In 2017, the U.S. Food & Drug Administration (FDA) issued 500 recalls of medical devices and/or parts of medical devices. Fifty-two of these recalls were identified as Class I: a class reserved for a situation where there is a reasonable chance a product will cause serious health problems or death [i]. So far in 2018, the FDA has already identified 64 Class I recalls, including resuscitation masks for infants, implantable cardioverter defibrillators (ICDs), and inhalation anesthesia machines. Capturing, defining, and delivering solutions that address requirements is key to prevent product delivery and quality issues.
Requirements management is the continuous and iterative process enabling stakeholders to collect, document, analyze, prioritize, and agree upon the requirements while managing changes as product development evolves. In some industries—such as consumer electronics and medical device—the development and production of a single product involves a multitude of parts, interdisciplinary team collaboration, and adherence to government regulated standards. With medical devices, there is less room for error since the consequences may include bodily harm or even death should a product fail.
Whether you deliver complex medical devices or other products, it’s critical to avoid product issues or failures to prevent risks to your customers and ensure their continued satisfaction with your product. Consider these six requirements management lessons from recent medical device recalls.
1. Do your research. While the English axiom is “Measure twice, cut once,” the Russian proverb advises: “Measure seven times, cut once.” Requirements management often necessitates extensive research up-front, particularly for new products and processes. Consider the ongoing case of the Olympus Corporation medical scope that was linked to an infectious outbreak resulting in at least 35 deaths[ii]. A Seattle judge recently cited Olympus Corporation for failing to disclose internal emails that revealed a prototype of the scope was criticized for not being easy to clean [iii]. Think of time spent doing research and feasibility studies as a wise investment—one with the possibility of a seven-fold return.
2. Directly engage indirect stakeholders. Identifying and engaging with supply chain partners, such as parts suppliers and contract manufacturers, can help eliminate sourcing issues, design errors, and manufacturing problems. In many of these cases, device failure is caused by only one part. Take, for example, last year’s FDA recall of the Philips Respironic V60 ventilators: pins loosened during vibrations prevented data transfer, resulting in unexpected shutdowns[iv]. While it may not be feasible to directly engage all indirect stakeholders at every single step in product development, providing partners with a way to see the big picture and emphasizing the importance of their roles is essential.
3. Assign responsibility. Depending upon your industry and organization, the requirements management process may be spread out across diverse teams, including engineering, product, and marketing. Ideally, one person—such as a business analyst or product manager—oversees the entire process, but that kind of oversight can be difficult in today’s world. As an alternative, consider having each team assign ownership to one representative so that he or she can act as a liaison as requirements are reviewed, modified, prioritized, and negotiated.
4. Ensure traceability. Traceability improves when you connect product requirements directly to your product record (parts, assemblies, or lines of code). As the design evolves from early concept through feasibility studies and testing, teams need to be able to trace requirements to design decisions and business objectives. Whether your organization favors waterfall or agile methodologies, traceability means you can follow the life of your product both backwards and forwards to see how high-level requirements impact low-level requirements and vice versa. Traceability is especially important when you’re creating products that potentially pose risks. Increasingly, in the medical device industry, software has been a leading cause of product failures and recalls, particularly for devices that are connected to the Internet of Things (IoT) and, therefore, more vulnerable to hacking [v].
5. Establish a baseline. Your product development cycle may be three months or more, but you need to establish a baseline and traceability to keep all teams and partners aligned. Though milestones can shift due to roadblocks beyond your control, creating a cross-functional requirements review process with internal teams and external partners establishes a baseline of accountability and increased transparency. Connecting requirements to the product design record also provides better traceability should stakeholders change their minds and introduce different requirements that may postpone or derail a product launch.
6. Agree on a communication strategy. George Bernard Shaw wrote, “The single biggest problem in communication is the illusion that it has taken place.” As Shaw wisely observed, the illusion of communication can be a prodigious pitfall. Whatever communication and collaboration tools you decide to use, explicitly agreeing upon how and when you will use them, maintaining regular meetings (even if they’re virtual and/or check-ins), and including stakeholders in the discussion will help to make certain communication takes place.
On average, recalls cost the medical device industry $2 to $5 billion each year [vi]. Beyond these substantial fiscal costs for the industry, federal insurance programs, such as Medicare, and private insurers shoulder a large part of the financial burden for recalls while patients pay up-front or out-of-pocket costs, including travel time to and from specialists. More importantly, some medical device failures and subsequent recalls may reduce the quality of life or even result in death.
Clearly, ensuring quality and compliance is essential not only to your product’s success, but also to your reputation and the well-being of your customers. There are many reasons for product recalls, but avoiding recalls starts with effective requirements management. This requires connecting requirements to product design to ensure traceability throughout the product lifecycle. So, consider addressing requirements early in the product development process to help deliver products that not only change the world but may also save lives.
Class II describes a product that may cause a temporary or reversible health problem or a situation where there is a slight chance a product will cause serious health problems or death; Class III applies to a product that is not likely to cause any health problem or injury .