MDMA Premium Associate Members
Akin Gump Strauss Hauer & Feld, LLP
Akin Gump Strauss Hauer & Feld LLP is a leading global law firm providing innovative legal services and business solutions to individuals and institutions. They are one of the world's largest firms, with more than 850 lawyers and professionals in 20 offices. The booming health care equipment market, though fertile ground for success for medical device and diagnostic companies, carries with it significant regulatory and compliance challenges, both domestically and internationally. Akin Gump's health care and life sciences lawyers and advisors have comprehensive knowledge of this complex, highly regulated industry and the rapidly changing issues that confront it that is derived from many years of hands-on experience.
For More information, visit www.akingump.com
Alliant's Life Science and Medical Products Specialty Group serves clients in every state and in many foreign countries because they deliver cost-effective solutions that optimize coverage and meet companies specific needs. Providing coverage audit, insurance/asset protection and risk management services to hundreds of life science manufacturers and distributors; Alliant clients include public and private companies with operations ranging from start ups conducting clinical trials to extensive global manufacturing & distribution. Ranking among the 15 largest U.S. insurance brokerages; Alliant provides property & casualty, workers' compensation, employee benefits, surety, and financial products and services to more than 20,000 specialized clients.
For more information, contact: Matthew Cohn, Senior Vice President, (O) 602-707-1917, (C) 602-980-3191, firstname.lastname@example.org
Arnold & Porter LLP
Arnold & Porter LLP, is an Am Law 100 international law firm providing counsel at the intersection of business, law and regulation. With more than 800 attorneys practicing in more then 30 distinct areas of the law, we provide strategic, client-focused and innovative legal services. Guided by our core values of excellence, professionalism, diversity and public service, we are committed to seeking creative solutions to help our clients succeed in a highly competitive and increasingly regulated world. Our team of more than 50 regulatory and compliance attorneys advise life sciences companies on addressing the risks confronted at each stage of product research and development, manufacturing, marketing sales and distribution. We routinely advise companies on the implementation and enhancement of global compliance programs, and vigorously defend our clients in a broad range of investigations and enforcement matters. Our global reach, experience, and deep knowledge allow us to work across geographic, cultural, technological and ideological borders, serving clients whose business needs require US, EU, or cross-border regulatory, litigation, and transactional services. The firm remains committed to partnering with our clients for the future. We offer counsel on the emerging topics in law, regulation, and policy. We remain at the forefront of legal policy issues and new developments in the law -- whether they be in securities law, environmental law, hedge funds, product liability, or nanotechnology -- and we continue to expand our experience.
For more information, visit www.arnoldporter.com
At Canary Insights, we are continuously mining coverage and reimbursement changes for your therapy and products. We perform a daily search on over 200 payers and related healthcare sites including Medicare, Medicaid and hundreds of commercial insurance companies. Canary Insights alerts you to these changes so you will be the first to know.
Canary Insights was created by coverage and reimbursement experts, able to recognize and navigate the complex healthcare environment. We understand how medical device, biotech and pharma companies need up-to-date information on payer coverage decisions. Canary Insights delivers these important changes to you, on time, so you can effectively manage your customer and business needs.
Please visit http://www.canaryinsights.com/ for more information.
Capital One Healthcare
Capital One Healthcare is a leading provider of financial services to the industry. Customers across healthcare sectors—including medical devices, long term care, pharmaceuticals, hospitals and outpatient services, healthcare IT and medical properties —rely on Capital One Healthcare to finance acquisitions, refinance existing debt, support working capital needs and fund growth initiatives. With in-depth expertise, our team of professionals creates solutions tailored to meet the needs of our customers.
Capital One Healthcare is a part of Capital One Commercial Banking, which leverages a relationship-based banking model that seamlessly delivers an array of products and services including loans and deposit accounts, treasury management services, merchant services, investment banking, international services and correspondent banking.
For more please visit: https://www.capitalone.com/commercial/healthcare/
Chubb Group of Insurance Companies
Since 2009, Chubb has been endorsed by MDMA as the preferred provider for a broad array of insurance solutions including clinical trials and product liability, products and services errors and omissions liability, directors and officers liability, employment practices liability, fiduciary liability, and cyber and data security insurance. As the world's largest publicly traded property and casualty insurance company, with operations in more than 54 countries, Chubb has been providing risk management and insurance protection tailored to the unique requirements of medical device companies for more than 25 years.
Chubb is the marketing name used to refer to subsidiaries of Chubb Limited, providing insurance and related services. For a list of these subsidiaries, please visit our website www.chubb.com.
Covington & Burling LLP
Covington & Burling LLP is an international law firm that represents medical device companies from start-up ventures to multinational manufacturers. Our attorneys include former offices of FDA, CMS, DOJ, and other government agencies, allowing us to represent clients on the full range of legal and regulatory matters, including FDA regulatory, reimbursement, data privacy, intellectual property, litigation, corporate and transactional matters, and government relations. Covington also assists clients in connection with government enforcement actions, ranging from 483 responses to criminal proceedings. With offices across the U.S., and in Europe and China, we are able to advise companies on a global basis.
For more information, visit www.cov.com
E.M.M.A. International Consulting Group, Inc.
E.M.M.A. International Consulting Group, Inc. is a global leader in management consulting services, with headquarters in Farmington Hills, MI. We focus on quality system, regulatory, and compliance services for the Biotechnology, Pharmaceuticals, Medical Device and all other FDA regulated industries, in addition to various non-FDA regulated industries. Think of E.M.M.A. International Consulting Group as a one stop shop for all of your quality, regulatory, and compliance needs. We provide a wide array of specialized services and solutions to our clients, backed by extensive knowledge and industry expertise. Our mission is to provide significant value to our clients’ operations, and leave them completely satisfied that their expectations were fulfilled. We are very flexible in the types of services we provide, from smaller limited assignments to long-term complex projects.
For more information, visit http://www.emmainternational.com/
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
With more than 350 intellectual property professionals, Finnegan is one of the largest IP law firms in the world practicing all aspects of patent, trademark, copyright, and trade secret law, including counseling, prosecution, licensing, and litigation. Finnegan has delivered successful, sophisticated legal strategies to help medical device clients protect, advocate, and leverage their valuable IP assets. Our experience in the medical device, pharmaceutical, biotechnology, and diagnostics industries—handling the most complex innovations—allows us to offer insight and advice on critical legal issues your business may face. From determining the competitive landscape for new products to developing winning litigation strategies, we provide a full range of services to our medical device clients, which include startups, Fortune 100, and Global 1000 companies.
For more information, visit www.finnegan.com
Straight talking. Understanding and solving the problem before it becomes one. Delivering clear and practical advice that gets your job done. Hogan Lovells offers extensive experience and insights gained from working in some of the world's most complex legal environments and markets for corporations, financial institutions, and governments. We help you identify and mitigate risk and make the most of opportunities. Our 2,500 lawyers on six continents provide practical legal solutions wherever your work takes you.
For more information, visit http://www.hoganlovells.com/
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 the major markets.
For more information, visit www.hullassociates.com
IQMS is a software company designed for and utilized by medical device manufacturers. IQMS offers a powerful manufacturing ERP software solution tailored to comprehensively meet the unique challenges of the medical device manufacturing industry. When FDA compliance, medical device quality and enterprise-wide traceability are critical factors of success, IQMS customers to to their customized modules (such as their suite of medical quality tools including DHR) to address their ever-evolving and complex needs.
For more information, visit www.iqms.com.
Knobbe Martens is a law firm practicing exclusively in intellectual property law including patents, trademarks, copyrights, licensing, and litigation. The firm has filed over 5,000 patent applications in the medical device arts alone, helped over 50 medical device companies get acquired or go public, and successfully litigated numerous medical device IP cases, including through trial and appeal.
We’ve been active in the medical device industry almost from its inception—providing leading-edge counsel and representation for the entire spectrum of clients, including “garage” inventors, start-up companies, venture capitalists, medical device incubators, and established, publicly held-corporations. Visit us at knobbe.com and knobbemedical.com.
Medical Technology Partners
It is Medical Technology Partners' mission to accelerate the rate of trial and acceptance of important new medical technologies, thereby enabling them to reach patients more quickly. Medical Technology Partners helps companies understand and work with new reimbursement realities within the health care marketplace by way of reasonable and functional strategies and plans. MTP is committed to excellent customer service, advancing patient care, making timely and accurate recommendations, and reasonable and flexible pricing arrangements.
Medical Technology Partners will enhance the development of important new medical technologies by providing high quality and fully integrated reimbursement support services to the medical industry, with an emphasis on medical device and diagnostic technologies.
For more information, visit www.medicaltechpartners.com
NAMSA is medical research organization providing expert regulatory, laboratory, clinical, and compliance services to medical device and healthcare product manufacturers. At every stage of the product development process, NAMSA provides strategic guidance and tactical support to help clients commercialize medical products in the major markets of the world.
NAMSA serve's as your trusted partner, using insight to identify strategies for saving time, while never compromising quality. NAMSA knows that compromised quality can quickly take your product right back to the starting line. That's why it's so important to have a smart strategy from the outset-and why NAMSA puts it at the forefront of every project.
The path to regulatory approval can be long and complex, NAMSA provides a reliable way to get there.
For more information, visit www.namsa.com
NSF Health Sciences - Medical Device Consulting
Medical device companies operate in a complex global regulatory environment with continually changing standards. NSF Health Sciences medical Devices assists companies in navigating U.S. and International regulatory hurdles from product inception through product marketing. Primarily, it provides clinical strategy, regulatory submission and panel advisory support, Quality system development and remediation, FDA response support to FDA 483's, Warning Letters and other enforcement actions and a full line of professional training and education programs. the NSF team of experts in the regulatory, scientific and compliance fields understands the industry and regulatory requirements to bring medical devices to market - and sustain them throughout their life cycle.
For more information, visit www.nsf.org.
OPTIM Associates, Inc.
OPTIM Associates, Inc., employs former FDA and industry professionals specializing in U.S. and European medical device regulations.Our knowledge base encompasses products of all device classifications, including combination products.
For more information, please visit http://www.optimcorp.com/services/
Pacific Bridge Medical
Pacific Bridge Medical (PBM) is a leading medical consulting firm dedicated to assisting medical companies with business development and regulatory affairs in Asia. We have helped hundreds of companies achieve success in the Asian medical markets 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 have offices in China, Japan, Singapore, and Hong Kong, and partners throughout Asia.
Visit our website for free, informative resources, including webcasts, publications, research reports, and a monthly Asia medical e-newsletter.
For more information, visit www.pacificbridgemedical.com
Porzio Life Sciences
Porzio Life Sciences’ regulatory compliance software solutions, products and services assist pharmaceutical, medical device and biotechnology companies in complying with marketing and sales regulations, including PDMA, anti-kickback statutes, False Claims Act, FDA, OIG, Physician Payments Sunshine Act, Affordable Care Act and state aggregate spend compliance regulations.
For more information on Porzio Life Sciences, please visit:
Precision for Medicine
Precision for Medicine is a specialized scientific services partner dedicated to helping life science innovators develop and commercialize next generation medical products. We understand the challenges and opportunities posed by the modern health care market and offer a unique combination of expertise, scientific infrastructure, and organizational scale to help guide products from development, through regulatory review, to market introduction, and commercial success.
Precision for Medicine offers best-in-class teams of scientists and industry experts coupled with a specialized portfolio of services to help accelerate research, enable market adoption, enhance patient outcomes, and realize the full commercial potential of innovative products.
For more information, visit www.precisionformedicine.com
RoundTable Healthcare Partners
RoundTable Healthcare Partners, founded in 2001, is based in Lake Forest, Illinois. We have a unique combination of operating and transaction professionals who have worked together for 20 years with over 200 years of collective healthcare experience in medical products, devices, pharmaceuticals and distribution.
RoundTable manages five investment funds totaling $1.9 billion of committed capital:
Fund I; $400 million; raised in 2001-2002; 7 platform investments in 3 years.
Fund II; $500 million; March 2005; 6 platforms; 5 1/2 years.
Fund III; $600 million; July 2006; 2 platforms to date.
Cap Fund I; $200 million; subordinated debt fund; July 2006.
Cap Fund II; $200 million; July 2010.
For more information, visit www.roundtablehp.com
STLGip is a boutique intellectual property firm counseling medical device and technology companies, with sound strategies from a lean prospective, utilizing our combined legal, technical, business, operational expertise, and consultative approach.
We represent companies at all stages of their development and work with founders, management, board, tech transfer offices, and in-house counsel to address challenges, create opportunities, and move your organization forward.
For us, operational excellence matters for every engagement. We are focused, agile, and have a great reach, both domestically and internationally, as well as the flexibility to act swiftly.
For additional information, please visit us at www.STLGip.com
Ximedica is a full-service product development firm exclusively focused on medical technologies. Entrusted by the world’s leading medical and pharmaceutical companies as well as emergent start-ups, we help our clients envision, develop and deliver their innovations to market. Both ISO 13485 certified and FDA registered, our Quality System ensures the breakthrough designs and intellectual property we create improve outcomes and enhance lives. Ximedica has offices in Providence, Minneapolis, San Francisco, Los Gatos and Hong Kong. For more information contact: Peter Thier, Executive Vice President of Business Development (o) 401-330-3163 or visit www.ximedica.com