The Sage Group Market Entry Consultancy Service comprises a wide range of services, from a single source, designed to optimize our clients’ entry into the dynamic US and European healthcare In Vitro Diagnostics (IVD) market.
The following services can be provided individually or as a complete turnkey package from Sage:
US/EU 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/EU 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
The Sage Group Directors involved in the new and authoritative Sage ‘One Source’ Service have many years of experience in this sector and many successful transactions. Their CVs can be found on this website by clicking any of the following links:
Wayne Pambianchi
Dr. Dan Tripodi
Dr. Bill Mason
We would be pleased to discuss this new Sage ‘One Source’ Service, or any other strategic advisory or transactional need regarding the US market, with you at your earliest convenience.
Please contact Bill in EU at +44 1223 844128 or Wayne in the US at +1 908 2306170 or by email to: onesource@sagehealthcare.com.
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