The following services can be provided individually
or as a complete turnkey package from Sage:
•
US Market Overview – an in-depth
review of the market or sector of interest to a respective
company, including input on technologies, products, companies,
and key market issues, pricing, reimbursement and future
trends:
• review of laboratory (clinical & research), POCT, OTC market sectors for IVD
• identification of trends, competition and regulatory issues
• review of leading companies and product offerings
• Analysis – either complete or
specific US market entry strategy, including key areas such
as – regulatory, IP, manufacturing, sales/marketing,
distribution, reimbursement, legal operating requirements
and implementation recommendations for addressing each:
• working through Sage, availability of US regulatory experts experienced in 510(k) submissions, CLIA-waiver, PMA filings, clinical trials, cGMP reviews
• working through Sage, availability of legal counsel experienced in IVD IP issues (molecular, lateral flow, biomarkers) across all US IVD market sectors
• assessment of sales and distribution channel options within market sectors
• input on current reimbursement policies, procedures that impact pricing strategies
• advice on guidelines for US operational and regulatory requirements
• Review of respective technology/product
categories - to identify/design strategies to enhance
market penetration and sustained participation:
• cost versus price assessments
• positioning versus competition
• identification of end-users within a market segment (lab, POC, OTC)
• technology adaption hurdles and acceptance criteria
• Operational alternatives – in conjunction with the above services, identify operating
infrastructures, direct versus distribution channels, manpower
needs, location options, legal requirements and support services:
• analysis of ‘optimum' operational infrastructure to support successful market entry and enhance initial penetration rates based upon above market, technology, reimbursement and pricing considerations
• identification of manpower needs, including support functions, to support ‘optimum'infrastructure
• analysis of US location options for business operations
•
Operational cost estimates – in conjunction
with the above, provide estimates of basic cost of operation and/or where appropriate prospective alliance conditions
if operations out-sourced:
• identify budget items necessary to support business operations for direct, distribution, alliance options in specific market sectors
• outline appropriate strategic alliance costs required to support a partnering relationship for technology,product(s)in desired market sector
•
Alliance/Partner Options – where
appropriate, review corporate partner options and identify
examples of companies and structure/terms specific for such
arrangements:
• identify appropriate alliance partners for technology, product(s) for either licensing, OEM, marketing or sales relationships in desired market sectors
• outline structure/terms appropriate for desired alliance based upon Sage experience and industry perspective
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