One subject that should be exposed to such scrutiny is content management. Obtaining and managing copyrighted content, such as scholarly journal articles, can be expensive. Content management includes the cost of locating, verifying, checking for compliance, formatting, updating, and translating or localizing device-related published content in the clinical and regulatory arenas. A separate challenge involves managing the published content that is used by sales and marketing teams to help promote the product. A content specialist service can assist with some of these efforts and help to streamline content management.   

Managing Copyrighted Content During the R&D Phase

During the testing phase for a product, a company’s researchers often search through millions of journal articles and other content that supports the scientific process. After this phase, clinical trials are carried out and the publication planning process accelerates, culminating in scholarly articles that will be submitted to peer-reviewed academic journals. Once published, they become a significant component of a company’s 510(k) premarket notification or premarket approval (PMA) submitted to FDA or other agencies if outside of the United States. If FDA approves the product, the articles take on a new role as the marketing efforts get underway and safety monitoring continues.

Of course, there are challenges associated with these uses of scientific articles, which are linked to issues of compliance and business process. For example, it is well known that a 510(k) or PMA documentation submitted to FDA can be lengthy, as it consists of reviews and copies of published studies of the device in question. Assembling, sending, and managing this mass of materials is a significant undertaking for any device manufacturer. It is crucial for a company’s bottom line that this task be completed inexpensively as possible and in a manner that avoids unnecessary duplication of materials or preparation errors that could lead to submission delays or rejections that ultimately affect shareholder value.  

Preparing Published Content During the Marketing Phase

Once a medical device has received an approval notification from FDA for commercial use, its manufacturer’s marketing activities switch into high gear as they prepare to pursue a return on their investments. As with the R&D phase, facilitating the flow and management of copyrighted content poses a challenge, this time among the company’s legion of sales representatives. As made manifest by the rising importance of evidence-based promotions, there is no better weapon in a sales representative’s arsenal than research studies that can be effectively spotlighted for the healthcare professionals (HCPs) with whom they meet. Being able to bolster one’s claims for a new medical device with scientific research —in addition to the educational value of promotional materials prepared by a company’s marketing firm—is not only a good idea; it has become the principal method by which the company can distinguish itself from rivals with competing products. It has also become one of the few ethical methods remaining to communicate with HCPs in light of the highly restricted code of interactions adopted within recent years.    

The arrival of the iPad as a marketing tool within the medical device industry poses a further motivation for companies to keep track of the key articles and other documents provided to their sales reps. Tablet computers enable a rep to transmit documents covering approved uses and the underlying science to an HCP. Timely access to a wide variety of these documents is a must while making sure that they are obtained at the lowest possible cost to the company.   

Minimizing Costs

For the most part, smaller and mid-sized medical device companies, with relatively few resources at their disposal face the greatest challenges in facilitating the acquisition and distribution of previously published content to their employees. A larger company is considerably more likely than a start-up to have a librarian on staff who has experience dealing with these issues. It is especially important for a smaller company to make sure that its research expenses are being minimized when it comes to the acquisition and distribution of paid content, including the decision to purchase journal subscriptions and the expertise in maximizing their use to rein in costs. In the ideal scenario, a device manufacturer low on resources would only need to depend on a small number of third parties to facilitate its content requirements.    

For regulatory submissions following the research phase, a medical device manufacturer without a library, whether small or large, also need not go it alone to deal with these challenges. A single company specializing in content repurposing can oversee some of the steps in these processes. For example, with regard to FDA submission, the content repurposer can process orders for articles either singly or in batches and procure them, make sure that the retrieved documents are digitally formatted to specifications, and oversee quality control and assurance processing. The service can also be tasked to report on the details of usage for every article requested by a company, and provide a dedicated project manager to oversee the whole process.

A content technology company can also streamline how bulk copies of reprints and e-prints can be legally obtained, while leveraging the manufacturer’s accumulated buying power. It can offer tools that make it simple to obtain and legally share these articles from secure online environments, via the manufacturer’s customer relationship management (CRM) or inventory system, and a range of other ways. Time savings and other efficiencies related to purchasing and deployment are an important advantage considering the costs accruing every day that a new product is delayed in getting to market.

An example of a service that simplifies document management is known as STM Document Delivery. This research service radically simplifies the procurement of articles, with copyright-compliant delivery to customers on the same day the order is placed. Most articles are delivered to a researcher’s computer within minutes or a few hours. And, by offering full user support, the service can save companies money—especially smaller companies on a tight budget—by minimizing the number of external document delivery specialists with whom they do business. In addition, reprints procurement and deployment services can help medical device companies effectively use multiple copies of an article in evidence-based promotions. 

Conclusion

There are considerable challenges linked to managing the flow of copyrighted content within a medical device manufacturing company, from the R&D phase of a new product to the post-commercialization phase. If the company partners with a dedicated content technology company, it can handle many of these challenges in a manner that reduces these overall expenses and organizational challenges.

Peter Derycz is chairman and CEO of Derycz Scientific (Santa Monica, CA).