Premium Associate Member Directory

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 technology 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

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, mcohn@alliant.com 


ANR Consulting, LLC

Adi Renbaum, owner of ANR Consulting, is a strategic advisor to medical technology companies commercializing devices in the U.S. She has led national campaigns for coverage and payment of new devices by Medicare and commercial payers, and negotiated regional and national payer/provider contracts. Her experience includes obtaining new payments for hospital-based surgical devices and implants, drug/device combination products, and office-based procedures and diagnostics. She works with specialty medical societies to build physician advocacy and consensus to secure new AMA CPT procedure codes for novel procedures. She serves on the CMS MEDCAC Panel (2017-2019), and is co-director of the National Association of Managed Care Physicians-Medical Directors Institute.


 

Arnold & Porter Kaye Scholer

Arnold & Porter Kaye Scholer, 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.apks.com


Baker & Hostetler LLP

BakerHostetler, one of the nation's largest law firms, represents clients around the globe. With offices coast to coast, our more then 940 lawyers litigate cases and resolve disputes, navigate laws and regulations, and help clients close deals that fuel their strategic growth.

We have five core practice groups: Litigation, Business, Employment, Intellectual Property and Tax. Within these groups are large specialty practices, including antitrust, healthcare, mergers and acquisitions, complex commercial litigation, data privacy and security, patent prosecution and international tax. Our attorneys have broad knowledge and experience in many industries, including energy, media, manufacturing, healthcare, financial services and hospitality.

For more information visit www.bakerlaw.com.


Canary Insights

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/ 


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


ELITE Strategic Services, LLC

ELITE Strategic Services, LLC, is a focused consulting firm based in the Washington, DC area. We provide strategic and advisory services to help clients anticipate, navigate, and mitigate government-imposed hurdles, identify and unlock business opportunities, and position themselves for business growth in regulated commercial sectors. ELITE is a customer-oriented service that leverages its assets in medical technology, public policy, business, and public affairs. We assess clients' regulatory exposure - now and over the horizon - and assist clients in developing strategies to mitigate those risks and to capitalize on new directions in federal policy - to minimize risk and maximize opportunity.

For additional information please contact CEO James Edwards, PhD at jedwards@ELITEStrategicServices.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 nearly 350 intellectual property professionals, Finnegan is one of the world’s largest IP law firms practicing all aspects of patent, trademark, copyright, and trade secret law, including counseling, prosecution, licensing, and litigation.  Finnegan delivers sophisticated legal strategies to help medical device clients protect, advocate, and leverage their valuable IP assets.  Our experience handling some of the most complex innovations in the medical device, pharmaceutical, biotechnology, and diagnostics industries 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 comprehensive 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


Hogan Lovells

Hogan Lovells

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

Hull  Associates is a global government affairs and reimbursement consultancy, focused on medical device and diagnostics issues in 22 markets worldwide. 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 

IQMS provides software designed for medical device manufacturers and their suppliers. IQMS offers smart and practical manufacturing ERP software solutions tailored to 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 turn to their specialized suite of medical quality tools including DHR, electronic signatures, and CAPA to address their ever-evolving needs. IQMS also enables smart, connected manufacturing using production monitoring technologies and real-time reporting to ensure consistent quality and practice the modern operating principles outlined in the FDA's "Case for Quality".

For more information, visit www.iqms.com.


  

Knobbe Martens

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.



Kohlberg, Kravis Roberts

KKR is a global investment firm that manages approximately $168 billion in assets and invests across multiple alternative asset classes, including private equity, energy, infrastructure, real estate, credit and hedge funds. Within the private equity business, the health care team pursues private equity, growth equity and royalty or structured debt investments.  The team invests across the health care landscape including medical devices, biopharmaceuticals and services. Representative past or present medical devices investments include Zimmer Biomet, Lake Region Medical, Panasonic Healthcare, Cohera, EchoNous, Spirox, AcuFocus, Ebb Therapeutics and Ajax Health.

 

For more information, please visit www.kkr.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



Musculoskeletal Clinical Regulatory Advisers, LLC

Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) is a leading advisory firm and Clinical Research Organization (CRO) to the neuro-musculoskeletal industry with growing experience in other specialties. Founded in 2004, MCRA is headquartered in Washington, DC, with offices in New York, NY, and Manchester, CT. MCRA has more than 50 team members, and serves over 400 unique clients globally. The true value of MCRA is the integration of five business value creators for orthopedic & other medical/surgical specialties: regulatory, reimbursement, clinical research, compliance, and quality assurance. MCRA provides “first-in-class” services through its superior knowledge base, global surgeon and physician relationships, and deeply experienced management team.

 

For more information, please visit www.mcra.com, contact us at 202-552-5800, or send us an email at info@mcra.com


  

NAMSA

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


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


PRIA Healthcare Management, LLC

As PRIA Healthcare Management (PRIA) has evolved into the medical device industry’s most predominant partner in market access, we have embraced the ever-changing landscape of barriers to adoption put forth by insurers, both government and commercial. By offering a vast array of patient access and reimbursement related solutions, PRIA drives new technology adoption by providers in the care setting and payers in the coverage setting.

Our unique place in the market positions PRIA between patients, providers, medical device manufacturers and payors. Our flexibility allows each client we service the ability to customize an approach to meet their individual needs. PRIA prides itself on understanding the current climate of healthcare and the unique challenges each manufacturer, physician and patient face in the process of gaining coverage.

By tactically addressing the needs of our clients, PRIA is able to deliver unmatched success in patient access to prescribed care. Strategically, our process of selecting only the most respected and experienced strategic reimbursement partners, as well as employing some of the most tenured professionals in the industry internally, we have effectively embraced the adaption, revision, and change necessary to navigate the success of the next life changing treatment in the market.We look forward to the opportunity to be your Helping Hand in Healthcare!

For more information, visit www.priahealthcare.com/.



RoundTable Healthcare Partners 

RoundTable Healthcare Partners was founded in 2001 and is based in Lake Forest, Illinois. We have a unique combination of operating and transaction professionals who have worked together for more than 20 years, and have over 200 years of collective healthcare experience in medical products, devices, pharmaceuticals and distribution.

RoundTable has raised $2.75 billion in committed capital, including four equity funds totaling $2.15 billion and three subordinated debt funds totaling $600 million. We are currently investing out of our $650 million Equity Fund IV and $200 million Capital Fund III, which were raised in September 2015. In our 15-year history, we have invested in 18 platform companies, completed over 60 add-on transactions, and exited 12 portfolio companies.

For more information, visit www.roundtablehp.com


Sughrue Mion, PLLC

As medical innovators continue to develop instruments, apparatus and software to promote health and to diagnose, prevent and treat disease, Sughrue has been at their service.  For 60 years, Sughrue has assisted clients across diverse medical technologies, such as surgical robots, drug-eluting heart stents, electro-mechanic medical devices, interventional cardiology, medical imaging,  and pain management, and many others.  Our attorneys have technical degrees in biomedical engineering, robotics, electrical engineering, pharmacology and chemistry.  Drawing from technical knowledge and legal expertise, our attorneys provide clients with solutions to protect and add value to their IP assets and navigate IP issues.

 

http://www.sughrue.com/ 


T3 Advisors

As the trusted real estate and workplace advisory firm to the world's leading innovators, T3 Advisors focuses on empowering companies to use their space as a tool to directly benefit their culture, profit and growth. With offices in Boston, Palo Alto, San Francisco, and New York, and projects all over the world, T3 Advisors is the only tenant-rep commercial real estate firm in the country that focuses exclusively on the technology and life science industries. By representing only tenants, T3 also offers a transparent, conflict-free look into real estate strategy. 

T3 advises innovative companies in all stages—from startup to post-IPO—and provides services in real estate brokerage, project management, government advocacy, workplace and culture advisory, real estate portfolio management, global location strategy, and other corporate real estate services.

For more information, visit t3advisors.com.

TAMM Net, Inc.

TAMM Net, Inc., is a, reimbursement and regulatory consultancy serving biomedical manufacturers. TAMM Net helps manufacturers navigate the federal government, capturing opportunities and overcoming obstacles to commercialization. Among our core services is facilitating clinical trials with federal resources, understanding and gaining reimbursement and marketing approvals/clearances and contracting with federal departments/agencies. Our reimbursement and regulatory experts have expansive resumes and relationships with key stakeholders. Learn more about TAMM Net, at  http://tammnet.com and discover how we can help you achieve your goals.


Ximedica  

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, Silicon Valley and Hong Kong.  For more information contact: Peter Thier, Executive Vice President of Business Development (o)  401-330-3163  or visit  www.ximedica.com