Product Development for Therapeutics - Perspective for Medical Devices

Aims and Objectives

This subject aims:

• To develop an understanding of the process by which medical devices are developed and made compliant with regulatory codes.
• Demonstrate the importance of product specification, design for manufacturing, and market expectation.
• Explain methods used for certification of devices.
• Provide an introduction to new design principles including nanotechnology and microtechnology.

On completion of this subject students will be able to:

• Create a process plan for the development of a medical device.
• Explain the principles eschewed in the international standards.
• Demonstrate an understanding of the international regulatory framework and the methods used to obtain certification in different jurisdictions.

Content

• Background - why the regulatory situation is as it is.
• Design for Manufacture (DFM).
• Introduction to manufacturing methods such as 3D CAD and Simulation, Rapid prototyping, prototype scale manufacturing, electronics, software and assembly and packaging.
• Importance of processes for defining specifications including considerations of disposability, reusability, sterilisation, cost of ownership and market needs.
• GLP and GMP for Medical Devices.
• Medical device or laboratory device?
• Diagnostic or Therapeutic?
• Regulatory regimes ( Australia , Europe, USA ,etc).
• Harmonized Euro Norms and ISO Standards.
• IEC 64641 Electrical Standard for Medical Devices.
• Methods for compliance certification.
• Problems, pitfalls and potholes - where are the regulatory gaps?
• New designs and technologies - nanotechnology, microtechnology, microengineering principles, Microfluidics, hand held devices and ambient intelligence.

Recommended Reading

To be advised at the beginning of the course, but will include:

• Standard IEC64641-1
• ISO 13485 - Medical Device Standards
• FDA 21 CFR 820 - GMPs for Medical Devices