As 2014 draws to a close, MassDevice.com asked several medical device company CEOs for their takes on 2014 and what they’re looking for in 2015.
We wanted to get their views on the major trends seen in medtech this year, including the red-hot M&A and IPO scenes, the medical device tax, the regulatory environment in the U.S., and more.
Below please find the chief executives’ responses, edited for clarity:
1. Which technologies do you think we’ll be hearing about the most this coming year? What’s hot in the spaces your firm plays in?
Mike Mussallem, CEO of Edwards Lifesciences: Moving into 2015, I think you will continue to hear about disruptive innovation that allows patients to live healthier, happier lives. This year alone, we witnessed a number of impactful developments, such as an artificial retina for blind patients through an implant that stimulates the optic nerve and a motorized device that helps people with certain spinal cord injuries to walk. For Edwards, our aspiration is clear: we want to be a company that is recognized as transforming patient care through innovative technology. We look forward to continuing to offer life-changing heart valve replacement therapies, while also increasing our emphasis on mitral transcatheter valve replacement, heart failure and enhanced surgical recovery.
Brian Concannon, CEO of Haemonetics: I think there will always be new technologies that will open new opportunities in medicine, but I think 2015 will be a year where we will see continued advances in healthcare software, especially providing access of information on cost, outcomes, and quality to consumers of healthcare making them a more informed buyer of services. For Haemonetics, we will see continued advances in software enabling better blood management, TEG 6s in the diagnostics space, BloodTrack software and HemoBank combined to streamline blood logistics. Each of these advances provides economic saving and better patient care.
Dave Johnson, CEO of Alliqua BioMedical, Inc: In 2015, I envision more entries into the regenerative space, as the science continues to demonstrate efficacious outcomes in chronic wounds. In addition, with infection still a major concern in many healthcare environments, I would expect more antimicrobial technologies entering into the market. Finally, innovative technologies that challenge the current standard of care are always big opportunities.
Dr. Shai Gozani, CEO of NeuroMetrix. : With regard to the technologies we’re likely to be hearing about the most this coming year, I believe they will include the convergence of medical devices, wearable technology, and consumer healthcare.
Terrence Norchi, CEO of Arch Therapeutics: We will continue to see improvements in biomaterials in terms of manufacturing, efficacy, safety and interfacing with biology. We should also see increased focus on using devices as a means of accomplishing tasks historically in the domain of pharmaceuticals.
George Cipolletti, Founder & CTO of OMNI: This coming year, you can count on orthopedics companies to start differentiating themselves from a standard implant offering. We believe that Stryker will significantly leverage its acquisition of Mako and will drive robotics to new heights. We also believe that the other big players will be in watch mode. Small companies without technological differentiation will feel more pressure. New technologies, centered around decreasing cost and time in the operating room, will be fostered. This will be divided into two categories: low-cost advanced robotic systems, and instruments and accessories that will provide additional accuracy and predictability.
2. The medtech IPO market was red hot in 2014. What drove that trend during 2014? Do you see that continuing or tapering off in 2015?
Concannon: The rebound of the stock market [was the driver.] As long as the market remains strong, I see that continuing though at a slightly reduced pace.
Johnson: I see no reason for a tail-off in the medtech IPO market. The backlog of great companies and exciting technologies remains. Of course, the big question in this area is how the overall markets will continue to develop in 2015.
Gozani: Regarding the medtech IPO market, it is certainly true that it was red hot in 2014; next year, I think this trend is likely to taper off, since many of the IPOs are pre-commercial companies and will disappoint investors.
Norchi: This trend still has legs.
Cipolletti: A "red hot" IPO market is sensitive to many factors that are unpredictable. I do, however, believe that companies with a solid history of revenue growth—and with technologies compatible with the new healthcare environment—will do well in the public markets in the foreseeable future.
3. M&A was also red-hot this year – what’s your insight on the drivers of that? Do you think we’ll see more or less consolidation in the coming year?
Concannon: Larger companies have more cash. Corporations that cannot grow organically, or grow as rapidly as they may have historically, need to find ways to leverage their positions in existing markets and move into adjacent markets where appropriate. About the same [level of consolidation in 2015].
Johnson: I believe that further consolidation in the medtech space will continue in 2015. The benefits of consolidation currently outweigh the associated risk as companies look externally for growth vehicles, cost synergies and the creation of greater shareholder value. The capital markets remain inviting: the cost of capital continues to be low; balance sheets among the large caps have become flush with cash; the small caps are still finding an appetite from investors for good stories with strong management teams. All of this bodes well for more consolidation in 2015.
Gozani: Additionally, I firmly believe that will will witness more consolidation in the medtech sector in the coming year.
Norchi: We should see more consolidation. Pipelines of larger companies are constantly under pressure, so all ways to increase the top line are on the table. Traditional pharmaceutical firms are also more likely to test the waters in what have historically been device markets. There also remains room for elimination of potential redundancies in large consolidations, helping not the revenue line, but contributing to earnings growth.
We should see more acquisitions of small companies by larger firms. Many large medical technology companies acknowledge that they are missing early stage R&D capabilities, bench-to-shelf track records, or both. Some have cited size and large company culture as factors that are counter to the entrepreneurial mindset required to drive new product ideas. Consequently, these companies will continue to look for new product ideas in the pipelines of smaller, nimbler, entrepreneurial companies that may simply become the next competitor to a specific product line.
Cipolletti: It’s likely that the sector will go from four to three major players. Smith and Nephew will likely be acquired by DePuy or Stryker. I think we will also see offshore companies looking to acquire U.S. device manufacturers.
4. What was the impact of the medical device tax on your business this year? Do you think the 114th Congress will repeal the medtech tax?
Mussallem: We are hopeful that Congress will address the device tax, and we think that will benefit medical innovation. Repeal would require an agreement between Congress and the White House, and we feel the odds are better than in the past. We estimated the device tax would cost Edwards approximately $20 million in 2013.
Concannon: We have publicly stated that it has cost us approximately $4M in FY15. Any incremental cost to a business that brings no value is always impactful. I think if it is going to be repealed, this Congress offers the best chance of that happening.
Johnson: I believe that Congress will repeal the medical device tax. This tax was a misguided initiative from the start, putting a governor in an industry that has proven to be one of the strongest economic enhancers in the past decade. This should be a bipartisan initiative for the sake of economic growth in this country, and I hope we see this action taken sooner than later.
Gozani: Finally, I also think the medtech tax will be repealed by Congress in 2015.
Norchi: The medtech tax is likely to be repealed. It is strange for a country seeking economic growth to not support its industries that have the best potential at home and abroad. The tax has been incredibly and broadly unpopular, and elected officials seem to understand that now.
Cipolletti: I think the tax will be repealed but I can’t imagine Congress will rebate payments, as has been proposed. There is a lot of support from both sides of the aisle.
5. How would you rate the U.S. regulatory environment in 2014? Has the DA lived up to its promises to reduce approval times and collaborate more with industry?
Mussallem: FDA is already taking on a number of initiatives to improve the regulatory processes to help improve patient access to innovative therapies. Thanks to FDASIA, FDA has agreed to improved review and approval performance metrics tied to dramatic increases in manufacturers’ user fees, and we are just beginning to see positive performance. Beyond that, during the last few years, Dr. Shuren and his team at FDA have outlined strategic priorities to strengthen the clinical trial enterprise, striking the right balance between premarket and post-market data collection and improving customer service. Recent initiatives, such as the House Energy and Commerce Committee’s 21st Century Cures Initiative, show a commitment to the goal of getting patients the therapies they need in a timely manner. FDA’s vision to improve the regulatory process must be accelerated. Congress could lend support to FDA by providing additional resources to FDA to help expedite important initiatives and give them room to innovate.
Concannon: About the same. The effort is there. I do expect this effort to translate into better results in 2015.