The Role of HTA for Innovative and Emerging Technologies · The Role of HTA for Innovative and...

The Role of HTA for Innovativeand Emerging Technologies

Prof Brendon KearneyVice Chairman of EuroScan

Chair HPACT Australia

9-11 September 2010 Bangkok Thailand

First Global Forum on Medical DevicesWorld Health Organization

A bit of history (I)

�Early warning systems part of the regular approval processes in European countries

� In January 1995, the Danish Hospital Institute organised a meeting entitled.� "International Collaboration Concerning Monitoring of Emerging Medical Technologies (MEMT)".

� Fourteen participants attended and discussed national experiences concerning MEMT and the possibility for a European collaboration.

A bit of history (II)

� A survey in 1998 among INAHTA members showed that 30% of agencies had continuing and structured early warning activities

� An international workshop "Scanning the Horizon for Emerging Health Technology" in Copenhagen in 1997

� A small working group was established with representatives from Denmark, the Netherlands, Spain, Sweden and the United Kingdom plus associated representatives from Canada and Switzerland

EuroScan Framework

� EuroScan – the international information network on new and emerging health technologies - is a collaborative network of member agencies for the exchange of information on important new and emerging health technologies.

� Each member agency is unique in the way it approaches its work but all have a common goal of informing their customers about new and emerging health technologies that may have a significant impact on their health system.

Avoid duplication and share

“The drug itself has no side effects, but the number of HTA agencies needed to prove its value may cause dizziness and nausea”

The international information network on new

and emerging health technologies

“A collaborative network of member agencies for the exchange

of information on important emerging new drugs, devices,

procedures, processes, and settings in health care”

Members

� 20 members

� AETS - Agencia de Evaluación de Tecnologías Sanitarias. Instituto de Salud Carlos III, Spain� AETSA - Agencia de Evaluación de Tecnologías Sanitarias de Andalucía, Spain� AGE.NA.S – Agenzia nationale per I servizi Sanitari Regionali, Italy� AHTA - Adelaide Health Technology Assessment, Australia� ANZHSN - Australia and New Zealand Horizon Scanning Network, Australia and New Zealand� CADTH - Canadian Agency for Drugs and Technologies in Health, Canada� CEDIT - Committee for Evaluation & Diffusion of Innovative Technologies, France� DACEHTA - Danish Centre for Evaluation and Health Technology Assessment, Denmark� DIMDI - German Institute for Medical Documentation and Information, Germany� DMTP - Division of Medical Technology Policy, Ministry of Health, Israel� FINOHTA (MUMM) - Managed Uptake of Medical Methods programme, Finnish Office for Health

Technology Assessment, Finland� GR - Health Council of the Netherlands, Netherlands� HAS - Haute Autorité de Santé, France� HIQA - Health Information & Quality Authority, Ireland� IHSP - Italian Horizon Scanning Project, Servizio Farmaceutico Territoriale, Italy� LBI–HTA - Ludwig Boltzmann Institut für Health Technology Assessment, Austria� NHSC - National Horizon Scanning Centre, England� NOKC - The Norwegian Knowledge Centre for the Health Services, Norway� OSTEBA - Basque Office for Health Technology Assessment, Basque Country� SBU - The Swedish Council on Technology Assessment in Health Care, Sweden� SFOPH - Swiss Federal Office of Public Health, Switzerland

Organization

� Executive committee� Made up of

representatives of member agencies

� Workgroups� By-laws� Strategy� Difussion

Present committee (2007-2009)Chair Iñaki Gutiérrez-Ibarluzea

(Osteba)Vice Chair Brendon Kearney

(ANZHSN)Registrar Kees Groeneveld (GR)Treasurer Christoph Kuenzli

(SFOPH)Head of Secretariat Claire Packer (NHSC)

Past committee members (2005-2007)Chair Jill Sanders (CCOHTA)Vice Chair Iñaki Gutiérrez (Osteba)Registrar Inger Norderhaug (SMM)Treasurer Anne-Florence Fay (CEDIT)Head of Secretariat Claire Packer (NHSC)

Organization

� Permanent secretariat� Based at NHSC (Birmingham)

� Head of the Secretariat

� 1 partly time researcher

� 1 partly time administrative

Joint research initiatives

� The influence of early warning activities on health care decision making and the diffusion of new technologies (current)

�Newsletter to inform on new and emerging technologies for the EUnetHTAproject (commissioned research 2007)

�Use of the Internet in identifying new technologies (2004)

�Comparative analysis of member agency systems (2002-2005) and 2007-2010.

Stockholm meeting

� To report theachievements and progress of theEuroScan collaboration

� To share informationon the methods and results

� To consider challengesto the collaboration

� To discuss its possiblefuture direction.

Actions

1. Improve the collaboration with other organizations

2. Diffuse the activities of the network

3. Create discussion groups and workgroups within the organization

4. Promote a newsletter on new and emerging health technologies (newsletter)

5. Make publicly available the methods and joint actions (methods toolkit)

1. Improve the collaboration with other organizations

� Collaborating partners of EUnetHTA

� Building bridges with HTAi

� EUSANH, IPTS, PHGEN

�MoU with INAHTA

� Final approval of INAHTA and EuroScanpartners

�MoU with WHO

� Preliminary draft sent to approval to WHO

�Shared actions

2. Diffuse the activities of the network

�Webpage

�Workshops

� Panel sessions

� Journal Articles

�Newsletter (6 monthly)

�Web 2.0, blogs

Webpage. http://www.euroscan.org.uk

Statistics

Usage Statistics for October 2009

Public Sessions Member Sessions Total Sessions

13426 151 13577

Event Totals

Public Follow Technology Report link 8085

Technology Search (Member Section) 4477

Public Technology Search 3859

View Report (Member Section) 1998

Land on home page 1084

Log In (Member Section) 177

Technology Update (Member Section) 72

Technology Created (Member Section) 14

3. Create discussion groups and workgroups

within the organization

� Internal work� By-laws

�External work� Strategy

�Special interest work groups� Research

� Disinvestment

Disinvestment

�Approval of an interest subgroup in the HTAi on disinvestment promoted by members of EuroScanand other allies

4. Promote a newsletter on new and

emerging health technologies (public)

� Six monthly

� News from members

� News on new and emerging technologies

� Space for otherinitiatives

� Statistics of ourwebpage

5. Make publicly available the methods and

joint actions (methods toolkit)

Aim:

� to outline the various methods that members of EuroScan employ to:� Find � Select� Evaluate important new and emerging health technologies

� to provide valuable information to those interested in establishing, or improving an existing, early awareness and alert system

Methods

� ANZHSN prepare a draft

� The draft was circulated by the Secretariat to all the members in groups of three

� Improved drafts were subsequently circulated to next group

� Final draft open to discussion in a meeting in Helsinki

� Editing and improving was done by Secretariat and Osteba

Results

� Final document with 9 sections� Identify your customers

� Determine your time horizon

� Horizon scanning and early identification

� Filtration

� Prioritisation

� Assessment or prediction of impact

� Peer review

� Dissemination

� Updating information

Final document

� Includes a final checklist� Help those promoting EAAS

� It will be self-printable in the webpage

� The scheme contains hyperlinks to sections

� Electronically available in EuroScan’swebpage and printed version available in INAHTA’s booth

Final document

3. Topic identification, filtration and

investigation

The NHSC’s identification process uses three principal approaches:

(i) Focussed routine scanning – an ongoing ‘horizontal scan’designed to identify significant and urgent advances regardless of clinical specialty,

(ii) Specialty-based scanning – a ‘vertical scan’ to ensure that each clinical specialty is allocated time for an investigation of newdevelopments in the field, and

(iii) In-depth vertical scanning – work in specific clinical or technologies areas of interest to individual customers

Team members routinely scan sources for new and emerging health

technologies and for information on technologies that we are

monitoring. Sources include:

� Commercial sources e.g. Script, Clinic, pharmaceutical company pipelines

� Health-related media and journal e.g. NeLM daily news alert

� Specialist trade publications, societies and journals e.g. IVT Technology, MEDICA

� General medical journals e.g. BMJ, The Lancet, NEJM, JAMA

� Licensing sites e.g. EMEA for orphan drug opinions

� Reports from specialist groups e.g. Gene Therapy Advisory Group

� Other horizon scanning units e.g. EuroScan database, ECRI, newsletter, CADTH (Canada), ANZHSN (Australia & New Zealand)

Identification of Sources by Technology Type

Devices and

Diagnostics – sources

Early Assessment & Alert Systems

Health Organisations

HTA Organisations

Journals & Trade Publications

Examples of Sources

Australia and New Zealand Horizon Scanning Network

National Horizon Scanning Centre

EuroScan

NHS

NHS National Library for Health

Canadian Agency for Drugs and Technologies in Health

National Institute for Health & Clinical Excellence (NICE)

The Cochrane Collaboration (only devices)

International Network of Agencies for HTA (INAHTA)

Centre for Reviews & Dissemination (CRD)

British Medical Journal

JAMA

Lancet

Archives of Surgery (only devices)

New Scientist

Clinica

Identification of Sources by Technology Type

Devices and

Diagnostics – sources

Marketing Authorisation Agencies

News sites

Related organisations

Societies

Examples of sources

U.S. Food and Drug Administration (FDA)

Medscape

Science Daily

Clinica

Clinica Diagnostics

Medgadget

ECRI Institute

HAYES

American Cancer Society

Drugs – sources


Health Organisation

HTA Organisations

Journals & Trade Publications

Marketing Authorisation Agencies

Examples of sources


Euroscan

NHS



The Cochrane Collaboration


JAMA

Lancet

Scrip

U.S. Food and Drug Administration (FDA)

European Medicines Agency (EMEA)

Drugs – sources

News sites

Societies

Examples of sources

National Electronic Library of Medicines (NeLM)

Pharmalive

Doctors Guide


Procedures – sources



HTA Organisations

Journals

Examples of sources

Australian and New Zealand Horizon Scanning Network


EuroScan

NHS

NHS National Library for Health



Interventional Procedures Programme (IPP)


INAHTA


ASERNIP-S


JAMA

Lancet

Archives of Surgery

Procedures – sources

News sites


Societies

Examples of sources

Medscape

Doctor’s guide

ECRI Institute

HAYES


Programs – sources



HTA Organisations

Journals

News sites


Societies

Examples of sources


Euroscan

NHS






JAMA

Lancet

Medscape

Doctor’s guide

ECRI Institute

HAYES


Settings – sources



HTA Organisations

Journals

News sites


Societies

Examples of sources


Euroscan

NHS


Canadian Agency for Drugs & Technologies in Health



JAMA

Lancet

New Scientist

Medcape

http://medgadget.com

ECRI Institute

HAYES


HEALTH PACT

� Horizon Scan Technology Classification

- Experimental

- Investigational

- Nearly established

- Established

- Established but changed indication or modification of technique

- Should be taken out of use

HEALTH PACT

� Once identified technologies prioritised according to pre-defined criteria

- Clinical need

- Rate and pattern of diffusion

- Estimated clinical impact

- Estimated cost impact

- Efficacy and safety issues

- Ethical issues

- Cultural or religious issues

- Other

HEALTH PACT

� A technology prioritised for Health PACT review if it reaches one or more of the following threshold criteria:

- associated with obvious safety or ethical issues or controversies

- it has not been assessed and is rapidly diffusing throughout the Australian health system

- it is applicable to a large proportion of the Australian population and may have considerable clinical or cost impact

- it is applicable to a small proportion of the population but has obvious and far-reaching benefits

� Those that do not reach the priority threshold marked for monitoring/periodic review or archived

HEALTH PACT

� Prioritising Summary

� Impact Summary:

� <Name of Industry> provides <Name of Technology> with the aim of <Purpose>. The technology is available through <Health Providers> for <Target group>

- Clinical Need and Burden of Disease

- Estimated speed and geographic and practitioner use

- Existing comparators

- Estimated clinical impact of the introduction of the technology

- Estimated cost impact

- Efficacy and safety issues

- Ethical issues

- Cultural or religious considerations

- Others issues

HEALTH PACT

� Outcomes of Prioritising Summary

- Horizon Scanning Brief

- Full Health Technology Assessment

- Monitor: 6-12 monthly

- Do not progress

HEALTH PACT

� Horizon Scanning Brief

- Introduction

- Background

- Description of the Technology: the procedure, intended purpose, clinical need and burden of disease, stage of development

- Treatment Alternatives: existing comparators

- Clinical Outcomes: safety, effectiveness

- Potential Cost Impact

- Ethical Considerations: informed consent, access issues

- Training and Accreditation: training, clinical guidelines

- Limitations of the Assessment: search strategy, availability and level of evidence, sources of further information

- Impact Summary

- Conclusions

- References

Conclusions

� Build on the basis that one doesn’t fit all

� It has been based on the heterogeneity of the members

� It gives suggestions and solutions

� It has been conceived as a live tool that should be enriched with new information

� The document is opened to suggestions

Other products and actions

�Status reports

�Database

�External collaborations and partnership

�Joint actions

Status report 2005

�Diffusion� Members

� INAHTA members

� Related organization

� Decision makers

� Copies available in HTAi

�Newsletter

Database

External collaboration and partnership

�INAHTA (almost all members)

�HTAi (active)

�ECHTA-ECAHI (steering committee)

�OECD (advisors)

�EUNetHTA�Associate and collaborating partners

�WP 7, 8 and 9

Joint actions (comparison of systems)

� Packer C, Simpson S, Stevens, A. International diffusion of newhealth technologies: a ten-country analysis of six healthtechnologies. International Journal of TechnologyAssessment in Health Care 2006; 22(4): 419-428

� Ibargoyen-Roteta N, Gutierrez-Ibarluzea I, Benguria-Arrate G, Galnares-Cordero L, Asua J. Differences in the identificationprocess for new and emerginghealth technologies. Analysis of the EuroScan database. Int J Technol Assess Health Care 2009;25(3): 367-373.

Joint actions (comparison of systems)

0,0

10,0

20,0

30,0

40,0

50,0

60,0

70,0

Device Diagnostics Drug Procedure Programme

Experimental phase II

Investigational phase III

Nearly established

Established

Other

Information not available

Missing

STAGE OF DIFFUSSION

Experimental-phase I-II Investigational- phase III Nearly established Established Other Total

n (%) n (%) n (%) n (%) n (%) n (%)

Agency 1 11 (3.0%) 255 (69.7%) 51 (13.9%) 16 (4.4%) 33 (9%) 366 (100%)

Agency 2 1 (0.4%) 16 (6,6%) 78 (32.2%) 142 (58.7%) 5 (2.1%) 242 (100%)

Agency 3 25 (15.3%) 26 (15.9%) 28 (17.9%) 22 (13.5%) 62 (38%) 163 (100%)

Agency 4 18 (17.1%) 33 (31.4%) 31 (29.5%) 17 (16.2%) 6 (5.7%) 105 (100%)

Agency 5 6 (11.1%) 9 (16.7%) 4 (7.4%) 30 (55.6%) 5 (9.3%) 54 (100%)

Agency 6 - 2 (11.8%) 7 (41.2%) 8 (47.1%) - 17 (100%)

Agency 7 2 (5.9%) 7 (20.6%) 7 (20.6%) 18 (52.9%) - 34 (100%(

Agency 8 2 (10%) 2 (10%) 2 (10%) 14 (70%) - 20 (100%)

Agency 9 4 (21.0%) 8 (42.1%) 6 (31.6%) 1 (5.3%) - 19 (100%)

Agency 10 2 (13.3%) - 10 (66.7%) 2 (13.3%) 1 (6.7%) 15 (100%)

Agency 11 1 (8.3%) 3 (25%) 3 (25%) 2 (16.7%) 3 (25%) 12 (100%)

Agency 12 - 2 (20%) 2 (20%) 5 (50%) 1 (10%) 10 (100%)

Agency 13 2 (25%) 6 (75%) - - - 8 (100%)

Agency 14 - - 2 (100%) - - 2 (100%)

Differences among agencies depending on the stage of diffusion?

TYPE OF TECHNOLOGY

Device Diagnostics Drug Procedure Programme Setting Other Total

n (%) n (%) n (%) n (%) n (%) n (%) n (%) n (%)

Agency 1 34 (9.3%) 28 (7.6%) 284 (77.4%) 11 (3%) 1 (0.3%) - 9 (2.45%) 367 (100%)

Agency 2 58 (22.5%) 18 (7%) 137 (53.1%) 24 (9.3%) - - 21 (8.14%) 258 (100%)

Agency 3 73 (44.8%) 34 (20.9%) 1 (0.6%) 23 (14.1%) 10 (5.5%) 1 (0.61%) 22 (13.50%) 163 (100%)

Agency 4 15 (14.3%) 7 (6.7%) 24 (22.9%) 34 (32.4%) 14 (13.3%) - 11 (10.48%) 105 (100%)

Agency 5 5 (9.3%) 3 (5.6%) 38 (70.4%) 3 (5.6%) - - 5 (9.26%) 54 (100%)

Agency 6 12 (60%) 3 (15%) 1 (5%) 4 (20%) - - - 20 (100%)

Agency 7 17 (50%) 2 (5.9%) - 7 (20.6%) - - 8 (23.53%) 34 (100%)

Agency 8 2 (10%) 5 (25%) 5 (25%) 6 (30%) - - 2 (10%) 20 (100%)

Agency 9 3 (15.8%) 1 (5.3%) 6 (31.6%) 7 (36.8%) 1 (5.3%) - 1 (5.26%) 19 (100%)

Agency 10 7 (46.7%) 1 (5.3%) - 7 (46.7%) - - - 15 (100%)

Agency 11 2 (15.4%) 1 (6.7%) 6 (46.2%) 1 (7.7%) - - 3 (23.08%) 13 (100%)

Agency 12 1 (9.1%) - 2 (18.2%) 5 (45.5%) 2 (18.2%) - 1 (0.91%) 11 (100%)

Agency 13 2 (25%) 2 (25%) - - 1 (12.5%) - 3 (37.5%) 8 (100%)

Agency 14 - - - 2 (100%) - - - 2 (100%)

Differences among agencies depending on

the type of technology?

What can we offer?

�Network experience working together

�Experience in the identification of new and emerging technologies

�Different approaches and agreed methodology in HTA of new and emerging technologies

�Experience in network productive research

What can we offer?

�Database with more than 1.000 identified technologies

�Clearing-house experience

�A newsletter or digest for non-members

�A formalised, centralised early warning activity

�An open-mind to new initiatives and collaboration networks

WHO call on innovative technologies

WHO call on innovative

technologies

�Invitation to participate

�Agreed joint action by members if more than 7 members agreed to participate

�14 members out of 20 agreed and volunteered�No experience assessing devices

�Lack of time or dedicated staff

EuroScan involvement

Agency Evaluators

Agencia de Evaluación de Technologías Sanitarias de Andalucía (DETECTA), Seville, Spain Dr Aurora Llanos

Agenzia Nazionale per I Servizi sanitari Regionali (Age.na.s), Rome , Italy Dr Maria Rosaria Perrini

Assistance Publique-Hôpitaux de Paris, Committee for Evaluation and Diffusion of Innovative

Technologies, France (CEDIT)

Ms Anne-Florence Fay

Australia and New Zealand Horizon Scanning Network (ANZHSN)/HPACT Prof Brendon Kearney

Australian Health Technology Assessment (AHTA) Prof Janet Hiller

Linda Mundy

Australian Safety and Efficacy Register of New Interventional Procedures – Surgical

(ASERNIPS)

Irving Lee

Alun Cameron

Basque Office for Health Technology Assessment (Osteba), Spain Dr. Iñaki Gutiérrez Ibarluzea

Canadian Agency for Drugs and Technologies in Health (CADTH) Andra Morrison

Deutsches Institut furMedizinisches Dokumentation und Information (DIMDI) Dr Hans-Peter Dauben

Health Council of the Netherlands (GR) Dr Kees Groeneveld

Cees Postema

Health Information and Quality Authority (HIQA), Ireland Martin Flattery

HTA Reviews and Dissemination Department, Norwegian Centre for Health Services

Research (NOKC)

Dr Inger Norderhaug

Helene Arentz-Hansen

Integrated Care & Aged. Department of Health, Victoria, Australia Dr Paul Fennessy

National Horizon Scanning Centre (NHSC), England and Wales Dr Claire Packer

Distribution of tasks

�14 members�Each technology evaluated by 2 members

�10 technologies per member

�Timeframe 3 weeks

�Secretariat pooled the results

Results

�The deadline was met in all cases, the majority, some days before

�The degree of agreement was high

�The assessment process was coherent

�The process was accountable

�Members who participated were happy to have taken part in this call

Selected innovative technologies

Call for innovative technologies that address global

health concerns

Applications have been evaluated by a team of international experts appointed by WHO. The

lists of selected innovative technologies include the technologies that the team of experts has

found to meet the selection criteria defined in the call for innovative technologies that meet

global health concerns.

CATEGORY 1

Category 1 is for commercialised products or products which are commercialisable. This includes

new products; products which have been commercialised for less than five years in high-income

countries and which are not (yet) widely used in low- and middle-income countries; recent

adaptation of existing non-health products for a health purpose; and/or recent adaptation of an

existing medical device for low- and middle-income settings.

CATEGORY 2

Category 2 is for products in a non-commercialised or a non-commercialised stage. This includes

products which are under development or otherwise in a conceptual stage.

1.1 The Global Initiative on Health Technologies (GIHT)

The goal of the GIHT is to help make available the benefits of

core technologies at an affordable price, particularly to

communities in resource-limited settings, in order to

effectively control important health problems. The GIHT

includes the formulation of Health technology policies,

guidance and management tools, as well as the ‘Call for

innovative technologies that address global health concerns’

STEP 1 Screening

WHO internal experts will screen all applications. The

ones which are incomplete or non medical devices will,

in principle, not be processed further. An identifier

code will be assigned to the application and all

information about the application will be removed to

maintain confidentiality

Step 2 Evaluation

After screening, eligible submissions are passed on to external

independent experts as well as to WHO designated staff for

evaluation. Evaluation will occur concurrently and independently.

Applications will have been made anonymous before the evaluation

procedure starts.

The WHO internal evaluators will, based on provided selection

methodology (Table 1), analyse and grade the submitted

applications. A total score for each submission will be used for the

selection of technologies to be presented to the meeting participants

in the Advisory Group on Innovative Technologies meeting. The five

submissions that have obtained the highest scores in each category

will be shortlisted and presented to the AGIT meeting on 27-29 April

2010.

Step 3 AGIT final selection

The AGIT will make a recommendation for a final selection of

a set of technologies for the two categories “commercialised”

and “non-commercialised” products. The AGIT will also

analyse the challenges that may face selected medical

devices when trying to successfully reach the intended

markets in low and middle-income countries with the aim to

present a way forward on how to overcome those challenges.

Selection Criteria

1. What is the level of safety for user, patient and the

environment

2. How effectively does the technology address the health concern(s) in question.

3. How well is the technology adapted to local infrastructures in resource-limited setting.

4. What is the ease of use level. What is the ease of maintenance.

5. How high are cost-effectiveness and affordability.

6. How high are cultural and social acceptability of the technology

7. Is the product innovative.

Innovation e.g.

� a product from a significant new drug class

� a product with potentially greater efficacy or reduced adverse effects than current options

� a new formulation of a licensed product that may have additional patient or service benefits

1.1 Stool sample collection and preparation kit

The intended purpose* of the stool sample collection and preparationkit is to simplify faecal examination by reducing the number ofconsumables and steps required for the procedure. The kit could therefore facilitate the diagnosis of parasitological diseases. Additionally, the kit does not appear to require water or electricity and is claimed to prevent recontamination of the environment.

1.2 LED phototherapy unit

The intended purpose* of the LED phototherapy unit is to treat hyperbilirubinaemia in newborn infants by phototherapy. The unit could increase the safety of the procedure by using a radiation source that producesblue light and minimizes the exposure to harmful ultraviolet radiation.Further potential advantages are that the unit measures the actual output of light at useful wavelengths and is claimed to have lower energy consumption than previous designs.

1.3 System for on-site production of wound irrigation solution

The intended purpose* of the system for on-site production of wound irrigation

solution is to produce aqueous solutions for the topical treatment of wounds

and infections using a power source, demineralised water and salt. Solutions

produced by the system could be used to treat a host of conditions including

traumatic injuries, post-natal infections and neglected tropical diseases that

cause ulcerations and infections.

1.4 SMS smoking cessation system

The intended purpose* of the SMS (short message service) smoking cessation

system is to provide tailored SMS-based smoking cessation support to its

users. According to preliminary research submitted, the system facilitates self-

management of smoking cessation and increases the likelihood of user

adherence to smoking cessation programs. The interactive system claims to be

capable of answering messages about cravings to support the user.

1.5 Reusable neonatal suction system

The intended purpose* of the reusable neonatal suction system is to remove

obstructive mucus from the air passages in newborn infants to reduce the risk

of asphyxia and to support neonatal resuscitation. The device is claimed to be

reusable and capable of being cleaned and boiled between uses. The device is

claimed to be made of durable silicone and not to require electric power.

1.6 Fluorescence visualisation system for cancer screening

The intended purpose* of the fluorescence visualisation system for cancer

screening is to use the natural fluorescence of mucosal tissues when excited by

a voilet/blue light to inform clinicians about the presence of abnormalities in

the mucosa in the oral cavity. This system could aid in the early detection of

oral/oropharyngeal cancers and thereby reduce morbidity and mortality

associated with these diseases.

1.7 Transcutaneous bilirubin measurement system

The intended purpose* of the transcutaneous bilirubin measurement system is

to provide an alternative to blood sample analysis for the diagnosis of

hyperbilirubinaemia in newborn infants. The system uses spectral analysis of

light reflected from the patient’s vascular bed to determine levels of bilirubin in

the blood. The device is claimed to be non-invasive and to rapidly give a read-

out.

1.8 Isotherma nucleic acid amplification system for tuberculosisdiagnosis

The intended purpose* of the isothermal nucleic acid amplification system for

tuberculosis diagnosis is to offer a point-of-care alternative to sputum smear

microscopy. The technology is claimed not to require any additional

equipment and to yield a rapid visual read-out of the diagnostic result.

2.1 Simplified anaesthesia unit

The intended purpose* of the simplified anaesthesia unit is to function as an

anaesthesia machine for surgical use in low-resource settings. The device

features an innovative valve system with reduced technical complexity

compared to traditional devices. The device is claimed to function with oxygen

from different sources including ambient air and therefore would not require

compressed oxygen.

2.2 Single use assistive vaginal delivery system

The intended purpose* of the single use assistive vaginal delivery system is to

assist foetus extraction in cases of prolonged second stages of labour without

having to use forceps, to use a vacuum extractor or to resort to caesarean

sectioning. The lack of rigid instruments in the system is claimed to reduce

the risk of injury to both mother and child.

2.3 Portable on site cell sorter and coutner for HIV and malaria diagnosis

The intended purpose* of the portable on site cell sorter and counter for HIV

and malaria diagnosis, a lab-on-a-chip, is to monitor AIDS in HIV-infected

people as well as blood cell alterations indicating malaria. The system appears

to be a small and portable device that would allow for rapid automated

screening of a blood sample for indicator of AIDS and/or malaria.

2.4 Decision support system for paediatrics HIV

The intended purpose* of the decision support system for paediatrics HIV is to

move away from paper-based medical records while ensuring easy and reliable

access to patient-centred information. This electronic health records system is

targeted at paediatric HIV cases and is intended to aid clinical decision-making

processes such as weight-based dosing support for antiretroviral drugs.

2.5 Transcutaneous anaemia monitoring system

The intended purpose* of the transcutaneous anaemia monitoring system is to screen populations

for insufficient levels of haemoglobin in the blood and to carry out diagnosis of severe anaemia. The

system is claimed to be based on spectrophotometric analysis. The device appears to be portable,

non-invasive and is claimed to give a read-out in less than a minute.

2.6 Solar-powered autoclave

The intended purpose* of the solar-powered autoclave is to sterilise medical instruments. It is

claimed to run solely on solar power. This technology could allow sterilisation of medical instruments

in remote rural areas with no access to electricity and hence reduce the risk of infections associated

with carrying out medical interventions with dirty equipment.

2.7 Portable infant warmer

The intended purpose* of the portable infant warmer is to improve the care of premature and low-

birth-weight babies by providing heat at a constant temperature in order to prevent hypothermia.

This portable device is claimed not to require electricity and would allow for close mother-to-baby

contact. The product is targeted fro use in urban and rural healthcare settings, and in home

settings.

Positive issues (SMART process)

�Specific

�Measurable

�Accountable

�Realistic-Reliable

�Time-bound

Previous experiences

�EUnetHTAnewsletter onnew and emergingtechnologies

Issues to think about

�Technical issues�Difficulties to fulfill the evaluation sheets

�Submission and evaluation processes�Definition of innovative technology

�Low quality of submissions

�Lack of information

�Same weight of criteria

Not only is technology

Ways of improvement

�Technical issues� Centralised web platforms for submission and evaluation

�Submission and evaluation processes�Definition of innovation

�Workshop on how to submit proposals

� Scoring system. Previous work on weighting criteria, defining cut-off points for each criterion or groups of criteria

Acknowledgements

� All members of EuroScan

� Participating organizations

� Dr Aurora Llanos; Dr Maria Rosaria Perrini; Ms Anne-Florence Fay; Prof Brendon Kearney; Prof Janet Hiller; Linda Mundy; Irving Lee; Alun Cameron; Dr. Iñaki Gutiérrez Ibarluzea; Andra Morrison; Dr Hans-Peter Dauben; Dr Kees Groeneveld; Cees Postema; Martin Flattery; Dr Inger Norderhaug; Helene Arentz-Hansen; Dr Paul Fennessy; Dr Claire Packer

Suggestions

� EuroScan Secretariat, Department of Public Health, Epidemiology & Biostatistics, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK Tel: +44 (0)121 414 7496

� http://www.euroscan.org.uk

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Date post:	03-Jun-2018
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