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Cost: $0 Event Details: Medical device with drug delivery technology has improved over the last 20 years to address issues with ease of application or implantation, biocompatibility, durability, bioabsorbability and drug dosage control. These developments have been applied to stents and lenses, heart valves and seats, vascular stents and shunts, hemostasis and embolization, post-surgical closure, liquid bandages, and other areas. The devices have also been used as drug delivery vehicles. New technologies must be tailored to the target physiologic environment since materials that function well in one environment may fail in another. Research has brought about a much greater understanding of the importance of the surfaces of medical devices in terms of the reaction to contact with bodily fluids and tissues, and novel materials have been developed that resist attachment to cells, platelets, calcium deposits, etc. Overall, greater understanding of the specific environment in which a device will be deployed leads to more reliable, durable and functional designs with fewer complications over time. This talk will explore some of the advancements in polymer chemistry and hydrogel-based materials and how these technologies have been applied to medical devices and drug delivery in numerous settings. Significant challenges remain in the medical device and delivery arena, and potential future advancements will be discussed. Syed's BIO Syed Askari, PhD, is a 20 year veteran of the Medical Device arena and is the Founder, President, and CEO of Maculus Therapeutix, an ENT medical device/drug delivery company. Previously he founded Medicus Biosciences, and launched two wound healing products, SutureSeal and HyFlex. Syed is also a Board of Director of bioZhena Inc. Syed’s technical expertise and area of research include polymer-based Medical Devices and localized drug delivery technology to treat multiple clinical indications using in vivo polymerizable biomaterials. Syed holds more than 25 patents/patents applications. Syed has a PhD in Organic Chemistry from the University of British Columbia and has completed his postdoctoral work at UCLA and UCSB in Prof Wudl and Prof Heeger (Nobel Laureate, year 2000) labs.
Startup to IPO/Acquisition: Case Studies of building IT Operations, Security and Compliance for emerging Medtech/Biotech companies with the end in mind. Mark Richards - CEO of KalioTek Cost: $0 Event Details: By making the smart choices at every stage of growth, emerging Medtech and Biotech firms can efficiently build toward a future with smooth-running IT, strong security and compliant systems without the fire drill, expense and disruption that is often experienced when an opportunity appears for an acquisition or IPO. We’ll discuss real-world choices our customers faced by stage of growth, the solutions they chose and the results they experienced. We’ll cover practical, inexpensive solutions to the top 10 security concerns. Mark Richards BIO Mark Richards is CEO of KalioTek, an IT and Security solutions provider for Life Sciences companies in the Bay Area for almost 20 years. Mark has spent 30 years developing technology solutions and leading teams serving Medical Technology and Biotech firms, from startups to public companies and all stages in between. Having experienced the journey from startup to IPO as a founding member of a management team in the early days of cloud computing, Mark has first-hand knowledge of the challenges faced by rapidly growing companies.
Embracing Change: Your Connected Medical Device Is Never Finished Aaron Joseph, Principal Consultant - Sunstone Pilot, Inc. Cost: $0 Event Details: Traditional approaches to medical device development focus on tightly controlling a final product design. In the modern healthcare environment of software-intensive, connected medical devices, there is no final design and companies must become adept at frequently updating their products. Only by embracing change can companies address the modern challenges of connecting to complex, evolving software and rapidly changing cybersecurity risks. This presentation will describe how to structure medical device development for rapid design iterations to speed up product development and to ensure devices remain safe and secure after product launch. Learn how to configure design control processes to support efficient software patches to address interoperability, cybersecurity, OS upgrades, and bug fixes. We will discuss techniques medical device companies can leverage to minimize the cost of change during product development and throughout the product life cycle. Aaron's BIO Aaron has 20 years of experience in medical device development over a wide range of products: surgical robotics system, digital x-ray fluoroscopy system, heart-lung bypass machine, robotic catheter system, drug inhaler devices, x-ray catheter for brachytherapy, laser eye surgery system, and endoscopy instrument with RF ablation. Aaron is an avid promoter of lean and agile methods for medical device development and helps clients implement requirements management tools for streamlined compliance. He works closely with product development teams in performing risk analyses, managing testing for software and hardware, managing product requirements, refining design control procedures, and training R&D staff. Aaron is an expert at medical device design verification and validation, including software, hardware, and system testing. He is able to apply design controls efficiently and rigorously to a broad range of products and adapt them to small and large organizations. Aaron has a BS in Electrical Engineering from Rice University and an MS in Bioengineering from the University of Washington.
JOINT B2DG & EPPIC - Cardiometabolic Disease among South Asians: Findings from the MASALA Study Dr. Alka Kanaya Professor of Medicine, Epidemiology and Biostatistics UCSF Cost: Must Pre-register thru the Bio2Device Group website $6 - Students/In-transition - Members only $11 - Early-bird Registration - Members only $20 - Late Registration and Non-Members $25 - Walk-ins Event Details: This is a JOINT B2DG and EPPIC Event South Asians comprise almost one-quarter of the world’s population and are the second fastest growing ethnic group in the United States. We have created a prospective cohort of South Asians called the Mediators of Atherosclerosis in South Asians Living in America (MASALA) study, which is closely tied to the Multi-Ethnic Study of Atherosclerosis (MESA) for valid cross-ethnic comparisons. We have followed this cohort for approximately 6 years and have learned that there are specific sociocultural, behavioral and biologic factors that are associated with higher disease risk as well as protective factors and sources of resilience in this distinct ethnic group. Dr. Kanaya's BIO Dr. Alka Kanaya is Professor of Medicine, Epidemiology and Biostatistics at the University of California, San Francisco (UCSF) in the Division of General Internal Medicine. She earned a Bachelor of Science degree in Biochemistry from the University of California, Davis in 1990 and an M.D. degree from UCSF in 1995. She completed her internship and residency training in Primary Care, Internal Medicine at UCSF in 1998, and served as Chief Medical Resident at Moffitt-Long Hospital from[masked]. She trained in clinical epidemiology during a General Internal Medicine fellowship at UCSF, and started on the UCSF faculty in 2001. Dr. Alka Kanaya is an expert in type 2 diabetes and cardiovascular disease prevention. She has focused her research on Asian American health disparities over the past decade. She conceived of the Mediators of Atherosclerosis in South Asians Living in America (MASALA) Study to better understand factors driving high rates of diabetes and heart disease among South Asians. She is a practicing general internist at UCSF and teaches residents and fellows both clinical medicine and research methods.