Design Control has been in the news lately, have you seen it? The devastating crashes of the Boeing 737 MAX planes in Indonesia and Ethiopia have led to investigations and tough lessons learned for the airline industry, but the takeaways from the alleged cause of the crashes can be useful to medical device manufacturers as well.
“Verifying and validating changes to the design is not limited to the change itself, but should include the impact the change may have on other aspects of the device.”
Back in 2010, Airbus announced it was making a new fuel-efficient and cost-effective plane. Boeing, the leading airplane manufacturer in the world, did not want to get left behind or lose out on market share so they rushed to get out their own version. Instead of designing a brand-new plane from scratch, the company made the decision to make changes to their very popular 737 airplanes. This became the Boeing 737 MAX.
Unintended consequences
What happened next is a lesson in unintended consequences. First, Boeing changed the engine design to create a larger, more fuel-efficient engine. When Boeing set out to develop the 737 MAX, engineers had to find a way to fit the new larger engine under the wing of the jet’s low-riding landing gear. This led to more design changes: a) move the engine slightly forward, b) and higher up under the wing, and c) extend the nose landing gear by eight inches. These changes gained the 737 MAX improvement in fuel consumption. However, during certification of the new plane, it was observed that the design tweaks to the engine location and shape changed how the jet handled and caused the plane to pitch upward in certain situations putting it at risk of stalling when flown manually. So, Boeing engineers implemented a fifth design change – they designed and implemented the ‘Maneuvering Characteristics Augmentation System’ (MCAS) software. The MCAS software was meant to offset the possibility of stalling brought about by the previous design changes. In the emerging picture of the two accidents, the software failed and pilots did not have sufficient training on how the MCAS worked or knowledge of all the design changes that required its implementation. The drive to make one change to compete on better fuel-efficiency led to a cascade of changes that ultimately delivered a potentially defective product, damaging Boeing’s reputation with the airline industry, international governments, and the public.
Design changes: Verification and validation
The FDA Quality System Regulations require device manufacturers establish and maintain procedures for identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation. Verifying and validating changes to the design is not limited to the change itself, but should include the impact the change may have on other aspects of the device. Change happens. Design changes occur as a natural part of product development, for product enhancement, to stop a trend seen in postmarket surveillance, and to stay competitive. You can be proactive by implementing a design control program that can foresee and limit the effects of a design change so it does not lead to a cascade of changes and potential disaster. Pearl Pathways has experienced Quality and Regulatory Advisors that can help you develop a proactive and risk-based a design control program to suit your product portfolio and business. Contact us today!