Editor’s Note: This posts on lessons learned around medical device development during COVID 19 was originally published here by MedTech Intelligence and written by Josh Turpen, Jama Software’s Chief Product Officer.
In the fall, I wrote about how the medical technology industry has struggled to keep pace with other, similar industries. In the piece, I discuss how important it is for engineers designing those products to move gradually and carefully, even when under immense pressure, to reduce time-to-market. Now, a year on from the stay-at-home order issuance across the United States, it’s time to take stock on what temporary measures need to be made permanent to grow as an industry.
As we move forward into a post-pandemic world, it is important that companies are explicit with the lessons that they have learned from this past year. Executive staff, rightfully so, have been focused on keeping things going. Now the focus should shift to “how do we exit the pandemic in a better place than when we entered?” This is where it becomes important to create an open dialogue about what was successful and what could have been done better. This will assist in making those temporary adjustments a permanent fixture in medical device production.
Before we look towards a post-pandemic world, though, we need to evaluate where things went wrong and how to better address them moving forward.
What Have We Learned?
If COVID-19 taught us anything it is that we need to be more efficient at speed-to-market when creating products, especially when it comes to medical product production. Additionally, gone are the days of person-to-person-only collaboration. Organizations now have the capabilities for a hybrid environment consisting of remote and in-person teams.
The complexities of product development within health and life sciences should not be a surprise. What is more alarming is that, as the complexity of medical devices increases, we still have many engineering teams that are relying on decades-old technology such as Word documents and spreadsheets to manage requirements, risk assessment and testing. These legacy tools have a place in most of the professional world, however, they are not adequate for development teams who need to achieve alignment with massive amounts of data, regulations and standards to ensure device safety and quality.
As these device management teams face immense pressure to innovate while collaborating across software, hardware and quality teams, it is essential that their work is tracked and seamless to meet the increasing pace of market demand. That’s why we have seen traceability evolve to account for the complex, ever-changing nature of requirements, test and risk management. For a growing company to be successful, everything must be able to work simultaneously, at scale and across teams. Legacy tools do not provide the agile capabilities that modern traceability does.
It hasn’t been easy for engineering teams to adjust to their fully remote workplace. Even organizations that offered a hybrid working model previously are struggling to ensure their teams are aligned to meet delivery dates and project deadlines. The organizations that will have a distinct advantage over others are those focused on collaboration and context within their teams. These teams will be best set up to quickly build high-quality products, further ensuring better patient outcomes.
Where We Go from Here
As mentioned previously, the best course of action following this difficult year is to ensure company leaders are shifting their focus towards figuring out how to leave their companies in a better place following the pandemic, versus where they were when they entered. Based on my experiences as the chief product officer for a leading requirements, risk, and test management platform, I have noticed a few key ways that executives in the medtech industry can better prepare themselves moving forward.
In general, companies that have adaptability embedded in their DNA have already handled the peaks and valleys of the pandemic far better than those that remained rigid in their approach. Looking ahead, it will be immensely important to evaluate your process assumptions and determine how resilient you are to change.
Without a malleable business model, a company will constantly be scrambling any time it hits a road bump. However, with the right digital tools at your disposal, your company will be able to adapt quickly and effortlessly, allowing your employees and customers to remain calm in times of crisis.
While companies in all industries adapt their business models to prepare for the new normal, innovative tech companies are transforming the devices and systems they build, and the technology and process they use to build them. Newer technologies in the medical field, like robotics nanotechnology and wearable health tech devices, bring added complexities for medical device companies. There is an additional risk for patients and consumers, which makes having the right product development solution in place even more important.
Medical device companies that embrace a proactive approach to quality will ultimately find fewer issues with their products, improve customer satisfaction, and stay competitive for the foreseeable future. To do this quickly and efficiently, though, teams must be aligned throughout the entire product development lifecycle. By leveraging an integrated platform for requirements management, teams can stay interconnected and deliver high-quality products that improve patient outcomes.
Benjamin Franklin once said, “by failing to prepare, you are preparing to fail.” As we look ahead into 2021, I believe it is unlikely we will see large regulatory changes in the medtech industry. However, over the next decade, a great increase in regulations for medical device development is definitely looming. So what can a company do in the meantime? Tighten up your risk management practices, before it’s too late.
The fact is, the medtech industry will always grow at a rapid pace, and regulations will follow. To avoid being left behind by events such as, finding regulatory issues in late-stage device development, and then having to implement confronting costly and time-consuming rework, your teams must align and future-proof the entire development lifecycle.
Future-proofing is the process of using digital tools to capture knowledge and ease accessibility for future employees, independent of the product development lifecycle stage. Employing future-proofing strategies helps company leaders and decision-makers ensure symbiosis throughout the entire process. Future-proofing is key in the age of digital transformation, as it helps address common concerns about collaborative environments, team efficiencies, and product integrations. A software that is up to this task will help you do this in three ways:
- Comprehensively enables collaboration by giving users a single source of truth to track decisions, questions, and problems
- Increase team efficiency by capturing knowledge within that single source—often without even realizing it—through feedback and team communication.
- Seamlessly integrates digital tools that track development and with other information gathering and tracking solutions, knowledge is captured at multiple levels, streamlining future projects.
Finally, to be successful, there will need to be harmonization on the development methodology across different devices, reducing the need to work off of different documents. Each product in development has its own particular set of customers, stakeholders and internal team members associated with it. Therefore, it is important that these individuals can be accurately connected to the items for which they are responsible. Enter traceability.
Traceability is all about relationships. To make informed choices, product development professionals need tools that allow them to see changes in real-time, within the team’s structure, and throughout the system where their product exists. Modern traceability makes it possible to manage and respond to change with confidence in a systematic and auditable way. When done correctly, traceability can be used as a key tool to allow for harmonious decision-making. Without it, accountability is incomplete and past decisions can’t easily be seen, learned from or built upon.
Overall, COVID-19 has been industry-defining as companies were made to quickly shift how their teams collaborated, now forced to have a remote workforce. As we see the light at the end of the tunnel it’s time to look towards the future of medical device development. Let’s take all that we’ve learned from this past year and use it to ensure that we’re putting out high-quality products, quickly and accurately.
- Lessons Learned: Medical Device Development Through COVID-19 and Beyond - June 1, 2021
- The Top Trend for Medical Devices in 2021? Putting Quality First - February 2, 2021
- How to Solve 3 Significant Development Challenges - January 28, 2021