October is Breast Cancer Awareness Month. In recognition of this awareness month, we are highlighting Innovative companies, like KUBTEC, that continue to challenge the status quo of breast cancer.
Post-pandemic, Medical Device Companies Need to Reimagine Approach to Accelerating Innovation
After spending more than 20 years of my career in R&D with leading medical device and life sciences companies, it’s no secret to me that speed matters when it comes to product development and go-to-market. Still, amid the pandemic, speed has taken on a whole new meaning.
In order to step up and meet growing demands from consumers, industry, and business leaders, medical device companies need to reimagine their approach to accelerating innovation. To do so, medical device companies should consider focusing on three critical best practices.
Learn from Both Your Successes and Failures
When I first joined my current medical device company, which provides innovative medical imaging technology to detect breast cancer, they had just experienced a pretty significant and unplanned disaster. A fire had ripped through their office building, destroying their space but, more significantly, the companies’ hard drive and paper trails specific to compliance, audits, and overall quality management. As a result, millions of documents and records went up in flames — never to be seen again.
Luckily, no one was injured in the fire. Still, we learned a hard but important lesson on the importance of ensuring all critical documents and work are saved in the cloud versus on-premise. The fire was no fault of our own, but we paid dearly for the loss of those documents — including roadblocks with audits and delays in our ability to bring life-saving medical devices to market.
The business implications were a tough pill to swallow, but our shared commitment to helping save patients’ lives with early breast cancer detection weighed heavily on us. As a result, we agreed as an organization to take our work — including product development and quality management — to the cloud moving forward so that we didn’t have to shoulder the burden of patients’ lives that could be lost as a result of a paperwork mishap or missing document.
Embrace Simple, User-Friendly Technology
On the heels of that fire, we experienced yet another disaster: the COVID-19 pandemic and resulting need for our product and quality teams to move from the new office space to working from their own homes.
Like other businesses, we encountered personal and professional challenges. Still, because of the prior commitment we had made regarding moving our teams and our work to the cloud, the transition was more seamless than expected.
As we transitioned to a nearly all-virtual work environment, our product and quality teams leaned even more heavily on our cloud-based product development and quality management platform. This platform allowed us to support anytime, anywhere access to insights, audits, compliance documents, sign-off capabilities, and more for our appropriate team members and our suppliers across the globe.
Amid the pandemic, our R&D reflected on the importance of the time and financial investment we made in our cloud-based product development and quality management system. We collectively agreed that if our approaches to product development and quality management had remained paper- versus cloud-based, the option to work from home and, in turn, reduce exposure to COVID-19 for our teams and suppliers would not have existed. In essence, we would have been forced to choose between potentially risking our own health and well-being — and that of our families — by going into the office as a team or to halt business as usual altogether.
We remain thankful that our decision to embrace cloud-based, intuitive product development and quality management technology came before the pandemic, even if it meant having to deal with the aftermath of the previously mentioned fire.
Build a Culture of Quality
To be clear, the transition from paper-based product development and quality management processes was not an overnight success. It took time, resources, collaboration, and a commitment to a greater vision for our teams, company, and the patients we serve. It also reinforced within our organization — and the companies and suppliers that we work with — the need to embrace a culture of quality that, in time, has helped us accelerate innovation at global scale.
When it came to building a culture of quality, our teams embraced three tenets: Document it correctly, review it with all stakeholders, and then implement it with speed and passion.
What was most critical, however, was that these best practices were adopted not only by our internal terms, but also by the partners we collaborate with day-in and day-out — from suppliers to auditors. We worked diligently to reinforce our organizational values around quality with all collaborators, and sometimes that meant having difficult conversations or even parting ways and identifying new partners.
Our collective focus on quality as a key differentiator for our culture and our product has paid dividends both in time saved and accelerated innovation capabilities. What was reinforced is that quality management in a silo or as a mere function doesn’t serve anyone well — most notably our patients. Quality is a source of pride for our company now and a rallying cry for us as we make business decisions — from hiring to product expansion plans.