Posts Tagged JP Morgan Healthcare Conference
Posted by Darshana V. Nadkarni, Ph.D. in Biotech - Medical Device - Life Science - Healthcare on January 27, 2014
The OneMed forum conference was launched in January of 2008, when economy was showing all signs of progressing to new heights, with an objective to showcase innovation in medtech. The conference aimed to bring together the companies and investors, during the large influx of healthcare investors and executives, during the JP Morgan Healthcare Conference, in San Franciso. Fast forward to 2014 and we are perhaps just emerging from one of the worst recessions; a downturn that hit the medtech sector more than any other industry segment.
This year, the location of OneMed Forum was changed and the venue was moved further away from the JP Morgan Conference. Since the weather in SF was gorgeous, it was not a problem; but if the venue continues to be further away in future, and in the event of cold and rainy weather, it can have an impact and lower the attendance at future OneMed events. This year also OneMed event seemed to be sparsely attended, although that appearance might also be enhanced because the meeting rooms were spread out on two different floors and there wasn’t a single spill out location for the participants to meet and network – another problem with the venue.
There was also a palpable difference between the JP Morgan conference and the OneMed Forum, this year, in terms of optimism. While biotech and pharma sector is returning to pre-recession levels with a large number of IPOs and higher numbers of dollars raised, medical technology companies have yet to see significant investment dollars. On talking with the participants, I heard a note of disappointment regarding low attendance from VCs and other investors, just like in the last few years.
However, despite slow pickup and staggering growth in the medtech sector, it is transforming and the companies are learning to operate more efficiently. It is also recognized that healthcare is at a critical point and medical innovation will have to address some key challenges. Various panels and speakers at the OneMed Forum, addressed the changing healthcare landscape and how the future of health and medicine will need to be shaped, in the coming years to address the key issues.
Personalized Medicine Panel discussed the promise offered by customized diagnosis and treatments, in lowering the cost and increasing effectiveness. Panel sessions addressing the JOBS Act and the Affordable Care Act, explored the impact of the legislation on cost of care and access to care. Companies and solutions that may be poised to offer effective healthcare solutions and may also present interesting investment opportunities were highlighted. In somewhat grim medtech landscape, digital health is emerging as the hottest new trend, with much potential. The Digital Health panel discussed the impact of Affordable Care Act in increasing information transparency and empowered consumers taking greater control of their health information. The changing role of the patients/ consumers will require change in the healthcare delivery and transformation in the business model.
A panel addressing “reimbursement strategy after the affordable care act”, discussed impact of medicare payment rules on medtech and hospital markets. The panel also discussed trends in coverage and payment for newly emerging molecular diagnostic tests. One key advice from the panel was that thinking upfront about the reimbursement strategy will be increasingly more important for companies with new, innovative products. A panelist also suggested that during clinical trials, companies can also think about reimbursement and instead of doing only what may be required by the FDA, if they can also collect reimbursement data then they would come out ahead. During innovation, the companies should relentlessly focus on disease management, and that would lead to them to appropriate and effective reimbursement strategy, advised the panel.
Financing and IPO issues were addressed in various panels. One interesting panel on Crowdfunding discussed a handful of portals that are beginning to raise some capital for emerging growth companies. One investor who was attending the panel, later told me, that it is too early to give an opinion on what kind of success this strategy would yield, but he had some grave concerns. AdvaMed CEO’s Unplugged Panel featured some of top leaders of the MedTech industry, who shared their insights on key challenges facing the industry. Stuart Randle, CEO of GI Dynamics advised startups to focus on crucial healthcare issues including obesity. He also advise companies to pursue capital intensive strategy, and at least initially sell products outside the US. Scott Brooks, CEO of Regenesis Biomedical, advised startups to get good legal and regulatory counsel early on. Patrick Daly, CEO of Cohera Medical was optimistic about the future of MedTech. “IPOs are coming back, M&A is picking up, and dollars are rolling in, big companies have record levels of cash, and I feel positive”, he said.
One of the most prolific financiers, Bill Hambrecht gave a keynote address. Hambrecht has over 500 IPO’s to his credit that include seed level funding in nascent industries. Although I did not attend the keynote, I heard some highly positive comments from an attendee. Steven Burrill, who has been at the helm of innovation in healthcare and shares and who regularly shares his insights through his annual reports, gave a second keynote. Again, I missed the address but both keynotes were major highlights of the event. Throughout the conference, over 800 emerging companies gave presentations. Following the presentations, partnering and breakout sessions gave the opportunity for conference delegates to meet the CEO’s of these companies.
Although it may seem hard to believe, it appears that now the MedTech sector has nowhere to go but up. The industry has learned some hard lessons, the companies are lean, operating with greater efficiency, spending cash wisely, and instead of hawking next new technology, they are focused on key problems facing the healthcare industry, and on providing effective solutions. If the healthcare providers are not eager to incorporate some of the solutions, then it will happen out of necessity. It will become incumbent upon the healthcare industry to implement solutions offering greater ROI in terms of improved health and lower cost. Healthcare providers will be looking for solutions that provide digital and point of care diagnosis and health monitoring and treatment options and solutions from personalized medicine and genomic health. Let us stay tuned for some cool innovations from the MedTech sector in 2014. Senior Analyst at Wells Fargo, Larry Biegelsen has also observed that not only acceleration in healthcare spending is expected in 2014 but there are number of other tailwinds including, “emerging technologies and emerging markets contributing more to growth and a more industry-friendly FDA, which should lead to faster approval times for medical devices”.
Posted by Darshana V. Nadkarni, Ph.D. in Biotech - Medical Device - Life Science - Healthcare on January 15, 2013
The 6th Annual OneMedForum http://www.onemedplace.com/forum/ conference featured a theme “Profiting from Distuptive Changes in Healthcare and Finance” and ran concurrently with the JP Morgan Healthcare conference, in San Francisco, CA. It was a gathering of some leading investors and the rest management of promising emerging life science companies in Asia and North America. Through panels, workshops, and up-close programming with top industry leaders, attendees explored strategies for company growth.
Overall, there was a palpable focus at this conference on how best to navigate the turbulent market changes and challenges. During individual company presentations, I saw and heard some cool technologies. But during almost all the panels, one cannot avoid noticing that these are challenging times for medical device industry. Panels explored bootstrapping and non-traditional approaches to navigate the companies in the environment of limited resources, little VC funding, uncertain regulatory and reimbursement climate, and looming tax changes. The attendees walked away from the panels with excellent advice, resources, and tools that could help them better steer their companies during this time. See highlights below from some of the panels.
The conference began with China Forum on January, 7. The objective in first two panels was to educate attendees on challenges and opportunities for emerging healthcare companies for doing business in China, while panel 3 aimed at providing tactical approach to innovate joint venture structures.
In his opening remarks, Bin Li, Managing Director & Senior Research Analyst for China Healthcare, Morgan Stanley Research, gave an overview of China’s healthcare landscape. China market is primarily pharma market and not a device market and is the 3rd largest market, right after US and Japan. China’s pharma / biotech market cap is at $200B, with chem/drugs being the biggest sub-sactor. Medical device industry is relatively small in China and hospital and services is an even smaller industry but is the most exciting sector to watch, in the next ten years, said Li. Hong Kong market is a big piece of the pie. China market is heavily regulated and is expected to grow 15-20% for the next 5 years. There are 3 major insurance programs and are sponsored by the Government. Almost entire population (97%) has some kind of coverage and it ensures that everyone in the value chain receives some benefits. Hospital patient traffic volume has now reached historical highs. Some of the challenges of the China pharma industry are; it is a highly fragmented market, it is too tightly controlled, there are price control issues, and there is fierce competition in the low end generic market. Some of the challenges of China medical device industry are; while it is the fastest growing sector, it is not well regulated yet, and there are price control issues.
China Case Study Panels
Several important points were made, during the first panel session, focused on entering the China market, moderated by David Chen, Managing Director with BFC Group. The panelists included, Alan Paau, VP & ED at Cornell Center for Technology Enterprise & Commercialization, Jay Dong, GM with Asia Pacific Region, Cell Signaling Technology & Vice Chairman of BayHelix, Mark Xu, GM at Trout Group, Shanghi and Peter Luo, Founder & CEO of Adagene. China has had success in innovative products and while it continues to grow and there are some first in class drugs, most drugs are “me too-s”. China had 7 NDAs approved in 2011, in comparison to 30 in US. Approval times have greatly shortened in China. In China, similar to US, the primary focus is in oncology, followed by CNS. Many panelists talked about the importance of building trust, in order to do business in China, but cautioned against blind trust and instead advised “trust but verify”.
The next panel focused on operational issues, once a company is on ground, in China. Panelists in the next panel included, Landon Lack, CEO of China MedConnect, Tony Zhang, Chair of BayHelix & Sr. Research Fello, Eli Lilly, Jimmy Zhang, Managing Director, MSD Early Investment, Greater China at Merck, and Jie Liu, Corporate VP of BD & Corp Communications and President of Simcere of America. One issue debated extensively was whether a company should find one credible, trustworthy distributor and hand over issues to them or find several regional distributors. The panelists suggested various other options that are in between the two extremes. Other options that were suggested include, setting up a small commercial team that does not take up a lot of capital; instead of a distributor, find a local company in the similar area and partner with them; and explore how a medical device US company can grow with pharma distributors in China. The panelists suggested frequent travel with extended stays, cautioning that flying visits were not enough. It was also strongly advised that a company entering China market get IP protection, both in US and in China, else few Chinese potential partners would be interested. It was also advised to prescreen potential partners, establish a firm control over the brand and market, go through regulatory process upfront and have a clear understanding of how the deal is structured and its tax implications.
“Connected Health” Panel
Connected Health panel discussed recent trends, implications, challenges and opportunities in technologies that provide patients with ways to monitor their own health. Whether through iPhone apps or through chips implanted in a patient’s body, these technologies are aimed at improving the quality of life. But are they making a big enough difference that payors will pay and investors will invest? These and other issues were discussed in this panel, moderated by Andrew Colbert, Senior VP at Ziegler. The panelists included, Jack Young, Director of Qualcomm Life Fund, Qualcomm Ventures; Peter Neupert, Operating Partner at Growth Buyout Fund, Health Evolution Partners; and Dirk Lammerts, Managing Director at Digital Health, Burrill & Company.
According to Neupert, the whole area of connected Health is growing mature from delivery standpoint, with efficient and accessible technologies. However, the challenge is about inducing change. Additionally, lots of capabilities can generate a great deal of data but the industry has not matured enough to put this data to good use. They are weary of investing in this field. According to Young, however, this is the time to stay ahead of the curve and their fund has invested 50% or $1.4B of capital into digital health. This is invested into six sub segments; wellness & fitness, change driven management, transition care, aging in place, clinical trials, and primary care. There is a need for better data aggregation, said Young. According to Lammerts, the important question is; “what problem is a specific technology solving”? Its is not about cool engineering, but about identifying specific problem that is addressed.
In response to the question, if the area will develop as a payor provided or consumer engaged area, Lammerts said, it has to be consumer engaged, where the consumer is empowered with tools to better manage their health. According to Neupert, it is not about who pays but who has the skin in the game and if there is alignment of interest between physician, patients and provider. According to Neupert, budle payment model with pull adoptions may be the key to induce behavior change. In the end, the usefulness of growing wave of digital health technologies will materialize only through large scale adoption by consumers, and it seems, no one has yet unraveled the key to lasting behavior change.
“CEOs Unplugged” Panel
In a panel session moderated by Stephen Ubi, President & CEO of Advamed, the panelists, David Dvorak, President & CEO at Zimmer, Virginia Rybski, President, CEO, and Director at Regenesis, and Peer Schatz, Managing Director & CEO at QIAGEN, discussed some of the medical technology sector’s most critical issues with a great deal of initial focus on alternative sources of funding and cost containment in development, given the current paucity of VC funding.
Rybski shared that their company was cash positive but it required a lot of focus and instead of the VCs, they raised $15M over 10 years, from Angels. They are now looking into crowd funding opportunities. Also, if the product is for export then a company can get money from the Government to develop, said Rybski. According to Schatz, on the diagnostic side, even if there is clear value proposition, if the mechanism of reimbursement is not clear then it would be hard to get funding from any source. Dvorak shared that they contained costs through improving outcomes, helping hospitals better manage the inventory, and through better communication between the company, hospitals, and customers. “We have been more proactive at increasing operational efficiencies in all areas of our business”, said Dvorak. Rybski also shared that given the intense focus on cost containment, while they were not laying people off, they were also not hiring and not focusing on innovation but solely on sales.
The panelists discussed the importance of key partnerships as key source of information and sharing resources, to help navigate through the current challenges.
Bootstrapping: Bringing Medical Devices to Market with Limited Resources
Christian Haller, VP of Product Development at MPR Associates, moderated this panel and panelists included, Thom Rasche, Partner in Earlybird Ventures, Vicki Anastasi, Senior VP, Medical Devices at Aptiv Solutions and Ashley Wallin, VP of the Emerging Growth Company Council at AdvaMed.
FDA continues to be at the top of the challenge list for small companies. However, according to Wallin, FDA wants to support more innovation through various initiatives such as the Entrepreneurs in Residence program. Sequestration remains a threat, however, which has the potential to result in understaffing at FDA. Additionally, companies struggle with obtaining coverage and payment, and are even losing coverage they once had. Wallin suggested that companies look into reimbursement strategies, early on. Also companies need to keep track of what’s changing in terms of the Physician Payment Sunshine Act, OUS regulations and so on. One example of a strategy companies use to bootstrap is to first commercialize lower class and consumer devices to get to revenue more quickly, which in turn supports commercialization of more complex devices downstream, said Wallin. Also, there are a number of free resources to be leveraged; in addition, a tax break for exported products can be leveraged.
“Don’t worry about reimbursement”, said Rasche. If a company has technology that would improve patients’ lives, then it will get reimbursed, he assured. The goal should not be to get in the US first, but eventually. And it would be hard to tell what reimbursement scenario would look like in next 5 years. Digital health technologies may have an easier regulatory path but would not be easy to get reimbursement. A company can get CE mark easily and get to proof of concept. However, funding situation in Europe is as challenging, as in the US, he cautioned. He noted that private pay models,would have looming challenges of commercialization and test marketing and even bigger challenge would be clinical adoption. However, if the technology offers the opportunity to find a private pay model in which patients and physicians are aligned then the company should pursue this strongly, said Rasche.
He suggested, companies try to outsource what they can and if they find a vendor willing to share the risk then it also looks good to the VCs. The path he suggested was, get regulatory approval in Europe, then tap into Asia market, and then come to US.
According to Anastasi, commercialization path would depend on the technology. For a technology to have faster approval process, it has to have fewer safety issues, preferably a single use with valid predicate. While entry into Europe can be easier, each market in Europe is different and one needs to be knowledgeable about the markets. And the same holds true of Asia, advised Anastasi.