Michael Plishka | President
`ZenStormingTM, LLC
`michael@zenstorming.com, Cell: (847)791-3655
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`Professional Experience Summary
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`Founder and President of ZenStorming, a Design and Innovation Consultancy.
`Twenty+ years designing, developing and launching medical products
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`FOCUS ON THE CUSTOMER
`Clinical Relationship Builder
`Extensive experience in Sterile Environments
`Trained clinicians and sales staff on device use in cadaver and mock labs
`Established hospital based training programs for engineers
`Market Research studies
`Product Research = Product Requirements = New Product Directions
`Product Complaint Support
`Assembled Clinical Advisory Boards to guide product portfolio strategy
`Instructional Videos and Label Copy
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`APPLIED CREATIVITY
`Idea Generation
`Innovator for Next Generation Products
`Product Platform Development
`Strategic Technology Planning
`Technology Assessment
`Intellectual Property Portfolio Development
`Expedited Project Feasibility
`3D Printing and Prototyping
`Product Problem Solving
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`REGULATORY SPECIALISMS
`Presenter at 2008 International Silicone Conference,
`“Working with Medical Device Companies – The Essentials”
`QSR Procedures (Design Controls, GMP, GLP, etc.)
`Validation and testing protocols for new products and processes
`Risk Assessment Process development
`Authorship of 510 (k) submissions
`Engineering Regulatory Compliance
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`001
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`Nevro Corp.
`Ex. 1004
`U.S. Patent No. 8,650,747
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`PROFESSIONAL EXPERIENCE
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`4/08 to Present
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`ZenStorming Solutions, LLC
` Carefusion/BD – New Product Conception/Strategy/Design/Development, Development of Disruptive Innovation
`Portfolio, Technology Assessment, IP Development, Sales/Clinical Training, Mobile App Story-Boarding, Expert
`Witness Support
` Hollister – New Product Idea Generation - Brainstorming Moderation
` King Systems (Ambu) – Respiratory Products and Emergency Airway Access, New Product Design/Development
` Surgimatix – Endoscopic Suture Device Development, and Quality System Development
` Hines VA – Electrode Deployment Device Development, Grant Funding and Engineering Support
` AOK Inc. – New Product Development: Thoracic Access, Toy Robot Development
` Ferring Pharmaceuticals – Developed Marketing Awareness Campaign
` Testicular Cancer Society - Developed Marketing Awareness Campaign
` Baxter Healthcare – IP Portfolio Development
` EndoEvolution – Expert Witness (Ethicon EndoSurgery vs. EndoEvolution) Arbitration and Patent Case
` Hologic - Expert Witness (Ethicon EndoSurgery v. Hologic Inc and Suros Surgical Systems, Case No. 1:07- CV-
`00834)
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`6/06 to 4/08
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`Baxter Healthcare
`Position: Engineering Specialist; Access Systems Business Unit
` Lead Innovator for generating IP for Next Generation Vascular Access Products resulting in multiple cross platform
`patent applications in heavily populated patent landscape
` Spearheaded development of resources that enabled manufacture of prototypes in half the time at a cost savings of
`50%.
` Determined the feasibility of new IV Access product and benchmarked against key competitive products in six
`months
` Engineering Lead for Market Research Studies
` Developed relationships with clinicians which resulted in six new hospital sites for engineers to study clinician
`behaviors.
` Led Clinical Advisory Board Meetings in conjunction with Marketing.
` Drafted business unit plan for World Wide Technology/Product Planning Committees
` Mentor for younger engineers
` Company Representative in off-site college recruitment program.
` Direct Supervisory Responsibility for Junior Engineer
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`4/99 to 6/06
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`Cardinal Health (Allegiance Healthcare Corporation)
`Position: Engineering Specialist; Special Procedures Business Unit
` Engineering Project Lead driving products from conception through launch while meeting aggressive timelines
` Physician Advisory Board Team Leader for new product development projects
` Technical Expert assessed and recommended new technologies and/or products for business development
` Developed patented, product platforms and line extensions that provided for 35% of all revenues in the Special
`Procedures business unit.
` Developed training materials and trained Sales Staff and Clinicians on new products in cadaver labs and lecture
`settings
` Developed and updated Quality System/Design Controls, minimizing documentation volume and time without
`sacrificing safety (Design Controls, Risk Analysis, GMP, GLP, etc.)
` Authored and performed validation and testing protocols for new products and processes
` Supported 510 (k) regulatory submissions
` Developed company-wide Technical Development Career track for non-degreed Designers/Technicians
` Direct supervisory responsibility for Designer and EDP (Engineering Development Program) Engineer
` Mentor for younger engineers
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`Indirect managerial responsibility for cross-cultural Project Team
` Company Representative in off-site college recruitment program.
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`3/95 to 4/99
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`Manan Medical Products
`Position: New Product Development Engineer
` Worked with clinicians to develop novel and patented catheter products
` Managed manufacturing scale-up through product launch.
` Developed advertising, labeling (instructions), packaging plans and manufacturing procedures for new products.
` Filed and successfully received 510(k) approval on new and modified products.
` Wrote and performed validation and testing protocols for products and processes.
` Head of Engineering Regulatory Compliance Team achieving ISO registration and passing FDA audit with no
`corrective action taken
` Developed Design Control and Hazard Analysis procedures as per QSR and ISO
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`Hines VA Hospital/Loyola Medical Center
`Position: Biomedical Engineer
` Developed bi-polar surface electrode for use on perineum.
` Co-developed implantable "mesh" electrode for use on bladder wall.
` Co-designed supra-pubic indwelling catheter for use in bladder studies.
` Generated computer simulation of bladder in cooperation with University of Illinois.
` Co-authored papers which applied research to practical, diagnostic use.
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`3/91 to 5/94
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`INVENTIONS (Partial List)
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`US5730724 Drainage Catheter Apparatus
`US5989241 Drainage Catheter Apparatus
`US 7018343 Biopsy Needle and Device Containing the Same
`D478987S Biopsy device
`CA2413665 Multi-Use Surgical Cement Dispenser Apparatus And Kit For Same
`CA2429357 Improved Paracentesis Device Having Multiple Detachable Components
`WO03086201 Improved Biopsy Needle And Biopsy Device Containing The Same
`WO03000121 Multi-Use Surgical Cement Dispenser Apparatus And Kit For Same
`WO03022337 Improved Paracentesis Device Having Multiple Detachable Components
`Curable Material Injection Device-Pending
`Curable Material Mixing and Delivery Device -Pending
`Paracentesis Device - Pending
`Luer Activated Device –Three Patents Pending
`Biopsy Devices – Two Pending
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`EDUCATION
`Bachelor of Science Mechanical Engineering
`University of Illinois at Chicago
`Honors: Phi Eta Sigma for Honor Roll in multiple consecutive semesters
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`Master of Arts
`Loyola University of Chicago
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`PUBLICATIONS
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`“Mind Opening Exercise” Illustration in "Lifespan Human Development" (Sigelman, Rider, De George-Walker, 2013)
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`Walter, J. S., Wheeler, J. S., Zaszczurynski, P., & Plishka, M. "Urodynamic measure of urethral cross‐sectional area: Application for
`obstructive uropathy." Neurourology and urodynamics 13.5 (1994): 571-582.
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`Damaser, M. S., Walter, J. S., & Plishka, M. "Letter." International Urogynecology Journal 5.3 (1994): 191-191.
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`003
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`Walter, J. S., Wheeler, J. S., Morgan, C., Zaszczurynski, P., & Plishka, M. "Measurement of urethral compliance in females with
`stress incontinence." Engineering in Medicine and Biology Society, 1992 14th Annual International Conference of the IEEE. Vol. 4.
`IEEE, 1992.
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`Walter, J. S., Wheeler, J. S., Morgan, C., Zaszczurynski, P., & Plishka, M. "Measurement of total urethral compliance in females with
`stress incontinence." Neurourology and urodynamics 12.3 (1993): 273-276.
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`Walter, J. S., Wheeler, J. S., Cogan, S. F., Plishka, M., Riedy, L. W., & Wurster, R. D. "Evaluation of direct bladder stimulation with
`stainless steel woven eye electrodes." The Journal of urology 150.6 (1993): 1990-1996.
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`HONORS/SKILLS
`Presentations:
` Presenter at 2008 International Silicone Conference, “Working with Medical Device Companies – The Essentials”
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`Awards:
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` Received Foster G. McGaw Contribution for Ava-Tex ™ Bone Cement Delivery System (2005).
` Received Karl D. Bays New Product Award for development of Temno Evolution Biopsy Device (2004).
` Received Karl D. Bays New Product Award for development of Safe-T-Centesis Drainage System (2003).
` Received Allegiance Innovation Award for development and launch of Ava-Tex ™ Bone Cement Delivery System
`in nine months (2001).
` Received Technical Excellence Award from Technical Council in 2001 and 2003.
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`004
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`ITEMIZED PROJECT EXPERIENCE ADDENDUM
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`Innovation: Worked with clinicians to design the following:
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`Innovation Process:
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` Biliary Catheters
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` General Drainage Catheters
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` Nephrostomy Catheters
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` Guide Wire Introducers
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` MRI Compatible Biopsy Needles
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` Vertebroplasty Systems
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`o Delivery System
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`o Mixing System
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`o Access System
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` Repositionable Para/thoracentesis Catheters
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` Drainage Systems
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`Fully Automatic Breast Biopsy Device
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` Catheter Fixation Disk
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`Interventional Drainage Bag
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`Laryngoscope
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` Anesthesia Filters
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`Endoscopic Suture Device
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`Tissue/Fiduciary Markers
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`Surgical Heating Systems
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`Introducer Sheaths
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`Electrodes
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`Perineal
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`Implantable Woven Mesh
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`Vascular Access
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`Luer Activated Devices
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`Clinical Procedural Attendance:
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` Biopsy
` Vertebroplasty
` PICC Placement
` Kyphoplasty
` Angioplasty/Stent Placement
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`Interventional Drainage Catheter Placement
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`Interventional Diagnostics
` Vascular Access
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`Improved Brainstorming Processes
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`Technical Expert involved in cross-business
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`innovation
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`Independent Reviewer of Cross-business products
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`IP Generation and Portfolio Management
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` Key Opinion/Clinical User Boards
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`Process Engineering: Manufacturing of the following
`devices:
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`Interventional Drainage Catheters
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` Needles
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` Hand Held Injectors
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` Cement Delivery Tubes
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` Hot and Cold Pads
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` Drainage Bags
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` Guide Wire Catheters
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`Luer Activated Devices
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`Tissue Markers
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`Anatomy/Physiology: Working knowledge
`following areas:
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`in
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`the
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` Human physiology
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`Spine Mechanics
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`Interventional Visualization Systems
` Vascular Biology
` Modelling of Heat Transfer under Anesthesia
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`Materials Knowledge: Partial list of materials used in product
`developed:
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`Coating/Impregnated Materials: Experience with the
`following coatings:
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`Implant grade steels
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` MRI Compatible Materials
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`Polycarbonate
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`Polyurethane
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`PMMA
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` ABS
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`Polypropylene
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`Silicones
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`PEEK
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` Nylon
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` Hydrophilic Coating
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` Antimicrobial Silver Coatings
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`Parylene & PTFE Coating
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`Lubricious materials (Impregnated)
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` Antimicrobials (Impregnated)
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`005
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