From new treatments and technologies to platforms and diagnostics, we may be living through the greatest period of innovation in the history of healthcare. The biopharma industry’s efforts to rapidly develop multiple safe and efficacious life-saving vaccines for the Covid-19 pandemic is just the latest example of the collective appreciation for innovation and its ability to impact human health. While the industry loves true innovations—and the brilliant minds who envision them—being an innovator is not for the faint of heart.
Today, companies that fall outside the norm or have a first or unique approach in the healthcare industry face greater scrutiny—even outright pessimism—from various stakeholders, including regulators, investors, industry, physicians, patients, and media.
We call this the “Innovator’s Burden.”
For example, companies with the second or third product in a class don’t typically face the same level of scrutiny as the innovator company with the first product in its space. That’s because regulators, investors, and other stakeholders have already categorized follow-on products, figuratively placing them in what they consider the appropriate healthcare “bucket” or category. Usually by the time the third or fourth product in a class is in development, its scientific underpinnings, regulatory pathway, benefits, and even market potential are fully understood.
But for innovators, there are additional hurdles. They may develop a medicine with an entirely new mechanism of action that has to be rigorously assessed. They may develop a medical device that defies the conventional “buckets” and requires development of an entirely new regulatory pathway.
The industry should embrace innovators, the companies doing things that have never been done before. Their efforts are what moves science forward and leads to breakthroughs.
By understanding potential challenges, planning for them, and using proven communications strategies, the Innovator’s Burden can be eased, enabling the realization of the potential of their discovery. It’s not easy, but then again, maybe it isn’t supposed to be.
Be flawless, but prepare for setbacks.
Of course, no company wants setbacks, and all try to avoid them. However, for innovator companies, any setback—no matter how small—may confirm doubts and walk back progress. This means carefully and transparently communicating if a setback occurs, to ensure the innovation isn’t dismissed outright. As previously stated, these setbacks are more likely in innovator companies that introduce a new idea, or different approach to solving a long standing problem. Rigorous FDA reviews, even potential Complete Response Letters, clinical holds, delays, and skepticism leveled by existing players in the company’s space can hamper progress. It’s the response that can make or break an innovator. No matter how small the setback, innovator companies need to communicate quickly and transparently about what the setback means, and more importantly, what it doesn’t mean—targeting all key audiences, including investors. These moments are a time to over-communicate, mitigate concerns, and detail the path forward. It’s also critical to have a pre-developed crisis communications plan and be prepared to quickly correct inaccuracies in media accounts. Erroneous information can be devastating to an innovator.
Explain, explain, explain.
Innovator companies inherently have a greater responsibility to explain their science, their hypothesis and the reasons to believe. Indeed, the scientific method is based on skepticism: any claim is not true until the evidence proves otherwise. So, it should come as no surprise that innovators face greater skepticism for their hypothesis. This is how science ensures a new idea is valid. Innovators must explain their science in understandable terms to build belief in their work. That said, there are competitive and even intellectual property (IP) concerns that need to be considered. Companies need to carefully weigh the benefits of unveiling the particulars of their innovation, approach, methods and technology, with the downside of tipping off competitors or revealing proprietary IP.
Find third-party validators.
Innovators must find like-minded believers who can advocate for the new approach. This is a challenge, as healthcare leaders often take a wait-and-see approach. Communicators can assist by creating opportunities to introduce an innovator company’s ideas to potential validators. This could range from adding prominent thought leaders to the company’s scientific advisory board, creating events and other opportunities to meet with key players during medical congresses and conferences, or even one-on-one briefings. Coverage in leading trade journals can also greatly assist in attracting validators and paving the way to finding new believers.
Focus on patients’ unmet needs.
Some innovators become so enamored with the invention itself—the new technology, differentiated mechanism of action, unusual approach—that they neglect how the product will change the lives of the eventual end-user: the patient. It’s never too early to communicate how an innovation addresses unmet needs, solves an intractable healthcare problem, fills a void, or offers new hope to patients who are desperate for new treatment options. Patient education or patient advocacy strategies should begin earlier in the process than many innovators may believe. Patients and physicians can become formidable forces if they are engaged early and often. They can also become third-party validators. Companies that wait to engage patients often find it harder to gain acceptance and support than companies that collaborate early.
Publish and present.
Innovators need an aggressive and comprehensive publications and scientific congress strategy. Stakeholders rely on peer-reviewed journals as checks and balances, and nowhere is that more critical than with an innovative idea. Some companies are slow to publish data due to IP concerns. Some have difficulty landing journal submissions because of skepticism voiced by other stakeholders. It’s important for innovator companies to seek validation the way the industry prefers: journals and congress presentations/posters. Communicators can support these strategies by highlighting journal articles, congress participation through trade media coverage, and engaging social media content.
Albert Einstein hinted at the Innovator’s Burden when he quipped, “If at first the idea isn’t absurd, there’s no hope for it.” I’m certain innovator companies, who have endured skepticism, attacks, roadblocks, and extreme scrutiny, would agree. Companies that drive innovation in healthcare can change patients’ lives and alter the course of an industry. We need more of them. But they don’t have an easy path. While it may be a more challenging journey—one that can be eased by using sound communications strategies—the ability to provide a revolutionary, life-changing innovation to patients in need is certainly worth it.
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Michael O’Brien is a Managing Director of public relations at ICR Westwicke. He can be reached at [email protected]