The Benefits of Capturing Product Data Are High - The Costs of Doing So Don’t Have to Be

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.


 

Buy vs. Build?

Buy - Ironically, capturing data can be one of the more challenging aspects of an outcomes collection study. It is important to offer sites data collection options that meet their needs in order to collect patient- and surgeon-reported data. Just as an engineer cannot successfully complete a task by using only one tool from the toolbox, a multitude of components is necessary to create a successful data collection strategy. Today’s data capture software systems can accommodate in-office, web-based data entry, wireless patient data entry, paper data capture and palm or tablet-based data entry. Many systems also offer the ability to capture radiographic images or forward patient follow-up directly to patients via email or paper. Some data collection platforms are also be equipped with a batch entry portal that allows mass amounts of data to be entered in minutes, for pennies per page. Typically, batch data entry can be performed by the site’s research staff or a third-party company.

Due to the variances in healthcare delivery systems, each site requires different support tools to become successful. Since these technology companies provide broad distribution and scale, many of these tools are very affordable and can dramatically improve the success of a study. In addition to potential cost savings, having a non-biased group responsible for all data capture and analysis is beneficial. This can be advantageous when enrolling surgeons who might be concerned about submitting data directly to a device company. It is also common for the data collection vendor to secure any necessary licensing for the use of proprietary forms, such as the SF-12v2™ or similar standardized instruments, which can save the device company time and money.

Build – Building a data capture system in-house can be achieved, but is expensive and requires staff to maintain software. One common challenge is that years into the study, when it is time to update case report forms or security features, or when a law such as the recently enacted HITECH Act impacts data collection efforts, system updates can be quite time consuming and costly. This challenge can be compounded if the staff that created the database is no longer employed at the device company. Another consideration is the willingness of a surgeon to participate in data capture, knowing that all data he collects will be available to the device company. As mentioned earlier, the more data collection options available to the surgeon sites, the more likely the study will be a success. Adding multiple data collection modalities to a homegrown data base can present challenges of its own.

What Data Should We Capture, and How Will It Be Used?

Most data collection efforts are designed to meet the interests of various stakeholders. Before the study begins, it is vital to envision how the data will be used both throughout the study and upon study completion. Today, most data collection technologies allow for real-time report generation. With web-based mobile technology, various stakeholders can generate many different reports to meet their needs anywhere, anytime. For example, Exhibit 1 shows outcomes scores from the Knee Society survey, one of many possible outcomes measurements captured in a Knee Arthroplasty study.

Exhibit 1: Knee Society Scores as seen in a Knee Arthroplasty Outcomes Report

ken-exh1


Generally, capturing more data points will drive up the cost of data collection. It is important to meet all stakeholders’ needs while keeping the number of data collection points to a minimum. Outcomes data can be collected to meet the needs of the following stakeholders:

Device Companies – Sales and Marketing need data to improve marketing efforts and fortify product claims. These customer-facing staff members can also utilize data to determine which surgeons are seeing the best product success, which in turn can lead to improvements in product placement and technique training for surgeons who may not be experiencing such positive patient outcomes. Quality, Regulatory and Compliance can use data to meet mandatory surveillance requirements or to meet audit and accreditation standards. Product Development teams use data to track existing technology and make incremental product improvements. There have been instances in the past in which a medical device company has been able to use post-market data to overturn negative managed care status.

Surgeons –Want data to follow patient outcomes in order to improve care, to compare competing products, to publish, to present at industry conferences or for improved managed care reimbursement (comparative effectiveness research). Actual product and patient outcomes data speaks volumes more than product advertisements.

Hospitals – Typically use data for improved reimbursement, to market the hospital or surgery center to patients, or for use in achieving various accreditations.

Outcomes studies can be very inexpensive if they capture only a few data points to meet the interests of one specific stakeholder. Studies can increase in scope and cost when capturing data to meet multiple interests, though new data collection instruments are continually being created that can condense data collection time and effort while still meeting the various needs.

Study or Product Registry?

The U.S. lags behind other countries such as Australia, Canada, Great Britain, Sweden and Switzerland in the collection of orthopaedic patient outcomes. While a U.S. registry that captures all orthopaedic products seems like a daunting endeavor, several worthy registries are under way. As this concept gains recognition, device companies have begun to use registry-style studies in earnest. While the cost of a large scale registry can be quite high, the per-patient or per-site cost can actually be minimal due to the limited depth of data that is typically captured in a registry.

A product study can take many forms, but is typically designed prospectively to answer a specific study question. While the number of instruments used can be more intense than what is commonly collected in a registry, the number of patients is typically much smaller. Since much of the expense of capturing data lies in the initial study/registry design and configuration of the data collection schedule along with a multitude of dependencies, it can be more expensive to run a study vs. a registry. However, in most cases, a study will meet more of the overall goals for a medical device company. Also, many of the benefits of conducting an outcomes study, such as increased product exposure to key surgeons, occur long before the conclusion of a study via white papers, abstracts, journals, etc.

When planning and initiating an outcomes study, it is important to be staffed appropriately with qualified, in-house personnel who are ready to meet the challenges of capturing data. A great number of experienced and qualified consultants and data management companies can meet the varying needs of physicians, research organizations and device companies, and these vendors can perform independently or in concert with qualified, in-house personnel. The cost to collect data depends greatly upon the amount of data collected, the level of technology used and whether or not the data collection system is built in-house or outsourced. To ensure success, a study should be designed to meet all stakeholders’ needs, maximize the available technology, attain the objectives and goals, and meet budgetary constraints.

Physicians, hospitals and medical device companies should investigate the options and consult with professionals to determine the best approach. The data collection process has become less time consuming and less costly due to many technological advancements and market availability, and the benefits of conducting an effective, successful outcomes data capture program typically far outweigh the costs, particularly in the orthopaedic industry.

Geoffrey T. Mather, President & Chief Executive Officer of PhDx Systems, has more than 19 years of experience in the healthcare industry with a concentration in sales, marketing and business development. Prior to his role as President, Mr. Mather served as PhDx’s Vice President of Sales and Marketing. Mr. Mather began his healthcare career at Lincoln National Corp. Through three company takeovers, Mr. Mather exceeded annual sales goals.

Keith D. Kennedy, Vice President - Sales and Marketing of PhDx Systems, has over 18 years of experience in sales, marketing and management. Mr. Kennedy also worked for a major Independent Review Board (IRB) on the Executive Leadership Team. During his IRB career, Mr. Kennedy’s clients included most major pharmaceutical companies, medical device companies and hundreds of individual physician and hospital sites. Mr. Kennedy may be reached at kkennedy@ phdx.com.

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