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Identifying and engaging with KOLs after receiving 510(k) regulatory clearance from the FDA

Market access for medtech companies

One of the most important ways that medical technology (medtech) companies can increase their market awareness is through key opinion leaders (KOLs) within their therapeutic area, as well as the KOLs’ specific areas of expertise (e.g., research, authorship, conference presenter, professional education provider, payer/provider representation, FDA/CMS representation, etc.).

The importance of KOLs in market access

To help achieve successfully market access, experienced healthcare professionals and researchers are used as independent advocates speaking to the value of the technology. In addition to speaking to the value of the product, KOLs have the potential to more directly advocate for utilization and coverage to industry peers, including those with coverage and implementation usage in payer organizations, healthcare systems and professional specialty societies.

The KOLs of medtech manufacturers, in turn, are uniquely equipped to use their expertise and industry standing to communicate the clinical benefit and product value to decision-makers at payer organizations and healthcare systems. KOL presence underscores the credibility of the therapy being proposed by the life science company, and signals buy-in on behalf of healthcare professionals.

For these reasons, it’s imperative for medtech companies to identify and select the appropriate KOLs to speak to the value and ultimately assist in the adoption of medical devices. Because KOLs offer a unique and important perspective, the sooner companies start engaging with KOLs, the better. KOL engagements can be made even more effective by developing a strategic KOL engagement plan.

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Making KOL engagement plans

KOL engagement plans are most effective when featuring comprehensive strategies from identification through completion of market access activity. The first and most critical part of KOL engagement is the identification of the appropriate leaders for participation. In order to maximize a KOL’s power of influence for a product, organizations must select experts that are not only leaders in the therapeutic area but that also have an established presence and credibility among peers. This creates a foundation of trust with external audiences as product findings and their clinical and economic implications are disseminated.

For these reasons, a disciplined strategy is to consider KOLs by manufacturer to ensure the right KOL for the right purpose; one KOL does not necessarily fit the need of several specific activities. Designing a targeted and efficient KOL strategy will ensure the most effective and efficient use of the KOL community and will likely lead to a more focused, higher success rate for the asset(s). Every KOL strategy should feature a thorough assessment of regional, national and global objectives, as well as the resultant KOL necessities for those purposes within the product’s therapeutic space.

Identifying qualified KOLs

Medtech companies must conduct detailed diligence to identify the most qualified KOL for the stated purpose. The organization needs to have a full grasp of each KOL’s professional standing, including relevant publications, leadership positions within key industry organizations, and proximity to key regulation and guideline-producing organizations.

Following identification, clear activity direction based on each KOL’s position within the overall KOL strategy must be expressed and agreed upon with the KOL to ensure the activities and expectations will benefit from their leadership. Through KOL expertise, medtech companies can improve the development and execution of evidence generation strategy, price and reimbursement strategy, and publication and collateral development for industry and payers, among other activities.

Reaching out to KOLs

KOL outreach should not only feature information outlining the product value and any existing RWE data, but it should also feature concrete information on what the proposed activities are and the level of commitment required. This not only ensures all parties’ expectations are aligned, but it also can help in setting project milestones. All of these factors, combined with direction from company’s internal leadership team, helps the selected KOLs remain actively engaged with meeting milestones throughout the entirety of the engagement.

Putting it all together

A well planned KOL strategy can strengthen the effectiveness of key market access activities both pre- and post-evidence generation. KOLs can contribute directly to evidence generation strategy development and implementation, which is the prime priority following 510(k) clearance. KOLs offer invaluable insights on real-world evidence generation that often are not captured in strategic plans developed by life science organizations.

The perspectives of physicians and industry leaders help ensure studies feature clinically appropriate methodology and outcomes that resonate with physicians, and also that they are generally reflective of the “real-world” state of the therapeutic area.

KOLs are often partly or fully involved with translating RWE into digestible and relevant findings for key industry leaders through manuscript and collateral development. The endorsement and disseminating of findings by KOLs, through the writing of scientific manuscripts, presenting at industry events, and other public facing communications, helps improve the perception and adoption of the product.

Baker Tilly provides expert KOL strategy planning (both as a definitive strategy plan and in alignment with our clients’ overall commercial strategy) and utilizes our access to the H1 KOL platform, a proprietary database of global KOLs that offers in-depth profiles of more than 10 million KOLs across most medical specialties. Once the strategy has been defined, Baker Tilly uses the database to identify the most prominent and effective KOL for every component and section of the strategy. Our engagement with the database is fluid, allowing updates to the strategy to add, remove and switch KOLs as the market environment dictates.

Baker Tilly’s market access services team can help medtech companies achieve their market access needs, answering questions, providing guidance and walking organizations through the next steps in the wake of receiving 510(k) regulatory clearance. For more information or to begin a conversation, contact our team.

John Finan
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