Community Research and Development Information Service - CORDIS

H2020

Stepwise Report Summary

Project ID: 761976

Periodic Reporting for period 1 - Stepwise (Stepwise Stapler is a laparoscopic device for vastly superior tissue closure)

Reporting period: 2017-02-01 to 2017-05-31

Summary of the context and overall objectives of the project

Laparoscopy has been hailed as the ‘future of surgery’. When operated correctly, its benefits in post-operational outcome is significantly advanced than traditional open surgery. Laparoscopy however, has yet to reach stellar enough standards to make it the surgical method of choice. High on the agenda is safe and efficient closure of organs/tissue after surgery through laparoscopic staplers.

Current gold-standard 12mm trocar ports used in laparoscopic tissue closure, increases risk of post-surgery hernia by up to 22%. There is also a 6% chance for post-operative bleeding, 5% chance of stale line leaks, and a 1% chance of Abscesses. In addition, there is increased post-operative pain and tissue trauma bringing recurring bouts of Stricture and Gastroesophageal reflux disease for almost half (47%) of all patients. Additional cost incurred with current staplers increases by €1500 in fees per patient per procedure. When including post-surgery fall-out from trocar usage, hernia repair rehospitalisation adds another €16,170 (USD 17,310) per procedure.

Stepwise Stapler carries out important tissue closure at the end of laparoscopic surgical procedures, providing vastly superior outcomes. Stepwise stapler gives surgeons much improved usability through patented engineering technology. It carries out all thick tissue procedures, involving the stomach, lungs, and large intestines; which together account for the fastest growing procedures in Europe.

Objectives of the feasibility include investigating the potential commercial landscape, and opportunity in the EU, for related surgeries, and ultimate needs from the involved customer and end-user stakeholders.

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

The Feasibility Study showed that the Stepwise Stapler solution is viable technical and commercially, and the determination of the business plan shown that it is also a profitable investment. The main achievements reported in the study were:

-The clear market demand and expected for laparoscopic/MIS surgery, of which will all need clinical, effective and safe tissue closure. This was found in to be the case for various conditions and resulting surgery types, especially in the go-to market segments of (laparoscopic) bariatric and thoracic surgery, facing high growth rates in the EU.

-The quantification of production costs and the selection of components suppliers with a target price for the overall solution, and definition of the value chain members to be involved in the proposed innovation project and initial commercialisation period. This includes third-party in-kind contributor First-In-Man, who will contribute expertise and facilities in iterated prototyping and device engineering of the Stepwise Stapler and reloads; third-parties University Hospital Virgen del Rocío Sevilla (UHVR), University Hospital Sapienza Università di Roma (UHSR), and the Hadassah Ein-Karem Hospital (HEKH) providing the facilities and principal investigators and healthcare staff required in the pre-clinical animal trial verification as part of the innovative project’s conclusive qualification; and subcontractor Aran involvement for the industrialisation of the volume produced Stepwise Stapler and reloads, which includes the industrial set-up, including equipment rental for moulding tooling, CNC/Machining, 3D printing, labour requirements, overall production and packaging capacity, to reach the commercially viable stage required by purchasing surgical departments.

The Phase 1 study ascertained Europe as the natural commercial entry point considering its fast growing rates of laparoscopic/MIS surgery, deriving it the most lucrative global market locality. This includes the strong value chain connections to the third-party hospitals in Italy and Spain, which will play a pivotal role in adoption from follow-on customer medical facilities in these countries. Furthermore, The Phase 1 allowed European regulations define a clinical pathway highlighting the safety and performance measures as key, of which Stepwise has clear indication on EU commercialisation requirements in the form of ISO 9001 and ISO 13485 for Quality Management Systems in production, and specifically involving medical devices; ISO 10993-1 compliance, ensuring Evaluation and Testing within a Risk Management Process, to assess the biocompatibility of medical devices and materials; and MDD Directive 93/42/EC as a Class B Device to undergo ‘Full Quality Assurance’ under Annex VIII on clinical safety and performance; and the CE mark as an all-encompass and verification for safety and quality for immediate commercial use in Europe.

-The business plan for the European and international commercialization of Stepwise Staplers and reloads. This included the definition of a reliable market price and the selection of the primary market and tertiary markets based on immediately addressable demographics subscribing to the MVP specifications on clear quantification for the stapler jaws for compressive force range, and neutralization of torque and shear force (in light of asymmetric structure); contributing to quantified value proposition metrics on procedural success (100%), and compatibility with 5 mm trocar (100%), sealing (100%), and line-complications (<5% over trial and observational/review period); as well as qualitative feedback on usability and performance (i.e. stapling, cutting, maneuvering) from end-user laparoscopic/MIS surgeons.

Confirmation of client customers from medical facility surgical departments through related third-party referrals and surgical device distributors in Europe. Distributors include AbMedica, CAM SRL, Aesculapius, Productos Médicos de Ána Blanca Bestit, Boente, Becker Medical, and Distri Service International; providing for medical facilities such University Hospital Virgen del Rocío Sevilla (UHVR), University Hospital Sapienza Università di Roma (UHSR), and Capio hospitals with jurisdiction in France etc.

-The definition of a workplan for the development of pre-commercial Stepwise Stapler and reload units and for its conclusive demonstration with third-party medical facilities UHVR, UHSR, and HEKH for purposes of the CE mark.

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)

Stepwise Stapler would impact Europe and the globe by pacifying Europe’s ageing population surgical health and its related healthcare. Sustainable and medically safe treatment of the elderly is of prime concern in Europe, as procedures have to be adapted with the less-resilient aged body in mind (Figure 4). With this in awareness, professionals have deemed laparoscopic procedure as the safest, most recommended form of surgery for the elderly. The quicker surgeries, faster healing times, and reduced risks would be enhanced even further upon successful introduction of Stepwise Stapler. This directly impacts the Human Development and Ageing agenda of the EU, as well as the European Innovation Partnership on Active and Healthy Ageing, stating clearly that better healing and safety outcomes for the aged will always be required. These agendas from the EC also stipulate the need to address the vastly increasing demand on long-stay healthcare of the ageing population, which also coincides with obese and child patients having longer-stay hospital recovery times. This has put increasing pressure on European Healthcare Systems and facilities from these demographic groups, and hence, the dire need to adapt to far less impactful surgeries of the elderly, obese and child populations.

This would be addressed through Stepwise Stapler’s market introduction, acting as an enabler to increase laparoscopic surgery due to superior safety, efficiency, and well-being outcomes. This in turn will dramatically lower long hospital stay, reducing infrastructure burden exceptionally. Stepwise Stapler also addresses the EC’s health strategy, not only through fostering better health in ageing Europe (as mentioned), but protection of citizens from health threats through greatly reducing negative post-procedure outcomes, and adding to the innovative technology fabric throughout the EU, specifically in surgery. These positive factors compound and reinforce sustainability of EU surgical infrastructure. Lastly, the cost expenditure for EU states, insurers and patients from all the above mentioned aspects may come up to €650 billion per annum in savings through Stepwise Stapler’s long-term adoption, positively reducing the financial burden on these key stakeholders.

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