Winning Together in Medtech

Orchestra BioMed is paving a unique path in the medical device industry with its innovative and collaborative approach. Under the leadership of David Hochman, a veteran entrepreneur with a diverse background spanning decades, the company has struck a chord by creating high-impact medical devices and the collaborative infrastructure that makes it possible for more to come. David puts it this way, “Our model tries to break those barriers now. We're only going to win when you win."

David is an entrepreneur and venture capitalist with over two decades of experience who has dedicated his career to developing purpose-oriented medical devices. His enthusiasm for medtech innovation is nothing short of contagious.

After various roles in telecom and media — industries worlds apart from the life sciences — he delved into venture capital, focusing initially on biotech investments before shifting to medtech. “I was really driven by what we refer to as a double benefit. If we're going to make money and generate returns for investors, we're only going to do that because we've impacted patients and provided tools or solutions to care providers,” he recalls.

When David realized that medtech offered a unique opportunity to turn ideas into products and, subsequently, into profitable ventures, he helped co-found a company in interventional cardiology in the early 2000s, which allowed him to work closely with key opinion leaders in the field. “What drew me to medical device innovation, at least in the early days, was this perceived shorter cycle of both turning an idea into a product, as well as turning that work into a return on investment,” he explains.

However, the landscape of device innovation shifted significantly around 2008. Larger companies were no longer readily acquiring early-stage, pre-revenue startups. Plus, timelines were getting longer, largely driven by growingly complex clinical trials and more rigorous regulatory guidelines. All of these challenges required more capital and fueled David and his team’s determination to reevaluate their approach. Orchestra BioMed was born in 2018 in response to this, drawing inspiration from the biotech industry's partnership-driven model.

The vision of the company was to seek alignment with established global medtech strategics by setting up a collaborative structure that allowed them to share both risks and rewards. By supplementing the R&D capabilities of larger companies, Orchestra BioMed was able to bring innovative products to market more efficiently.

Orchestra is not just an investor or accelerator. It is an operating company with unique capabilities to drive research, development, and clinical trials. David takes pride in having assembled a team of seasoned executives, each averaging over 25 years of experience, who share a passion for their work.

As David puts it, they aspire to inspire the industry by demonstrating that alternative approaches can yield success. As Orchestra continues to grow and forge partnerships with industry giants like Medtronic and Terumo, David and his team are challenging traditional norms in the medtech industry. He says, “If we do our job well, we won't be the only people doing it this way. We're looking to be flattered by other people realizing this is the smart way to do things, rather than trying to do everything by themselves.”

Their two flagship products, BackBeat CNT and Virtue SAB were born from this collaborative spirit. 

BackBeat CNT, also known as Atrioventricular Interval Modulation Therapy (A-V-I-M therapy), tackles a major global health issue: high blood pressure, affecting over a billion people worldwide. It's designed as an add-on for standard pacemakers, requiring no hardware changes. Instead, it uses the pacemaker's capabilities to control blood pressure and adjust the autonomic nervous system's responses. This is especially helpful for patients with both pacemakers and high blood pressure, which is quite common. BackBeat CNT has the potential to benefit millions of pacemaker patients, making it a significant advancement in cardiovascular care.

The second product, Virtue SAB, is designed to enhance angioplasty procedures. Unlike traditional drug-coated balloons, Virtue SAB uses a microporous balloon to deliver sirolimus, a proven anti-restenotic drug, directly to the target area. The design allows for precise drug delivery while eliminating the risk of drug-coating particulates. By ensuring the drug reaches the target area directly, Virtue SAB provides extended focal release of sirolimus over approximately 30 days. 

Orchestra BioMed's flagship product, BackBeat CNT, has received full IDE (Investigational Device Exemption) approval from the FDA. While Virtue SAB has received conditional IDE approval, David’s team is actively looking to apply their model to more groundbreaking technologies.

Key Learnings From David’s Experience

• Embrace creativity in structuring partnerships and business models. The nature of collaboration depends on you and your partner organization’s vision, capabilities, and long-term goals. When done right, sharing risks and rewards can be highly productive.

• Having robust operational capabilities enables you to generate more clinically meaningful data. The more impactful the data, the more value you can build.

• Prioritize a long-term outlook over short-term gains. Do not cut corners in favor of reaching certain milestones, especially in clinical trials that ladder up to your regulatory strategy.