Next Meetup

Medical Device Product Life Cycle
EVENT DETAILS: Medical Device Product Life Cycle Eyad Kishawi, Director- R&D Medical Devices PLEASE NOTE: In order to cover the costs of dinner provided at our evening events, there is a nominal fee and registration is required. Walk ins are welcome. For registration and information on cost, click here (http://www.b2dg.org/content/medical-device-product-life-cycle-eyad-kishawi-08142018-600pm). Price listed above ($25) is the onsite registration fee. Discounts apply for early preregistration through the Bio2Device website. The event starts at 6:00 pm with a light dinner and networking. The meeting starts at 6:45 pm with Harry Wachob (Bio2Device Founder) presenting the industry news for the week. The main presentation starts around 7:15 pm and is followed by questions. There is open networking and 1-on-1 questions until 9:00 pm. For more information about the event click here (http://www.bio2devicegroup.org/content/transforming-dental-implant-bio-engineered-medical-device-issa-karkar-dds-05082018-600pm). To learn more about the Bio2Device Group visit our website (http://www.bio2devicegroup.org/). PRESENTATION DETAILS: Much of the value of a good medical device is accumulated and assumed in the design process. The inherent value of a medical device does not automatically lead to its market viability. To develop a commercially viable device, the manufacturer must follow a minimum set of rules so that the device is competitive, non-disruptable for a considerable amount of time, approved by regulatory agencies, with a clinical value that is self-evident, all enabling clinical adoption and subsequent success of a newly introduced device to the market. Many medical device organizations mandate a design-control process. This presentation focuses on the basic features of technology and product development process steps, phase gates and exit strategies, all oriented towards creating measurable value in the team and organization so that the newly introduced device could carry the organization to a higher state of valuation. The pathway from concept definition to scale up and manufacturing is critical to the product’s success and for building confidence in the team and the organization. Certain levels of autonomy, accountability to the corporate mission, checks and balances must be designed at the ground level to attain the realizable value (ROI) of the multi-year endeavor. Design control processes must therefore account for more than blind compliance with CFR (code of federal regulations) 21 part 820. SPEAKER BIO: Eyad Kishawi has overseen product development of both implantable devices and capital equipment from clinical need and concept development, to positioning the applicable IP, technology and product development and finally product roadmap planning and product sustenance. He is an experienced medical device engineering leader and corporate executive with over 23 years’ experience in the medical space. Eyad has led technology and product development teams in neuromodulation, interventional cardiology and radiation oncology. His most notable innovation was in collecting signals from the basal ganglia, deep in the brain, and modeling the relationship between brain tremor centers and limb motion for closed-loop stimulation of thalamic structures for Parkinsonian patients. Eyad studied electrical engineering and biomedical engineering with focus on systems neuroscience and kinematics and emphasis on automation, control systems, robotics, instrumentation and biosignal acquisition and processing. He was mentored by Dr. John Simpson at Fox Hollow Technologies and Mir Imran at Spinal Modulation, both serial entrepreneurs.

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650 Page Mill Road · Palo Alto, CA

What we're about

Want to build your network and knowledge of the Biomedical Industry? Join us at one of our Tuesday events. The Bio2Device Group (B2DG) is a premier organization dedicated to all professionals in the Life Sciences industry within the San Francisco Bay Area. Membership is free and open to anyone in the Pharmaceutical, Biotechnology, Medical Device, Diagnostics, Healthcare, Life Science Tools, and Laboratory Service industries. The Bio2Device Group’s events provide the latest industry information through weekly educational programs and face-to-face interactive opportunities to build and maintain a career network. The educational talks are designed to help members keep up to date, continue to grow in their field, as well as explore other industry sectors and corporate functions. Members are experienced professionals in the life science industry sectors representing start ups to Fortune 500 companies and professional firms partnering with the industry. This organization is highly interactive, volunteer-driven and unique to the San Francisco Bay Area.

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