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.
