EndoTrainer - A revolution in non-invasive surgery training

Project Information

EndoTrainer

Grant agreement ID: 817335

DOI

10.3030/817335

Project closed

EC signature date 7 May 2018

Start date 1 June 2018

End date 30 November 2018

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

SURGITRAINER, SL
Spain

Periodic Reporting for period 1 - EndoTrainer (EndoTrainer - A revolution in non-invasive surgery training)

Reporting period: 2018-06-01 to 2018-11-30

Summary of the context and overall objectives of the project

Our aim is to help surgeons improve their skills in Minimal Invasive Surgery (MIS). We want to increase the number of procedures completed using this technique as it offers multiple benefits for patients and hospitals from a safety, well-being and cost point of view. To do this we have a custom developed tool that is based on robotics and advanced software to create the world´s first combined Hardware and Software MIS simulation and performance monitoring platform.

In this SME Phase 1 project our highest priority has been to (1) validate the performance of our pre-industrial simulator under real training conditions, (2) analyse and select the best business model and promotional route for our product inside and outside of European Society for Gynaecological Endoscopy (ESGE) training usage.

Over the six months we have proven T1 Technical feasibility and User Acceptance through real-environment trials at three Hospitals ( Hospital Sant Pau and Hospital Igualada (Barcelona, Spain) and Hospital Gasthuisberg (Lueven, Belgium)). We have developed a T2 Cloud Software Beta Release + Hardware next steps in order to fully industrialise the solution. Finally we have reviewed our T3 Business feasibility and positioning by surveying the stakeholder landscape, attending a trade fair and talking to and analysing Trainee users, practicing medical professors and route to market stakeholder positions and needs.
Overall, this SME Phase 1 6 month Feasibility Study has been an excellent support for us in a crucial moment where we needed to stress test various aspects of our business and feasibility planning. We are very pleased with the results from this project that both demonstrate the performance and technical feasibility of our product, and provide a Business Plan for a first commercial release of our initial product with the route to take it through the initial market entry phase.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

1) With our HTv1.0 Beta release, we completed training trials at the Hospital Sant Pau and Hospital Igualada (Barcelona, Spain) and Hospital Gasthuisberg (Lueven, Belgium). These were completed together with GESEA. The results were excellent.
The study is composed by:
- 42 subjects from Hospital de Sant Pau (20) and Igualada(21). This group executed trials oriented to validate Face Validity.
- 59 subjects from Hospital de Sant Pau (26), Igualada (21) and Leuven Hospital (12) (Belgium). This group executed trials oriented to validate Construct Validity.

Obtained results demonstrate:
- an important improvement of all subjects, independently of their expertise, with well-defined learning curves in all evaluation indices. Obtained results demonstrates the construct validity on 30deg real endoscope management for a uterus visual inspection in realistic conditions for all expertise groups.
- Experts have obtained better results during all trials compared to novices, certifying that the training platform can distinguish subject’s expertise.
- Also results indicate an overall improvement in all measured aspects independently of the subject’s expertise.
- Benefits of training and the validity of the proposed platform is reflected in the learning curves which show noticeable improvements. It is possible, as will be shown in detailed results review, to conclude that there is a noticeable improvement during first 7 to 10 trials and, from trial 20 to 25, the slope of the learning curve is close to be null.

2) We identified the main stakeholders to use, purchase and provide channels for the sales of our product (user-resident doctor, user-Teaching expert Doctor, Purchaser – Hospital Care Directors, Influencer – Scientific societies). We also obtained more contacts with these and generated a survey showing extremely high acceptance and interest in our product. This included information showing a minimum expected price for our product of 1093 Euros and a maximum of 6557 Euros. (These figure are within our expected selling price and allow for good sales margin).

3) During the final 3 months of the study, we finalised our cloud software. Running on Microsoft Azure, the cloud platform has been designed to be end-product agnostic, but for now it runs using HysTrainer module the database is MYSQL. The client-side components of the software system operate within common web browser environments using Secure Sockets Layer (SSL) / Transport Layer Security (TLS) cryptographic protocols at a minimum encryption level of 128 bits.
4) We have brainstormed and further developed details of our first serious game.
SMART: Functionality incorporated in EndoTrainer. Based on the evolution of the user, number of trials of each exercise and the obtained scoring, SMART suggests next exercises and theoretical lessons.
EndoTrainer training program is based on serious gamming to promote the training of users. Jointly with Smart functionality, EndoTrainer provides new challenges to be accomplished by each user.
5) We worked together with our industrialisation partner Stimulo, analysed the prototype and defined changes to improve the mechanical industrialisation of the overall product and also revised the construction of our product in order to support a lower cost and faster assembly process. We plan to have a first complete built version of this Industrial release (HTv2.0) during Q2 of 2019.
6) We attended the following Congresses/Fairs:
- November of 2018 we attended the endoscopy congress / fair EndoClubnord in Hamburg, Germany in order to get qualitative market insights. We obtained very useful information regarding the German endoscopy training market as well as contacts to obtain stakeholder information and future marketing actions.
- October of 2018 we attended Healthio fair in Barcelona (Spain) in order to get commercial contact and also insights about simulation training market in heathcare. In the course of the congress SurgiTrainer established commercial contact with the following centers; Institut of Recerca Germans Trias i Pujol (GIBT), Campus Docent Sant Joan de Déu.
- October 2018. Surgitrainer has participated in the Congress SEGO in celebrated in Barcelona in October 2018. During this congress, Surgitrainer showed in Ethicon (a J&J company) stand during the congress the passive simulation platform MisTrainer. During the congress Surgitrainer gather interest from some Hospital responsbiles (i.e. Head of Gynaecology & Obstetrics Service in Albacete Hospital). Also Our passive simulation platform MisTrainer was used during the course of
- suturing skills celebrated at the congress.
7) During the course of the feasibility study we have updated our roadmap adding a new specialism (laparoscopy portable trainer = MISTRAINER). This we had been working on in ‘stealth’ mode, but have now added to our roadmap with a commercial launch timed with the Industrialised release of HT in 2019.
8) We launched our second Seed Round that has been conducted by the private investment expert legal consultancy Bellavista Legal and successfully closed by 60,000€ at the end of December.
9) During the feasibility study, we learnt a lot regarding ‘on-the-ground’ realities and risks. Discussions with Hospitals and Doctor´s in different Hospitals have either confirmed some previous potential risks that we identified, or thrown up a new one.
10) Business Plan redefinition: Using direct market interaction we have been able to recalculate Market figures and refined our SAM and SOM whilst updating our Commercialisation Plan based on 3 strategic steps, that will be supported by a designed Multi-Channel Marketing Communication Strategy until 2023.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Endoscopy simulation training is divided into two categories. Physical systems teach mechanical and physical skill development in surgeons but lack visual reality for the target organ/cavity and do not measure endoscope tracking during an exercise. This is the current system preferred and validated by entities such as the European Society for Gynaecological Endoscopy (ESGE) as it allows the surgeon to experience the all-important physical environment before training with real patients. Virtual systems are a newer entrant, they allow for a computer-based simulation of the cavity/organ and operational environment. While performing exercise tracking and assessment, they do not provide mechanical and physical skill feedback to the trainee and are thus not considered for official training by the ESGE.
Surgitrainer is the first simulator combining both aspects and represents a real game changer for the industry.
We have designed our ET hardware platform to be modular. With 2 initial specialities under development:
• HysTrainer (HT) - Hysteroscopy involves visual examination and sampling of the uterus. The medical speciality that uses this technique is gynaecology and end users are women. Our first product release, we count on several expert Gynaecological approval. It is a launching pad for our company, serving to promote and establish our brand, SurgiTrainer, in the world of medicine. Guaranteed work with ESGE along with our focus on product quality and high service levels (E.g. planned ISO9001 & cloud assistant) supplies prestige and credibility.
• Cystrainer (CT) - Cystoscopy involves visual examination and sampling of the urinary bladder. The medical speciality that uses this technique is urology and end users are male & female. We are discussing with doctors Dr. Juan Palou dept. head Urology Oncology, Puigvert Foundation, a prominent member of various societies (European and American). Also, with Dr. Ben Van Cleynenbreugel resp. training programs European Society for Urology, ESU.

Expected impact:
1) Our company Increasing turnover from 49k€ by 2019 to 5.9M€ by 2023 and increasing Net Profit from negative figures in 2019 to 2.09M€ by 2023 through selling 1,198 Simulators within the period 2019-2023.
2) Surgitrainer will lead to much greater uptake of MIM procedures with lower-risk for patients as well as improving the efficacy and safety of the performed procedures.
3) Surgeons will Improve their surgical skills and obtaining society accreditation and faster specialism advancement.
4) Hospitals: Large cost reductions as expensive operating room (OR) training time is reduced; Access to the most difficult surgical techniques; Improving the ability of surgeons in the hospital directly affects prestige and revenue. Also dramatic increase of training needs would be possible without a strong simulation strategy outside the OR. OR will not be capable of assuming such potential training needs.
5) Manufacturers of surgical equipment will benefit Increasing visibility to surgeons; Preferential provider of surgical equipment (Using the tools of a particular manufacturer during training can lead to increased sales in hospitals because surgeons are accustomed to them.

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