MDMA
MedicalDevices.com supports The Medical Device Manufacturers Association (MDMA), a national trade association based in Washington, DC providing educational and advocacy assistance to innovative and entrepreneurial medical technology companies. Since 1992, MDMA has been the voice for small companies, playing a proactive role in helping to shape policies that impact the medical device innovator. This is accomplished by maintaining relationships with key Members of Congress, senior staff at FDA and CMS, and through the grassroots support of our members. For more information please visit www.medicaldevices.org
ALLIED MEMBERS
 A visionary market leader, Access MediQuip provides proven, innovative and comprehensive medical device solutions. Access MediQuip delivers proven device benefit management for payors, streamlines the procurement process and reduces financial risk for healthcare providers and creates greater market opportunities for manufacturers through our flexible implant management platform. With insight gained through the management of over 80,000 life saving and life enhancing medical implants since 1997, Access MediQuip’s expertise is unrivaled. Access MediQuip leverages its extensive industry knowledge, robust technology platform, and trusted relationships with payors, healthcare providers and manufacturers to deliver exceptional value and insight. www.accessmediquip.com |
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 You can rely on Centurion Sterilization Services for your sterilization needs. We specialize in turnkey sterilization validation programs and customized EO cycles, featuring 3 and 7 day release options. Centurion is capable of handling all product volumes—from single cases to truck loads. Our on-site, full service laboratories provide faster turn-around times. We have three facilities strategically located to handle logistics for every region of the country. You can count on full regulatory support, including protocol preparation, full documentation and final report package. Centurion is ISO13485 certified, EN550 compliant, and FDA registered. www.centurionsterile.com |
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 Disposable Instrument Company manufactures custom metal disposable medical components and devices, as well as a line of standard wound drainage trocars for the medical manufacturer. As components, our devices contribute high value through overall quality including unsurpassed sharpness, smoothness and cleanliness, freedom from manufacturing defects and corrosion, outstanding appearance and reasonable prices.All of our products are manufactured to our customer’s specifications and require additional components, packaging and sterilization before they are ready for distribution or sale to doctors or hospitals. In addition to wound drainage trocars, the company manufactures aluminum and stainless-steel products such as laparoscopic trocars, Steinmann pins, K-wires, obturators, tunnelers, introducers, passers, guide pins, bone drills, special suture needles, and cannula/trocar assemblies. The company also offers prototyping services for product development. www.disposableinstrument.com |
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 Minnetronix is a medical device outsourcing company, specializing in the design, manufacturing and support of electronics-based medical devices. Minnetronix’ experienced engineers and manufacturing teams provide expertise on a wide range of Class II and Class III medical equipment, such as cardiovascular systems, point-of-care diagnostic instruments, therapeutic devices, implantable devices, and monitoring equipment. Minnetronix has completed more than 100 development and manufacturing projects for more than 75 different medical device companies that range in size from small start-ups to large established firms. Minnetronix is ISO 13485:2003-certified and is an FDA-registered contract manufacturer. www.minnetronix.com |
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 NDH Medical, Inc. is a contract manufacturer of single use medical devices specializing in thermoplastic extrusion. Single and multi-lumen tubing, co-extrusions (striped and layer), taper tubing, paratubing, and wire and coil coating are available in a wide range of medical grade thermoplastics. Injection molding, insert molding, tip forming, hole punching, printing, and packaging services are also available as is turnkey manufacturing and inventory management. Strategic alliances with other firms allow NDH to offer a complete turnkey solution to a medical device startup company or a global firm. www.ndhmedical.com |
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ASSOCIATE MEMBERS
Premium Members |
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 If you are looking for world class service, look no further than the member insurers of the Chubb Group of Insurance Companies (“Chubb”). Chubb is a leader in the property and casualty insurance industry as a result of consistently striving to build lasting relationships. For more than 20 years, Chubb has been providing cost-effective risk management and insurance products and services tailored to the needs of medical device companies. Chubb’s insurance professionals specialize in the medical device market; they understand the issues and develop responsive solutions. www.chubb.com |
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 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. www.hullassociates.com |
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 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. www.imshealth.com |
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 Jaeger Medical Research Associates specializes in securing coverage and reimbursement of medical devices and procedures. Does it seem like you’re running into coverage, payment or coding hurdles at every turn …..“Your technology is promising, but it is “investigational” because there is insufficient clinical evidence to support coverage”. The way to get Medicare and commercial payers to pay for new devices and procedures is to show a positive impact on the endpoints of clinical outcomes, functionality, and/or lifestyle improvements in well-designed trials. We offer the consulting services needed to guarantee a positive coverage and reimbursement outcome for your product. www.jaegermedicalresearchassociates.com |
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 Pacific Bridge Medical (PBM) is a leading medical consulting firm dedicated to assisting medical companies in Asia. Our consultants have helped over 200 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. |
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 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. www.r2ss.com |
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 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. www.ropesgray.com |
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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. www.quintiles.com/quintilesconsulting |
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 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. Go to www.tarius.com for more details and your free trial offer. |
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 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. www.threearchpartners.com |
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 Vasco Advisers is a small European consulting company working with business and strategy development – mainly in the medical sector.
Our clients are medtech / biotech and pharma companies, investment and VC firms, public and private healthcare service providers, healthcare policy makers and other players active in the healthcare sector. Our consultants have solid understanding of:
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Standard Members
| 4Site Interactive Studios
Multi-media design and development
www.4sitestudios.com |
| Alta Partners
Venture Capital Firm www.altapartners.com
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| Arent Fox PLLC Full service law firm, leader in life sciences www.arentfox.com |
| B & D Consulting National advisory and advocacy firm www.bakerdconsulting.com |
| Crowell & Moring, LLP Legal counseling and transactional services www.crowell.com |
| Deloitte LLP International professional services firm www.deloitte.com |
| DGResearch Gov’t Affairs and Corp. Communications Research and Consulting |
| Healthpoint Capital, LLC Research and private equity specialists in orthopedics www.healthpointcapital.com |
| Holland & Knight LLP Legal / Consulting www.hklaw.com |
| Jeffrey J. Kimbell & Associates Federal affairs and political strategy |
| JR Associates Medical Device reimbursement – strategy/implementation |
| MPR Associates, Inc. Engineering/design for new medical product development www.mpr.com |
| NAL Worldwide Specialty logistics provider www.nalworldwide.com |
| Neocure Group LLC Reimbursement consulting www.neocuregroup.com |
| New Enterprise Associates Venture Capital Firm |
| Preferred Health Strategies Private payer reimbursement and coverage issues www.phsconsult.com |
| The Reimbursement Group Reimbursement Consulting www.thereimbursementgroup.com |
| Reimbursement Principles, Inc. Reimbursement consulting |
| Step One Communications Public relations planning |
| Strada Consulting Corporation Strategy/Execution: Minimally Invasive Devices |
| Synergy Life Science Partners Venture Capital Firm www.synergylsp.com |
| The Weinberg Group, Inc. Science & regulatory consulting www.weinberggroup.com |
| Vector Resources, L.C. Assist with the commercialization of emerging technologies www.vectorresources.com |
| Wilson Sonsini Goodrich & Rosati Legal / Life Sciences & Technology www.wsgr.com |
