… the first ever incision-free endoluminal bariatric surgery procedure was performed in South Asia. Incidentally, this is the first ever known endoluminal revision of a prior sleeve gastrectomy performed to their knowledge in the world. The operation was performed by New York bariatric surgeon, Dr. Elliot Goodman, with the able assistance of Dr. Rajkumar Palaniappan [...]
Category Archives: Ideas For Surgery News
FDA Pathway Burdensome And Uncertain – U.S. MedTech Start-up Does Pilot Trial Outside-the-U.S. (OUS)
Friday, February 10, 2012
Also filed in A different way of doing the procedure, AAGL, Abdominal aortic aneurysm AAA
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Tagged 2012 California Biomedical Industry Report, accelerated investments to serve the emerging markets, accelerating globalization, Access to capital, acquisition of technologies, acroMIS, acromis implementation and development, address patients’ need, address the high risk, adoption of austerity measures, advantageous position, adverse impact on technology, age-related disease, angel investors, around the globe, availability of capital to fund future innovation, BayBio, biggest long-term opportunity, Biomedical Access to Capital, biomedical cluster, biomedical company CEOs, biomedical innovation, biotechnology, Boston Consulting Group, burdensome and uncertain regulatory environment, California Biomedical Industry 2012 Report, California companies are adaptive and resourceful, California Healthcare Institute, California’s biomedical industry, Candidates in queue, CE Mark trial of the next-generation, challenging environment, CHI-California Healthcare Institute, choosing the right delivery method, clinical value, commercialize medtech, comparative effectiveness data CED, competitive landscape is likely to change, compounding investors’ apprehensions, Congress, considered as a first line therapy, constitutional challenges to healthcare reform legislation, constrained coverage and payment for innovative products, constrained healthcare budgets, corporate partnerships as a source of financing, corporate venture capital as a finance source, Corporate venture funding, cost-effective solutions, countries with more certain regulatory pathways, coverage and reimbursement issues are extremely important, critical decision factor, current global economic situation, cyclical problem of depressed macroeconomic conditions, dealing with high risk complications, declining performance at the FDA, declining procedure volume, delay a research or development project, deliver value to the overall healthcare system, delivered through two approaches, delivering better economic value, demonstrate the economic value at both the provider and payer levels, develop specific plans to accelerate our global growth, devices approved for procedures, devices are priced at a hefty premium, diagnostics or medical equipment, disease foundations/non-governmental organizations, disruptive business models, each of the major emerging markets, easier access to capital, economic downturn, economic potential of this specialized, emerging markets, engaging primarily with the physician, enrollment in the pilot study, establishment of healthcare insurance exchanges, Europe, European Market, evaluated the merits of our products solely on the clinical value, Evolving Market, expanding insights into these markets, expanding markets, factors have discouraged investments in biotech and device startups, FDA has the best regulatory approval process in the world, federal efforts to contain the escalation of Medicare spending, Findings of the CEO Survey, first mover advantage, First-in-man, focus on emerging markets, force the players to increasingly compete on price, forced to look for other solutions, Forty-four percent of biomedical CEOs surveyed said they will look to licensing agreements, global growth goals, global leadership position, global P&L responsibility, government grants, government initiatives, great expansion of Medicaid to cover the uninsured, growth opportunity for our industry, Haio Fauser is a local market expert in each of the geographic regions, high surgical risk, Implementation, Implementation of the Affordable Care Act, improving our ability to attract investment and grow, In the face of these challenges, in the OUS market, inconsistent communications, increased pressure in utilization, increasing pressure on drug and device margins, Independent Medicare Payment Advisory Board, innovation and state-of-the-art medical technology, innovative technologies, issues being discussed throughout the biomedical industry by executives, key opinion leader KOL, Lack of funding, lack of innovation and productivity, less invasive treatment, licensing agreements, looking beyond California’s and our nation’s borders, maintain the high standards of safety and effectiveness, major California venture capital firms, many patients with age working against them, market in Europe, Medical devices, medical devices companies, meet the urgent need of patients, meeting the needs of the billions of people in emerging markets, moved out of investing in life sciences companies, multinational, myriad of complications, nascent technologies, necessity of the procedures to be performed in specialized centers, new law being implemented with direct consequences for the biomedical industry, new taxes on drug and devices, noninvasive, onditions, Optimize Innovation And Accelerate Globalization, outside the US OUS, Outside The USA (OUS) Global Markets Amid Soft US Sales, overt risk, partnerships, pharmaceuticals, physicians may have to perform 30 cases before they attain the desired level of proficiency, physicians’ learning curve, pivotal trial, prevailing economic uncertainty, principle investigator, products in clinical development, progressive, project delays cited by private company CEOs, proper selection of patients, providing expertise. early clinical evidence, PwC, raising concerns about coverage and payment for medical technologies, recent launches, recreate the ecosystem that has made the US the leading biomedical region, regions with financial incentives, regions with financial incentives and easier access to capital, Regulatory Environment will Determine R&D Productivity, regulatory framework that is based on consistency, Regulatory risk at the US Food and Drug Administration, reimbursement pressure, representatives on their staff from each region, restructuring initiatives, review our businesses, scheduled for completion, seeking diverse funding sources, sharply reduced their asset allocations, slower growth of US markets, snapshot of the biomedical industry in California, solutions that deliver better economic value, source of funding to the industry, state-of-the-art procedure, strong and collaborative partnership between our business, sustainable growth, targeting a limited launch, tax incentives for innovation, Team work, The CEO Survey, the continuing healthcare cost crunch, the current FDA regulatory approval process has slowed the growth, the current trajectory of rising healthcare costs is unsustainable, the future of global economic recovery, the investment of corporate funds into external endeavors, the standard of care, threats to the biomedical industry’s growth, three major areas reflecting government policy, to countries with more certain regulatory pathways, To Improve Execution, training of the physicians and staff is significant, unclear standards for what clinical data are necessary for product approval, Under development, unexplained regulatory delays, unfavorable reimbursement decision from the CMS, unsuitable for this open surgery, Venture Capital, we must prioritize our investment, widespread economic uncertainty, Widespread rollout, Working collaboratively with other stakeholders
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