Medical Device Daily Contributing Writer

Product recalls are an unfortunate yet very real aspect of doing business in the medical device industry. In the years ahead, it is likely that manufacturers will come under pressure to exercise increasing levels of vigilance in recalling devices and products. More recently, there have been calls from prominent members of the healthcare community requesting that the FDA play a more active roll in policing medical device manufacturers, and that they broaden the scope of actions manufacturers must take when a recall occurs.

One of the more notable calls came in a New England Journal of Medicine article authored by William Maisel, an authority on medical device safety at Beth Israel Deaconess Medical Center. Maisel wrote in the article titled, Semper Fidelis – Consumer Protection for Patients with Implanted Medical Devices, The welfare of medical device recipients must become a higher priority for the FDA and manufacturers, and it is increasingly apparent that such a change will require Congressional action.

Under these circumstances, how can medical device manufacturers best prepare themselves to ensure compliance with stricter regulations and to manage risk appropriately? Smart decision makers seek technology investments to help establish good governance models that will in turn help maintain regulatory compliance and lower operational risk.

MDM can advance compliance efforts

Master data management (MDM) is exactly this kind of investment and it offers the potential to substantially advance device manufacturers compliance efforts. MDM ensures that critical enterprise data is validated as correct, consistent and complete when it is circulated for consumption by internal or external business processes, applications or users. But not all MDM technologies can address the various compliance requirements facing today s businesses. Only an integrated, model-driven, and flexible MDM platform that is easily configurable can provide the functionality needed to meet compliance requirements and lower risk.

Medical device manufacturing is one of the most highly regulated industries, with strict federal and state government oversight in R&D, manufacturing, sales, marketing, and device recall activities. Complying with opt-out and recall regulations are two of the most difficult challenges faced by medical device manufacturing companies.

The Opt-out compliance challenge

Device manufacturers frequently use direct marketing techniques to reach out to the users of their products, using the medium to communicate important product announcements, to cross-sell or up-sell other products, to announce special offers, and so on. However, as with the retail industry, device manufacturers need to be mindful of the regulations governing direct marketing practices. The Federal Trade Commission (FTC) mandates the collection and maintenance of consumer preferences for mailing marketing literature. Failure to respect a consumer s request to not receive marketing literature can result in an $11,000 per incident fine for the company. To ensure that the manufacturer respects its customers privacy, it is important to provide different channels for the customer to opt-out of receiving communication, including: mail, phone, fax, email, and website.

Quite often, companies in the medical device industry use different systems for each of the various communication channels. Customer service representatives use CRM applications to capture the preferences, while opt-out preferences for mail or fax might get entered into a different database. Also, manufacturers might use a separate web content management system for online interactions. As a result, multiple copies of the same customer s record are duplicated across different systems.

When the customer communicates by phone that they do not want to be contacted, this information may be updated in the CRM application, but perhaps not in the other two systems. Without a holistic view of the opt-out preference, a marketing campaign targeting device users who have contacted the company through its website would totally ignore the opt-out preference phoned in by the customer and updated in the CRM system.

As a result, the company would continue mailing its marketing literature to the customer who had already communicated his or her choice to totally opt-out of any such communication. Such incidents can result in the company being fined by the FTC; continuation of such practices will often result in customer dissatisfaction leading to attrition and brand dilution.

Recall compliance challenge

Certain devices manufactured by medical device companies – blood glucose monitors, for instance – are subject to some of the strictest FDA regulations. One such regulation governs the recall of these devices when a malfunction is detected. The FDA mandates that in a medical device recall, the manufacturer should reach at least 80% of the device users. If 80% cannot be reached, the manufacturer must contact the users by telephone. Usually, medical device companies use low-cost media such as emails and snail-mail to reach users, as direct phone calls are labor intensive and expensive.

Despite the importance of accurate and reliable data, it is not uncommon among medical device companies to capture customer information in different systems. In the event of a critical incident such as recall, the resulting lack of correct contact information can be problematic. When these companies try to reach their consumers via snail-mail, they might get 20% to 30% returns due to incorrect addresses, prompting an expensive calling campaign.

MDM to the rescue

MDM can provide medical device manufacturers with consistent, complete and accurate consumer, contact, opt-in/ opt-out and communication preference information even when it is captured and stored in different systems. Companies can use this information to reach customers rapidly and avoid costly and ineffective device recall campaigns. With MDM, if opt-out information is entered into the CRM system, that opt-out information will quickly be reflected in the web content management system and other customer-facing systems. This means that any campaign using data from the central MDM system would always use the correct preference setting, regardless of the system of origin.

However, not all MDM systems provide the necessary functionality to meet the compliance requirements. If the MDM system is rigid in its functionality, (i.e. if it has a fixed data model), then you may end up compromising your compliance initiatives in order to adapt to the limitations of the technology.

Further, such systems make it difficult to extend the compliance efforts to other lines of business or geographies. Taking this approach undoubtedly will require costly and extensive custom coding. In order to prevent these costly pitfalls and to reduce the risk of choosing the wrong solution, it is important that you include key business data requirements across several critical business functions including sales, marketing, customer support and, of course, compliance. By ensuring the MDM technology supports the following 10 requirements, you will be well on you way to laying the foundation for a complete compliance program with the ability to evolve it to address unforeseen future requirements across the organization.

  • Manages multiple business data entities within a single MDM platform.
  • Permits data governance at both the project and/or enterprise-level.
  • Works with your standard workflow tool.
  • Handles complex relationships and hierarchies.
  • Provides support for service-oriented architecture services.
  • Allows for data to be cleansed inside of the MDM platform to provide clean data for compliance reporting.
  • Enables both deterministic and probabilistic matching to address a particular class of data matching. A single technique, such as probabilistic, will not likely be able to find all valid match candidates, or worse may generate false matches.
  • Creates a golden master record with the best field-level information and stores it centrally to enable compliance monitoring and reporting.
  • Stores history and lineage providing the ability to audit such data changes over several years.
  • Supports both analytical and operational usage.

Taking the time to build the foundation for a sound MDM program is critical to the success of any compliance effort. The ten requirements listed above will enable you to identify and evaluate a suitable technology platform.

Once your organization starts to make its departmental compliance projects operational, you are likely to find that your larger compliance requirements will expand to include other lines of business or geographies.

Finally, it is wise to check vendor references to evaluate the enterprise-wide deployments of their customers and to ensure that the vendor s MDM solution is both proven and includes all 10 enterprise MDM platform capabilities described here.

Ravi Shankar is senior director of product marketing at Siperian, a provider of an MDM platform.

Published: October 7, 2009