Case Studies in Biomedical Device Development

This course reviews the biomedical product development process for real-life products in the marketplace. The critical material selection process is covered including the extremely important testing and qualification for use, its fabrication into components and finally the finished device. Examples highlight actual challenges faced by biomedical engineering teams in taking products from the concept stage through early lab work, to prototype development and scale-up, and then into production. Some of the hurdles faced and in most cases overcome are shared.

Time is also devoted to walking through the process of developing your medical device or reviewing the current biomedical product development challenges you are facing.

This course can be applied to the Plastics Technology Certificate.

Instructor

Len Czuba

Len Czuba

Len Czuba is the president of his own product development firm, Czuba Enterprises, headquartered in Chicago. His product development experience and polymers expertise assist partner firms to take products, especially medical devices, from concept to market. He has a bachelor’s ... read more

Benefits and Learning Outcomes

Learning outcomes

  • Understand best practices for the processing of plastics for biomedical devices
  • Learn the FDA classification of biomedical devices
  • Examine case studies in biomedical device development
  • Discuss testing of raw materials and the role of antimicrobials
  • Evaluate the role of biomedical and custom manufacturers
  • Determine when to outsource
  • Explore hot topics
  • Learn the different types of materials of construction
  • Understand the role of compliance in the product development process
  • Discuss the sterilization of biomedical devices for health care

Course Outline/Topics

1. Fluid containers:
IV Bag
Blood Bag
Pre-mixed Drug
Irrigating Solution
Lipid Emulsion
Renal Dialysis Solution

2. Renal or Kidney failure products – the evolution of products and therapy to treat
Washing machine prototype to prove concept
Coiled dialyzer
Parallel plate dialyzer (Holtzenbein dialyzer)
Hollow fiber dialyzer
CAPD solution exchange therapy

Process considerations
• Start with a PRD or Product Requirements Definition (and the MRD or Material Requirements Definition)
• Sterilization and how it affects selection of material, design of product and packaging
• Assembly of components into finished device or product
• Packaging of finished device
• FDA device classification

3. Fluid delivery accessories:
Tubing sets
Connectors
Injection site
Y-site
Valves
Pump segment
Drip chamber
Filter

4. Catheters
IV or peripheral catheters
Drainage
Shunt
Gas delivery or sampling

5. Molded components
Syringe
Inhalers
Fluid collection accessories

6. Specialty products
Implantables:
Orthopedic implants
Sutures, clips, adhesives
Mesh
Stents
Grafts and scaffolds

7. Examples from attendees
Bring your product development challenges to be discussed with class
Material selection, design, processing, assembly, packaging and sterilization

8. Other examples if time permits
TheraCyte
Chemotherapy ports
IV catheter connection
NRL replacements
BPH catheter

9. Process improvements to make a successful product
Vinyl Chloride Monomer (VCM)
Latex Rubber hypersensitivity leading to eliminating NRL from use

10. Sterilization to kill / deactivate pathogens
Bacteria
Viruses
Prions

Methods
Heat
Dry or steam
Ethylene oxide gas
Radiation
Gamma or beta (via e-beam)
Other
Hydrogen peroxide bath or mist
Nitrous oxide
UV light
Antiseptic wipes

All sessions are Face-to-Face unless otherwise noted.

Date: Thu-Fri, Apr 23-24

Time: 8am-4:30pm

Location: UWM School of Continuing Education

Instructor: Len Czuba

Fee:

$1,090 by Sun., Feb. 23.
$1,190 after Sun., Feb. 23.

CEUs: 1.4, PDHs: 14

Enrollment Limit: 40

Program Number: 4830-12477

Registration Deadline: Thu., Apr. 23

Register Now

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