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Life Sciences SIG
3rd Monday of the Month
, unless there's a holiday, 5:30p-8p $20 Advance (by the Friday before program at 5pm) /$35 Door unless otherwise noted. Includes food. See the Calendar for future programs.

SIG SPONSORS:  Medpresso                                                               


Our life sciences special interest group includes medical devices, cell biology, pharmaceutical development and medical records.


October 20: LIfe Sciences (incl Med Dev) SIG - Syncing Business, Marketing and Regulatory Strategies

Timely regulatory approval is a critical component to seizing first mover advantage for medical device, biomedical and biotechnology products.  Compliance with standards and government approval is typically and unfortunately the “last step” in the product development process.  Success in Pre-Clinical testing sets up the Validation testing and documentation submission to the respective Regulatory agencies. 

Tonight, we will walk through the regulatory process, defining the strategy that makes sense for  various types of businesses, and then dive into how to pull it all together in an organized manner.  It’s not enough to select a market based on extraneous information, only by conducting in-depth market research aligned with a solid regulatory strategy can a company realize its revenue goals with each target market.

Panel:

              janetkwiatowski.jpg   Mike Drues    Clair Strohl

Janet Kwiatkowski is the President of MAE Consulting Services, LLC.  An experienced Regulatory and Compliance Executive with a proven track record in the medical device industry. Recognized for creating effective cross-functional teams to bring products to global markets and develop regulatory strategies aligned with business plans.  Successful achieving results through creative and innovation solutions.  Janet received her B.S in Mechanical Engineering from Johnson & Wales University, her MBA from Nichols College and her Masters of Science Regulatory Affairs, Regulatory Affairs & International Studies.

Clair Strohl, is a President, Strohl Product Engineering.  He has more than 30 years of experience in medical product development both for major device manufacturers and several start-up companies.  He has extensive experience in the new product development and manufacturing implementation processes and has coordinated safety and efficacy testing for submission to the FDA.  He received a B.S in Electrical Engineering and an M.S in Biomedical Engineering from Drexel University, and an MBA in Finance from the University of Chicago.  He has authored several technical papers, is a Registered Professional Engineer and holds a number of medical product patents for products actively used in clinical practice today.

Mike Drues, PhD is President of Vascular Sciences, an education, training, & consulting company offering a broad range of services to medical device, pharmaceutical & biotechnology companies including (but not limited to): stimulating & innovative educational programing, brain-storming sessions, prototype design, product development, benchtop & animal testing , regulatory strategy & clinical trial design, FDA presentation preparation & defense, reimbursement, clinical acceptance, business development & technology assessment.

Mike received his B.S., M.S., & Ph.D. degrees in Biomedical Engineering from Iowa State University. He worked for & consulted with leading medical device, pharmaceutical & biotechnology companies ranging in size from start-ups to Fortune 100 companies. He also works for the U.S. Food & Drug Administration (FDA), Health Canada, the US & European Patent Offices, the Centers for Medicare & Medicaid Services (CMS) & other regulatory & governmental agencies around the world.

Schedule:

5.30-6pm – Networking (registration and food)

6pm-8pm – Panel talk with a moderator

8pm-8.30pm – Networking


Committee: Kryngle Daly, Patti DurrAri Giaya, Alan Gonsenhauser, Andrew HalpertKartik Shah, Jerry Shapiro, Jeff Tingle

Committee Co-Chairs,  Kryngle Daly,  Jerry Shapiro

        Medical Devices, to Biotech, to Pharma and Cell Biology, to eMR, imaging, medical robotics, 510K, FDA   Kryngle Daly, Founder and CEO, KBioBox at TechSandBox  Jerrold Shapiro, PhD FemMedical    Jeff Tingle, at the intersection of healthcare and mobile  Kartik Shah  Patti Durr, Tri-Star Design  Andrew Halpert Ari Giaya   Past Programs
Thanks to past Chair, Ed Ross!  


 

 


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