This article first appeared in Medical Product Outsourcing.
by Carl Ning, Senior Director, Quality Strategy, Veeva Systems
When it comes to the medtech supply chain, it isn’t a matter of if but when the next major disruption will occur. As the industry heads into the new year, it will be essential to establish a modern quality management foundation using a digital, cloud-based system that is agile and scalable. This could have prevented some of the challenges brought on by COVID-19 and solved some of the industry’s long-standing supply chain issues. However, attempts to bring on a quality management system (QMS) can spark paralyzing conversations about how best to approach digital transformation and achieve a return on investment.
The path to implementing a modern QMS does not need to be complex. Start by making a solid business case for the technology. Traditionally, compliance is the star of the show but experts say it is time to think broader to influence decision-makers.
“Compliance isn’t necessarily a cost savings issue until it’s in front of the organization, when you’re dealing with new regulations or potential fines. Otherwise, it’s not a driver,” said Steve C de Baca, executive vice president of quality and regulatory enterprise at Cardinal Health.
He added that the CFO and CEO must see technology as a competitive advantage, a way to improve efficiency and productivity. It also helps to show the technology will help the company respond to customers faster and more easily, as well as demonstrate cost containment and efficiency to investors and shareholders.
Here are insights to position technology as a competitive advantage, accelerate implementations, and improve quality processes over the long term.
Making a solid business case is difficult given business volatility, economic factors, and regulatory demands for evidence of a coherent QMS and riskbased thinking. When choosing QMS technology, Steve C de Baca suggested that medtech companies focus on the strategic, long-term picture. For example, companies whose growth strategy includes acquisitions will frequently onboard systems and people. This may introduce intermittent quality issues.
Agile and flexible systems capable of merging and transferring data from one system to another may not be needed immediately but will be used in the future. While evaluating technology, consider robust solutions that enable rapid onboarding. “Sell tomorrow’s need, not today’s process,” he advised.
To ensure you address future business needs, assess your current state fully. A common issue is bringing on new tools while still continuing to use outdated processes or digitizing ineffective workflows. Your QMS roadmap should be specific to your company’s unique quality management pipeline and consider the range of users across development, manufacturing, and beyond.
An excellent way to plan is to assemble a team of experts executing processes in and out of the system daily, discussing what could be done differently if all resource limitations are removed. Here are some questions that can help get to an answer quickly:
The optimal roadmap rethinks the QMS model with an enterprise-wide lens. This is critical because many system users are not involved in quality control. For example, many execute workflows such as commercial launch plans, document management, and supplier audits across different areas and teams.
When faced with a challenging workflow, the result often manifests as a less than stellar experience, even with new technology. According to Kareem Elwakil, partner at PwC, the key to change is focusing on establishing behaviors based on new thinking. “The transformation is about moving toward value, getting your process from your current state of quality management to something else that’s significantly better and more impactful,” he said.
The industry is adapting to unpredictable supply chains and evolving regulations that require new ways of working. To keep up, forward-thinking partners can help. Elwakil advises medtech companies to look beyond a potential partner’s initial burst of energy and past the implementation of core functionality to consider their track record with innovation. “See what they’re doing with artificial intelligence (AI) and machine learning (ML) and how they’re growing their platform to provide future supplier QMS capabilities,” he added.
The financial ROI often dominates the conversation of implementing new technology but consider the long-term improvements and the impact they can have on the business. The right technology provider will support the organization’s goals and remain laser focused on delivering efficiencies and innovation.
A modern QMS will streamline quality operations, making the company more competitive while safely bringing products to market. Compliance is critical and a new system will help, but drawing out differentiators and advancements in operations will make a stronger business case to move transformation conversations forward.
Carl Ning is responsible for Veeva Vault Quality solutions strategy. With more than 20 years of experience delivering transformative solutions in the life sciences, consumer products, discrete manufacturing, and financial services industries, Ning has extensive experience in quality management, including system design and implementation. He can be reached at carl.ning@veeva.com.