30 credits at level HE7
This module describes the innovative aspects of medical devices and IP management, market potential and critical factors for success. The lectures are supplemented with industry visits. The purpose of the module is to create awareness of new technologies and diverse applications of medical devices. Students will be taught the IP issues relating to healthcare medical devices and IP exploitation.
History of medical devices.
Product development process.
Critical factors for successful product development.
Prior art and market potential.
Introduction to the UK, EU and international IP issues related to medical product development.
Important components of patent documents.
Basic legal implications and application process.
The module will be delivered in the form of short courses and workshops. Each short course will be self contained. The short courses will be of 5 days duration. Assignment in the form of Integrated Learning Package (ILP) will be provided so that participants would be able to complete the work within three months after the start of this module. The module will be assessed by completion of the ILP that must not be less than 4000 words. ILP consists of three components in which Part 1 examines candidate’s basic understanding of the concept, principles and awareness of the module, Part 2 requires probing and investigating type answers which reflect deep understanding of the subject and Part 3 tests the candidate’s ability to digest, analyze and criticize the state of the affairs and demonstrate ability to defend, challenge and offer suggestions. In addition, individual or group seminar presentations will be organised to assess the candidate’s knowledge and attainment.
300 hours campus based learning
Classroom sessions 35hr (5 x 7)
Practical work 7hr
Self study 120hr
& presentation) 21
when you have successfully completed this module you will:
to demonstrate that you have achieved the learning outcome you will:
|1.||Recognise the brief history of medical devices and their growth factors.||
Describe the evolution of medical devices.
Explain how the history helps as a role model to develop novel medical devices.
|2.||Describe and discuss the critical factors for an ideal product development.||Outline the essential requirements for successful product deveolpment.|
|3.||Analyse medical device market in the UK and EU.||
Identify the potential market for healthcare products according to application.
Name the profile of principal medical device companies in the UK and EU.
Find out medical device import and export statistics.
|4.||Acquire a comprehensive understanding of the principles of patent law and practice with respect to medical devices.||
Explain how to protect innovative and established medical devices.
Assess what is patentable in the medical device field and how to defend or challenge existing patents.
Apply the impact of patent law on your business.
Solve the problems of intellectual property management.
|5.||Prepare and present an oral presentation.||Deliver an oral presentation and answer questions.|
Your achievement of the learning outcomes for this module will be tested as follows:
|Description||ILP not less than 4000 words. ILP consists of three parts. Part 1 - Short answer questions||Part 2 - Questions relating to probing and investigating||Part 3 - Questions relating to in-depth analysis, critical examination, defending, challenging and judging||Seminar presentation and question and answer session|
Before taking this module you must have successfully completed the following:
You cannot take this module if you are taking or have taken:
1. Jones T (2002), Innovating at the Edge: How organizations evolve and embed innovation capability, Butterworth-Heinemann, Linacre House, Jordan Hill, Oxford OX2 8DP.
2. Medicines and Healthcare Products Regulatory Agency, http://www.mhra.gov.uk
3. Medical Device manufacturers Association, http://www.medicaldevices.org
4. Medical Device Market: http://www.researchandmarkets.com/reports/Healthcare_and_Medical_Devices12_1.html
5. Regulatory Affairs Journal (RAJ) Devices, http://www.pjbpubs.com/raj_devices/index.htm
6. Regulatory Affairs Journal (RAJ) Devices, http://www.pjbpubs.com/raj_devices/index.htm
7. Flinn P (1999), Handbook of Intellectual Property Claims and Remedies, Aspen Publishers, ISBN: 073551125X.
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