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Larry Kiliszewski

Larry Kiliszewski has 30 years of experience in the product development industry. For the last twenty-five, he has been involved in the development of medical devices, ranging from class I adhesive products to class II invasive systems. In this time, he has managed the delivery of over 100,000 hours of services related to device development through sister company Zewski Corporation for over 200 clients.  This experience has allowed him to gather a wealth of information on the process, players, risks, costs and roadblocks. For some time, he has shared his experience through talks and mentorships at institutions, but today through The Zewski Reports, he is unlocking this information to individual inventors, students and educators, in order to provide them with roadmaps to the development of their ideas.  

Expert in the areas of:
Design Controls
Disposable Devices
Delivery Systems
Molding (Injection, Dip, Forming)
Sheetmetal and Machined Parts Design
Pressure Systems, Seals, Gaskets
Adhesives and Convertibles
Casting Component Design
Mechanical Testing Systems
High and Low Volume Manufacturing
Additive Manufacturing
Subtractive Manufacturing
3D CAD Design
Project Management
System Development
Extended knowledge in:
FDA Regulatory Controls
EU Regulatory Controls
Electrical Testing Requirements
Biological Testing Requirements
Institutional Protocols
  • Clients:
  • Neotech Products LLC
  • OsmeTech Molecular Diagnostics
  • Medtronic Diabetes
  • PALL Medical
  • Biosense Webster
  • SpectRX
  • Medegen
  • Numatic Engineering
  • Baylor College of Medicine
  • Seattle Childrens Research Center
  • Baxter Healthcare
  • Apogean Anesthesia
  • ARC Surgical
  • Cormedics
  • Fairway Medical
  • Infusion Systems, LLC
  • UniLife
  • Ion Therapeutics
  • Ivera Medical Corp.
  • Dr. Jackie
  • Kosin Technologies
  • M&S Biotics
  • Peeq
  • Photetica
  • Seattle Childrens Research Center
  • Wichita State University
  • Patents:
  • Variable Length Tubing Feeder • US 7,524,309
    Radially Self-sealing Septum • US 2003/0201239
    Auto Insertion Device • EPO 1467783
    Insertion Set Device • US 6,607,509
    Insertion Set Device • US 7,318,816
    Insertion Set Device • US 8,292,849
    Insertion Set Device • US 8641674
    360 Speaker Clamp • US 8,641,674
    Frozen Beverage Dispenser • US 8,794,485
    Exercise ball • US 8,870,719
    Retinal Exam Apparatus • US 9,289,199
    Mobile Device Holder • US 8,474,832
    CPAP Cannula System • USD884154S1
    Transilluminator  • US 10,274,135
    Drug Delivery Cannula • US 2021/128849
    CPAP Delivery Cannula • US 2021/128863
    Drug Delivery System • US 17/210,163
    Breath Monitoring using • US 17/210,199
Employers:
U.S. Navy Submarine Service
Trus Joist
Nibecker and Associates
Ricon - VMI
Medtronic Diabetes
 
Mentorships and Presentations:
2016 Mentor on architectural team project for global disaster response - Rice University
2017 Speaker on technical careers in the medical field - Sam Houston State University
2020 ION Challenge Project Mentor - The ION Houston
2020 Capstone Sponsor/Mentor, Delivery Device - Rice University [Winner - Best Interdisciplinary Innovation]
2021 Capstone Mentor, High-Frequency Oscillator - Rice University
2021 Capstone Mentor, 3d Print Waste Disposal - Rice University [Winner - Best Interdisciplinary Innovation]
2021-2022 Speaker on Design for Manufacturing - Rice University   
2022 Speaker on Institutional Pathways for Design for Manufacture - Public Invention
2022 Speaker on DFM in a Bioengineering Career - Texas A&M
2022 Panelist on Careers in Medical for Industrial Designers - University of Houston
2022 Speaker Careers in Medical for Biomechanical Engineering - University of Houston
2022 Presenter, global health solution for grant pitch - University of California, San Fransisco
2023 Speaker on costing projects for production - Rice University
2023 Capstone Mentor, Endoscope environmental protection - Rice University