Investors and CEOs of Biomedical Start-Up Companies Voice Concerns, and Opportunities for Early Commercial Milestones
Are the biggest opportunities for the U.S. biomedical industry's growth and commercialization available outside of the U.S.? According to CEOs, surveyed at the largest gathering of healthcare financiers and executives, commercialization opportunities outside of the U.S. (OUS) are very attractive.
Portland, OR, February 08, 2012 --(PR.com)-- Biomedical and MedTech start-up CEOs meet each year at the JPMorgan Healthcare Conference and the OneMedForum, during the largest gathering of healthcare financiers and executives and the biggest health care investing event of the year. Each year attendees and investors figure out where they’re going to put their money and a new trend evolves. This year, that trend is that emerging, rather than developed, markets are steering U.S. start-ups away from a burdensome and uncertain regulatory environment in the U.S. “A large meeting of investors and CEOs is the ideal event for international business experts to present opportunities and build relationships in an environment designed for networking,” says Haio Fauser, International Commercialization Principal at acroMIS. “We use events like this conference to demonstrate the merits of early international clinical success by presenting on-time and on-budget solutions for clinical work and pilot trials with centers of excellence in markets outside the U.S.”
In 2012 the conference has again grown in size. In a time when the U.S. MedTech industry has experienced a dramatic slowdown in the rate of growth, and venture financing dropped for the fourth (4) consecutive year. In a November 2011 CEO Survey of one hundred (100) biomedical companies in California, CHI-California Healthcare Institute, BayBio and PwC US reported that eighty percent (80%) of CEOs said that the current FDA regulatory approval process slowed down the domestic growth of their start-up. The majority of CEOs said their companies had to delay a research or development project in the past year due to lack of funding, demonstrating that the pace of R&D productivity depends on the availability of capital and a favorable regulatory framework. In this unfavorable economic environment, CEOs need to demonstrate success in hitting clinical and commercial milestones earlier, while investors focus on “de-risked” later-stages companies that are profitable, cash-flow positive, or at the very least, generate sales.
"U.S. Biomedical companies have long relied on domestic pathways to clinical trials, but funding conditions are shifting, timelines are shorter and companies will need to adapt to a new budget reality. Because of limited resources to address commercial opportunities, my clients now need to achieve milestones with less time and less money," said Mr. Fauser. “As provisional coverage of new technologies can be expected to become a new standard practice for private payers’ coverage decisions in the U.S., access to international markets might be of interest to more early stage companies."
Clinical work and first commercial success outside of the U.S. can generate the comparative effectiveness data (CED) which is a potential condition of coverage by private payers and Centers for Medicare & Medicaid Services (CMS) in the U.S. Alternative sources for clinical evidence and commercial success are available, but the new pathways to success highlight the shifting opportunities and dynamics in the American life sciences business.
About acroMIS:
acroMIS aims for a rapid and cost-efficient pathway to achieving clinical and sales milestones, and we created significant sales for our clients with the international commercialization of technology for minimally invasive, cardiovascular, interventional and endoscopic applications. Haio Fauser is the founder of acroMIS and a multilingual sales & marketing professional with work experience in Europe, Asia and America. He offers flexible, and cost-effective contractor services for emerging biomedical companies that seek to build early evidence, generate comparative effectiveness data (CED), and implement early commercial success. acroMIS works as a contractor in long-term assignments or completes individual project-based tasks. Contact Haio at (650) 336-8641 voicemail, info@acroMIS.com email, or http://www.acroMIS.com website.
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In 2012 the conference has again grown in size. In a time when the U.S. MedTech industry has experienced a dramatic slowdown in the rate of growth, and venture financing dropped for the fourth (4) consecutive year. In a November 2011 CEO Survey of one hundred (100) biomedical companies in California, CHI-California Healthcare Institute, BayBio and PwC US reported that eighty percent (80%) of CEOs said that the current FDA regulatory approval process slowed down the domestic growth of their start-up. The majority of CEOs said their companies had to delay a research or development project in the past year due to lack of funding, demonstrating that the pace of R&D productivity depends on the availability of capital and a favorable regulatory framework. In this unfavorable economic environment, CEOs need to demonstrate success in hitting clinical and commercial milestones earlier, while investors focus on “de-risked” later-stages companies that are profitable, cash-flow positive, or at the very least, generate sales.
"U.S. Biomedical companies have long relied on domestic pathways to clinical trials, but funding conditions are shifting, timelines are shorter and companies will need to adapt to a new budget reality. Because of limited resources to address commercial opportunities, my clients now need to achieve milestones with less time and less money," said Mr. Fauser. “As provisional coverage of new technologies can be expected to become a new standard practice for private payers’ coverage decisions in the U.S., access to international markets might be of interest to more early stage companies."
Clinical work and first commercial success outside of the U.S. can generate the comparative effectiveness data (CED) which is a potential condition of coverage by private payers and Centers for Medicare & Medicaid Services (CMS) in the U.S. Alternative sources for clinical evidence and commercial success are available, but the new pathways to success highlight the shifting opportunities and dynamics in the American life sciences business.
About acroMIS:
acroMIS aims for a rapid and cost-efficient pathway to achieving clinical and sales milestones, and we created significant sales for our clients with the international commercialization of technology for minimally invasive, cardiovascular, interventional and endoscopic applications. Haio Fauser is the founder of acroMIS and a multilingual sales & marketing professional with work experience in Europe, Asia and America. He offers flexible, and cost-effective contractor services for emerging biomedical companies that seek to build early evidence, generate comparative effectiveness data (CED), and implement early commercial success. acroMIS works as a contractor in long-term assignments or completes individual project-based tasks. Contact Haio at (650) 336-8641 voicemail, info@acroMIS.com email, or http://www.acroMIS.com website.
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Contact
acroMIS International Commercialization
Haio Fauser
(650) 336-8641
www.acromis.com
Haio Fauser
(650) 336-8641
www.acromis.com
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