… India is an acknowledged clinical trial destination for drugs and building on this reputation, the country has been garnering its fair share of medical device trials as well. But there are some speed breakers preventing the latter from achieving its full potential. Sachin Jagdale analyses the ‘trials’ and ‘errors’ plaguing this sector in India. [...]
Tag Archives: adverse impact on technology
New devices can be tested in Indian territory, without permission/NOC from DCGI
Monday, March 19, 2012
Filed in Ideas For Surgery News
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Also tagged 2012 California Biomedical Industry Report, A business plan is key, academic medical center, accelerated investments to serve the emerging markets, accelerating globalization, Access to capital, acquisition of technologies, acroMIS, acromis implementation and development, add value through research, address patients’ need, address the high risk, adopted within the culture of surgery, adoption of austerity measures, advantageous position, age-related disease, angel investors, applications of technology, 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, bring jobs to the community, burdensome and uncertain regulatory environment, business plan competitions, California’s biomedical industry, Candidates in queue, categorized by the FDA as class I II or III, CE Mark trial of the next-generation, challenging environment, CHI-California Healthcare Institute, choosing the right delivery method, cities hit hard by the economic recession, clinical value, commercialize medtech, competitive landscape is likely to change, complex demands and challenges, Congress, considered as a first line therapy, constrained healthcare budgets, copyrighting and patenting, corporate partnerships as a source of financing, corporate venture capital as a finance source, Corporate venture funding, cost of the device, cost-effective solutions, coverage and reimbursement issues are extremely important, creating a prototype, critical decision factor, current global economic situation, cyclical problem of depressed macroeconomic conditions, dealing with high risk complications, declining procedure volume, degree of risk to patients, delay a research or development project, deliver value to the overall healthcare system, delivered through two approaches, delivering better economic value, demonstrate that company is hitting milestones in development, demonstrate the economic value at both the provider and payer levels, demonstrating it in clinical in-patient trials, develop new products, develop specific plans to accelerate our global growth, device requires regulatory approval at some level, devices approved for procedures, devices are more expensive and time-consuming to bring to market, 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, Early funding from angel investors, Early seed funding is used for preliminary business operations, economic downturn, economic potential of this specialized, emerging markets, engaging primarily with the physician, enrollment in the pilot study, equivalent or investigational, Europe, European Market, evaluated the merits of our products solely on the clinical value, Evolving Market, executives who provide start-up capital to businesses in exchange for ownership equity and tax benefits, expanding insights into these markets, FDA approval, FDA has the best regulatory approval process in the world, federal government offers economic assistance to small businesses, 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, From Idea to Clinical Use, fund companies during their growth phase, funding from venture capital firms, gain social status by being affiliated with socially conscious projects, global growth goals, global leadership position, global P&L responsibility, government grants, growing regulatory barriers, growth opportunity for our industry, Haio Fauser is a local market expert in each of the geographic regions, high surgical risk, how prospective innovators can navigate these issues, Idea in and of itself has absolutely no value, idea should be patented and protected as intellectual property, idea that can actually raise funding, Implementation, Implementation of the idea is where the value lies, improving our ability to attract investment and grow, in the form of laboratory testing and regulatory submissions, in the OUS market, increased pressure in utilization, innovation and state-of-the-art medical technology, innovative technologies, intellectual property protection, IRB institutional review board approval, 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, maintain the high standards of safety and effectiveness, Many centers require approval from a number of committees, many patients with age working against them, market in Europe, market research and product development, Medical devices, medical devices companies, meet the urgent need of patients, meeting the needs of the billions of people in emerging markets, Most cities and some states provide local assistance to start-up businesses, multinational, myriad of complications, nascent technologies, natural orifice transluminal endoscopic surgery NOTES, necessity of the procedures to be performed in specialized centers, NeuRx DPS, nonclinical factors, noninvasive, not be able to secure bank loans, onditions, opportunity to network with potential investors, Optimize Innovation And Accelerate Globalization, outside the US OUS, Outside The USA (OUS) Global Markets Amid Soft US Sales, overt risk, partnerships, patients with spinal cord injuries or Lou Gehrig’s disease, percutaneous endoscopic gastrostomy catheter, pharmaceuticals, physicians are not true businessmen, physicians may have to perform 30 cases before they attain the desired level of proficiency, physicians’ learning curve, pivotal trial, plan to study it in patients, potential to draw funding for development, premarket device requiring an investigational device exemption, prevailing economic uncertainty, principle investigator, products in clinical development, progressive, project delays cited by private company CEOs, proper selection of patients, provided advice, providing expertise. early clinical evidence, PwC, Raising Money, recent launches, recreate the ecosystem that has made the US the leading biomedical region, Regulatory Environment will Determine R&D Productivity, regulatory framework that is based on consistency, reimbursement pressure, representatives on their staff from each region, restructuring initiatives, review our businesses, scheduled for completion, seeking diverse funding sources, slow down and even halt the development of a product, slower growth of US markets, Small Business Innovation Research program, snapshot of the biomedical industry in California, solutions that deliver better economic value, source of funding to the industry, stamp the foot there, state-of-the-art procedure, stepwise progression from prototype to approved commercial device, strong and collaborative partnership between our business, study results published, substantially equivalent to one legally in commercial distribution, successful surgeon-inventors, Surgeons can use a device off-label at any point, sustainable growth, take ideas from the drawing board to the operating room table, takes a lot of money, targeting a limited launch, tax incentives for innovation, Team work, testing it in the laboratory, The business of clinical trials, The CEO Survey, The cost of innovation in the medical device and drug area currently is not sustainable in the US, the current FDA regulatory approval process has slowed the growth, the current trajectory of rising healthcare costs is unsustainable, the funding process, the future of global economic recovery, the institution will gain some equity as a result, the investment of corporate funds into external endeavors, The process of generating innovative technologies, The role of IRBs is a contentious one among device developers, the standard of care, the type of device or stage in testing, threats to the biomedical industry’s growth, To Improve Execution, trademarking, training of the physicians and staff is significant, try and maintain some control, Under development, unfavorable reimbursement decision from the CMS, unsuitable for this open surgery, Value for a device is created through the development commercialization and regulatory process, Venture Capital, Venture capital financing typically has three or four stages, venture capital is invested in exchange for an equity stake in the business, we must prioritize our investment, wealthy retired entrepreneurs, widespread economic uncertainty, Widespread rollout, Working collaboratively with other stakeholders
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