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 (including digital/software medical devices, and software as a 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.  

Content/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 Sarah Byron, Programme Director for Devices, Diagnostics and Digital Systems at NICE, Mark Campbell, former Associate Director of the Medical Technologies Evaluation Programme at NICE and Dr Duncan McPherson, Clinical Director of Medical Devices at MHRA. The course provides opportunities for networking and includes a drinks reception and course dinner..

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.

An example of the programme content can be seen here - example of EMD course programme (PDF , 46kb)

Costs & how to book

This three-day course is:

Standard rate:

• Private sector rate £1,975, Early bird £1,900 - use promo code EMDEARLY3
• Worldwide public sector rate £1,350, Early bird £1,275 - use promo code EMDPUBLIC1
• Public early bird EMDPUBEARLY1

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.

EMD 2023 terms and conditions (PDF , 81kb)

Faculty members

• Dr Cynthia Iglesias
• Professor Andrea Manca
• Dr Claire Rothery
• Dr Matthew Taylor
• Hayden Holmes

Accommodation

Course Venue

The 5-star The Grand Hotel, Station Rise, York, YO1 6GD, UK. 

The Grand was originally built in 1906 as a ‘Palace Of Business’ for one of the most powerful railway companies in Edwardian England. With no expense spared in the pursuit of luxury, The Grand now boasts some of the finest meeting rooms, event spaces and conference facilities in York.

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 Grand 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.

Funded places

Please note that all funded places have now been taken.