Centre for Surgical Invention and Innovation

Customized Patient Support Platform

CSII001

Closing Date: 04/02/2012 5:00:00 PM ET

Detail:

CSii is looking for a company to partner with for the design and development of a customized patient support platform that will interface with our robotic system in the MRI machine to facilitate the breast biopsy process. The requirements for our breast biopsy support are:
• Must be MRI imaging compatible (safe to use during active imaging)
• Must be compatible with both GE and Siemens MRI tables
• Must include the breast imaging coils in the proper alignment to allow for accurate clinical imaging
• Must allow for proper prone patient positioning, and integration of the breast compression plates required
• Must allow for the integration of the IGAR Breast Biopsy Robot under the patients head to facilitate access to the breast for the procedure and allow for robotic anchor points to ensure the systems are firmly integrated
• Must accommodate patients up to 6 feet in height and support a weight of 250 lbs
• Must pass all medical regulations required for patient safety and Health Canada/FDA certification for an IDE trial and eventual regulatory approval.

Assumptions & Constraints
All disclosures of technology will be confidential and any IP development will remain the sole property of CSii. The successful bidder will be asked to sign non-disclosure agreements prior to any further information on our system is provided. The successful bidder will have access to our robotic system and MRI information to apply to the patient support to ensure that seamless integration is optimized.

The successful company would be responsible for the concept design, development, testing and delivery of 4 systems ready for use in a clinical trial starting in March 2013.

The timelines required would be all 4 systems must be ready and certified for use in an Investigational Device (IDE) trial for Health Canada. CSii will support the IDE registration/application – but the supplier must ensure that all requirements for certification are met. Trial is scheduled to begin March 2013. Device would have to be complete and tested by December 2012.

CSii would own all newly created foreground IP/technology developed as part of this project. Required Background IP required to utilize the Foreground IP must be accessible. CSii will be filing and owning all patents related to this contracted work.

As part of this RFP response – CSii would require evidence of past medical product development projects.

Selection Criteria
Selection Criteria will be based on
1. Design expertise in robotics and/or imaging - years of experience, number of successful projects
2. Project similarity - has work been done on similar systems or equivalent systems
3. References
4. Competitive Rates