established five points, the team selected Parasoft’s C/C++test along with TechMatrix’s provision system in Japan.

“We initially conducted checks with strict filtering conditions, which resulted in thousands of rule deviation notices. Reviewing these notices with our own eyes, including the parts reused from past assets, we were able to visualize the overall code quality from the objective perspective of the tool, and deepen our understanding of our own code.”

—Yoshizo Mihara, Personal Mobility Development Section 4 at WHILL

The Results

At WHILL, development for the release of new products and services is ongoing. The team has been able to establish a system where C/C++test efficiently performs code checks to ensure compliance with various functional safety, security, and coding standards and deliver high-quality software. It’s a great advantage in terms of enhancing the competitiveness of their products and services.

“Being able to create an environment where we can quickly pick up code issues [with C/C++test] within a limited development period and focus on the areas that need concentration has been a very meaningful effort in improving software quality and, in turn, the quality of WHILL’s products and services.”

—Tsuyoshi Iriyama, Chief Officer of the Quality Headquarters and Head of the Regulatory and Certification Department

With goals of developing new products on the horizon, WHILL aims to continuously improve the quality of its products using Parasoft C/C++test.