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Argenta Reimbursement Advisors provides strategically integrated reimbursement solutions to life science companies. Argenta’s focus is to deliver actionable strategic reimbursement counsel in order to work in concert with achieving the client’s business objectives. The Argenta team has the unique ability to leverage its expertise along the full continuum from strategy formation and coding and payment systems analysis to payer negotiations and customer reimbursement support. This means that Argenta can be a single-source solution for addressing the unique and often complex reimbursement needs of companies in the medical device industry.

Chubb has the total insurance solution for the risks faced by life science companies, with a tailored portfolio of products and services to help protect a company's bottom line from the financial devastation of a loss or lawsuit. Medical device technologies are a key focus of Chubb's specialty.

Since 1995, Chubb has had a dedicated team of underwriting, loss control and claim staff focused exclusively on this face-paced industry. This experience and knowledge is evident in Chubb's products and services, and has earned the recognition of the Medical Device Manufacturers Association as their preferred insurance provider.

Hull Associates is a global government affairs and reimbursement consultancy, focused on medical device and diagnostics issues in the major markets outside of the United States. We specialize in managing the relationships that are critical to successful implementation of reimbursement and market access strategies. We focus with our clients on building their capabilities to manage and execute solid international reimbursement strategies. Hull Associates successfully manages all dimensions of reimbursement, from understanding the technical aspects of payment systems to leveraging maximum political advantage of key stakeholder interests. Our firm delivers fully integrated support to maximize market outcomes for medical device clients, from dossier preparation to sales force trainings and coalition building. Seasoned medical device consultants in all major markets of the Globe. Providing reimbursement analysis, market forecasting, pricing studies and lobbying support in all the major markets.

Operating in more than 100 countries, IMS Health is the world's leading provider of market intelligence to the healthcare industries. With $2.2 billion in 2007 revenue and more than 50 years of industry experience, IMS offers leading-edge market intelligence products and services that are integral to clients' day-to-day operations, including portfolio optimization capabilities; launch and brand management solutions; sales force effectiveness innovations; managed care and over-the-counter offerings; and consulting and services solutions that improve ROI and the delivery of quality healthcare worldwide.

IMS applies evidence-based intelligence - combining the best global healthcare information with powerful analytics and healthcare consulting expertise – to help our clients shape business strategies, make superior decisions, and achieve a competitive edge.

Kaye Suzuki Device Consulting, LLC, the Japan Black Box Buster, is a strategic consultant partner for medical device companies that have entered or are considering entering the Japanese market.

Based on eighteen years of experience in development, marketing, production, quality, regulatory, reimbursement and compliance for world-class companies pursuing profitable growth strategies in Japan, we offer practical advisement and a wide range of technical support for:

  • New Market Development
  • Product Development
  • Regulatory Approvals
  • Reimbursement
  • Post Approval Compliance
  • General Management

 

Pacific Bridge Medical (PBM) is a leading medical consulting firm dedicated to assisting medical companies in Asia. Our consultants have helped hundreds of medical companies with business development and regulatory affairs in Asia since our founding in 1988. Our services include registering medical products, finding distributors, sourcing/manufacturing, setting up joint ventures, conducting market research, and more. We can help you in China, India, Japan, Korea, Taiwan, and other Asian countries. We also host monthly Asia medical webcasts and publish updated medical reports available for sale. We publish a FREE monthly Asian Medical eNewsletter. Please see our website at www.pacificbridgemedical.com to subscribe.

Quintiles Consulting provides global regulatory, product development, clinical, compliance and validation consulting services to the medical device industry.

We are results focused and have established an impressive record of tangible benefits for our customers – we do what we say. Out cadre of experts include former FDA investigators and seasoned industry experts with years of “know-how” in designing and implementing compliant systems. Our former FDA reviewers can guide you through the device review process efficiently and effectively.

Whether your needs are small – an hour of expert advice; or large – fulfilling the requirements of an FDA consent decree, Quintiles Consulting has the depth of expertise and the right resources to fulfill them.

R-Squared — for “reimbursement and regulatory”— provides compliance software and services for healthcare and life sciences organizations. Our solutions combine expert knowledge from leading health lawyers and compliance officers with the latest in technology, and range from off-the-shelf software products to full service engagements that encompass compliance program assessments, internal controls enhancements, risk mitigation controls, and full-featured custom software solutions and training. As leading proponents of “Evidence-Based Compliance,” and to satisfy government enforcements efforts, R-Squared created RADS—“regulated arrangements database solution”—which consists of two independent software modules: Arrangements Keeper, which manages and evidences compliance around financial relationships with referral sources (e.g., consulting agreements, grants, case studies); and SpendTracker, which reduces the administrative burden and facilitates compliance with state marketing/gift reporting and disclosure laws. Currently, RADS is used to manage over 5,000 regulated arrangements for leading companies throughout the United States.

Ropes & Gray is a leading global law firm built on a foundation of more than 140 years of dedication to forging strong client relationships. Our 1000 lawyers and professionals provide comprehensive legal services to leading businesses and individuals around the world. Clients benefit from our unwavering standards for integrity, service and responsiveness. With offices in preeminent centers of finance, technology and government, we are ideally positioned to address today's most pressing legal and business issues.

Tarius® offers customized regulatory and quality intelligence web portals for pharmaceutical and medical device companies. Given the complexity of the regulations and the high cost of non-compliance, more and more companies are turning to Tarius for a single view of up-to-date regulatory directives, FAQs, expert opinions and reference documents from over 60 countries. Tarius is valued for its “google-like” simplicity that makes it more efficient, reliable and faster to access the regulatory and quality information needed to reduce regulatory risk.

Three Arch Partners was formed in 1993 to provide young companies with access to relevant clinical and business resources, as well as capital.  Three Arch Partners has helped create, build, and fund more than 100 healthcare companies.  The investment focus in on opportunities in medical devices and healthcare services, as well as biotechnology and information technology.  The partnership manages over $1 billion in capital.

Underwriters Laboratories, Inc. (UL) is a regulatory service provider helping medical device companies through the regulatory process. UL is the only provider based in North America offering a complete regulatory solution for today's global medical device market including registration to ISO 13485:2003, QMS Registration for Canada, Technical File approvals for Europe and Japan, InMetro qualification for Brazil, gap assessments for Risk Management to ISO 14971, and FDA 510(k) Third Party Reviews. UL continues to support the medical device industry through ongoing expansion of regulatory services and support of organizations like MDMA who support the medical device industry.