Bonvisi has been satisfied with Innokas familiarity with the field and very strong experience in QA/RA requirements
Bonvisi AB is a privately owned Swedish company located in Nacka, Stockholm. With a clear focus on fluid management, the company develops, constructs and manufactures medical devices for the endoscopic market. The Bonvisi’s ENDO Pump System is developed for endoscopic surgery use. When performing transurethral resection (TUR) of the prostate or the bladder, surgeons pass fluids through the region in order to irrigate the area. The current method uses irrigation bags suspended above the patient, using gravity to control fluid flow. Rudimentary and imprecise control of pressure is achieved by raising or squeezing the irrigation bag. Bonvisi’s new innovation, the ENDO Pump system introduces greater flow and pressure control by using a urology pump. The novel and patent protected method allows for more accurate control of the pressure at the operating site giving the surgeon better visibility, thus reducing the operating time and improving safety.
“After the evaluation performed by Bonvisi, Innokas was selected as the best alternative from our point of view. We’ve been satisfied with Innokas familiarity with the field and very strong experience in QA/RA requirements.”
Managing Director, Bonvisi
Innokas Medical and Bonvisi have recently signed an R&D agreement, and shall soon sign a manufacturing contract for the Bonvisi ENDO Pump system. At the first phase of the co-operation between Innokas and Bonvisi, Innokas engineers are adopting the initial, clinically evaluated and CE-marked concept of ENDO P®, to design a full product which will meet all the clinical requirements. Bonvisi has also defined new project continuation to develop additional products of the ENDO Pump System, to be executed with Innokas as well. At the same time Innokas’ production engineering team is supporting the design transfer of the product to full-scale manufacturing of ENDO P®, where the product technical file is translated to a manufacturing package and integrated into Innokas manufacturing line. According to the Managing Director of Bonvisi, Anders Möllstam, the cooperation between Innokas and Bonvisi has worked well. He states that Innokas was chosen to be Bonvisi’s partner because of its longtime experience in medical device design and manufacturing as well as its very strong experience in QA/RA requirements.
“The potential market value for ENDO P® and additional products in the ENDO Pump System is estimated to be 1.6 – 1.8 Billion SEK in the dealer/distributor level, so we are very excited at Bonvisi that the ENDO P® project has been executed fast and precisely. Innokas Medical was chosen as a partner based on the result from a RFQ performed by Bonvisi, where totally of 17 potential contract manufacturer were evaluated. After the evaluation Innokas was selected as the best alternative from our point of view. The most important criteria affecting the choice were Innokas’ long-term know-how in medical device design and manufacturing as well as company’s very strong experience in QA/RA requirements”, Möllstam says.