Over the 11 years I’ve spent at DRG, I’ve had the opportunity to engage with many of the leading medical device companies and to see unprecedented growth in innovative medical device and pharmaceutical diagnosis and treatment options. Looking forward, however, success via traditional approaches will be increasingly difficult. Blockbuster drugs will be harder to identify and more expensive to produce. On the device side, while medical devices have benefited from rapid technology evolution, the industry is now facing commoditization and it’s increasingly hard to compete on the value of a technology alone. We see this challenge over and over again with new devices failing to gain traction.
To succeed in the future, I am placing a bet that we’ll see more and more non-traditional partnerships working together to bring novel combination therapies to market. Convergence offers opportunities for both the medical device and biopharmaceutical industry to develop technologies that can offer differentiated value in the market and can combine the efficacy benefits of both a physiological and a mechanical mechanism of action to address an unmet clinical need.
The idea of leveraging the value of a device for a drug therapy or of leveraging the advantages of a drug for device therapy is well established. There are numerous drugs with low oral bioavailability that are reliant on device-enabled delivery; here is where you’d think about insulin pumps, injection needles, inhalers, nebulizers etc. Similarly, you’ll be familiar with how adding a slow release pharmaceutical to a stent scaffold in the form of a drug-eluting stent revolutionized the treatment of ACS. What is changing is that technology advancement is increasing the potential for combination products much beyond traditional drug plus device combinations. We are now seeing increasingly sophisticated combinations that often include a digital component with a drug or a device or both. The excitement here is tremendous and includes sensors, smart inhalers, and even gene editors!
Traditional convergence products have resulted from the convergence of mature technologies that combine an approved drug and an approved device late in the development process. Going forward, convergence products will increasingly leverage leading-edge technologies including nanotech, digital, and regenerative medicine technologies. These future convergence products will need to be combined earlier in the development process and will continue to blur the lines that have traditionally separated the siloed medical device and biopharmaceutical industries, with implications on all aspects of the commercialization process.
I did my graduate studies in cardiovascular stem cell technologies and am keenly watching the progress of several of the novel cardiac stem cell therapeutics in development. With one such technology, you first create a 3D image of the heart using cardiac mapping technology. Depending on the image, cells are then injected through a specialized catheter into specific areas of the heart to augment the function of the damaged cardiac muscle. This type of therapy is convergence with no precedent for anything like it… there are no predicated devices used to deliver cell-based cardiac biologics, and the regulatory and reimbursement process will follow the biologic path, but the product will likely be sold and delivered to the market like a device. Converged health will define the future of our industry. I for one am excited!
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