The ADVI team is a strong, thoughtful, creative and highly collaborative group of healthcare executives, public policy alumni, and medical professionals from public and commercial payer settings, proven at identifying, creating, managing and realizing opportunities for tranformational change, generating ideas or accelerating growth. Together their people offer a rare combination of leadership experience, industry relationships, knowledge of the political and policy processes, reimbursement background, and transactional expertise to help clients build true value in healthcare.
For more information, visit www.advi.com
Comprehensive Reimbursement Solutions
Comprehensive Reimbursement Solutions provides personalized reimbursement services by leveraging 25 years of Medtronic experience in reimbursement, value proposition/business case development, and evidence creation to medical device companies in all stages of product development. This includes reimbursement due diligence and strategic reimbursement planning supporting capital acquisition and U.S. market access.
For more information, contact Bob.Thompson@CompReimSol.com
Coombs Medical Device Consulting
Craig Coombs has been the President of Coombs Medical Device Consulting (CMDC) since 2000. His company specializes in hands-on, innovative US, European and Asian regulatory strategies for start-ups and companies that need to change their strategies. CMDC is highly experienced in organizing effective FDA/NB meetings and all types of regulatory submissions (510(k), PMA, deNovo, Design Dossier, Medical Device License, etc.). CMDC skills include cost-effective First-In-Human (& VC milestone) clinical trial design, management and analysis. During his 26 years of medical device regulatory work, he has been instrumental for the early regulatory success of dozens of start-ups, and has been a Vice President of Medtronic in the areas of Regulatory Affairs, Quality Assurance and Clinical Studies. Mr. Coombs received his BS (Biology) from Stanford University. Mr. Coombs is adjunct faculty for the University of California (Santa Cruz) in Medical Device Submissions. He can be contacted at CraigJCoombs@gmail.com
DuVal & Associates, P.A.
DuVal & Associates, P.A. is a boutique law firm that specializes in FDA regulations for products at all stages of the product life cycle. Clientele includes companies that market and manufacture pharmaceuticals, medical devices, biologics, nutritional supplements and foods. these clients range in size from Global Fortune 500 companies to small start-ups.
For more information, visit www.duvalfdalaw.com
ELITE Strategic Services
Medical technology firms need an advisor on their team experienced in health and med tech policy to assess the regulatory risks their particular business plans, new products or innovations will face and to create strategies to mitigate those risks and turn them into opportunities. Located in the Washington, D.C. area, ELITE Strategic Services offers strategic advice, research, and other services, based on understanding how Congress and federal agencies can change the regulatory landscape before a medical innovation can move from discovery to patent to market.
For more information, please visit www.elitestrat.com or contact jedwards@ELITEStrategicServices.com
Experien Group, LLC
Experien Group is a team of more than 30 professionals whose senior executives possess over 100 years of combined experience helping companies succeed in the medical device industry. A growing number of medical device companies have benefited from our unmatched expertise in the regulatory, quality and clinical affairs areas. Our team enjoys a track record exceeding 1,000 FDA and international regulatory submissions with a 99% approval rate.
For more information, visit www.experiengroup.com
Healthpoint Capital is a values-driven, research-based private equity firm exclusively focused on the musculoskeletal sector - specifically orthopedics and dental. Healthpoint Capital manages in excess of $750 million of institutional capital.
For more information, visit www.healthpointcapital.com
Hyman, Phelps & McNamara PC
Hyman, Phelps & McNamara PC is a niche law firm focused on FDA regulation of medical devices, drugs, biologics, foods, dietary supplements and cosmetics. Members of our firm have decades of experience as former FDAers and as counsel offering practical advice for navigating the complexities of the FDA. We tailor our services to meet the specific needs of clients from Global Fortune 500 companies to midcap to small start-ups. We assist with premarket strategies and submissions and post‑market compliance. Ranked as a Top Tier FDA firm for 7 years running by The US News & World Report.
Learn more at www.hpm.com and www.fdalawblog.net.
Medical device innovation is tricky business. Often, many complex issues stand between promising technologies and commercial acceptance. For nearly two decades, JR Associates has been at the forefront of the reimbursement field - helping device manufacturers, clinicians, and others in the healthcare realm navigate the dynamics of a rapidly changing market.
For more information, visit www.jrareimbursement.com
Kemp Clinical Consulting Co. LLC
Kemp Clinical Consulting Co. LLC can provide your company with a range of services suited to your needs. We provide strategic advice for early and mid-stage medical device companies who may not have the in-house clinical expertise required to fulfill the clinical and regulatory requirements of today’s medical device industry. With more than 25 years of clinical trial experience, we can advise on the overall trial design and operational aspects from start to finish, including:
- Clinical standard operating procedures
- Investigational plan/protocol development
- Consent forms
- Data collection
- Site selection
- IRB submissions
- Monitoring plans
- Advertising and recruitment
- Contracts and budgets
- Regulatory posting and reporting
- Publication and presentation strategies
Other customized clinical study services may be available as needed. Contact us at email@example.com or go to www.kempclinicalconsulting.com to find out how we can help you navigate the complexities of today’s clinical requirements during the multiple phases of medical device development.
Kimbell & Associates
Jeffrey J. Kimbell & Associates provides legislative solutions to clients in the healthcare community facing issues related to product approval, coverage and reimbursement, marketing practices, and more.
For more information, visit www.kimbell-associates.com
King & Spalding LLP
King & Spalding is an international law firm that represents a broad array of clients, including half of the Fortune Global 100, with 800 lawyers in 17 offices in the United States, Europe, the Middle East and Asia. The firm also represents hundreds of clients with new ventures and mid-sized companies in emerging industries.
For more information, visit www.kslaw.com
At Leavitt Partners, we understand the emerging role of value in health care and the significance of this development to the future of your organization. Our insights and tools in this vital arena can help you make smart decisions, successfully navigating from today’s uncertainty to tomorrow’s prosperity. For more information please visit http://leavittpartners.com/
Longitude Capital Management
Longitude Capital is a private investment firm that focuses on venture growth investments in drug development and medical technology. The firm builds balanced portfolios of mid-stage to commercial-stage companies with clinically de-risked assets that are likely to achieve key value-creating milestones within three-to-five years. Besides traditional venture capital investments, Longitude’s investment team also proactively searches for "special situations", such as spin-outs, recapitalizations, PIPEs and structured transactions, across both privately-held and publicly-traded companies.
For more information, visit www.longitudecapital.com
MRIGlobalMedDevice is a recruitment firm with over 17 years specializing exclusively in placing medical device professionals in the areas of: R&D, Manufacturing, Operations, Quality & Regulatory. With a unique team based approach and total commitment to excellence, we are the trusted industry experts you can count on to provide superior talent for your specific hiring needs. Our commitment is to partner with you to ensure your business goals and objectives are met through hiring the very best talent in the medical device industry.
For more information: www.mriglobalmeddevice.com
New Enterprise Associates
NEA provides venture capital to help innovative entrepreneurs and business leaders build transformational, industry-leading companies around the world.
For more information, visit www.nea.com
Norton Rose Fulbright
Our global life sciences and healthcare team advises a range of innovative pharmaceutical, medical device and biotechnology companies as well as investors in the sector. We provide cutting-edge advise on the full range of legal issues that arise in the sector, from regulatory and compliance strategy to patent litigation and corporate transactions.
For more information, visit www.nortonrosefulbright.com
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
Proskauer Rose, LLP
Proskauer Rose LLP is a leading international law firm focused on creating value. Their roots go back to 1875, when they were founded in New York City. With 700+ lawyers active in virtually every major market worldwide, Proskauer Rose is recognized not only for their legal excellence, but also their dedication to client services.
For more information, visit www.proskauer.com
Quintiles (NYSE: Q) helps biopharma and other healthcare companies improve their probability of success by connecting insights from our deep scientific, therapeutic, and analytics expertise with superior delivery for better outcomes. From advisory through operations, Quintiles is the world's largest provider of product development and integrated healthcare services, including commercial and observational solutions. Conducting operations in approximately 100 countries, Quintiles is a member of the FORTUNE 500 and has been named to FORTUNE's list of the "World's Most Admired Companies."
To learn more, visit www.quintiles.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
Regulatory and Clinical Research Institute (RCRI)
The Regulatory and Clinical Research Institute (RCRI), based in Minneapolis, MN, is a leading provider of strategic regulatory and quality consulting and integrated clinical trial services to medical device, IVD and combination product manufacturers. Since 1999, RCRI has been partnering with clients worldwide to turn medical product concepts into successful, revenue-generating businesses. Our rich breadth of experience spans early regulatory strategy development through post market clinical studies. RCRI’s services include regulatory and clinical strategy, reimbursement, health economics, clinical study design, study operations, biostatistics, data management, regulatory affairs including FDA/regulatory body negotiation, quality systems support and compliance.
To learn more, visit www.rcri-inc.com
Ropes & Gray LLP
Ropes & Gray is home to one of the nation's first practices dedicated to health care law. With more than four decades of experience, their lawyers have played instrumental roles in milestone acquisitions, partnerships and new ventures, and today, clients to to them for innovative solutions and sophisticated advice for their transactions, regulatory issues, government investigations and strategic counseling.
For more information, visit www.ropesgray.com
SDRS LLC is an independent consultant/contractor providing regulatory services for pharmaceutical and medical device companies.
For more information, visit www.sdrsllc.com
Seabrook Technology Group
Seabrook’s focus is on the use of the latest technologies to create value for our clients. Our people are specifically trained to integrate these latest technologies with your business.
As a company, and as individuals, we value integrity, honesty, personal excellence, continual self-improvement, and mutual respect. We are committed to our customers and partners and have a passion for technology. We hold ourselves accountable to our customers, partners, and employees by honouring our commitments, providing results, and striving for the highest quality.
For more information, please visit www.seabrookglobal.com
Silicon Valley Bank
For more than 30 years, Silicon Valley Bank (SVB) has helped innovative companies and their investors move bold ideas forward, fast. SVB provides targeted financial services and expertise through its offices in innovation centers around the world. With commercial, international and privatebanking services, SVB helps address the unique needs of innovators. Forbes named SVB one of America’s best banks (2015) and one of America’s best-managed companies (2014). Learn more at svb.com.
Versant Ventures is a leading venture capital firm that specializes in investments in game changing medical devices, biopharmaceuticals, and other life science opportunities. Founded in 1999, the firm consists of an experienced team of managing directors committed to helping entrepreneurs build successful companies that impact healthcare and improve quality of life.
For more information, visit www.versantventures.com
VWR International, LLC
At VWR, we enable science by supplying critical products to the world's top pharmaceutical, biotech, industrial, educational, governmental, and healthcare organizations. We provide our customers with an expansive choice of premiere products, such as chemicals, furniture, equipment, instruments, apparel and consumables, from a vast group of leading scientific manufacturers.
For more information, visit www.vwr.com
WG Biomedical partners with abattoirs across the entire US to provide animal tissue for use by medical device, scientific education, and biomedical research and development companies for the ultimate goal of bringing hope, healing, and improved quality of life to people all over the world. Our collection capabilities range across many different species and many different tissue types.
Wiley Rein LLP
Wiley Rein's Food & Drug Law Practice handles complex legal and regulatory challenges, as well as the more routine but crucial regulatory tasks faced by medical device companies under FDA-enforced laws and regulations. Members of the practice group have held high-ranking positions within FDA and other agencies, and have decades of experience offering business -oriented advice for navigating the complexities of the FDA. Our attorneys receive regular recognition from independent organizations as leaders in FDA law and frequently speak at educational and industry conferences and symposia. We maintain a flexible client-team approach to easily tailor our services to best meet the specific needs of small, medium and large sized companies.
For more information, visit www.wileyrein.com
Wilson Sonsini Goodrich & Rosati
Wilson Sonsini Goodrich & Rosati is the premier legal advisor to technology, life sciences, and other growth enterprises worldwide. We represent companies at every stage of development, from entrepreneurial start-ups to multibillion-dollar global corporations, as well as the venture firms, private equity firms, and investment banks that finance and advise them. The firm's broad range of services and practice areas are focused on addressing the principal challenges faced by the management, boards of directors, shareholders, and in-house counsel of our clients.
For more information, visit www.wsgr.com