Summary
- Profile Type
- Business request
- POD Reference
- BRGR20240219016
- Term of Validity
- 19 February 2024 - 18 February 2025
- Company's Country
- Greece
- Type of partnership
- Outsourcing agreement
- Targeted Countries
- All countries
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General information
- Short Summary
- A Greek consortium offers a novel series of surgical instruments that provide an unparalleled view of the operative area and integrates five routine surgical functions into one instrument, thus significantly reducing operative time and complications. The consortium is seeking a manufacturer through an outsourcing agreement who is experienced in producing surgical instruments to EMA and FDA standards.
- Full Description
-
Prolonged operative time is correlated with an escalated risk of operative complications: an approximate two-fold increase for operative durations surpassing 2 hours and an additional 14% rise for every additional 30 minutes of operating time.
Operative complications not only detrimentally impact clinical outcomes but also substantially elevate overall costs and impose a heightened burden on the health system.
The main time-consuming task of surgical procedures is to achieve a clear view of the operative field through the utilization of various instruments, including:
• Aspiration probes for evacuating fluids and fumes from electrosurgery.
• Irrigation catheters for washing out clots and debris.
• Non-traumatic forceps for tissue manipulation,
• Bipolar forceps for haemostasis,
• Scissors for precise tissue dissection.
• Adequate illumination, provided by ceiling-mounted light sources.
A clear surgical view necessitates the coordinated movements of two or more surgeons in a confined space under time pressure. This coordination is time-consuming and frustrating and is interrupted by the need for scrub nurses to continuously exchange instruments. Additionally repeated adjustments to the ceiling’s light sources are needed. Combining all the above significantly increases operative time.
The Greek consortium’s instrument set offers a transformative solution, streamlining these intricate processes into a singular, user-friendly device. By consolidating essential functions, the offered device substantially reduces operative time. This reduction directly corresponds to minimized operative complications, thereby enhancing clinical outcomes and significantly decreasing overall treatment costs and the operational burden on healthcare facilities.
Given the projected surge in the demand for surgical care, the heightened risk of postoperative complications in many countries, and the escalating economic challenges in healthcare funding, there is an imperative need to mitigate surgical complications. The device is uniquely positioned to champion this cause without demanding alterations to established surgical techniques. It simplifies operations by allowing for fewer movements, thus less time and with fewer complications. This concept device facilitates the needs of healthcare, such as efficiency, cost-effectiveness, and improved patient outcomes.
The consortium seeks a manufacturer of this unique device through an outsourcing agreement. The manufacturer should also be experienced in producing medical equipment that meets EMA (European Medicines Agency) and FDA (Food and Drug Administration, USA) standards. - Sustainable Development Goals
- Goal 3: Good Health and Well-being
- IPR description
-
The Greek consortium is actively seeking a partner in the field of electrosurgical equipment and bipolar cautery manufacturing with a specific set of technical specifications and expertise. The ideal collaborator should be an established manufacturer with a proven track record in producing similar instruments, specifically surgical forceps. Additionally, a crucial aspect of our collaboration involves the manufacturer's expertise in bipolar cautery equipment and the regulatory approval of such instruments.
Key technical specifications and expertise sought are:
1. Experience in surgical forceps manufacturing:
• Proven track record in the production of surgical forceps.
• Demonstrated expertise in crafting high-quality, precision instruments for surgical applications.
2. Proficiency in bipolar cautery equipment:
• Established experience in manufacturing bipolar cautery equipment.
• In-depth knowledge of the design, functionality, and safety standards associated with bipolar cautery devices.
3. Willingness to collaborate on the device’s prototype finalization:
• Openness to actively contribute to finalizing the device’s prototype.
• Ability to provide valuable insights and enhancements to ensure the prototype meets industry standards and regulatory requirements.
4. Commitment to collaborate for regulatory approval in Europe and U.S. (CE mark, FDA approval):
• Proven experience in navigating regulatory processes.
• Collaboration potential for overseeing and participating in clinical trials to validate the safety, efficacy, and performance of medical devices.
5. Capability to streamline production processes:
• Demonstrated ability to optimize and streamline manufacturing processes.
• Implementation of efficient production methodologies to ensure scalability and consistency in the manufacturing of the final marketable product.
6. Commitment to long-term collaboration:
• Dedication to establishing a long-term collaborative partnership.
• Willingness to contribute ongoing expertise to enhance product iterations and address evolving market needs.
The objective is to form a collaborative partnership that goes beyond the immediate production requirements. A manufacturer is sought who can actively contribute to the refinement of the prototype, ensuring it evolves into a final marketable product, and who is committed to a sustained collaboration for developing a full series of instruments.
Partner Sought
- Expected Role of a Partner
- Undertake the manufacturing of the surgical instruments and cooperate for regulatory market approval (CE marking), as described above.
- Type and Size of Partner
- OtherSME 50 - 249SME 11-49Big company
- Type of partnership
- Outsourcing agreement
Call details
- Coordinator required
-
Yes
Dissemination
- Technology keywords
- 06001017 - Surgery06001021 - Single Use Products and Consumer Goods06001013 - Medical Technology / Biomedical Engineering
- Market keywords
- 05004001 - Electromedical and medical equipment05004006 - Surgical instrumentation and equipment05007001 - Disposable products05007007 - Other medical/health related (not elsewhere classified)
- Targeted countries
- All countries