A methodology for identification and evaluation of New Technologies in Animal Health DISCONTOOLS Project Disease Control Tools Work Package 4 “Technology Evaluation” IFAH-Europe 1 rue Defacqz 1000 Brussels 1 WP 4 Methodology Paper Final 20120831 Contents 1. Introduction 2. Scanning for new ideas 2.1 New Technology Sheets 2.2 PESTLE analysis 2.3 Scanning reports 3. Evaluation of alternative solutions 3.1 Method 3.2 Set of criteria 3.3 Technology Assessment Team 4. Communication 5. Conclusions 6. Annex 1: Template ‘New Technology Sheet’ 7. Annex 2: Scoring criteria 2 WP 4 Methodology Paper Final 20120831 1. Introduction A core function for any company that works in an innovative industry is the identification and evaluation of new technologies. The procedure requires diligence and detailed analysis from technical, legal and commercial perspectives. The technical assessment needs to include a sound analysis of the likelihood of success of the introduction of the new technology, and the scope of its application. The legal assessment needs close scrutiny of any intellectual property associated with the new technology and the freedom to operate in developing the idea. Finally, there typically needs to be a reasonable commercial opportunity associated with the technology for the technology to be pursued. In this situation commercial interest is interpreted as a typical private sector opportunity or more broadly, an opportunity where a market is underwritten by a donor agency or government. New technologies can be identified internally through targeted surveillance of literature and public presentations. In addition, technologies may be presented by third parties for opportunity assessment. The key aspect of either mode of presentation is that a robust, transparent and rapid assessment process is in place to provide a business development unit with the information it requires on potential utility to support subsequent negotiations for access to a new technology. One of the strongest paradoxes to be faced when considering detection and selection of new technologies is an uncertain future, whereas forecasting and prediction are essential for investing in future innovation. The outcome is never predetermined and something of little value today may become priceless tomorrow. Therefore an open mind is fundamental to detect and select new technologies. Innovation frequently comes from unexpected and/or unrelated areas and there is a benefit in looking beyond a particular sector to identify new technologies. There are two methods of identifying a new technology: 1. Begin with a problem which requires a solution and review the new technologies available to eventually solve it. Several tools are available to detect, evaluate and make a final choice between technology alternatives (mathematics, sociology, economic tools). These tools are useful in a methodology when starting with a problem to solve and comparing different alternatives (old technologies against new ones). 2. Identify an innovative technology originating in a completely different sector which may be of potential interest for an application in animal health and may create new market opportunities. When looking beyond a specific sector to discover new technologies that might be useful, the exercise is more likely to involve a scanning method through the analysis of published literature and conference proceedings. The methodology developed in this paper attempts to address both the above approaches as they were judged complementary. In the case of the first method, the problems facing the animal health sector are highlighted by the work of DISCONTOOLS Work Package 3 (WP3) who have developed a gap analysis method for research related to a list of 52 diseases covered by DISCONTOOLS. Identification 3 WP 4 Methodology Paper Final 20120831 of areas where research is needed and where diagnostics, vaccines or pharmaceutical tools are lacking, inadequate or could be improved will help focus the selection of new technologies to fill in those critical gaps where possible. One of the major deliverables from DISCONTOOLS Work Package 4 (WP4) is the development of “an acceptable methodology to identify current and newly developed technological innovations which contributes to the development and delivery of new or improved tools”. This paper is the result of work by WP4 during the first two years of the project and is based on a review published on the DISCONTOOLS website entitled “A review of existing approaches to the identification, evaluation and selection of New Technologies which could be applied to the Animal Health sector”. A workshop organised in December 2009 has also contributed to the development of this methodology. There was participation by speakers from a range of sectors including mobile technologies, machinery, nanotechnologies, diagnostics, information systems and a science scanning programme. Each described the technologies in their sector and the methods used for technology detection, evaluation and selection. The aim of this paper is to provide a basic and flexible methodology, enhancing partnerships and cooperation while giving consideration to the public communication aspects. Indeed, public perception is influential in this sector and improvements are needed to ensure that new technologies would be accepted on a potential market. There is little value in developing and marketing a product or a process that will not be accepted widely by society. The objective of the proposed methodology is to ensure that new technologies are identified quickly and evaluated to assess their potential contribution to the development of more effective diagnostics, vaccines or pharmaceutical tools for the control of animal diseases. Such techniques for identifying innovations and applying them across a range of different diseases are however still in their infancy. A holistic rather than a specific approach will be explored in this paper and methods to compare existing and new technologies will also be addressed. 2. Scanning for new ideas Identification of new technologies may be achieved through scanning literature reviews, routine analysis of published literature and participation in relevant conferences. The DISCONTOOLS website has the potential to be at the core of this approach gathering information received on innovation, providing feedback from events, allowing exchange of information between members of the project and communicating on this issue to the general public. A team of 5 to 10 scanners would be needed involving individuals with experience in various relevant sectors and at least one with expertise in innovation and new technologies. Scanners would have the following tasks: - Review literature Routine scanning of articles, patents and events 4 WP 4 Methodology Paper Final 20120831 - - Assessment of regulatory guidelines (to rapidly identify potential regulatory hurdles) Participation in conferences Collaboration with other programmes and initiatives dealing with technology detection and selection Patent screening Preparation of ‘New Technology Sheets’ (see Annex 1) on all ideas and technologies identified by scanners and judged relevant to the animal health sector. These would describe future trends and potential applications related to diagnostics, vaccines or pharmaceutical tools. Providing input to the production of annual scanning reports based on PESTLE Analysis (see 2.2) A holistic rather than a specific disease approach should be taken by the scanners to ensure that potentially wider applications of innovative ideas are identified and transferred from other groups or sectors to the animal health sector. This would assist in focusing research in those areas which will provide the greatest benefits in terms of control of animal diseases. It is recognised that a system of alerting researchers to new ideas and new technologies is important. It is also recognised that the protection of ideas is important and that the sharing of ideas from academia and industry must be stimulated via an appropriate attribution and recognition/protection of the source. 2.1 New Technology Sheets From their scanning observations scanners would draft ‘New Technology Sheets’ on each topic judged relevant by WP4 and the DISCONTOOLS Project Management Board (PMB). Final approval by WP4 and PMB would be needed before placing the ‘New Technology Sheets’ on the DISCONTOOLS website. These documents would provide a summary of future trends identified and could be publically available to the entire animal health sector. They would be filed by sector of activity (when a sufficient number of sheets were available) to provide a convenient display to users. This would facilitate finding an idea or technology that could be useful to a particular sector. A database with a search tool could represent a future step in this exercise to allow searches by criteria (such as ‘type of potential application’, ‘type of technology’, ‘sector’). Where relevant, technologies should be grouped by area of application (diagnostics, vaccines or pharmaceutical tools) as different new technologies might be available for one type of application or one type of activity; as an example, in the case of gene sequencing, there are many different technologies available. The New Technology Sheets would include a summary, a description of the new technology, current applications, identify differences from existing technologies, and potential applications in animal health. A template ‘New Technology Sheet’ is available in Annex 1. These sheets are intended primarily for the animal health stakeholders, but would also be available to other sectors and the general public. 2.2 PESTLE Analysis Scanning information would be analysed using PESTLE Analysis, a method originally designed as a business environmental scan. PESTLE is an acronym for “Political, Economic, 5 WP 4 Methodology Paper Final 20120831 Social, Technological, Legal and Environmental” factors. These are often factors which are beyond control but are important to be aware of when doing product development. This simple method aims at providing a clear analysis of the external macro environment (big picture) in which a business operates. As an example, the ‘Panoptic’ tool from the New Zealand Futurewatch programme was designed based on this technique to capture the macro environment and future trends in that country1 . The PESTLE Analysis is generally used as a generic orientation tool, finding out where an organisation or product is in the context of what is happening outside that will affect what is happening inside an organisation or sector. It is often used in combination with a Strengths, Weaknesses, Opportunities and Threats analysis (SWOT). Example: PESTLE diagram. Such an analysis could be used to summarise the identified future trends and observations, to place them in a bigger context with factors and constraints that could change the decision to develop a new technology or not. This could feed into future annual scanning reports. 2.3. Scanning reports Scanning reports will summarise the accumulated scanned observations and trends over a year. They would be placed on the website to be publically available. This would be implemented only when the exercise has been running for a sufficient length of time. 3. Evaluation of alternative solutions 1 http://www.slideshare.net/naresdam/futurewatch-panoptic 6 WP 4 Methodology Paper Final 20120831 3.1 Method Building on the work of WP3, a list of available diagnostics and vaccines tools has been produced but further work is necessary in relation to pharmaceuticals. This will ensure that existing technologies and tools currently being used for disease control are clearly identified. The Gap Analysis exercise on tools available will also help to focus interest on the most critical gaps identified, with the aim of rapidly developing new or improved tools using new technologies detected by scanners. Existing technologies must be evaluated against new technologies when possible. A number of approaches are available and are discussed below. There are two cases where a comparison of alternatives would be useful: - When a new technology is identified where another old technology(ies) is(are) already in use - When many new alternative technologies are identified by scanning that appear to be relevant to fill-in the same gap in diagnostics, vaccines or pharmaceutical tools (identified by WP3) or to the same type of application The methodology proposed in this paper is a type of Delphi2 method, which is a subjectiveintuitive method of foresight based on surveys and involving an expert panel responding to questionnaires3 . Panels would generally involve 10 to 50 expert members whose identity would be kept secret from the other panel members4 . The methodology would rely on the creation of an expert team incorporating a range of expertise in products, research techniques, R&D, and regulatory issues. This latter area is essential to check for feasibility when a technology is proposed. The final objective would be to commercialise a product or a process that would be judged as ‘better’ than that which already exists or as ‘the best solution’ when nothing existed previously. This can only be done if the legal framework allows it. Steps for the proposed methodology are described below: 1. Gather a team of motivated experts (panel) covering the agreed range of expertise (will have access to the ‘megatrends’ identified by the scanners) 2. Define a problem to solve or a critical gap to fill 3. Define all alternative solutions (existing and new) 4. Define a set of criteria (limited number – not more than 10) for the evaluation of the alternative solutions 5. Score the criteria by importance for the sector or with regards to the future application (this will help defining weights of criteria and assist in taking a final decision) 2 http://www.unido.org/fileadmin/import/16959_DelphiMethod.pdf http://www.biomedcentral.com/1471-2288/5/37 4 http://www.biomedcentral.com/1472-6963/10/109 3 7 WP 4 Methodology Paper Final 20120831 6. Score the various alternatives with a very simplified grid of scores (high, medium, and low). This will help measuring performances of the alternatives against each criteria 7. Compare the alternatives (2 by 2 first if numerous) 8. Draft a diagram or table summarising the various scenarios 9. Finally, make the choice of the best solution. It can be that an old technology is judged more appropriate than a new one, especially if the new one is too expensive to develop. The conclusion may be that at a specific point in time, the existing method and/or product is the more appropriate and performing more effectively. 3.2 Set of criteria The first set of criteria used (Annex 2) will be scored by the panel in order to rate the importance of each criterion using a 5 point Likert scale, where 1 indicates low and 5 high importance or level of agreement5 . The scale should be as follows: 1. 2. 3. 4. 5. = very low importance – or strongly unfavourable to the criterion = low importance – or somewhat unfavourable to the criterion = undecided = medium importance – or somewhat favourable to the criterion = high importance – or strongly favourable to the criterion The final analysis would then help to identify advantages and disadvantages for each technology and to decide whether or not to develop a new technology and apply it to the animal health sector. The older pre-existing technology can also be compared with emerging technology. 3.3 Technology Assessment Team A Technology Assessment Team should be created to decide on the ‘best alternative’ following the main results from the questionnaire used. They would be experts in new technologies, in animal health products (industry) and in regulatory affairs. They should meet regularly (every three to six months) to perform a broader analysis. They would look at the general background, literature review, New Technology Sheets, alternative technologies, the scored results, potential clinical trials, cost and legal issues6. 4. Communication During the WP4 workshop held in Brussels in December 2009 participants identified public perception and dissemination as a major hurdle in the animal health sector. There is a need to 5 6 http://www.socialresearchmethods.net/kb/scallik.php http://www.nice.org.uk/MT 8 WP 4 Methodology Paper Final 20120831 better communicate on innovation and to ‘demystify’ technical activities for the general public. A better risk/benefit communication along with risk perception approaches would be needed to help promote novel technologies to a predominantly “risk-averse” public. Moreover, communication within the animal health sector to research funders, research workers and development groups in the industry should not be forgotten. A list of relevant meetings and conferences could be regularly sent out to the DISCONTOOLS WP4 members for update, comments and to check who might be attending the listed events. People attending such events could then draft a one-page document to summarise ideas/tools that could be relevant and/or useful to the animal health sector. These brief “summaries” could be circulated to the group members and then to relevant stakeholders if judged interesting. All information linked to the activities of WP4 would be placed on the DISCONTOOLS website, either in the public area or in the private section (documents for comments…). Links to other websites and programmes will be made available and cooperation and activities coordination is envisaged. 5. Conclusions A major deliverable from DISCONTOOLS Work Package 4 is the development of “an acceptable methodology to identify current and newly developed technological innovations which contribute to the development and delivery of new or improved disease control tools (diagnostics, vaccines and pharmaceuticals)”. Techniques for identifying new technologies and applying them across a range of different diseases are still in their infancy. WP4 has reviewed existing methodologies from different industry sectors and has proposed a simple and flexible, holistic approach to scan new technologies and to analyse these in relation to the broader industry and socio-political environment in order to identify those innovative ideas which may be transferred beneficially to the Animal Health sector. Furthermore, an approach to evaluate existing technologies against new technologies or to compare alternative solutions has also been proposed. Practical application of the approaches proposed, in order to facilitate the development of new or improved disease control tools, is a long term objective which exceeds both the resources available and the timeline of the current DISCONTOOLS project. It is intended that the methodology proposed here, together with some illustrative examples of New Technology Sheets, will serve as a future “road map” for the evaluation and application of new technologies in the development of improved disease control tools. 9 WP 4 Methodology Paper Final 20120831 Annex 1: Template ‘New Technology Sheet’ DISCONTOOLS New Technology Detection and Selection Fact Sheet – [Name of the technology] 1. Summary 2. Description of the technology 3. Differences from existing technologies 4. Opportunities 5. Challenges 6. Potential application to Animal Health 7. References 10 WP 4 Methodology Paper Final 20120831 Annex 2: Scoring criteria Scoring criteria are focusing on performance, cost, complexity and maturity of the technology studied. 1. The disease or pathogen to which the technology will be applied can be clearly defined 2. Prevalence or incidence of the disease or pathogen can be estimated 3. The potential that the technology will have an impact on morbidity and/or mortality of animals 4. The accuracy of current methods used 5. The new technology improves the ability to eliminate the disease or pathogen 6. The cost effectiveness is better than current methods 7. The degree of complexity of the technology is acceptable 8. The level of maturity of the technology is well known 9. It would be feasible to change current practice to incorporate the technology 10. Policy and regulatory acceptance 11 WP 4 Methodology Paper Final 20120831