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, email@example.com
Arnall Golden Gregory. LLP
Arnall Golden Gregory LLP, with more than 150 attorneys in Atlanta and Washington, D.C., employs a "bsiness sensibility" approach to serving clients domestically and abroad. founded in 1949, the firm is known for its deep bench and having the capability to handle nearly any business-related legal issue. Key practices include Healthcare, Food and Drug, Government and Regulatory, Government Affairs and Public Policy, Corporate and Securities, and Government Investigations and Special Matters. AGG is a previous honoree on The National Law Journal's prestigious Midsize Hot List of 20 firms nationwide that are making a difference.
For more information, visit. www.agg.com
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
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
For more than 25 years, member insurers of the Chubb Group of Insurance Companies ("Chubb") have been providing cost-effective risk management and insurance protection tailored to the unique requirements of medical device companies. Chubb's insurance professionals specialize in the medical device market; they understand the issues and develop solutions for unique insurance needs. this experience and expertise, coupled with Chubb's financial strength and superior claims service, were the reasons MDMA selected Chubb as its preferred insurer for Property, Package, Clinical Trials Liability, Errors and Omissions Liability Insurance, Products Liability & Professional Liability Insurance. To learn more, please visit http://www.chubb.com/businesses/csi/chubb13029.html
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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/
Faegre Baker Daniels
Faegre Baker Daniels is a global law firm partnering with medical device companies in the U.S. and abroad to bring products to market and enhance business strategies. We guide our clients through every stage of the product life cycle, including R&D, clinical trials, FDA approvals, marketing and promotion compliance, and potential product liability litigation. FaegreBD Consulting's health & biosciences team, based in Washington, D.C., works with medical device manufacturers, industry groups and voluntary health associations to offer advisory, advocacy, regulatory, reimbursement, government funding, federal affairs, strategic counseling and economic development services.
For more information, visit www.FaegreBD.com or www.FaegreBDC.com
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
With more than 350 intellectual property lawyers, 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.
For more information, visit www.finnegan.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.
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
Reed Smith represents many of the world's leading companies in complex litigation and other high-stakes disputes, cross-border and other strategic transactions, and crucial regulatory matters.
With lawyers from coast-to-coast in the United States, as well as in Europe, Asia and the Middle East, Reed Smith is known for its experience across a broad array of industry sectors. Reed Smith counsels 13 of the world's 15 largest commercial and savings banks; 25 of the world's 35 largest oil and gas companies; and the world's three largest pharmaceutical distribution and wholesale companies. Reed Smith's shipping practice has been designated among the most preeminent in the world, and its advertising law practice is regarded as among the legal industry's finest.
For more information, please visit www.reedsmith.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
SDED Global works with companies that need to be FDA compliant. The firm accomplishes this by working with their systems and remediating all the systems that are at risk. SDED's experts take a risk-based approach, doing what's right to ensure our customers are compliant by making sure they understand what needs to be done. Their small business has over 23 years of experience.
For more information please visit www.sdedglobal.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
Strathspey Crown LLC is a strategically positioned growth equity firm that partners with physicians to foster the development of innovative healthcare technologies, therapies, procedures, and services. However, new barriers are being created as governments throughout the world continue to aggressively regulate the reactive/reimbursement healthcare sector. Barriers that severely limit consumer choice. Barriers that dramatically impede the innovation and growth of medical technologies and services. Which is why Strathspey Crown specializes in identifying and supporting emerging opportunities in the proactive/private-pay healthcare sector that offer compelling new medical wellness and/or “lifestyle” benefits.
For more information, please visit www.strathspeycrown.com