Supply chain disruptions are affecting people in all walks of life. Consumers feel the impact through longer wait times, higher prices, and out-of-stock notices. Manufacturers caught off guard by social and political upheavals are working to stay resilient by expanding their pool of potential suppliers.
As they cast a wider net for supplies, medtech manufacturers must pay special attention to supplier quality. How can they enforce high standards without adding to their customers’ frustration? Two leaders from Boston Scientific—Scott Nilsen, senior manager for supplier quality systems and James Markfort, global IT manager—shared their perspectives on their company’s digital transformation in a recent Veeva MedTech Supplier Quality Management panel discussion.
In one sense, disruptions such as COVID-19 and the Ukraine war haven’t changed anything for medtech manufacturers. They’ve always dealt with sourcing and quality challenges as they strive to find specialized quality components. But today, these issues aren’t just coming up weekly or monthly—they’re a daily challenge. They’re exposing the medtech manufacturers that don’t have reliable selection processes in place.
Asked how Boston Scientific is maximizing product flow and minimizing disruptions, Scott Nilsen said his company is focusing on building stronger relationships with its supply base to increase agility. Additionally, by leveraging a new supplier quality management (SQM) system, they’re able to streamline and support this objective.
James Markfort explains that many organizations ignore the “people” side of a digital transformation and focus only on process and technology. He advised companies to come up with a change management strategy that recognizes how people, process, and technology all play different but integral parts in a digital transformation. It’s not just about selecting and implementing the next tool for your organization. To transform successfully, organizations must take advantage of the opportunity to focus on process design and optimization – not do a “lift and shift” of their existing process into the next solution. Besides technology partner selection and process optimization, organizational readiness (i.e., people) completes the trifecta that contributes to success. Failing to understand the importance of organizational change management will reduce user embrace, protract adoption timeline, and diminish the probability of success of transformation efforts.
None of this is to suggest that technology no longer matters. In fact, profound changes in technology are making it easier for medtech manufacturers to innovate.
As Markfort noted, the many low-code and no-code solutions on the market enable companies to point and click to spin up SQM tools quickly, rather than writing code for weeks or months. This is good news to supplier quality engineers who, lacking technology to streamline their most burdensome tasks, have been saddled with hours of data transcription duties each day. Today’s best SQM systems enable data transfer that eliminates the need for endless scanning of artifacts, copy and pasting, and transcribing data.
Boston Scientific believes it’s not just the technology that has changed—it’s the whole nature of the IT-business relationship. Ten years ago, medtech IT departments tended to follow waterfall processes. Business teams would ask IT for a solution and then get back a tool based on IT’s interpretation of those requirements. As Markfort recalled, “The business would throw their requirements over the wall to the IT team asking them to build a red car only for the IT team to come back 6 months later and the car was purple, not red.”
Today, IT teams and business stakeholders — and solution providers such as Veeva MedTech — collaborate in real time through all stages of planning, development, and implementation. By working in the same environment online, teams contribute freely to design and development. Misunderstandings have become rare. “We’re delivering much more than an application,” Markfort explains. “We’re delivering a product and we’re delivering a relationship.”
As IT and business stakeholders achieve new levels of trust and transparency they can achieve that quick win for the initial deployment, and then further evolve and refine the solution with both the internal team as well as the solution partner. While business users may claim to need a long list of features from day one, IT can help them determine what constitutes a viable product for the initial release and then add features over time based on priorities. In conjunction with the true SaaS technology partner focused on purpose-built medtech solutions, the industry-specific innovation release cadence can only add further value to the solution and make it an appreciating asset. Because of the agile approach Boston Scientific’s IT organization now takes in developing supplier quality solutions, functionality releases happen every two to four weeks. Markfort likes to remind his leaders that it’s like having Christmas 12 to 26 times per year, instead of just once.
None of this is to suggest that technology no longer matters. In fact, profound changes in technology are making it easier for medtech manufacturers to innovate.
When Boston Scientific engaged Veeva MedTech to design and build an SQM solution, the company was prepared for a 12-to-18-month implementation timeframe given what they heard in the industry. However, the process with Veeva MedTech took just six months. During Boston Scientific’s first four-week sprint, the company collaborated with Veeva MedTech to build 70 percent of the workflow that would eventually form the core of its solution. “We’re not talking about a lot of collaboration,” says Markfort. “We’re talking an hour or two per day, a few days per week, to make sure we had alignment and understanding of what was going on.”Underpinning the project was an attitude, shared across Boston Scientific and Veeva MedTech, that there’s no such thing as a failure in agile delivery. If a new development didn’t work, the teams immediately pivoted to another approach. It’s a mindset that will help all the project’s stakeholders to keep producing impressive results in an era of constant change.
Next: Hear how a quality transformation with Vault QMS unified people, processes, and technology at Heron Therapeutics.