Keywords: electronic commerce, medical devices

REQUIREMENTS ANALYSIS OF THE MEDICAL DEVICES COMMERCE COMMUNITY O. Panou-Diamandi 1, N.Katevas 1, M.A. Bianchi 2, C. Andreucci 3 and S. Copelli 4 1 National Technical University of Athens, Biomedical Engineering Laboratory, 9 Iroon Polytechniou Str., Zografou Campus, H/Y Building, 15773 Athens, Greece. e-mail: diamandi@biomed.ntua.gr 2 AUSL DI MODENA, Dept. of Direzione Sanitaria, Via S. Giovanni del Cantone 23, 41100, Modena, Italy. e-mail: modena08@nettuno.it 3 ESAOTE S.p.A, Programmi R&S, Via Di Caciolle 15, 50127, Firenze, Italy. e-mail: claudio.andreucci@esaote.com 4 R&S Informatica srl, Via Lazzaroni 4, 20124 Milano, Italy. e-mail: rsinfo@tin.it Abstract - The development of a Europe wide telematics application for electronic commerce of medical devices targets a broad variety of users from single users to huge organisations (customers or suppliers), and aims at concentrating the forces of organisations interested in globalisation of medical products market for establishing an environment hosting all the interactions of customer-supplier. In this study the user profiles involved in Medical Devices electronic commerce are addressed and assessed in correlation with the procedures followed today. Description of the medical products assessment and planning procedures performed up-to-date by large medical product consumers is given, as well as, their selection criteria and procedure. The description highlights those points related to the integrated environment electronic commerce/presentation of medical products and the way an electronic environment can benefit the procedure. The right information to the buyer is considered the key issue for a medical products electronic commerce system. This can enlarge the market to the size of its own potentials and thus perform the target of trade: sales that satisfy buyer needs. Keywords: electronic commerce, medical devices I. INTRODUCTION Medical devices commerce community can be divided into two major categories: I) the medical products consumers, and II) the medical products providers. Although their interest differs, there are some major common requests originated by both edges of commerce partners, that is, easy to find, widespread and reliable information exchange. This simple and basic principle seems to be missing from the conventional way commerce is performed and that would benefit by the integration of information technology in the commerce process. One can not expect that all people involved in medical products commerce activities are experienced in information technology searching tools. Additionally, it is obvious that not all-available information is interesting for everybody. It is of interest to point out that the majority of the successful market approaches - that are market researches that finally conclude in a commerce activity - are employing either a bottom-up or a top-bottom approach. The first market approach (bottom-up) starts on a specific interest initiated by a specific, and sometimes emerging requirement for a medical product. The second approach (top-bottom) is initiated by the general interest in a new technology. The later will be progressively specified in all details to finally conclude to a specific request of information as in the bottom-up approach. But in general the interest will be either well focused or fuzzy. The role of a medical devices electronic commerce system would be to guide the users by picking up from the data pool the particular information required in each case and further on follow up the user expertise in the seeking of information. Users that would like just to have a tour around the virtual market place and be informed on technology and products available are not excluded by no means from this environment. These are usually persons or organisations that are keen to see themselves involved in medical products commerce, but they are not yet commit to this sector and that is why the possibility of performing a purchase is very low and these activities if there are any are limited. This electronic commerce environment should also integrate in the IT system those users coming from the academic communities. Academics usually provide new ideas, as they are motivated from their interest on the science part of an issue than in the potential exploitation. In general the role

of the system should enhance the confidence between the commerce partners and provide creditable environment required in commerce in addition to the standard facilities already foreseen. The objective of this paper is to identify and analyse the requirements of Medical Devices Commerce Community. This study was performed within the framework of the MEDICOM 1 project [1] that is supported by the EC under the ESPRIT program and aims at the development of a Europe wide telematics application for electronic commerce of medical devices. The user profiles involved in Medical Devices electronic commerce are addressed and assessed in correlation with the procedures followed today. This paper addresses the market requirements for both durable equipment and consumables. Description of the medical products assessment and planning procedures performed upto-date by large medical product consumers is given, as well as, their selection criteria and procedure. The description highlights those points related to the integrated environment electronic commerce/presentation of medical products and the way an electronic environment can benefit the procedure. The right information to the buyer is considered the key issue for the medical products electronic commerce system. This can enlarge the market to the size of its own potentials and thus perform the target of trade: sales that satisfy buyer needs. II. THE ANALYSIS METHODOLOGY AND RESULTS Performance of business modelling of the process, that a medical products electronic commerce environment is going to address, precedes the user requirements analysis. By this, the various user profiles involved in the business processes are identified easier and in a complete but also flexible manner, enabling expansion of the analysis in deeper (wider) level. The methodology followed has been derived from ARMA (Agent Relationship Morphism Analysis). The methodology is building on raw data collected from interviews and contacts with the actual participants of the commerce activities, as they are performed today. Description collected is including the job titles, followed by simple sentences, describing the way the actual process is performed. Sometimes interviews are performed especially in the cases where the relationships between the various job titles and inter-process communications are not clearly described in the forms or tables used to gather data. All related material, as forms exchanged between the job titles, is also collected. The methodology provides in tabular form all the information related to the process under analysis. The table(s) contains image of the real process and from this transformation of the collected information, one can easily identify user profiles ("job titles") involved in a particular process, their relationship, as well as, the kind of information they are interested for. The last is quite important, as the information have to be filtered before presentation to the various user categories and only the users of information themselves can identify what they need to see. Medical products' trade analysis was focused on the following tasks: medical products assessment and planning process description, medical products purchase procedure description, the study of electronic commerce from medical devices' providers point of view and medical market nomenclature and vigilance issues. According to data collected from user organisations (hospitals) and product assessment and planning processes as described in the literature in at least three EU countries, the objective of medical equipment assessment and planning process is twofold: i) to collect, evaluate and provide the organisation (usually a hospital) with relevant information pertaining to medical device technology assessment and also ii) to promote organisation s strategic planning awareness of internal and external technological factors influencing health care. In most cases, an interdisciplinary "medical product assessment and planning" committee exists, appointed by the organisation (hospital) management, which is responsible of ensuring that all professional aspects needed are met in the medical technology assessment. In this committee, representatives of organisation (hospital) management, clinical engineering department and clinics participate. More specifically, this committee has to: (a) Study the reports relevant to the use of the existent medical product (b) List the hospital needs in biomedical equipment (c ) List product (equipment) in need of replenishment (d) Study the potential adopting of new diagnostic as well as new therapeutic techniques together with the entailed product acquisition and (e) Propose to the hospital management the purchase of specific medical product. Physicians having already been informed on new medical products can also send a request of a new medical product purchase directly to the hospital management. The most common ways of getting this information are (i) Directly from manufacturers of medical product, or their representatives MEDICOM is supported by the EC, under the Contract #25289 of the ESPRIT program.

(ii) International bibliography (iii) Scientific Community (iv) Media (v) Other colleagues. The hospital management in relation to the budget, which is allocated along with the definition of the objectives, makes the final selection. The cost/benefits ratio in relation to the objectives of the organisation is the most important parameter for the selection of a new technology. Particularly in the case of new medical equipment planning, the committee must clearly define the medical problem originating the need for a new technology, the efficiency of the technology, the base of population which can be treated and the conditions (logistic, organisational, etc.) under which the technology requires to be applied. Medical products purchase procedure has been also examined and analysed for both durable medical products and consumables. In the case of durable medical products purchase Hospital management appoints a "purchase" committee responsible. In this committee representatives of clinics, hospital management and clinical engineering department participate. In addition, hospital management appoints a "purchasing manager" responsible for the procurement process. The procurement process is always monitored and evaluated by the hospital management. When a specific product is selected for purchasing, the procedure followed for purchasing follows five steps: (1) Medical device specifications editing (2) Selection of evaluation criteria (3) Tenders' gathering (4) Final evaluation - order process (5) Delivery. Regarding medical device specifications editing, the following specifications must be provided to the suppliers : Description of the type of technology type required, a list of minimum functional parameters and the degree of accuracy, International standards to be met (i.e. CE marking), the clinical applications of the technology requested and description of the environment (logistic, etc.) in which the technology will be installed and used. Hospital must receive from the suppliers a set of information to allow objective confrontations. The information requested can have the form of questionnaires that providers have to fill in. Often, there is a big difficulty in confronting parameters for which the different producers don t have homogeneous and standardised definitions. Upon the type of equipment, the purchasing manager or purchase committee decides on the type of purchase process to be followed (Private negotiations, European Tender, Local Tender, Direct order or Limited Call). Some important issues for the technical evaluation criteria establishment are (i) The technology must not be obsolete and the spare parts must be available for at least 8 years ahead (average life of a biomedical equipment) at known costs (ii) Before purchasing it must be possible to decide the maintenance modality: by internal technical staff, by external contracts, etc. (iii) It must be possible to assess the issues related to security and to define the limit of acceptable risk (iv) Adaptability of the equipment to the user environment: size, weight, complexity of use (v) Integration / Interoperability with the Information System of the Hospital (vi) Availability of user manuals, of technical and reference manuals, etc. (vii) Price. The committee, carrying out the purchase integrates then the technical evaluation with an operational and economic evaluation for the global management of the equipment. This includes also the assessment of possible hidden costs (e.g. use of proprietary disposable, ). All in-coming medical devices undergo an acceptance testing, to ensure that they are safe before being used in the clinic ( in the presence of a responsible committee, usually consisting from clinical engineering department staff and clinicians from the clinic, where it is going to be used). The delivery shall comply with the requirements specified in the purchasing and delivery documents, and shall include all accompanying accessories, user instructions, and technical service manuals. Furthermore decisions on the preventive maintenance procedures (service contracts) shall be made as a part of the acceptance procedure. In the case of consumables, the procurement office of the hospital has the general coordination role for the consumables. It performs the procurement of consumables, either with open or limited call purchase procedures. The evaluation of the tenders is performed by the purchase committee which judges both the technical tenders conformance with the required specifications as well as the financial part of it and the cost effectiveness ratio presented from each provider. Most of the times, the final evaluation results to a one-year contract between the hospital and the supplier. The lack of a consistent nomenclature system to uniquely identify the medical consumables is the cause of many communication problems between customers and suppliers. There are many different codes corresponding to several producers, for the same type of consumable. Lack of consumables coding often results to mistakes made by the staff of the procurement office, in filling in the ordering forms with consequent remarkable delay in carrying out the specific orders. Moreover, communication problems often occur between the procurement office and the warehouse, resulting to new orders on products already existing in large amounts in the hospital s warehouse or the delivery by the warehouse of different products to that actually requested. Moreover, producers do not usually give in public full description of their products. There is also great variety of medical consumables which combined with the common confidentiality policy met in medical product providers makes the task of user information a difficult one. The common case is that a consumable is identical or similar to many other coming from the same or another provider, but this information is either hidden or unknown to a potential

customer. Additionally, producers of durable equipment and consumables are restricting the use of the products they are producing to those of the same trademark, their trademark. Study of electronic commerce from providers point of view, key role in the marketing process plays the promotion of the products. The focal point of the selling procedure is primarily the effort to inform the market for the company and its products and then, the establishment of a good relation with the customer. This effort beyond the creation of general-purpose material common to all users, includes the categorisation of the audience in order to address every different group of users with the adequate information. Before the establishment of the Internet Era the basic tools to approach the customers were and still are: (i) Classic advertising in specialised magazines and newspapers, which though it is expensive, it can target very well the market, giving the producer the opportunity to selectively emphasise in significant products (ii) Direct Mail - Brochures, which although is not inexpensive, is a fairly good method to approach targeted customers because the distributed information is more detailed than the advertised (iii) Personal Contact, an excellent way, highly appreciated from the marketing sections because it is probably the most influential. It includes the benefits of the previous methods and with the combination of site visits it becomes the only convincing way for capital products (iv) The participation in major Exhibitions, Tradeshows and Events, although expensive and difficult to implement, it remains for many companies the major promotional event. It is a way to combine almost all the benefits of the other methods. The customer beyond advertising and brochures can have personal contact with people from every level of the company starting from low background salesmen to senior engineers. Customers have also the ability to see the products and have a first level of testing basic features (i.e. ergonomics). Contacting business partners is another important issue for medical products providers, especially for those with big expansion throughout Europe or even the world. The information provided -the content- could be similar, thus included, to that offered to the end users, but in this case is differently structured, enriched and is combined with tools to assist the selling procedure. The main issues covered are Product and Market Overview, Positioning-Competition and Future, Selling Strategies - Success Factors, Success Stories and Frequently Asked Questions. Up to now the approaches in the field of medical device vigilance in the EU countries, prior to the implementation of the directives, were very different and no formal, commonly adopted communication structure between the involved authorities existed. The medical device directives have imposed new requirements and the need for a harmonised approach and cross-national exchange of information has been recognised. Effective and efficient data handling and exchange tools are required. Evidently, we are currently experiencing the new communication era and it is naturally expected that an application for electronic commerce of medical devices should include post-market surveillance facilities by providing the appropriate means and tools for an effective, commonly accepted approach in information exchange. Post Marketing Surveillance (PMS) systems [2,3] are usually meant for reporting and investigating adverse incidents related to the use of medical devices. According to the European Community (EC) directives for Active Implantable Medical Devices (AIMD) and Medical Devices (MDD) [4,5], manufacturers of medical devices introducing their products into the EC market are obliged to report to the Competent Authority adverse incidents related to his devices which have or could have led to death or to serious harm to patients or users. This obligation is elucidated in a MEDDEV document entitled Guidelines on a Medical Devices Vigilance System [6] issued by the European Commission. The German Institute for Medical Documentation and Information (DIMDI) is developing a regulatory data exchange system for the implementation of the EC medical device directives: EUDAMED (European Database on Medical Devices). A progress report [7] issued by DIMDI discusses forms for the registration of medical devices, data field definitions, coding systems for Competent Authorities, Manufacturers etc. and ECRI s Universal Medical Device Nomenclature System (UMDNS) [8]. UMDNS is a medical devices nomenclature system to identify medical devices on a generic level. As UMDNS is widely used in Europe already and is adopted by the European Commission as interim standard, it is strongly recommended to the projectgroup to use it throughout the MEDICOM system where necessary. Finally, the users and user groups involved in medical devices electronic commerce, as they derived from the analysis, are presented. Organisation Management: It defines the global objectives of the organisation (e.g. hospital, health care institution) related to technologies with global impact. It makes the annual planning for buys according to the budget available and the propositions made by lower levels in the hierarchy. It takes the final decisions and it has the overall responsibility of the medical equipment assessment. It is supported by several appointed committees and experts. Purchase Committee: It is responsible for all purchase activities of the organisation. It has an overall view of the medical equipment market. It issues call for tenders, process and evaluates the results.

Purchasing Manager: It is the person that overtakes the responsibility of all actions of the Purchase committee. He monitors and evaluates all purchase procedures and organises the Committee activities. He has to be informed in every detail about the technical details (specifications, expansion options, etc.), the price, service plans and the life-cycle cost of the potential purchased equipment. Additionally, he is also interested in general and financial information about the manufacturer. Clinicians: They practice medicine on the final service receptor, thus they need to have a view of the technology and have access on the details of the products they use in their daily duties. They are rising requirements according to the grade of satisfaction they and the patient is gaining from the treatment and the means used for that (medical products). Technical Staff: They are the persons that maintain in operational condition the equipment and facilities used for the health care service provision. Their opinion on particular equipment is affecting the opinion of people that can initiate the purchase procedure. They need to have access to new products info in order to be familial with the technology improvements and methods. This can trigger the trade chain. Patients: Patients are included in the potential customers of medical consumables. Competent Authorities: They receive reports concerning medical device serious incidents, death or serious injury, submitted by the manufacturers. Generally, they have to monitor the manufacturer's investigation and intervene, if necessary. Their role is to ensure that medical devices are, whenever appropriate, subjected to continuous monitoring and quality control of their functional status in the postmarketing life cycle. Doctors- Independent specialised practitioners like radiologists, dentists, etc.: They need to have access on medical market information and state-of-the-art technology in order to apply medicine in a better way or investigate new ways to enhance their performance. They consist one of those user categories that are able to initiate new market sectors. As end-users of medical devices, they will generate reports on device related incidents and inform Hospital Management. Paramedical: They will generate reports on device related incidents during the use the devices concerned and inform hospital management. They need to have access and to actively contribute to post market surveillance. Consultants: These are individuals or organisations that are providing services to health care service providers. They need information on the latest technology achievement as well as an updated view of the market and what the market can offer. They consist one of those user profiles that are triggering trade activities. Salesmen: They need to be informed about the competition in order to improve their personal sales policy. Clinical Engineers: They participate in "medical equipment assessment and planning" committee and need to get information on new products and techniques. In the medical product purchase process, they are responsible for the technical specifications editing. They perform the acceptance testing of all in-coming medical devices. They have to know the state-of-the-art technology in the medical equipment market. Their role in the hospital demands access to all technical details of medical equipment in use. They would like to exchange experiences with colleagues from other organisations. Finally, they need to generate reports on device problems discovered during maintenance that could lead to an adverse incident. Providers - Manufacturers: Medical product providers have a central role as their scope is to make business and that they are the engine of the trade. They make decisions on the marketing policy of the company for the promotion of their products. Their marketing department aims at the establishment of a good relationship with the customers as well as with their business partners, through certain, costeffective whenever possible, communication channels follows these procedures. Manufacturers of medical devices will receive incident reports from health care institutions. They have to decide on the follow-up of these reports. Business Partners: They have strong interest on keep the business alive and they require to participate and use all tools that could enhance their activities. Procurement office: It has the main coordinative role for the procurement of all medical products. Health Care Institution Warehouse personnel: It has the responsibility to check the medical products stock and inform, whenever is requested to, on the lack of any products. It is also responsible for the delivery of the requested consumables to the Clinics. Medicine Oriented Researchers: They are interested to follow the latest technology achievements regarding medicine. Also, they are keen to test advanced products available in the market to get ideas for their own research. III. DISCUSSION-CONCLUSIONS

It is clear that the market, that a Europe wide telematics application for electronic commerce of medical devices is addressing, is a huge, healthy and still developing market. Thousands of new medical products are made available each year. It was evident from our research that it is not easy given the current status for the information consumer to find the required information at the right time. From the medical products' trade analysis, It was clear that information consumers involved in medical products assessment and planning found quite difficult getting information on any new technology being available in the market. In more details and at the points where the market is reformulated, clinicians and clinical engineers are lacking information channel that can provide them not only first sight but also detailed technical specification or information on state-of-the-art. The existence of several nomenclature and codification systems for medical devices as well as the non-uniform terminology applied in different countries are some of the major problems that need to be resolved, in order for all parties involved to effectively exchange information, on medical devices. The lack of homogeneous and standardised definitions on medical products specifications among suppliers prohibits objective confrontations. Moreover, the complete lack of a nomenclature system for the consumables results in many communication problems between all the parties involved. An agreed and widely used nomenclature system for the identification and description of medical devices in general terms is needed, allowing collation and data exchange across Europe. The medical device directives have imposed new requirements and the need for a harmonised approach and cross-national exchange of information has been recognised. Effective and efficient data handling and exchange tools are required. Evidently, it is naturally expected from a medical products electronic commerce application to support Post-Market surveillance facilities in order to ensure continuous monitoring and quality control of medical devices, tracking the product and user needs throughout the product life, offering advanced on-line after sales and promotion support, and collecting valuable material for products revisions. Marketing policies that are using old-fashioned methodologies to enhance profits should be reconsidered. These along with the volume of the market and the variety of the products offered conclude to a fuzzy image of the market as the potential customer sees it. Products are not sold because the potential customer ignores their existence or is not aware about their use and functionality. The right information to the buyer is considered the key issue for a Europe wide telematics medical products electronic commerce application. This can enlarge the market to the size of its own potentials and thus perform the target of trade: sales that satisfy buyer needs. REFERENCES [1] Project programme MEDICOM (Medical Products Electronic Commerce) - Annex I, ESPRIT IV PROJECT 25289, financed by the Commission of the European Communities. [2] A. Lowery and J. Puleo, Models for medical device regulations. Medical Devices - International Perspectives on Health and Safety (editor C.W.D. van Gruting), p.153-159; ISBN: 0 444 89242 7 [3] M. Carlisle, Medical Devices Directive: industry s perspective. Medical Devices - International Perspectives on Health and Safety (editor C.W.D. van Gruting), p.223-236; ISBN: 0 444 89242 7 [4] Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Official Journal of the European Communities, L169, ISSN 0378-6978 [5] Council Directive 90/385/EEC of 20 June 1990 concerning active implantable medical devices. Official Journal of the European Communities, L189 [6] Guidelines on a Medical Device Vigilance System (Final Draft), Commission of the European Communities MEDDEV 3/93-rev. 2 [7] B. Hartmann, R. Jonas and R. Laby, WP1: Database Design and Implementation - T1.1: Database Design. Progress Report European Database on Medical Devices (EUDAMED), project PRS 96/87031, DIMDI, 15.05.97 [8] Medical Product Purchasing Directory with Official Universal Medical Device Nomenclature System, Health Devices Sourcebook, ECRI, ISBN 0-941417-50-6.