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Request for Proposal
Status: RFP is Closed

Development Partner for Part of Next-generation Medical Balloon Catheters

Request Number
RFP_2018_3801
Due Date
Oct 26
Program Manager

Opportunity

Joint or entrusted development, licensing, supplier  agreement (materials, systems)

 

Timeline

Phase A. Technology validation within 1 year

Phase B. Technology establishment for the product/manufacturing process within 2 years after Phase A

 

Financials

Necessary development expense will be covered
 (Details to be discussed).

How to  Apply
Click on "Respond", complete the form to the extent possible, and submit along with other attachment files available. After creating your account for NineSights, your draft will be automatically saved and you can resume later from "Control Center". Please note you do not submit confidential information at this process.
This request for proposals in PDF format is available here.
 
SOLUTION PROVIDER HELP DESK

If you have any questions or request, please feel free to contact us at: phd2@ninesigma.com

RFP was closed on
Nov 2018

RFP Title

 

Development Partner for Part of Next-generation Medical Balloon Catheters
RFP Description

NineSigma, representing a multi-billion-dollar medical instruments manufacturer, is looking for development partners to realize next-generation balloon catheters. The main development object involves balloon parts that act as components for balloon catheters. The client seeks technology that resolves the challenges of pressure resistance, flexibility, etc., and that is applicable to the field of medical instruments. The client also widely welcomes materials, structural designs, manufacturing methods, etc., that are used in other fields.

Background

Background

The client is proceeding with the research & development of such devices (including balloon catheters) in the field of medical devices to perform medical treatments by inserting such catheters into blood vessels. Balloon catheters are devices that recover blood flow by pushing out the narrowed part of the blood vessel from inside the blood vessel. The path to the affected area (the blood vessel) may be winding in a complex way or partly calcified. Therefore, the balloon parts need to have flexibility and scratch resistance, as well as pressure resistance and resistance to making a hole, etc., so as to push through the affected area. The typical materials for balloon parts are resins such as polyamide, polyester, polyurethane, etc., which achieve both pressure resistance and flexibility at the same time. The client has continuously committed to development in this area; however, they seek applicable technology from all over the world, including technology from other fields, in order to accelerate the performance improvement of products to quickly contribute to patient QOL improvement.

Key Success Criteria

Key success criteria

A specification example of the balloon parts as requested is as follows.

  • Shape: Cylindrical (see above figure)
  • Outer diameter (representative diameter)
    • When expanded: 3.0 mm
    • When collapsed or shrunk: 1.0 mm or smaller
  • Length: 30 mm
  • Thickness: Approximately 20 µm or smaller

The technology requirements are as follows; however, all requirements do not necessarily have to be met. Also, actual past performance in applications for medical instruments is not required, as a wide variety of propositions are welcome.

  • Pressure resistance: 40 atm inside the balloon (average)
  • Patency: (1) It shall be able to go through a winding blood vessel with an inner diameter of 3–8 mm without causing damage to the inside wall. (2) In the affected area (narrowed blood vessel section), slipperiness of the balloon part surface and scratch resistance of the balloon itself is required (shall not make a hole easily when contacting the affected area, which is partly calcified), etc.
  • For example, after the outer diameter becomes 3 mm at 10 atm inside the balloon, the relationship between the inside pressure and outer diameter when the atmospheric pressure inside the balloon is increased furthermore shall be within the required range in the figure below

* Ideally, it can be set freely within the required range.

  • Durability: It shall be durable with expansion and shrinkage repeated 10 times or more.
  • It shall not lose its performance after the sterilization process of either of below:
    • Radiation sterilization (gamma ray or electron ray)
    • Ethylene oxide gas sterilization
Possible Approaches

Possible Approaches

Possible approaches might include, but are not limited to:

  • Technology to strengthen it with fiber (resin or metal)
  • Materials technology (including orientation, crystallization, cross-linkage, etc.) and a multi-layer structure of materials with different functions
  • Coating and surface processing technology
  • Manufacturing method to form balloon shapes via these approaches
Items to be Submitted

NineSights, the platform of NineSigma’s Open Innovation community, allows you to manage all your proposals. Please contact the Solution Provider Help Desk phd2@ninesigma.com for assistance about registration and proposal submission.

Proposal may include the following items along the response form shown by clicking the “Respond” button.

  • Overview and type of the technology (materials, structures, manufacturing methods, etc.)
  • Uniqueness of the technology
  • Development stage (Concept phase/ Under development for practical use / Implemented for practical use)
  • Possibility of prototype production
    • Sample supply quantity, costs, time periods, contract conditions, etc. when prototype production is possible
  • Current performance (within the possible range)
    • Pressure resistance and durability
    • Patency (such as application cases)
    • Biological compatibility
    • Sterilization resistance
    • Formability and workability
  • Current challenges and future development plans
  • Requests regarding the handling of intellectual property rights
  • Past performance (additional information to show research & development capability, such as research papers, patents, etc.)

 

Notes on Response

Proposal shall have clear points and should not include confidential information. Supplemental files and samples may be submitted in addition to the proposal.

 

Response evaluation

The client will evaluate all responses with the following criteria.

  • Overall scientific and technical merit
  • Approach to proof of concept or performance
  • Economic potential of concept
  • Realism of the proposed plan (action items, timeline, roles, deliverables, cost estimation)
  • Potential for proprietary position (monopoly, priority, etc.)
  • Respondents’ capability and related experiences

 

Anticipated Project Process

After the submission due date, the client will review all submitted proposals. NineSigma will send the review results to each proposer 6-8 weeks after the due date. The client possibly asks clarifying questions before selecting the most suitable candidates for collaboration. The client will select best candidates through evaluations. During the selection process, the client may execute NDA with selected respondents, seek further information disclosure, and discuss specific development targets or potential opportunities.

The client will execute necessary agreements with the selected respondents and move to the advanced development phase. Specifics of any collaboration will be determined through consultation with the concerned parties.

Preferred Collaboration Types
Area of Interest