Evaluation of Medical Devices for Product Development and Health Technology Assessment

Overview

Unlike pharmaceuticals medical devices are invented rather than discovered. This has profound implications for the development, regulation and evaluation of these healthcare technologies. 

The course provides a comprehensive overview of key issues associated with medical devices clinical and economic evaluation and the creative alternative methods available to robustly evaluate them. It is aimed at medical device developers, manufacturers, regulators, healthcare practitioners, analysts, consultants, and health technology assessors interested in optimising the evidence generation processes aimed at informing key decisions they are faced with throughout the full development and evaluation pathway of medical devices.

Those attending may be new to the field of health technology assessment of medical devices but wish to appreciate and appraise studies done by others and commission research to support value claims associated with medical devices part of submissions to regulatory and health technology assessment agencies.  Similarly, the course will be suitable for experienced analysts interested in having a deeper understanding of medical device evaluation.  

Course content and learning outcomes

The course programme includes a discussion of unique characteristics of medical device evaluation and their impact on designing robust and efficient evidence generation processes, consideration of the large range of analytic methods to evaluate medical devices such as early modelling, outcome measurement (e.g. clinical, preference based, survival), epidemiological study design, costing methods, trial and model based economic evaluation.

The course is delivered by a faculty of international experts from the: Department of Health Sciences, York Health Economics Consortium and Centre for Health Economics at the University of York. They have extensive experience evaluating health technologies and contribute as committee members and / or external assessors to the Medical Technologies Evaluation Programme (MTEP) and the Technology Appraisal Programme of the National Institute for Health and Care Excellence (NICE).

In addition, there are a number of tutored practical group exercises, which provide the opportunity to reflect, discuss, interact and learn by doing. The programme includes keynote contributions from Mark Campbell, Associate Director of the Medical Technologies Evaluation Programme at NICE and John Wilkinson, Director of Medical Devices at MHRA. The course provides opportunities for networking and includes a ghost walk and course dinner.

Evaluation of Medical Devices course programme (PDF , 401kb)

Learning outcomes:

To inform and promote understanding of key challenges associated with the evaluation of medical devices to estimate their expected value from early stages of development through to HTA (e.g. safety, clinical efficacy, effectiveness, and cost effectiveness). At the end of the course, participants will be able to:

• describe key characteristics of medical devices that have direct impact on the type of analytical methods required to evaluate  proof of concept, safety, efficacy, effectiveness and cost-effectiveness of these products
• design an efficient evidence generation strategy that will enable them to collect appropriate data (e.g. clinical, epidemiological, resource use, health related quality of life, preferences) to support value claims from early stages of development through to HTA
• understand alternative methods available to demonstrate treatment effect in terms of improvements in efficiency and those required to demonstrate equivalent or differential clinical efficacy, effectiveness and cost-effectiveness
• conceptualise the decision problem and identify appropriate evaluation methods to ascertain the expected value of medical devices from early stages of development through to HTA
• engage critically with published evidence and determine its potential contribution to inform decisions regarding the mechanism of action, safety, efficacy, effectiveness and cost effectiveness of medical devices
• define the type of analyses required to robustly evaluate medical devices and understand the need to characterise, explicitly and fully, the uncertainty associated with value estimates.

Costs and how to book

This three-day course is:

• Standard rate £1,700
• Early bird rate (book by 30th September 2018) £1,630 - use promo code EMDEARLY
• Worldwide public sector discounted rate £1,150 - use promo code EMDPUBLIC

Prices are exempt of UK VAT.

Book a place.

The course provides an opportunity for networking and includes a ghost walk and course dinner. Please note that registration fees do not include accommodation.

This course does not carry formal CPD (continuing professional development) accreditation, but participants will be awarded a certificate of completion.

Online Registration
Registration is done online by Credit/Debit Card for instant payment and a guaranteed secured place. Please note that the University of York cannot accept American Express cards.
If you or your organisation cannot pay by credit/debit card please email cpd@york.ac.uk. Payments by invoice are subject to a £30.00 administration fee per invoice, places cannot be reserved or held in advance of booking or payment. All payments must be received before attending the course.

Faculty members

• Dr Cynthia Iglesias
• Ms Michelle Jenks
• Professor Andrea Manca
• Dr Claire Rothery
• Dr Matthew Taylor

Accommodation

Course Venue

The 4-star Principal York Hotel, Station Road, York, YO24 1AA, UK. 

The stunning Principal York Hotel workshops' venue is conveniently located directly next to York railway station. Newly refurbished and restored to its former splendour, this luxury hotel was voted 'Hotel of the Year' and 'Conference Venue of the Year' at the 2016 Visit York Tourism Awards.

Accommodation

Delegates are responsible for booking their own accommodation and arranging payment directly with the hotel of their choice.

For delegates seeking other accommodation options, there are numerous hotel establishments within easy walking distance of The Principal York Hotel. Once delegates complete and return their online Registration Forms cpd@york.ac.uk will email a formal letter of provisional confirmation, including information and guidance on booking accommodation in York. 

For information on York, visit the 'Visit York' website.