What Has Covid Taught us about Medical Device Development?
Like most sectors of the US economy, the Covid pandemic has laid bare every existing product development challenge that the Medical Device industry has had for years. In March of 2020, when Covid cases started spiking and emergency orders closed offices and manufacturing plants across the country and around the globe, most executives didn’t focus on the impact on their product development efforts first.
The crisis drove the companies into survival mode – implementing an unprecedented change in operations for nearly everyone. The shutdown of offices forced companies to become virtual development teams overnight – with all the expected and some unexpected ramifications of such a core change in how product development teams operate within many organizations. One of the key indicators of how successfully organizations could navigate this dramatic change was how well organized and documented their existing development processes were in March of 2020 – change management is exponentially more difficult without a clear understanding of the baseline process.
The reopening process itself has exacerbated a different set of issues related to recruitment and training of engineering talent. The intense shortage of experienced engineers has directly impacted everything from development schedules to availability of field support and maintenance, and the cost of technical labor.
Very little has been left unaffected by the occurrences of the past twenty-four months. We have analyzed the key points of failure and distilled out the critical learnings as it relates to product development.
Long-term gaps in core development processes became clear in nearly every engineering organization. It took a few months for stabilization of sorts to occur. Zoom calls became almost normal relatively quickly, with less time spent fumbling for the ‘Mute’ button and more time discussing meeting topics; fairly quickly management focus returned to the day-to-day issues of operating the company. One of the key issues to address was how to run complex product development programs in a time of social distancing. With limited – or no – face to face meetings, plus with suppliers unable to travel it was near impossible to work through design details and implementation trade-offs in an ad-hoc manner. Successful distributed development, even across separate organizations is certainly possible, but processes and tools need to be evolved to support the challenges of fewer face-to-face conversations. Three areas in particular have caused significant program delays and increased costs;
- Poorly written system and software requirements
- Ineffective risk management understanding and processes
- Insufficient test and integration planning.
The need for strong system and software requirements and detailed risk analysis– always important in the early stages of development in the Med Device industry, took on an increased criticality. Unfortunately, for many engineering organizations, the on-going weaknesses in the formal requirements capture and analysis processes were exacerbated when daily interactions in the coffee room ceased to occur. Without the continuous ‘out of band’ communications between the team, poorly formed requirements have regularly and visibly had negative impacts on implementation efforts, causing a jump in rework and delays in overall schedules.
Risk management, always a challenge, became much more difficult without the benefit of in-person meetings for detailed review of documents, designs, actual progress and schedules. The challenges became especially constraining when tackling issues such as assessing risks associated with usability, as it put an extra burden on a team’s communication skills when having to postulate together about the role of the user in reacting to and mitigating hazardous events. Companies, in the best of times, struggle to have a solid risk management mindset, meaning that it is hard to envision what scenarios are possible for products in the field that could lead to hazardous events. Consequently, appropriate mitigations do not get put in place. All of these factors ultimately reduced the overall throughput of risk management teams, while highlighting persistent challenges with the discipline.
Lastly, insufficient focus on developing a formal testing and integration strategy became a particularly difficult issue in this time of disrupted communication pathways. Testing in complex systems has long called out the need for comprehensive integration and testing plans. The inherent difficulty of testing a complex system after integration, which then depends solely upon ‘black box’ testing, leaves large holes in test coverage. The need for more sophisticated emulators to allow now socially distanced software engineers to more fully test functionality and fault recovery became an absolutely essential element of a successful program for the successful program. Organizations that have the proper processes and skills have been able to keep programs moving even with their distributed teams, others ran into one road block after another.
During the height of the pandemic and now, as the crisis seems to be dissipating in the US and other areas, shortages of key labor categories increasingly bite development organizations. Almost immediately, with the cessation of international travel, the global supply chain related to engineering services froze. “Throwing bodies” at a development program to improve velocity is often tried, but usually not the best solution. With the labor shortages, it has ceased to be an option, which is forcing many in engineering leadership to rethink approaches to improve predictability, and where possible, velocity as well.
As reopening has progressed, the inability to meet recruitment targets and get workers back into the office continues to wreak havoc on both development and product support efforts. The answer for many companies has been to turn to engineering service companies to help fill the gap. A key to this succeeding is to have a formalized strategy for how to utilize outsourced engineering– even if expected to only be a transient challenge – simple addition of individual contractors has a very uneven level of success. In many cases, adding more staff to the existing organization exacerbated challenges caused by the lack of mature processes, adding cost without the hoped for positive impact.
Companies will need to formalize many aspects of how they do development in order to thrive in a new working environment that show many signs of long-term, not temporary, change. If this isn’t a core competency, then it is an area where moderate amounts of outside expertise can have an outsized impact on overall development velocity and efficiency, including how to more effectively onboard new talent and outsourced support. Some questions worth consideration include:
- Do we want to utilize service suppliers to meet peak needs or transient shortages in a staff augmentation manner?
- Do we want to integrate long term, high quality suppliers into specific parts of the development process, such as testing, software development, transition to manufacturing, etc, thereby freeing up in-house engineers to focus on higher-value core elements of product development such as requirements generation and analysis, program and risk management, integration management, etc.
- Do we want to identify key partnerships related to areas of technology that are evolving faster than our Med Tech company can keep up with, such as cybersecurity, artificial intelligence, robotics, and virtual/augmented reality?
- Do we want to work with engineering service companies that can manage more stand-alone development programs for secondary or follow-on products keeping our own engineers focused on cutting-edge, market-defining product development?
Each of these approaches may be appropriate in different situations in companies with different strategies. We have found that many of our clients who are succeeding in this new environment have prioritized building an outsourcing strategy that is better suited for the 2020’s, where shortages in labor, reduced travel, enduring remote working and unpredictability are part of the new normal. Full Spectrum is well positioned to help companies evolve their mindsets and approaches to product development, from both a strategic and more tactical perspective. We’d benefit from getting your perspective and are happy to share what we have learned. Reach out today to set up some time to discuss this in more detail.