First Global Forum on Medical Devices World Health Organization 9-11 September 2010 Bangkok Thailand The Role of HTA for Innovative and Emerging Technologies Prof Brendon Kearney Vice Chairman of EuroScan Chair HPACT Australia 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 EUnetHTA project (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 the achievements and progress of the EuroScan collaboration To share information on the methods and results To consider challenges to the collaboration To discuss its possible future 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 EuroScan partners 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 EuroScan and 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 other initiatives Statistics of our webpage 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’s webpage 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 new developments 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 Examples of Sources Early Assessment & Alert Systems Australia and New Zealand Horizon Scanning Network National Horizon Scanning Centre EuroScan Health Organisations HTA Organisations Journals & Trade Publications 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 Examples of sources Marketing Authorisation Agencies U.S. Food and Drug Administration (FDA) News sites Medscape Science Daily Clinica Clinica Diagnostics Medgadget Related organisations ECRI Institute HAYES Societies American Cancer Society Drugs – sources Examples of sources Early Assessment & Alert Systems National Horizon Scanning Centre Euroscan Health Organisation NHS HTA Organisations Canadian Agency for Drugs and Technologies in Health National Institute for Health & Clinical Excellence (NICE) The Cochrane Collaboration Journals & Trade Publications British Medical Journal JAMA Lancet Scrip Marketing Authorisation Agencies U.S. Food and Drug Administration (FDA) European Medicines Agency (EMEA) Drugs – sources Examples of sources News sites National Electronic Library of Medicines (NeLM) Pharmalive Doctors Guide Societies American Cancer Society Procedures – sources Examples of sources Early Assessment & Alert Systems Australian and New Zealand Horizon Scanning Network National Horizon Scanning Centre EuroScan Health Organisations NHS NHS National Library for Health HTA Organisations Canadian Agency for Drugs and Technologies in Health National Institute for Health & Clinical Excellence (NICE) Interventional Procedures Programme (IPP) The Cochrane Collaboration INAHTA Centre for Reviews & Dissemination (CRD) ASERNIP-S Journals British Medical Journal JAMA Lancet Archives of Surgery Procedures – sources Examples of sources News sites Medscape Doctor’s guide Related organisations ECRI Institute HAYES Societies American Cancer Society Programs – sources Examples of sources Early Assessment & Alert Systems Australia and New Zealand Horizon Scanning Network Euroscan Health Organisations NHS HTA Organisations Canadian Agency for Drugs and Technologies in Health National Institute for Health & Clinical Excellence (NICE) The Cochrane Collaboration Centre for Reviews & Dissemination (CRD) Journals British Medical Journal JAMA Lancet News sites Medscape Doctor’s guide Related organisations ECRI Institute HAYES Societies American Cancer Society Settings – sources Examples of sources Early Assessment & Alert Systems Australia and New Zealand Horizon Scanning Network Euroscan Health Organisations NHS HTA Organisations National Institute for Health & Clinical Excellence (NICE) Canadian Agency for Drugs & Technologies in Health The Cochrane Collaboration Journals British Medical Journal JAMA Lancet New Scientist News sites Medcape http://medgadget.com Related organisations ECRI Institute HAYES Societies American Cancer Society 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 new health technologies: a tencountry analysis of six health technologies. International Journal of Technology Assessment in Health Care 2006; 22(4): 419-428 Ibargoyen-Roteta N, GutierrezIbarluzea I, Benguria-Arrate G, Galnares-Cordero L, Asua J. Differences in the identification process for new and emerging health technologies. Analysis of the EuroScan database. Int J Technol Assess Health Care 2009;25(3): 367-373. Joint actions (comparison of systems) Experimental phase II Investigational phase III Nearly established Established Other Information not available Missing 70,0 60,0 50,0 40,0 30,0 20,0 10,0 0,0 Device Diagnostics Drug Procedure Programme Differences among agencies depending on the stage of diffusion? 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 type of technology? 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%) 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 nonmembers 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 preparation kit is to simplify faecal examination by reducing the number of consumables 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 produces blue 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 selfmanagement 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 readout. 1.8 Isotherma nucleic acid amplification system for tuberculosis diagnosis 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 lowbirth-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 RealisticReliable Time-bound Previous experiences EUnetHTA newsletter on new and emerging technologies 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 AnneFlorence Fay; Prof Brendon Kearney; Prof Janet Hiller; Linda Mundy; Irving Lee; Alun Cameron; Dr. Iñaki Gutiérrez Ibarluzea; Andra Morrison; Dr HansPeter 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 Questions?