Exponent's Medical Device Seminar Series: List of Past Seminars
Off-Label Use of Medical Devices: Promotion and Compliance
November 18, 2009Virginia Gibson
US Attorney's Office
Mark C. Levy
Saul Ewing
Drugs, biologics, and devices are increasingly used to treat patients in ways that were not approved or cleared by FDA. While FDA does not regulate the practice of medicine or off-label use, it does regulate off-label promotion. However, the FDA has released a "reprints" guidance that permit companies, in limited circumstances, to distribute certain types of materials that discuss off-label use of the products.
In addition to FDA, the U.S. Department of Justice has firmly taken control of off-label use allegations against pharmaceutical, biotechnology, and medical device manufacturers through the Food, Drug and Cosmetic Act (FDCA), the Anti-Kickback Statute, and the False Claims Act.
This tension between patient benefit and government enforcement puts companies in a difficult position. Should they remain silent when data is developed that may benefit patients, or risk prosecution and litigation related to off-label promotion by disseminating scientific information that may indicate important therapeutic options for patients?
In this seminar, the panel will discuss problems arising from off-label use and promotion, while providing practical instruction on how to deal with them.
Topics Include:
- Training and monitoring sales and marketing representatives
- Product liability litigation and other civil actions including Allergan vs. United States of America, et al.
- Government enforcement of off-label sales and marketing compliance
September 9, 2009Steve Niedelman Crowell & Morning
Dan Miller
Inteprod, LLC
Jason Clevenger Exponent, Inc
Medical device manufacturers are becoming increasingly dependent on suppliers of raw materials, parts, and even components or entire medical devices. These suppliers may be situated locally, across the country or in a developing country halfway around the world. Regardless of where the supplier is located, it is essential that the manufacturer establish efficient and rigorous supplier control programs to assure the quality of the materials and products used in finished medical devices. Supplier quality problems have been at the center of issues regarding recalls, adverse event reports, and good manufacturing practices noted recently in warning letters. The impact of supplier quality on your bottom line, reputation and risk cannot be underestimated.
Highlights that will be discussed by this panel include:
- What issues have appeared in recent warning letters leading to recalls regarding supplier quality?
- Qualifying a supplier—what should their quality and risk management systems be like?
- How should you audit a supplier?
- How much of the increased regulatory burden should suppliers share?
- What if you need to change a supplier?
- How should you optimize cost and quality in your selection of a supplier?
- Where are most of the supplier quality problems taking place geographically?
- How do you handle communications between a supplier and FDA ?
November 12, 2008
Virginia GibsonCivil Division, US Attorney’s Office
John Reiss, Ph.D. J.D.Saul Ewing
Norm Johanson, M.D.
Drexel University
Jorge Ochoa, Ph.D.
Exponent, Inc.
Do consulting agreements with physicians result in the development or improvement of life saving products, or could they be kickback schemes rewarding high volume physicians for brand loyalty? Unlike drugs that usually are developed in company laboratories, medical devices frequently are created or improved by physicians. These physicians are involved in the design and development processes and are often hired to train colleagues in their use. As a result, many physicians may have a financial stake in the success of the device. Medical device manufactures frequently develop relationships with these physicians, as well as those who prescribe their products and act as opinion leaders within their field. Physicians may be compensated through royalty payments, consulting fees, speaking honorariums or subsidized trips to attend conferences and training sessions. Recently, the government has alleged that companies’ payments are inducement to use the company's products, thereby making the payments illegal. How can you mitigate the likelihood of enforcement action while maintaining a competitive position in this very competitive industry?
Highlights that will be discussed by this panel include:
- Recent DOJ activities that have impacted the industry
- Increased compliance activities by medical device and pharmaceutical industry
- Handling conflict of interest in the academic setting
- Physician involvement with the industry and role of bias
- Value of physician input for the advancement of technology
July 16, 2008
David W. Anderson President and CEO, Gentis, Inc.
David R. King
Venture Partner, Quaker BioVentures
What attracts venture capitalists to fund certain start-ups and not others? Many of today's leading medical device and biotech companies began as start-ups funded by VCs who took a risk. This seminar will provide a forum for discussion of how lower-risk strategies combined with successful commercial marketing plans can be achieved to help entrepreneurs attract the capital vital to a start-up's success. Members of the business community who have played critical roles in bringing start-ups to fruition will provide key expertise on this subject.
Highlights that will be discussed by this panel include:
- The real-life experiences of CEOs in growing an early-stage company
- What criteria do investors use to evaluate a biotech or device start-up?
- At what stage should VCs be approached?
- What concerns VCs when considering their next investment?
- How important is it for the start-up to have other products in the pipeline?
- What role does patent protection play in the consideration of funding?
- How to differentiate your start-up to make it attractive for funding.
November 30, 2007
Katayun I. Jaffari, Esq.
Saul Ewing, LLP
Maria Maccecchini, Ph.D. Robin Hood Ventures
Jeffrey J. Totten, MBA Dean & Company
Entrepreneurial firms and well established corporations play an important role in the development of medical devices. Often, these firm’s business plans include merging or being acquired as an exit strategy or to add value to their existing portfolio. We hope to provide a forum for interactive discussion to explore the important factors that will lead to a successful merger or acquisition. This panel discussion will feature members of the business and legal community who have played integral roles in providing key expertise, participated in mergers and acquisitions, and will provide case studies of mergers and acquisitions.
Highlights that will be discussed in this panel discussion include:
- How is value created during a merger or acquisition?
- What are the important issues to consider from the point of view of company being acquired or merged?
- What are the important issues to consider from the point of view of a larger company?
- Who should be included as part the team during a merger or acquisition?
- What contractual and legal issues are important in the M&A process?
- What regulatory/compliance issues are important?
May 22, 2007
John Reiss, Ph.D., J.D.Saul Ewing, LLP
Marta L. Villarraga, Ph.D.
Exponent, Inc.
In today’s fast-paced environment to get devices to the market you need to make sure that as you are planning your regulatory strategy to get your device cleared or approved by the FDA, you are also considering how it will be reimbursed.
This case study presentation will identify and analyze critical reimbursement considerations for developers trying to bring innovative devices to market.
Highlights include:
- Providing an example where a device was cleared but the reimbursement strategy took much longer and why
- Making your organization more attractive to potential investors by not only thinking about the regulatory pathway but also the coverage for the device
- Case studies of examples of adequate and inadequate coverage strategy
- Case studies of examples of success stories in both the regulatory and reimbursement landscape
September 7, 2006
Lynn Malinosky, Esq.
Woodcock Washburn, LLC
Joseph Lucci, Esq. Woodcock Washburn, LLC
Maurice Valla, Esq.Woodcock Washburn, LLC
Robert McGrath, Ph.D. Associate Vice Provost for Entrepreneurship and Technology Commercialization, Drexel University
In today’s research environment with so many discoveries being made that could lead to commercialization of medical devices, awareness of intellectual property protection needs to be a priority. Steps taken at the initial stages of development to protect the intellectual property can lead developers down an easier road to success.
This panel discussion will provide an overview and analysis of critical awareness that inventors need to maintain in order to protect their inventions, increase the value of the commercialization, and avoid future infringement claims.
Highlights include:
- Protecting your intellectual property: What, When, Who
- Making your organization more attractive to potential investors with adequate IP protection
- How to balance the protection of IP with the desire to publish
- Case studies of examples of adequate and inadequate IP protection Case studies of examples of IP situations that led to infringement challenges
April 12, 2006
Michael J. Bronzino, CPCU, ARM Underwriting Manager, Chubb Group of Insurance Companies
Michael B. Yeager, CPCU, ARM
Sr. Life Sciences Underwriting Specialist, Chubb Group of Insurance Companies
Given today’s highly competitive business environment and the pressure to bring a new product or idea to the marketplace, would you or your organization be able to withstand any type of delay, interruption, or shut down in operations?
This seminar and discussion will provide an overview and analysis of critical risk management techniques that you can use to address those exposures that could potentially interrupt, delay or shut down your early stage medical device or biotechnology company.
Highlights include:
- Protecting your investment and intellectual property
- Making your organization more attractive to potential investors
- Establishing a review process to successfully identify and analyze potentially catastrophic loss exposures
- Development of a disaster recovery and/or contingency plan
- Use of various risk control and risk financing techniques to effectively manage critical exposures - including the utilization of commercial insurance as a means to minimize and transfer specific loss exposures
Emerging legal trends in product liability
- Importance of choosing appropriate business partners
- Case studies will highlight various situations
January 11, 2006
Tony Dimun Chairman, Nascent Enterprises, LLC
Rob Pritchard President, Pritchard, Bieler, Gruver & Willison, P.C.
Michael Bronzino Regional Manager, Chubb Group of Insurance Companies
This seminar and panel discussion will feature members of the business community who have played roles in providing key expertise for emerging medical device and biotechnology companies as they transition from idea to commercialization. Beyond having a great idea and identifying a market niche for a new medical technology, emerging companies will stand a better chance of success if they identify proper business expertise as they develop their enterprise. If you are in the field of biotechnology or medical devices as an entrepreneur or an investor, or someone providing services to such industry, this panel will provide an overview of resources available for these emerging businesses.
Highlights include:
- Choosing an appropriate management team
- Understanding the organizational structure of a company
- Setting up an advisory board that will enhance the success of your technology
- Identifying adequate sources of capital investment and managing the investment properly
- Understanding what investors are looking for
- Selecting the proper entity based upon key foundational elements
- Understanding what early accounting controls you need and how to change them as you grow
- Positioning the company within the business plan to maximize the exit strategy
- Considering insurance and liability coverage to protect your investment
- Planning for a successful marketing strategy
September 21, 2005
Gail Crane Managing Director, Southern Cross Management, Inc.
Michael P. Herr President & CEO, IntuiTouch, LLC
Maria Maccecchini Member, Robin Hood Ventures
Chris Starr Executive Director, Mid-Atlantic Angel Group
What is Angel Funding? How should an entrepreneur approach early stage investors? What should the entrepreneur bring to the table? Four members of the entrepreneurial and early stage funding community will present a brief seminar and engage in a panel discussion with the audience to provide insight about these and other questions. We hope to provide a forum for interactive discussion to explore the important factors that will lead to a successful early stage investment. If you are in the field of biotechnology or medical devices as an entrepreneur, a member of a large corporation in that field, an investor, or someone providing services to such industry, this panel will provide a great perspective on the various tangible and intangible aspects affecting early stage funding.
Highlights include:
- The role of Angel investments in the funding stages of a company
- The requirements of these different funding stages: How do Angel requirements differ from VC requirements?
- The significance of an entrepreneur’s ability to establish credibility among the funding community
- The intangible factors viewed as important in the decision making process for Angel investment groups
- The value of relationships and referrals in increasing exposure to more opportunities
- The trend of investing in progressively later stages and requesting a progressively faster exit: What does that mean for the entrepreneur?
- The importance of managing expectations in early stage funding
- The perspective of biotechnology and medical device funding as seen by the Angel community
March 24, 2005
Joseph Bronzino
President, Biomedical Engineering Alliance and Consortium (BEACON), Hartford, CT
Richard A. Miller Vice President, Marketing and Communications, Innovation Philadelphia, Philadelphia, PA
This seminar and panel discussion will feature speakers from two major non-profit trade organizations that have a role in the development and commercialization of new medical technology in the northeast United States. If you are in the field of biotechnology or medical devices as an entrepreneur, a member of a large corporation in that field, or someone providing services to such industry, this panel will provide a great overview of resources available and the outlook of this industry.
Highlights include:
- Major advances in medical technologies that have enabled the United States to be a major exporter of medical technology.
- Academic, medical, and corporate entities that are members of the collaborative effort that forms BEACON, which is dedicated to the development of new medical technology.
- Goals, objectives and operation of BEACON and the benefits it provides to its members.
- Overview of Innovation Philadelphia and its role in the development and commercialization of medical technologies in the greater Philadelphia area.
- Overview of Innovation Philadelphia, its resources for early-stage life science organizations, and its role in the development and commercialization of medical technologies in the greater Philadelphia area.
- Strategy that is positioning Innovation Philadelphia as a leader in technology-based economic development.
December 16, 2004
Arthur L. Caplan, Ph.D. The Emanuel and Robert Hart Professor of Bioethics & Director, Center for Bioethics, University of Pennsylvania
This one-hour seminar will discuss the trend of evaluating medical device performance in international subjects. Many medical device and drug companies (large and small) use foreign patient populations to evaluate the success of new medical devices and drugs. This has typically played an important role in the path toward regulatory approval and setting up IDE studies in the United States. Topics include:
- Why International Subjects? Why are companies turning to international subjects to evaluate their new medical devices and drugs? How are these kinds of studies regulated in foreign countries? How do those practices compare to those in the United States? Who is responsible for obtaining informed consent?
- Is it an Ethical Dilemma? What ethical implications are at issue in this kind of practice? How much are these international subjects benefiting from the access to these new technologies? How much are the companies benefiting from these practices? What obligations are there to those enrolled in these studies when the studies end?
September 15, 2004
Lynn A. Malinoski, Esq.
Partner, Woodcock Washburn LLP
Paul F. Prestia, Esq. Shareholder, RatnerPrestia, P.C.
This one-hour seminar will discuss strategies for protecting, enforcing and litigating intellectual property in the biotechnology and medical device industries. This discussion will provide an interactive forum from both the prosecution and litigation perspectives to provide insight on key issues that come up during the development and management of intellectual property. Recent trends and practices will be discussed in the context of case studies. Topics discussed include:
- Limit of Claims: When are broad claims more appropriate than narrow claims? What are the advantages and drawbacks of each perspective? How can claim construction have an effect on future infringement litigation?
- Timing of Filing: When is it appropriate to file? When is early or deferred filing more strategically appropriate? How can funding affect this decision? When is a provisional application appropriate? How much should be included? How can a provisional application affect future litigation?
- Inequitable Conduct: Is a full disclosure more appropriate than a restrictive one? Should all the test results or examples be included in the application? How can the timing of disclosures affect the management of the IP? What should be disclosed about pending litigation or pending patent applications?
- Due Diligence: How much should be disclosed to potential investors? How will this affect the prosecution and potential future litigation?
June 17, 2004
Brian K. Halak, Ph.D. Principal, Domain Associates, L.L.C.
Geoffrey R. Erickson, Ph.D. Senior Associate, Fund Management, A.M. Pappas & Associates
Alastair Clemow, Ph.D.
CEO, Gelifex
This one-hour seminar will discuss strategies for obtaining seed capital for medical device companies and lessons learned from specific case studies. This seminar will provide an interactive forum from both the entrepreneur and VC perspective to understand how to approach funding sources, decide how much capital to raise, and assess current trends in funding strategies.
Where to Look: Finding the right funding source is imperative to getting an early-stage medical device off the ground. Understanding what VCs and other investors are looking for is essential for securing funding. Locating alternative sources of capital, including government grants, is also critical.
How to Get It: Different funding strategies have shown varying degrees of success. Deciding how much capital to raise, from whom, and when to approach VCs and other funding sources, as well as understanding the requirements necessary to raise capital, play significant roles in successful funding. It’s not just about the money – a catchy pitch, a demonstrable need in a sizable market, an experienced corporate team, a realistic plan for becoming cash-flow positive, technical acuity, and a sound financial plan are also important.
Lessons Learned: The funding market has changed dramatically over the last few years. The resulting movement towards greater adversity to risk has seriously affected the disbursement of funds by VCs for early-stage companies. Is the most likely exit still a sale, or is it preferable to move towards becoming a publicly traded company? Are reimbursement strategies beginning to take a bigger role?
March 24, 2004
William M. Janssen, J.D. Partner, Chair of Life Sciences Practice, Saul Ewing LLP (Philadelphia)
This one-hour seminar will discuss three important developments in the litigation of plaintiff injury cases against the biotechnology and medical device industries. Effective risk management is essential for success in these industries, whether one is long established or a new entrant. Keeping current on major litigation developments -such as these- helps the risk manager stay well informed. Each of the three topics will be introduced, followed by a brief summary of how the Nation's courts are applying these principles:
Fraud-On-The-FDA: Three years ago, the U.S. Supreme Court ruled that the federal Food, Drug, and Cosmetic Act impliedly pre-empted claims alleging that the FDA had been defrauded. How has this case been applied in the years since the decision was released?
Breach-of-Dignity Claims: In 2001, Maryland's highest court ruled that participants conducting clinical trials might be liable for violating a subject's "right to be treated with dignity". What type of new liability might this type of claim create?
Punitive Damages Limitations: Last April, the U.S. Supreme Court ruled that the Constitution imposes limits on the sizes of punitive damage awards. Because products liability claims represent a significant volume of all punitive damage awards, how might this ruling apply in our industries?
December 3, 2003
Janice M. Hogan, J.D. Partner, Food, Drug, Medical Device and Agriculture Practice, Hogan & Hartson, LLP
Marta L. Villarraga, Ph.D. Managing Engineer, Biomechanics Practice, Exponent, Inc.
This one-hour seminar will discuss how to get the most out of your pre-clinical testing data and computational data (where applicable) in preparation for your FDA submission. Major decisions and investments are typically made by the biotechnology and medical device industry when designing pre-clinical studies to collect data for regulatory approval. It is important to ensure that the best set of data is provided to facilitate a successful application and expeditious approval. Hypothetical case studies will be utilized to describe different scenarios.
This is your opportunity to learn about:
- The role that guidance documents and industry standards play in the design of pre-clinical studies for regulatory submissions
- Pathways to follow when such documents do not exist or do not provide enough detailed information specific to your application
- How to incorporate computational data (if applicable) in your submission
July 16, 2003 / September 15, 2003
John B. Reiss, Ph.D., J.D. Partner, Saul Ewing LLP
This one and a half hour seminar will introduce manufacturers of biotechnology and medical device products to the coverage and payment decisions made by various health care third-party payors, and to suggest strategies that they should develop during the early stages of product development and any FDA application to minimize potential later problems with coverage and payment.
Coverage involves those sets of decisions that third-party payors make about whether to cover a product or service in the first place. For example, many policies have exclusions for experimental products and services. If a brand new product is being developed, to the extent it can avoid being characterized as experimental, it will facilitate the coverage and eventual payment decision. If the product is so new that it has to fall into the experimental class, then what strategies can be used to minimize the impact? For example, if a device is investigational but not experimental, Medicare will pay for it. If it is experimental and investigational, Medicare will not.
Once third-party payors have decided to cover a product, they still have to decide how much to pay for it. If the product falls into an existing CPT code classification (CPT codes are developed by the American Medical Association to describe certain products and services) then there will already be a market price for the product. The product needs to be designed and manufactured so that the manufacturer can make a profit given the price already set by third-party payors. If that price is insufficient, then the device has to be differentiated sufficiently (without necessarily causing, for example, a PMA to be required rather than a 510(k)) so that it will need a new CPT code that can be paid a higher price.
These are some of the strategic issues about which thought should be given early in the product development process so that the manufacturer is not later caught by surprise at either too low, or no, payment.
Topics Discussed Include:
- What are coverage determinations?
- How are coverage determinations made by third-party payors?
- When are coverage determinations made by payors?
- What are existing payment methodologies used by third-party payors, and how do devices and biologics fit into those?
- The CPT coding system and how you can get a new code.
- Understanding the coverage and payment issues in the context of product development and the FDA approval process to see what strategic issues a manufacturer should consider.
- FDA labeling provisions and the relationship to coverage and reimbursement issues.
To subscribe to our seminars, please email
mcle@exponent.com