Co-authored by Keith Kennedy
Perhaps more than at any other time in recent years, we are witnessing rapid changes in the way products and procedures are developed and measured in orthopaedics. In addition to innovative product advancements, there is a groundswell of interest in tracking product and patient outcomes. Initiatives such as pay for performance, comparative effectiveness research and the recent 510(k) process review by FDA have led to an increasing appetite for product data by the orthopaedic device industry. Recent high profile product recalls that highlight the need for real time product data feedback have also fueled this demand.
In the past, the cost to collect medical device product information and outcomes data was high, and capturing data on approved products was not required. Today, collecting product information and outcomes data is essential to fulfill government requirements for safety surveillance, as well as help meet the needs of business objectives such as developing future product enhancements, improving reimbursement rates, gaining valuable product and surgical technique information or for product marketing purposes. A number of more cost-effective means of collecting medical device data have emerged, making the process more affordable for companies of all sizes. As a result, orthopaedic surgeons expect medical device manufacturers to have supporting data, which in turn requires the manufacturers to know what types of collection methodologies are available.
The stakes are high. Choosing the right data collection partner and process can help device companies differentiate themselves in the minds of surgeons, creating a significant market advantage. This article will focus upon a few of the many cost effective-data collection options available to a device company, and discuss the benefits and pitfalls of each.
Hire vs. Outsource
As the orthopaedic device market has evolved, so too has the data collection market. In the past, hiring a team of in-house clinical project managers was the only option to operate a successful trial. Today, an entire industry comprising niche companies specializes in supporting data capture for orthopaedic products and techniques. These data collection companies are skilled at:
Study Design – From conducting literature searches to writing entire protocols, these reputable and highly capable companies have the experience and staff to design a study that meets any number of research goals. They have knowledge of hundreds of orthopaedic trials and know the issues to consider when conducting a product-specific data capture study. A study must meet objectives that are appropriate to the costs and benefits. For example, if the initiative is simply to collect marketing data to support product claims, it is not necessary to incur the immense cost, time and effort to construct and manage a study with all the features of a regulated trial. If, on the other hand, the study is for a regulatory purpose, it must be designed to capture the appropriate data points and be powered properly to meet regulatory approval. By working with medical device engineers, product managers and affiliated surgeons, medical data collection specialists use their expertise to develop a custom, streamlined data collection strategy that answers only the most important questions, reducing the time and effort required to administer the study at each surgeon’s office.
Regulatory Expertise – The cost of hiring the appropriate quality and regulatory personnel can be steep, especially for small and mid-size companies. For a fraction of the cost, competent consultants can help navigate the ever-changing regulatory process, especially for mandated Investigational Device Exemption trials. Specialized clinical project managers can greatly ease the burden otherwise placed on device engineers, product developers and product managers, allowing these medical device professionals to focus on crafting the device instead of investigating data collection methodologies.
Professional Study Support Services – A successful outcomes study requires continual attention to ensure that sites are capturing data at appropriate intervals. Utilizing in-house staff to conduct these services has benefits, as this increased communication with sites can strengthen relationships with key surgeons. The downside of using in-house staff for study management can be the time commitment and associated costs of a full-time employee. There can also be negative associations if the medical device company is continually contacting lower performing sites about low enrollment data. This task too can be performed in-house or contracted out to a company that specializes in equipping surgeons with the proper tools to maximize data collection and utilization. In many cases, outsourced professionals maintain specialized clinical research credentialing (e.g. CCRA, CCRP), bridging the gap between device manufacturers and clinical research staff at participating sites.