Intellectual Clinic Methodology of Conformance Evaluation to Conditions of Participation in the Project President of “Academy of Expert Analytics” Company Boris Zalmanov

The project "Intellectual Clinic" is an integral part of the global project "Intellectual Health Care", initiated by All-Russian public organizations "Society of Physicians of Russia", "Russian Society of Surgeons" and "Society of Endoscopic Surgeons of Russia". The intellectual clinic includes all subdivisions of a medical treatment facility integrated into a single management system providing medical care to patients, the operation of medical equipment, routing of patients within the facility, utilizing the technologies of remote consulting and other processes. The basis of project "Intellectual Clinic" is total integration of all equipment located in the department of anesthesiology and intensive care through the system center. The project participant can become any manufacturer or one of its officials, whose products meet established professional standards for medical equipment, consumables, IT systems and solutions. Selection of the project participants is done by examination of the subject of the application for compliance with the criteria of the project. Intellectual Clinic

Positive decision about participation of the manufacturer or one of its officials filed an application in the "Intellectual Clinic" project is accepted if medical equipment/ medical product meets the following criteria: 1.Technical parameters and characteristics of medical equipment/ product correspond to the range of consumers' requirements, identified as a result of survey of equipment/ product end users. "From Minimum to Maximum" Criterion 2.Clinical safety and functionality of medical equipment/product in case of intended use (post market clinical follow-up) is confirmed. "Safety and Functionality" Criterion In addition, technical possibility to integrate equipment into the single system "Intellectual Clinic“ needs to be confirmed. Analysis of product conformity to the "From Minimum to Maximum" Criterion and "Safety and Functionality" Criterion on the basis of feedback data from equipment users is carried out by the «Academy of Expert Analytics» Company which is the General Partner of the Project. Possibility to integrate equipment into the "Intellectual Clinic" system is confirmed by the Company-Integrator К5К, which is an official partner of the Project. Methodology of Conformance Evaluation to Conditions of Participation in the Project

I.The process of correspondence expertise execution is preceded by the annual market research for each kind of equipment/ product, composing the project. The aim of market research is revelation and formation of key consumers' requirements to products existing in the market and determination of the rate of product parameters and characteristics from minimal to maximal ones. 1. Market research is executed according to the following plan: volume, dynamics, rate of growth of the market in the natural and monetary terms; tendencies of the market development: sales volumes of producers, rate of growth; market shares of all producers, dynamics; segmentation of equipment on the basis of: technical parameters, functional, configuration, price; analysis of price segments: technical characteristics, parameters, area of usage and possibilities of this equipment segment usage; determination of "leaders" among equipment units, presented in the segment; description of segment "leaders". Formation of "From Minimum to Maximum" Criterion

2.The second stage of market research is revelation and evaluation of consumers' requirements to equipment/product on the basis of data, received as a result of desk studies and survey of end consumers of equipment/product by questioning and interviewing. The following parameters are determined in the course of survey: level of significance of equipment various parameters and characteristics for a specific user – rating evaluation; "positive" parameters and characteristics of equipment, which, from the user's point of view, are realized best of all in the equipment and make working activity more convenient; parameters and characteristics of equipment which do not satisfy the user, complicate working activity and are not used/ excessive; parameters and characteristics, which, from the user's point of view, should be realized in the equipment, but are absent at the present moment. As a result of analysis, the key parameters and characteristics of equipment/product are determined. The general list of consumers' requirements for the project is formed. Formation of "From Minimum to Maximum" Criterion

3.At the third stage of market research, the list of obligatory and desirable parameters and characteristics, which should belong to the equipment/product of this segment, is formed. 4.At the fourth stage of market research, the requirements for values of parameters and characteristics of the equipment/product in each segment are formed. The range "From Minimum to Maximum" is determined, namely the range from minimum to maximum values of parameters and characteristics, which should belong to the equipment/product: the "maximum" value of parameters/characteristics is determined on the basis of parameters/characteristics of top segment which are obligatory for realization; the "minimum" value of parameters/characteristics is determined on the basis of parameters/characteristics of lower segment which are obligatory and partly desirable for realization; The results of research are published at the web-sites of the Russian Society of Surgeons and "Academy of Expert Analytics" as well as in other open sources not later than 1 st of March of the year following the report year. Formation of "From Minimum to Maximum" Criterion

Producer of equipment/ product or its official, whose technical characteristics fit well into the mentioned range, apply to the "Academy of Expert Analytics" Company for carrying out the correspondence expertise. The Company-integrator К5К confirms existing or potential possibility of equipment integration. The "Academy of Expert Analytics" Company performs gathering and processing of feedback data from consumers of medical equipment/ product (the base of consumers is provided by the producer on conditions of full confidentiality) and determines whether the equipment/product corresponds to the project criteria. The Russian Society of Surgeons and "Academy of Expert Analytics" guarantee confidentiality of information about filing of an application by the producer or its official for correspondence expertise. The list of producers or their official representatives received a positive result from the correspondence expertise is published at the web-sites of the Russian Society of Surgeons and "Academy of Expert Analytics" as well as in other open sources. Correspondence Expertise to Conditions of Participation in the Project

Correspondence to the criterion "Safety and Functionality" is confirmation of clinical safety and functionality of medical equipment/ product during intended use (post market clinical follow-up). Post market clinical follow-up is related to the measures of post-marketing supervision, which is an integral part of the quality management system. Post-marketing surveillance is overseeing medical device in the course of its life cycle in case of its intended use, containing gathering information from consumers about safety of device and quality characteristics of medical device. Post market clinical follow-up is carried out in accordance with the requirements of standard MEDDEV 2.12/2 rev2 Guidelines on Medical Devices/Post Market Clinical Follow-up Studies in order to confirm clinical safety and functionality of medical equipment/ product in case of intended use. "Safety and Functionality" Criterion

1. Correspondence analysis to the "Safety and Functionality" criterion is a check of absence of incidents with medical equipment/ product. The producer or its official provides information about incidents occurred in the course of operation, about damages or violation of equipment/product functional, which influenced negatively or could impact negatively on the health of patient or resulted or could result in death. If any incidents were recorded, the producer or its official provides documented data about correcting activities, which were carried out to prevent a possibility of occurrence of such incidents in the future and a conclusion from Roszdravnadzor and/or other official organizations about he fact that the incident is "closed". If the producer or its official refuses to provide information about incidents, the Russian Society of Surgeons and "Academy of Expert Analytics" reserve the right to find the necessary information independently. If no incidents with equipment/product were registered or if they are considered as "closed", the following procedures are carried out: Correspondence Expertise to Conditions of Participation in the Project

2. Gathering of initial information on functionality of medical equipment/product: The producer or its official provides registration certificates for medical equipment/product, which is valid at the moment filing of application, as well as detailed description of their functional and technical characteristics. The producer or its official provides the base of medical institutions, where equipment/product of the producer is operated/used. The base must includes the information about date of production and commissioning of equipment/product, contact information of the medical institution. ! The Russian Society of Surgeons and "Academy of Expert Analytics" guarantee confidentiality of provided information, that will be indicated in the separate point of agreement in accordance with the RF legislation. Correspondence Expertise to Conditions of Participation in the Project

3. Survey of users and consumers: The questionnaire form with a 10-grade evaluation system is developed for each type of medical equipment /product considering functional and technical characteristics in accordance with the “from minimum to maximum" range to survey consumers and users. The quoted sample of medical institutions for relevant evaluation of clinical usage of equipment/product during the whole period of operation is formed. The survey is performed using the method of telephone or personal interviews. All data are systematized and introduced into the data base. In addition to evaluations, which reflect correspondence to declared functional and technical characteristics of equipment/product, comments from consumers and users in relation to usage of equipment/product will be registered. Informational and staff resources of the professional community are used in the course of survey and data processing. The survey data will be processed and the conclusion about correspondence of equipment/product to declared functional and technical characteristics will be made. Correspondence Expertise to Conditions of Participation in the Project

Thus: Conformity to the "From Minimum to Maximum" criterion means for the producer that equipment manufactured by it has all necessary parameters and characteristics from the user's point of view, in addition, such equipment corresponds to requirements for values of these parameters and characteristics set by consumers. Conformity to the "Safety and Functionality" criterion means for the producer the absence of incidents with equipment manufactured by it or if the incident is considered as "closed". The "Academy of Expert Analytics" Company provides the producer or its official with a detailed report about performed researches. If the producer or its official is interested, the report may contain recommendations on evaluation and practice data included in the report (Note: it is outside the framework of the Project and negotiated separately). Correspondence Expertise to Conditions of Participation in the Project

Terms: 1. Key consumers' requirements to each kind of equipment/product, which is the part the Project, and requirements to values of parameters and characteristics of equipment/product are published at the web-sites of the Russian Society of Surgeons and "Academy of Expert Analytics" as well as in other open sources not later than 1 st of March of the year following the report year. 2. Filing of application from the producer of equipment/product or its official for carrying out the correspondence expertise is performed during the whole year. 3. Conclusion about carrying out the correspondence expertise is performed twice per year – 1 st of July and 1 st of December. Conclusions for applications filed before 1 st of April are issued in 1 st of July; Conclusions for applications filed before 1 st of October are issued in 1 st of December. ! Conclusions may be issued oftener than twice per year at the discretion of the Russian Society of Surgeons and "Academy of Expert Analytics“. Correspondence Expertise to Conditions of Participation in the Project

Each participant passes the correspondence confirmation expertise to participation conditions in the project annually. Algorithm of the confirmation expertise passing is absolutely identical to the algorithm of the primary expertise. 1.Application for passing the correspondence confirmation expertise to conditions of participation in the project is filed by participants within the period since 1 st of September to 1 st of October of each year. 2.Conclusion about passing the correspondence confirmation expertise is issued in 1 st of December. Confirmation of Correspondence Expertise to Conditions of Participation in the Project

Correspondence Expertise to Conditions of Participation in the Project Correspondence expertise Application filling for passing the correspondence expertise Annual Market Research Aim: revelation and formation of key consumers' requirements to products existing in the market and determination of the rate of product parameters and characteristics from minimal to maximal ones. Result: Formation of "From Minimum to Maximum" Criterion Confirmation of existing or potential possibility of integration equipment into the single system Analysis of correspondence to "Safety and Functionality“ criterion Check of absence of incidents with medical equipment/ product Gathering information about functionality of medical equipment Analysis of correspondence to "From Minimum to Maximum" criterion Gathering and processing feedback data from consumers with the aim of confirmation of medical equipment/ product correspondence to declared functional and technical characteristics no yesyes yesyes

As a result of performed expertise procedures to determine correspondence to conditions of participation in the project, the unlimited number of participants of the project from producers and their officials is determined. The Russian Society of Surgeons gives comprehensive support to the project as a whole, not to the project participants. The project participants promote their own products at the market and include them in the integration solution formed by each supplier independently. The project integration solution is considered as three or more products, which passed the correspondence expertise to conditions of participation in the project successfully. If an official application comes from the third party, the Russian Society of Surgeons and "Academy of Expert Analytics" are ready to carry out the integration solution correspondence expertise to conditions of participation in the project. The correspondence criteria for integration solution are as follows: existence of positive correspondence expertise to criteria of the project; 51% and more products included in the integration project must be produced domestically. Integration Project «Intellectual Clinic»

The order of receiving the correspondence expertise is as follows: Supplier files an application for the expertise to "Academy of Expert Analytics". The application must contain the whole list of products included in the integration solution as well as official documents, confirming the country of origin for each product. The Russian Society of Surgeons provides its expert conclusion within 3 working days since the moment of filling application. The Russian Society of Surgeons provides its conclusion to each supplier who filed an application. Integration Project «Intellectual Clinic»

Within the frames of presenting the evaluation methodology to conditions of participation in the project, "Academy of Expert Analytics" company carried out market research of laparoscopy tower systems and electrosurgical modular units. As a result of performed survey with representatives of professional community, the list of obligatory and desirable parameters and characteristics, from the users' point of view, was formed for laparoscopy tower systems and electrosurgical modular units, in addition, the requirements for values of parameters and characteristics of equipment were formed. You can find the list and the range of parameters and characteristics of equipment at the web-site of All-Russian public organization "Russian Society of Surgeons" and "Academy of Expert Analytics“ company The "Academy of Expert Analytics" company expresses gratitude to surgeons, who took part in the survey, as well as to the public organization "Russian Society of Surgeons" for assistance in organization of this research. We’re looking forward to mutually beneficial cooperation! Formation of “From Minimum to Maximum" Criterion

Thank you for attention!