The pandemic years have brought both obstacles and opportunities to medical device companies. While venture capital investments in medtech reached all-time highs in 2021, device companies also struggled to cope with massive supply chain disruptions, a rocky talent market and a customer base preoccupied with treating large numbers of extremely ill patients.
As the world enters the maintenance phase of the pandemic, all of that economic inertia is catching up with us. Recession seems imminent as global manufacturers continue to fall short of demand and inflation accelerates at record rates.
Even though medical device companies produce essential products and are therefore relatively shielded from the worst the economy can throw at them, executive leaders are still looking for ways to trim excess spending, secure their supply chains and continue to win regulatory approvals in a timely manner.
To achieve these goals, companies need to have the data-driven strategies and technologies in place to clearly and thoroughly demonstrate their value to potential investors, new clients and eagle-eyed regulators in a highly competitive market.
With no room for error, medical device companies must make shrewd decisions about how to navigate this uncertain economic environment while maintaining the pace of innovation and continuing to bring vital technologies to the patient care environment.
Know the pathway forward
The complex world of medical devices is governed by a maze of regulatory requirements. To ensure patient safety, companies must demonstrate compliance with these rules every step of the way.
Many companies begin their design process with a great idea but less-than-complete knowledge of how to bring that idea to life. As a result, companies end up deploying noncompliant processes that must be completely revamped as soon as the FDA looms into view.
This can waste both time and money, leading to missed milestones, unplanned workarounds and increasingly concerned investors.
Instead of diving in first and sorting it out later, medical device companies should take a measured, structured and data-driven approach to designing, manufacturing and documenting the quality of their products.
For example, the FDA’s Design Controls framework is a clear and well-vetted development methodology to support regulatory compliance and structured processes, giving medical device companies the guidance they need to get it right the first time around.
Improve efficiency and reduce costs by outsourcing
Outsourcing can be a high-value strategy for companies that want to operate leanly or don’t have the in-house resources to own the design and manufacturing process from start to finish.
Manufacturing physical devices comes with its own array of logistical and documentation challenges, including detailed quality assurance processes. Relying on an established, trustworthy partner for these competencies can reduce the burdens on a medical device company without sacrificing quality or outcomes.
Be sure, however, that partners offer complete insight into their manufacturing processes from start to finish and that their documentation meets all applicable standards for regulators, investors and customers.
Each member of the team must be able to confidently and honestly answer all due diligence questions thrown at them by any of these groups. This may be especially important as organizations pivot quickly due to issues with the supply chain and availability of raw materials.
Device companies can also consider outsourcing some of their needs for administrative and executive talent, especially startups that have not yet completed the full go-to-market cycle on their own. Forming strong relationships with experienced partners to guide process development, regulatory submissions and quality assurance documentation can help new entrants avoid waste and bring their products to customers faster.
Don't make assumptions about regulatory approvals
The regulation landscape may seem convoluted, but the FDA is actually very clear about what it is looking for (see framework mentioned above). Companies that try to take shortcuts or gloss over key components of their submissions will invariably be called out and will be subject to even deeper scrutiny the next time around.
The best way to avoid an even closer examination from the FDA is to get it right the first time. Don’t assume that regulators will overlook any part of the application. Instead, create complete and comprehensive documentation from Day One and continue to carefully monitor quality and compliance throughout the entire production cycle.
With the economic tide turning against us, medical device companies must work smarter, not harder, to remain competitive and attract new customers. Implementing structured processes, partnering creatively and being proactive about interacting with regulators can save time, impress investors and clients and prevent costly do-overs.
By focusing on instilling smart processes across your organization, outsourcing where it makes sense to trusted partners and enforcing impeccable quality that closely adheres to regulatory guidance upfront, medical device companies can operate leanly, build resilience and successfully navigate the ups and downs of the modern healthcare environment.
Kelly Stanton is director of quality at Qualio.