“The biggest risk is not taking any risk…In a world that is changing really quickly, the only strategy that is guaranteed to fail is not taking risks.”
– Mark Zuckerberg, CEO & Founder of Facebook
Although this is true of many of today’s greatest product innovations and the people behind them, when it comes to aerospace and avionics systems and product development, winning is rarely about taking a huge risk and having it pay-off. In fact, most of the time winning is about building a safe, reliable, working product. (Extra credit is given for products that come in on time, under budget, and exceed your customers’ expectations for usability and durability). Of course, to Mr. Zuckerberg’s well-established point, innovation typically demands some level of risk. The secret lies in taking on only an acceptable amount of risk relative to your design assurance levels.
At Jama Software, we know for certain that the more efficient the requirements management process and the more you can define and approve (reach consensus) requirements upfront, the higher your likelihood of coming in ahead of schedule and under budget – and mitigating those risks. In his new “DO-254 Costs Versus Benefits” whitepaper, Vance Hilderman points out the more assumptions that are minimized, the greater the consistency of requirements and their testability is assured, and iterations and rework due to faulty and missing requirements is greatly reduced. One of the leading causes of project failure is poor requirements management. The benefit of DO-254 is the rigor it adds to your requirements management process, thereby increasing your odds of success.
DO-254 can also help save you time by reducing the number of bugs found during testing. Vance states: “Since DO-254 mandates thorough and testable requirements along with design / implementation reviews, far fewer bugs will occur and the test / fix cycle should be expedited.” Voila! Not only will you have a better functioning product, but you will save time and money as a result of the process.
In our ongoing work with heavily regulated industries like Medical Device / Life Sciences, Aerospace, and Automotive, we often hear companies immediately associating cost with regulation. And although that is true, the benefits far outweigh the cost. One is that the most significant cost escalation across DO-254 DALs occurs between Level C and Level B – the cost for Level B is the same as for Level A. It is important to realize that the most expensive design iteration will be when you initially begin designing towards a standard. As you become more familiar with the regulations and rules, it will become easier, and you will also begin to be able to reuse requirements that are reviewed and approved to fit the standard. In complex, regulated environments an investment in DO-254 is not only strategic, but can maximize time to value and save from costly rework and technical debt.
To read Vance’s whitepaper where he goes in-depth on these ideas and concepts, please download the paper here.
And to learn more about how Jama can help you adhere to and provide traceable proof of adherence to these standards, please start a free 30 day trial today!
The Seven Steps to Performing FMEA - February 22, 2024
Overview of FDA ISO 13485 and 21 CFR Part 820 Harmonization - February 20, 2024
Secure by Design: A Crucial Imperative for Medical Device Teams - February 15, 2024