The following examples represent some of the projects and efforts undertaken by our principals:
Market Analysis and Business Strategy
A young company planned to develop a non-invasive diagnostic device for a specific breathing disorder.
We advised the company to focus its resources on developing software-based products and services that utilize the company's proprietary artificial intelligence technology, rather than competing with the established manufacturers of devices in this field. The company has subsequently pursued the proposed strategy, obtained significant financing, and introduced a number of innovative software products.
A division of a large conglomerate considered licensing an invention with a clinical application in the pre-hospital emergency services market.
We analyzed the opportunity for the device and identified key success factors and risks. Our multi-faceted analysis included a review of the clinical landscape, NIH and other organizations' programs in the area, impact of competing and complementary technologies, regulatory considerations and scope of clinical trials required to support approved indications and clinical acceptance, as well as primary market research to determine projected adoption rate and pricing sensitivity.
A small company acquired a technology that can be integrated into various medical products. The company asked us to assess short term and longer term opportunities for this technology, specifically in the area of cardiac monitoring and diagnosis, and to identify key features that will enable future products to be viable and competitive in, otherwise, mature and crowded markets.
Key efforts undertaken included clinical assessment of competitive technologies, review of the reimbursement environment, and a market research, including detailed feedback from over seventy cardiologists from around the country.
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An off-shore start-up company developed a technology for the orthopedic and rehabilitation market. The company requires ongoing business advice and support in penetrating the US market.
One of our principals handles the business development function for the company, providing ongoing presence, services and advice to the company's management. The services provided are considerably more cost effective for the company than maintaining a local staff and office in the US . We identify potential distributors as well as clinical and business partners, handle the required communication and advance towards contractual relationships. In addition, we author business plans in support of financing campaigns and provide general management advisory services.
A large medical technology company is continuously seeking innovative technologies, mostly from small and young companies that can be integrated into its current product portfolio.
We have identified and presented to the company a number of technologies, and sourced a number of young companies seeking outlets for their products and strategic relationships.
A company developed a new technology to diagnose a medical disorder and planned to sell it mostly to its existing customer base.
We analyzed the market opportunity and recommended to the company to focus its marketing efforts on a much larger providers' network, albeit outside its current market. Furthermore, we advised the company to postpone market introduction until the conclusion of additional clinical studies to demonstrate the efficacy of the technology by key opinion leaders in the larger market. We have also pointed to the company optimal distribution channels that could provide the required education and detailing effort required to successfully introduce the technology to the respective providers.
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Regulatory Affairs and Clinical Trial Management
Over the years, we have submitted numerous applications for 510(k) Pre-Market Notifications and Pre-Market Approvals (PMA) for diagnostic and therapeutic products, including complex electromechanical systems, computer-controlled devices, disposables and single-use devices, implantable devices, combination devices, etc.
A company developing revolutionary new technology required a regulatory clearance prior to marketing.
To reduce costs and allow faster product introduction, we have identified a unique patient group that could immediately benefit from the device. Communications with the FDA led to the qualification of the device as a Humanitarian Use Device, allowing early submission of the device for marketing clearance, under the Humanitarian Device Exemption statute.
A company developing a new surgical instrument required an approval from the FDA to conduct clinical studies within a limited timeline.
We formulated and presented to the FDA the scientific, clinical and regulatory evidence of the technology, and obtained approval for a clinical protocol that significantly shortened the trial duration and allowed meeting the clinical end points with a smaller number of patients. This resulted in significant savings in trial costs and acceleration of the time to market.
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Reimbursement and Contracting Strategies
A start-up company developing devices that enhance post orthopedic trauma recovery requested us to conduct a review of reimbursement issues associated with its technology.
We analyzed coverage guidelines for clinical services and respective durable medical equipment applied by government and commercial payers for similar technologies to determine their applicability to the company's products. We also determined the potential impact of such guidelines on product pricing, product labeling and marketing plans.
A company marketing a new technology which was not covered by all third party payers needed ongoing reimbursement support to complement its marketing and sales efforts.
Our activities in this area included the development of a detailed Reimbursement Guide, authoring a comprehensive review of all scientific evidence supporting the technology, establishing a phone service to assist clients' submission of proper claims and appealing denials, drafting proposed new guidelines for payers and conducting legal review of pricing policies to ensure compliance with the Office of Inspector General guidelines.
A healthcare company providing diagnosis and treatment service needed to improve contracts with regional payers in order to enhance its profitability.
Activities undertaken included the development of a specific strategy for each payer based on its own guidelines and policies, historical reimbursement patterns and competitive position of the provider, subsequent communications and negotiations, which have eventually resulted in expanded and substantially improved contracts with all regional and national payers operating in the company's markets.
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A new healthcare company required start-up financing, and subsequently additional capital to support growth.
We raised multiple rounds of financing from investors including 'angel' investors, venture capital funds, strategic partners, and lending companies, supporting the company until it became profitable cash flow positive.
We evaluated 75 medical device start-up companies involved in a National Technical Incubator Program, and selected 22 of them for a US road show. Over 100 meetings with potential strategic partners and investors were arranged for these companies, leading to a number of successful deals.
A self-financed company with a product assisting people with physical limitations has supported itself with ongoing sales. To scale up its operations, it was seeking additional equity investment.
We worked with the company's management to substantially increase the target market, and developed a new business plan and financial pro-forma to support the road show.
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