Provision of implantable actuator for a medical device

AI-generated analysis of the documents. Check the official notice and any amendments for current submission details.

1. At a glance

2. Scope of Work

The University of Galway seeks a contractor to develop an implantable electromagnetic actuator for a medical device, specifically targeting heart failure. The project involves multiple phases, with the contractor expected to provide both technical advice and prototype development.

• Phase 1: Rapid consultation to explore feasible actuation solutions, including electromagnetic and electric motor actuation.
• Phase 2: Design and development of a bespoke prototype actuator or provision of an off-the-shelf solution. The contractor must deliver at least one prototype, with an expectation of several for experimental use.
• Phase 3: Further optimization and de-risking of the actuator through testing with a benchtop model, leading to two developed versions for large animal model testing.
• Phase 4: Additional optimization and de-risking in vitro and in vivo, contingent on funding and project progress.

The contractor must ensure delivery of the implantable actuator by October 2026 or at a mutually agreed date. The work will take place at various University of Galway locations, including academic departments and research institutes.

3. Background & buyer context

This tender is part of the University of Galway's Saoirse Flow Project, which aims to address abnormal flow patterns in heart failure through innovative medical devices. The project is funded by Enterprise Ireland, reflecting a strategic push towards advancing medical technology and research within the university. The urgency for this procurement arises from the need to transition from theoretical research to practical application, necessitating the development of a prototype actuator.

4. Eligibility & selection criteria

Bidders must meet the following eligibility criteria:

• Turnover requirement: Minimum average annual turnover not specified for this tender.
• Insurance:
• Employers Liability: €13 million or local minimum
• Public Liability: €6.5 million
• Professional Indemnity: €1 million
• Certifications: Not specified for this tender.
• Past experience: Minimum of two comparable projects within the last five years.
• Personnel: Not specified for this tender.
• Geographic / facility constraints: Not specified for this tender.

5. Award criteria & scoring

Bids will be evaluated based on the following criteria:

The evaluation will follow a Most Economically Advantageous Tender (MEAT) approach, with a minimum score of 50% required in each qualitative criterion to proceed to cost evaluation.

6. Submission requirements

Bidders must submit the following documents:

• Method statement / response document: Complete Appendix 2 - Tender Response Document (TRD).
• CVs: Not specified for this tender.
• Pricing schedule: Complete Appendix 3 - Pricing Schedule Document.
• Case studies: Minimum of two relevant projects.
• Declarations: ESPD, Bona Fides, Tax clearance, Conflict of Interest.
• Mandatory site visit: Not specified for this tender.
• Submission portal: eTenders, with adherence to specified format rules.

7. Key dates & process

8. Contract terms that matter

Key contract terms include:

• Duration: The framework agreement lasts for a maximum of four years, with the possibility of extension.
• Payment terms: Pricing must be fixed for the duration of the contract, inclusive of delivery charges.
• Performance monitoring: Supplier performance will be monitored quarterly, with clear milestones.
• Termination clauses: The framework can be collapsed with one month’s notice.
• Intellectual Property: Ownership of designs and prototypes will be governed by the contract terms.
• Sub-contracting rules: Not specified for this tender.

9. Risks, red flags & unusuals

Potential concerns include:

• The turnover requirement is not specified, which may raise questions about financial viability for smaller firms.
• The framework is a single-party agreement, limiting competition and potentially favoring incumbents.
• The project is contingent on future funding, which may affect the continuity of work.
• The timeline for prototype delivery is tight, with significant consequences for delays.

10. SME fit assessment

This tender is suitable for small to medium-sized enterprises (SMEs) with expertise in medical device manufacturing and design. Viable bidders should have:

• Experience in developing medical devices, particularly in electromagnetic actuation.
• The capacity to meet insurance and compliance requirements.
• The ability to deliver within the specified timeline.

Consortium or subcontracting arrangements are permitted, allowing SMEs to collaborate to meet the tender requirements. Preparation for the bid may require several days of effort, particularly in compiling technical and financial documentation. The presence of a single-party framework may indicate a strong incumbent presence, which could affect the probability of winning (Pwin) for new entrants.

11. Where to dig deeper

• Source RFT filename: COSE1845-26 Call for Tender .docx
• eTenders CFT ID: Not specified
• Contact email: Via eTenders messaging function only
• Important attachments:
• Appendix 1 – University of Galway Contract Terms and Conditions
• Appendix 2 - Tender Response Document (TRD)
• Appendix 3 - Pricing Schedule Document