Date(s) - 02/28/2019
1:00 pm - 6:30 pm CST
MetroPoint Business Center
NAMSA’s complimentary Start-Up Summit event provides a unique opportunity for early-stage medical device organizations to learn directly from NAMSA’s teams of medical device testing experts. This small, intimate gathering will offer attendees with limited medical device knowledge to draw upon NAMSA’s 50+ years’ experience with efficient, cost-effective product development. Presenters will draw upon real-world global development efforts to share recommendations, best practices and resources that are critical to successful market introduction and commercialization, including:
- Design and development
- Medical device testing
- Clinical research
- Regulatory strategy
Highlighted during the event will be the following presentations:
Product Development Process
Times have changed for the medical device industry. Any new or innovative medical device concept now days is rarely enough to gain investor interest or commitment, even when supported with unique or novel IP. Development professionals within the field not only need to understand why this ‘truth’ has evolved so dramatically, but also how it will drive change for future development efforts. Only then will device organizations truly recognize how to operate effectively within the new paradigm to become, and remain, competitive.
This presentation will:
- Explain how and why investment in novel medical device technology has quickly evolved
- Formulate expectations related to paradigm shifts and understand their impact to the New Product Development operating environment
- Identify necessary activities in order for start-ups to remain competitive in medical device innovation and development efforts
- Identify the various development options that exist, and their key differences
- Understand the benefits of the Medical Research Organization (MRO®) development approach, a process that accelerates development, reduces costs, and drives value.
FDA Trends & Guidance for Industry
The old adage that “the only constant in life is change” directly applies to the medical device landscape, and even more so to the U.S. Food & Drug Administration (FDA).
With a new Medical Device User Fee Act in its fourth iteration, a series of changes from the FDA are expected over the next five years. Likely shifts include shorter approval decision times, more patient involvement, and increased utilization of real-world evidence. Broader trends in government, technology, and society will also directly drive new requirements within the medical device industry. Staying abreast of these trends, and understanding practical aspects of FDA roll-out, is key to accelerating development of innovative technologies and creating successful product introductions.
This presentation will:
- Provide an understanding of current FDA regulatory trends
- Allow an understanding of how to navigate the ever-evolving U.S. regulatory landscape
- Examine proven, time-tested strategies and frameworks that lead to accelerated regulatory approvals for any device type
Reimbursement for your Novel Device
Prior to the Patient Protection and Affordable Care Act of 2010, most technologies found their way into the marketplace based upon FDA clearance. Now for many, Reimbursement has become a greater barrier to success than dealing with the FDA or designing comprehensive clinical trials. Successful Reimbursement pathways are less clear and more variable. This presentation will:
- Identify the fundamental components of a successful Reimbursement Strategy
- Discuss the challenges for obtaining broad coverage of new technologies among government and commercial insurers
- Demystify the process by which a successful strategy can be developed
- Present the case for early Reimbursement Planning that is fully integrated into your strategy development for Regulatory, Clinical, and Product Development processes
For if you don’t have a Reimbursement Strategy, you don’t have a Business Plan.
Meet our Speakers:
Throughout more than 24 years’ in medical device development, Mr. Naglreiter has led hundreds of innovative medical products from concept to commercialization – from liquid embolic programs and catheters for drug delivery, to hernia fixation devices and other leading-edge technologies.
As the Principal and President of NAGLREITER Medical Device Development Organization (MDDO), he has leveraged his extensive development expertise to create an industry-leading medical device development organization, which possesses the passionate expertise, professional experience, and proven processes to deliver unsurpassed medical device development services.
Mr. Naglreiter has assembled a team of industry device development veterans. Each of them driven by an entrepreneurial spirit. All of them committed to minimizing risk and optimizing the opportunity for return on investment for medical device companies and entrepreneurs in pursuit of next generation device technologies.
Mr. Naglreiter holds a Bachelor of Science in Mechanical Engineering from Clemson University, and a Master in Science in Mechanical Engineering with a focus in Electromechanical Engineering from Stanford University.
Chris Mullin is currently the Director of Product Development Strategy at NAMSA where oversees and manages client partnerships surrounding product development and market commercialization strategies. Mr. Mullin began his career working on National Institute of Health (NIH)-funded clinical trials, and over the last ten years, he has consulted for medical device organizations throughout the U.S. Asia, and Europe on various clinical trial programs. A highly sought-after industry expert, Chris has helped hundreds of global manufacturers optimize study design and research, providing proven strategies to address regulatory requirements for market approval and introduction. Chris has worked with multiple innovative technologies across a wide array of therapeutic areas, which has allowed him to provide valuable perspectives to clients on scientific and regulatory challenges – and suggested strategies for success – that impact the advancement of novel medical technology. Chris has authored multiple peer-reviewed publications a book chapter on clinical study design for translational research, and serves as a journal editor. Chris holds a Master’s Degrees in Biostatistics from the University of Minnesota. He earned his Bachelor’s Degree at the University of Wisconsin-Madison in Mathematics.
Before starting Reimbursement Strategies in 2008, Edward Black invested over 25 years in health and provider network management positions with Blue Cross Blue Shield working with hospitals and physicians in the upper Midwest. He also served on two national advisory boards responsible for leading consistency in medical, benefit, and payment policy throughout. From 1994 to 2002, Edward served as the executive director of three managed care business partnerships with large multispecialty clinics for which he was awarded the 1995 Outstanding Contribution to the Healthcare Industry Citation by Medical Alley (now LifeScience Alley).