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Business Of Healthcare
August 25, 2021 @ 5:30 pm - 7:00 pm$10 – $25
Do you have a novel biotech idea but need help bringing it to market? What regulations may impact your product development? How much money will you need and where to raise it? Which ideas investors fund and why? And finally, how do you convince healthcare providers and patients to use your invention?
1.5 Hours Towards Your Continuing Education
James (Rusty) Lusk, Co-founder LifePulse, LLC
Scott Johnson, Director of Technical Services at Square-1 Engineering
Anait Altunian, OCRA 2021 Member at Large
OCRA has partnered with the Small Business Development Center (SBDC)@UCI Beall Applied Innovation to present a Business of Healthcare event. Local entrepreneurs, investors, marketing strategy experts will share their valuable knowledge and real-life experiences in what it takes to turn an idea into a successful venture. Understand the correlation between risk management, clinical evaluation, and other post market surveillance activities to ensure the necessary linkages and references needed in multiple QMS procedures in order to comply with new Global Regulatory expectations
*Feel free to email questions ahead of time! [email protected]
James (Rusty) Lusk has 40+ years of experience in FDA/ISO regulated industries from early-stage to Fortune 100 companies. He is currently with Quality Systems International, a consulting company serving FDA/ISO regulated industries with a focus on Medical Devices. He is the co-inventor and co-developer of a non-invasive device intended to delay or reverse cardiovascular disease and improve quality of life. He co-founded LifePulse, LLC to develop and market the product. He is an active member and past President of Orange County Regulatory Affairs (OCRA), a nonprofit organization educating the regulatory professional.
- MBA, Pepperdine University
- BS, Biological Sciences, The University of California, Irvine
- AA – Electronics, Orange Coast College
Previous Domestic and International Certifications:
- American Society for Quality: CMQ/OE, CQE, CQA, CQAHACCP
- Quality Management Systems Lead Auditor – Exemplar Global
- Regulatory Affairs Professional Society: RAC (US & EU)
Scott Johnson, MBA is a life science consulting executive and serves as Director of Technical Services at Square-1 Engineering, and as President of Device Alliance, a multi-disciplinary, non-profit, professionals association exclusively serving the medical device industry in Southern California. He consults to provide end to end technical project services to companies that design, develop and or manufacture Medtech products in Southern California. Scott has worked directly with Medtech companies to strengthen their capital funding strategy, business models, and ensuring they have all the components necessary for their round of investment capital. Expertise performing due diligence on emerging MedTech startup innovations and translating business value into investor presentations and funding opportunities. He received his MBA from Chapman University’s Argryros School of Business, his B.S in Marketing from CSULB, and graduated from the Medical Device Sales College certified in Orthopedic Reconstruction & Trauma.
Dr. Jane Zhang’s background is in biomedical engineering, including developing diagnostic solutions for the point of care. In Becton Dickinson, she developed a low-cost automatic microscope for TB diagnosis for the developing market. She has then worked as a management consultant and engagement lead in patient level data analytics, commercial strategy, forecast, and insights for major healthcare companies to launch 4 major biotech products into the market. As a senior manager in Amgen, she oversaw forecasting and sales performance for over $2B in the oncology business unit. Dr. Zhang is a 4-time NIH and FDA small business innovation research award winner in 3 startups, has 27 scientific publications with more than 500 citations along with 5 patents. Her experiences dealing with her young son’s recurring ear infections prompted the idea of Remmie Health, in order to aid others in recognizing and caring for their family’s ENT diseases.
Volker Hüther, having lived in Germany, Mexico, Brazil and the United States, is a multilingual German, who has spent much of his life traveling between three different continents. His experiences have been fundamental in the development of his negotiating skills and business acumen. He continuously strives to be a catalyst for reform, both in his business and personal life.
Having started his career in Investment Banking, Volker soon determined that his interest lay in the scientific disciplines, which promoted his leap into the Chemical Industry. This, in combination with his passion for serving others, directed him to venture into the Life Science sector and the Health Care Industry before founding his personal business, Global Bridge LLC, which places emphasis on interim C level management. He has been serving as a board member for multiple corporations, has taken on the role of mentor and advisor for organizations and
continues to enjoy offering a helping hand at all hierarchical levels. In his free time, Volker enjoys volunteering at community events in Orange County, where he puts his passion for ham radio operation to use. As a hobby mechanic, he also enjoys working on his old-timer Mercedes. One of his current projects involves raising puppies for Guide Dogs for the Blind
- OCRA Members: $25
- Non-Members: $100, includes 1-year OCRA membership
- Government and Student Members: $10, with student/government ID
- Non-Member Government and Student Rate: $45, includes 1-year OCRA members
OCRA Registration Instructions
It is important that you register with the name and email address where you want the webinar information sent and with the name you want to appear on the certificate of attendance.
Certificates of attendance will be emailed within 2 weeks of the event.
Registration deadline is August . There is no same-day registration for in person events.
OCRA’s non-profit Federal Tax ID# 33-0630455
For a refund, please email your cancellation request to OCRA Program Chair ([email protected]) by August 24, 2021.
If you have any questions or require additional information, email OCRA Program Chair ([email protected]).