The complexities of product development within health and life sciences should come as a surprise to no one. What is shocking is that even as medical devices have become increasingly complex connected systems, many engineering teams still rely on decades-old technology to manage requirements, risk assessment and testing.
Documents and spreadsheets have a place in the professional world, but are not adequate for development teams who need to achieve alignment with regulations and standards to ensure device safety and quality. And as teams face pressure to innovate, collaboration amongst software, hardware and quality teams must be tracked and seamless to meet the increasing pace of market demand.
In the current environment, many engineering teams are attempting to find their footing in a fully remote workplace. This is no easy feat. Even organizations that previously offered a hybrid working model are struggling to ensure their teams are aligned to meet delivery dates and project deadlines. With no sign of the COVID-19 pandemic letting up, organizations must ensure their development teams have technology that enables effective collaboration to avoid disruption and setbacks.
There are innovative companies in this space that are not only transforming the devices and systems they build, but also the technology and process they use to build them. Leveraging an integrated platform for requirements management, their teams can stay aligned and deliver high-quality products that improve patient outcomes.
Let’s dig into three reasons why your business needs a requirements management solution.
1. Preventing Product Failures
Let’s be frank, product failures happen. They are frustrating and costly and can largely be avoided. One recent report reveals that nearly 80% of design teams have experienced product failure due to substandard requirements management. These failures include, more often than not, exceeding cost requirements and losing time-to-market.
That very same survey notes organizations using a dedicated requirements management (RM) platform received fewer instances of warnings, recalls, fines and production stoppages than their counterparts. The benefits don’t stop there, either. Nearly half of those polled reported not experiencing those problems at all.
2. Products With Unmet Requirements Ship Anyway
In an equally frustrating vein to product failures, recalls due to unmet requirements happen more often than they should—and at a hefty cost. So costly, in fact, in the medical device industry alone a single product recall can reach upwards of $600 million. There are several reasons why requirements go unmet and products ship regardless, including:
- Increased product complexity, including the use of microprocessors
- The need to adopt different materials
- Increased demand in embedded software
In addition to suffering the price—literally—for shipping a product before all requirements are met, organizations are faced with potential reprimands from outside regulatory agencies. This can lead to permanent damage to a brand’s reputation and position in the market, only further adding insult to injury.
3. With Advanced Discoveries Comes More Complexities
The medical device industry, like many industries today, has advanced at a pace never seen before. However, you cannot speak about innovation without mentioning in tandem the complexities that have increasingly presented themselves.
Going back to the aforementioned survey, several respondents acknowledged that as they increased the complexity of their products they spent an excessive amount of time tracking the requirements. The biggest culprit for this issue? A poor requirements management solution or lack thereof.
Products are getting smarter and the pace of development and innovation is not slowing down. Yet, as apparent as it seems for design teams to adopt the intuitive and powerful tools available to help manage requirements, there are still too many that rely on disconnected, document-based requirements management systems. In an industry that values quality, safety and speed-to-market, it’s no secret a requirements management platform proves its value.