[Photo credit: EKG Technician Salary]
Medical device organizations are required to register medical devices with notified bodies in all countries where they sell those products. This process is fairly well understood and expected.
However, there are pitfalls in the practice of compiling the dossiers to register, and mistakes can end up costing a company money, according to Carl Ning, director of global solutions architecture for Sparta Systems (Hamilton, N.J.).
Ning highlighted the common errors medtech companies make in thinking about product registration and offered some solutions:
1. Your regulatory department is understaffed.
The global registration process is a time-consuming process. For the most part, medical device organizations only keep a few regulatory professionals on staff. That means that only a few people are dealing with hundreds, if not thousands, of SKU’s that are marketed globally. They are working lean and they can’t get ahead of the transactional volume.
2. You think of your regulatory department as being pigeonholed as a cost center, not a revenue generator.
Regulatory folks are responsible for a wide range of tasks,spanning from pre-market approval activities to post market surveillance. But thinking that your team is only perceived as a cost center is an underestimation of the value of your regulatory staff. The perception couldn’t be further from the truth. Consider that if a product isn’t properly registered in a country, the cost to the company can be enormous. Consequences could range from potential civil penalties levied against the organization to top-line revenue impact if the sales team cannot gain timely and lawful access to the product for sales execution.
3. Your regulatory personnel is using home-grown spreadsheets or even paper tracking.
The “cost center” misconception can lead to a lack of investment in the department. As such, many regulatory staffers use homegrown spreadsheets to manage global registration. Tracking something as complex as global product registration with a spreadsheet is the regulatory equivalent of bringing a proverbial knife to a gunfight. These complex spreadsheets are often updated by multiple people, so the real-time accuracy becomes questionable while the staff continuously plays catch-up. Further, such “systems” do not integrate with enterprise resource planning solutions. Companies have often invested heavily in an ERP, but fail to make the connection for product registration. This non-integrated landscape perpetuates the operational redundancy organizations face today, but it doesn’t have to be.
4. You are in reactive mode all the time.
Without a comprehensive (and integrated) registry system, the regulatory staff is reacting to information rather than getting ahead of it. That means that keeping up with changes takes longer than it should. And producing even simple reports for a leadership team – reports that could be generated in a few hours – can take two to three days to finish.
5. Besides the cost center perception, your regulatory department may be viewed as a new product introduction/sales launch blocker rather than an enabler.
With outdated technology in hand and a lean team to boot, regulatory teams trudge on fighting the good fight. While they may be able to contain a blaze, the time it took to fix the problem was likely borrowed from impending sales launch efforts. Any delay in new product/sales launch puts the responsible party under intense scrutiny, and no regulatory team intentionally protracts the launch timeline.
How to fix these mistakes
Of course, there are ideal situations. Regulatory leaders would love to have more staff, but adding technology may suit more organizations. An end-to-end management system offers both scalability and cost containment.
To make internal changes, regulatory leadership can help to educate the C-level teams on investing in technologies that can integrate product registration process into the other critical pillars within the organization’s technology stack – such as ERP systems for product holds, or QMS by linking product registration process to quality processes; e.g., a systemic issue requiring a CAPA that leads into change management, which in turn initiates the necessary product (re-)registration process automatically.
One of the key tenets is data integrity. If your regulatory staff is using outdated solutions, a “single source of truth” may be difficult to reach. That means getting answers to simple questions takes too long. A good tracking system will introduce data integrity, ensuring all users are consuming consistent and up-to-date data across the organization.
The right technology also provides a way to manage registration schedules and (recurring) commitments, so that regulatory teams get ample lead time, and can work quickly to ensure deadlines are met. An organization can benefit tremendously by having a collaborative platform to enable sales, marketing, product management and regulatory to work in unison to define, build, launch and sell the product. Finally, do ensure that the solution provides the proper alignment to your organization’s IT strategy (cloud versus on-premises).
