Partnerships and the Pursuit of Innovation at Large and Small Companies

In a recent interview, Anne Sissel, managing director of Baxter Ventures and Adam Berman, CEO of TVA Medical, Inc. shared their perspectives on topics related to innovation and partnership between large, commercial organizations and small, venture-backed start-ups. The following Q&A shares some of their insights into the value of the partnership between small and large companies like TVA Medical and Baxter, and keys to successful collaboration.

Anne E. Sissel, M.B.A., C.F.A. is managing director of Baxter Ventures and has been in that role since she joined the company in 2014. She previously served as a member of the founding team and vice president, head of finance and business development at Veracyte, Inc., a molecular diagnostics company. Prior to Veracyte, Anne was an investment banker with Goldman, Sachs & Co. and completed over $200 billion in financing and M&A transactions over her banking career. Sissel earned her B.S. degree in finance and international business from Indiana University and an M.B.A. in health care management from the Wharton School of the University of Pennsylvania. She is also a Chartered Financial Analyst.

Adam Berman, M.S.E. is an experienced medical device leader with a focus on minimally-invasive cardiovascular technology commercialization, R&D and operations. Berman co-Founded TVA Medical with cardiovascular surgeon Dr. William Cohn, built the team and has lead the strategy and execution of the company since its inception, including venture and strategic investment rounds. In prior roles at Coalescent Surgical, Inc. (now Medtronic), MedicalCV, Inc., Castlewood Surgical and Computer Motion, Inc. (now Intuitive Surgical), Berman has been responsible for the development and commercialization of laser ablation systems, anastomotic devices and robotic surgical systems. Berman received his B.S.E. magna cum laude in biomedical engineering from Rensselaer Polytechnic Institute and his M.S.E. in bioengineering from the University of Washington.

Q: How does the mission of a large or a small company influence its focus on and pursuit of innovation? How do you determine where to focus the efforts of your team as it relates to both the mission and the business?

BERMAN: There are many similarities between large and small companies when it comes to having a mission. For medical technology companies, whether it’s a 5-person startup, or a 5,000-person organization, the mission is to help patients and improve the human condition by providing a device or technology, a drug or therapy. At TVA Medical, we focus first on maximizing clinical impact and building a great business around a patient-centered approach.

SISSEL: I agree. Our mission at Baxter to save and sustain lives inspires where we focus our innovation efforts. In a larger company such as Baxter, the technology has to fit within the overall mission and strategy to justify investment and focus. The mission helps to remind us of the ultimate goal of saving and sustaining lives, but provides some room in how to achieve that goal. We have to stay disciplined and choose those opportunities carefully where we believe we can have the biggest impact, but recognize that any given technology is only one piece of the broader picture.

Q: How does risk affect the approach a small or a large company will take? Does risk play in differently?

BERMAN: From a smaller company’s perspective, we can manage risk by moving things forward as quickly as possible. Because we’re a single product, early-stage company, we have more flexibility to execute on a path and timeline that might be considered aggressive by a larger organization. A well-thought out plan, methodical implementation and frequent course correction are necessary, but there is an inherent agility that I think smaller companies can leverage to get a product to market quickly. We don’t have to think about other products that are under review by FDA in commercial spaces parallel and adjacent to what we’re working on, we have a single purpose and a single mission.

SISSEL: The interesting piece here is how you think about the key constraints at a large company versus a smaller company. In a smaller company, the key constraints involve those elements required to reach that next technology and financing milestone. So, while you're concentrated in risk in one technology or one technology platform, each decision becomes that much more valuable to achieving that next milestone. At a larger company, the benefits of diversification allow you to constantly be re-evaluating different technologies at different stages of development. The constraints become more time and people resources across the various project plans, rather than just those impacting the ability to hit that next milestone.

Q: How do you approach the scenario of eggs in one basket versus portfolio or diversification?

BERMAN: For the smaller company in particular, it's all about focus. Initially you want to keep a wide net until you find the most powerful clinical application for your technology or therapy. At that point, it's important to drill down and get specific and drive that highest clinical value component in your project. However, at the same time, you have to keep a broad outlook to make sure you are taking care of critical activities and that you don’t miss other important opportunities to adjust your course.

If you identify an area that is outside of your core therapeutic area, and it feels worthwhile to pursue, at the right time you make sure that you explore how to diversify. That could mean adding personnel or resources, or brainstorming other creative ways to maximize that new opportunity.

SISSEL: That’s where a partnership with a larger company like Baxter can be really helpful. When the team is so focused, you start to invite biases into the equation. If you can draw upon the resources and the breadth and depth of experience of a larger company, you can find domain experts and broader teams that can challenge your ideas and your thinking and get to the best solution, which is really a benefit to that small company. The experience of the larger company can help you have additional outside perspective to make sure that that decision not only is timely, but that you're really considering all the factors.

BERMAN: This is an area where our partnership with Baxter has been invaluable, particularly due to their expertise and success in providing innovative renal disease therapies to patients. We have been able to ask questions of domain experts within Baxter as we evolved our business strategy and plan. The team received feedback that has shaped our global commercialization, reimbursement and marketing strategies. For example, our European commercial and Japan regulatory plan and the timing of these business initiatives were shaped by these discussions. I know our small company is more effective because of this extensive resource and the support of their team.

Q: What are some of the challenges of building a disruptive technology with the limited resources of an early venture-backed company?

BERMAN: With a venture-backed company, developing a disruptive technology starts with early engineering R&D work, and then transitions into a phase of expanded scope and higher spending as you initiate clinical studies, regulatory approvals, global reimbursement strategies, and engineering work to reduce cost of manufacturing. Those initiatives can require substantial resources and expertise compared to the earlier product development, proof of concept efforts. And all of those areas have their own challenges, requiring a team that can be creative about how to address the challenges. Having experienced investors and business partners that can advise on these larger initiatives is imperative, especially those with deep operational experience in the therapeutic area.

SISSEL: Speaking of those larger initiatives, an example of the benefit we bring is as a partner with deep global experience. Having additional resource teams to evaluate the factors across geographies and important functional areas, and being able to address each of those with a partner is beneficial to the venture-backed company. The international strategy is becoming more important and challenging for a focused, small team to address. It's not just about Europe and the U.S. It is about a global strategy and developing that strategy together in a way that is effective and efficient, again realizing that the most precious commodities are often time and capital. This is a great way that we can work together and pressure test all of the different pieces in a broader strategy.

Q: Are the challenges different if you’re taking the view of a large company?

SISSEL: In a large company, you can take a project plan and seek approval for the development of the technology from start to finish. You are not just funding through the next milestone. In a corporate project you could have some cost variances without affecting the overall value of the company. Instead of requiring you to pivot or to scrap an idea, you have flexibility in utilizing your resources knowing you have the full support for a project through the point of a go, no go decision. This is really supportive to the overall team as they seek to create new technologies where you can’t always predict the path that research and development is going to go.

Q: What additional benefits exist for the smaller company in terms of speed and efficiency? When you can get everybody in a conference room quickly, does that mean decisions with a small team are more efficient?

BERMAN: In a small company, in order to make a design change on a product based on feedback from a clinician, you still run through a thorough product development and documentation process, but there are fewer layers to go through. Getting to a core decision can be done quickly as fewer people are involved in the process, but the team still has to make sure engineering, marketing, clinical, regulatory, sales, finance and legal are involved in important decisions. The speed and efficiency can be a powerful fuel for innovation.

However, there is risk in moving too quickly so its important to have strong quality systems and processes in place and hold the team to those systems.

At TVA, we make every decision thinking about the patient first, and what the physician and other healthcare providers tell us they need.

Q: How has the expertise of Baxter been valuable to TVA specifically in the project you're working on now?

BERMAN: We interact with Baxter as an extension of our core team. TVA Medical started with two of us, and is now 22 employees. Through our partnership with Baxter, we have the ability to go to domain experts for input and guidance. Being able to collaborate with a larger team that has additional global expertise across many functional areas is very valuable to us.

Our partnership with Baxter has helped us lay out a plan for future global commercialization and optimal scalability. Together, we want to improve the lives of patients with kidney disease and Baxter understands these patients from many angles and in global markets. Sharing these perspectives helped us shape our short-term and longer-term operating plan.

SISSEL: One of the areas that we worked on together very early on in the process is very thematic of the healthcare system today, relating to reimbursement. We both had a view on the cost economics here and shared those perspectives in the investment evaluation process. It has led to a richer perspective on both sides. From the investor side it helped us evaluate the future potential of the investment partnership and, within TVA Medical, helped the team think further ahead into commercialization from where they were then.

Q: Are there benefits or risks that come from the fact that small companies think about the individual patient versus a large company thinking more about the population?

SISSEL: Large companies know how to succeed at blocking and tackling large projects. They can see big projects and build project plans with a top-down approach from start to finish. Venture-backed or small companies, in my view, are often founded with a great vision for a certain technology. It's more of a bottoms-up, step by step approach to their research and to their trials.

BERMAN: I agree. From a small company perspective, you think about the first 100, the first 1,000 patients and you plan for modifications in the plan when you're on that order of magnitude. When you then scale that to a much larger view and the global project plan, you consider factors like distribution efficiencies and how you're going to distribute the product and gain access to a larger patient population. It is more of a bottoms-up approach.

Then there's a phase where when it becomes more efficient for a large company to commercialize and scale compared to a small company. This is common in medical devices. You see small companies focused on the early clinical trials, the product development, the regulatory clearances, and potentially some reimbursement initiatives. Then there's a natural shift to where the resources and expertise in a larger company on a full-time basis would be more efficient at evaluating the options for global commercialization.

SISSEL: I do see additional benefit to work with teams at larger companies who have been working together. They draw upon past experiences, through collective successes and failures and also with comparable technologies. This concept of pattern recognition and having a historical perspective of what could work and what may not work is a way of heading down a more efficient path that may lead to a better expected outcome. Having that experience within one team, within one company, is one advantage that a larger company can bring. When we partner with smaller companies, we can share those experiences and perspectives with the directed focus of the smaller company.

About Baxter Ventures

Baxter Ventures identifies companies with promising technologies, products and/or therapies, and provides them with the capital and expertise needed to drive successful innovation. Baxter Ventures was created in 2011 by Baxter International Inc., which has an 85-year legacy of supporting healthcare innovation and saving and sustaining lives worldwide.

Baxter Ventures invests in companies with innovative technologies, products and therapies that have the ability to improve patient care globally and maximize value for investors and entrepreneurs. The company’s focus includes therapeutic areas complementary to those of its medical products business, as well as cutting-edge technologies and therapies outside of its current product portfolio that have sustainable long-term growth potential. For more information, please visit www.baxter.com.

About TVA Medical

TVA Medical, Inc., is a medical device company developing minimally invasive therapies for patients suffering from End-Stage Renal Disease (ESRD). Baxter became an investor TVA Medical in October 2015 as part of the company’s Series C financing for its everlinQ™ endoAVF System*, a catheter-based technology designed to create hemodialysis access for chronic kidney disease patients in a minimally invasive procedure.

Worldwide more than 2 million patients with ESRD receive hemodialysis therapy and require vascular access to connect to a dialysis machine. Surgical AV fistulas are currently the standard approach to achieve vascular access but are associated with high failure rates, often as high as 60 percent. Surgical AV fistulas also require frequent revisions, resulting in increased morbidity and unnecessary costs. The everlinQ endoAVF System is designed to create an AV fistula for hemodialysis access using a minimally invasive approach. The system has been studied outside the United States and has received CE mark. The everlinQ endoAVF System is not currently available in the United States and has not been approved for commercial use by the U.S. Food and Drug Administration. More information is available at www.TVAMedical.com.

*everlinQ is a trademark of TVA Medical.