Conducting technical and pre-clinical research and development of a novel cardiovascular 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

This tender seeks to establish a multi-party framework agreement for the technical and pre-clinical research and development of a novel cardiovascular medical device. The framework will have a maximum duration of four years, with an estimated total spend not exceeding €370,000 excluding VAT. Individual contracts awarded under the framework are expected to range from €50,000 to €250,000. The work is divided into two lots.

Lot 1: R&D Consultant This lot requires a consultant to provide full technical leadership for the development of a novel cardiovascular device. Key activities include:

• Concept Development & Prototyping: Leading device concept development, prototype design, and iterative refinement based on pre-clinical findings.
• Pre-clinical Testing: Designing and planning pre-clinical protocols, executing studies in collaboration with external facilities, and analysing results to guide device optimisation.
• Supplier & Manufacturer Liaison: Managing technical interactions with suppliers, manufacturers, and service providers for specification development, prototype manufacture, and component sourcing.
• Regulatory & IP Support: Providing technical input into regulatory, intellectual property, and commercial strategy development, including pre-clinical evidence planning and IP support.
• Documentation: Preparing and maintaining technical documentation, reports, and data packages for design reviews, regulatory planning, and investor engagement.
• Reporting: Reporting technical progress, study outcomes, and development recommendations to project stakeholders.
• Phased Approach: The work is structured into three phases: Phase 1 (approx. 100 days) for concept development and initial refinement; Phase 2 (approx. 150 days) for further optimisation and de-risking, including manufacturability strategy and IP support; and Phase 3 (approx. 150 days) for continued optimisation, documentation, and reporting.

Lot 2: Pre-Clinical R&D Services This lot requires services for the evaluation of the novel cardiovascular medical device in a large animal model. Key activities include:

• Study Design & Protocol Development: Developing comprehensive pre-clinical testing strategies and study protocols, including objectives, endpoints, statistical considerations, and animal welfare.
• Acute Animal Studies: Designing and executing initial and subsequent acute large animal studies to evaluate device performance, haemodynamic endpoints, and demonstrate directional improvement.
• Model Validation: Establishing and assessing the feasibility, reliability, and reproducibility of the disease model and study methodology.
• Device Performance Assessment: Evaluating device performance against predefined objectives and success criteria.
• Data Analysis & Optimisation: Collecting, analysing, and interpreting study data to identify opportunities for device, procedural, or model optimisation.
• Reporting: Presenting study outcomes, findings, and recommendations to the project team and preparing detailed technical study reports.
• Phased Approach: The work is structured into three phases: Phase 1 for initial acute study and model establishment; Phase 2 for a second acute study with an optimised device; and Phase 3 for additional studies if required, such as chronic studies or long-term safety assessments.

Deliveries may be required at various University of Galway locations across the Republic of Ireland.

3. Background & buyer context

University of Galway, established in 1845, is a research-led university with over 19,000 students and 2,700 staff. It is a significant employer and contributor to the economic, social, and cultural fabric of Galway. The university's vision is to be a driver of transformational change, focusing on sustainable development and societal impact. This procurement aligns with the university's strategic goals of advancing research and innovation, particularly in areas like medical technologies. The project is funded by Enterprise Ireland, indicating a focus on commercialisation and economic development. The incumbent provider is not named.

4. Eligibility & selection criteria

To be considered for this tender, bidders must meet the following minimum requirements:

• Turnover requirement: Not specified in the provided text.
• Insurance:
• Employers Liability: €13 million or local minimum.
• Public / Product Liability: €6.5 million.
• Professional Indemnity: €1 million.
• Motor Insurance (if applicable): Third party cover with a property damage limit of €6.5 million per claim.
• Certifications:
• Tenderers must demonstrate a commitment to quality assurance, with details of quality assurance policies and systems. Third-party certification is preferred.
• Tenderers must demonstrate operation of health and safety systems and procedures in line with relevant Safety, Health & Welfare at Work legislation.
• Ideally, tenderers should demonstrate compliance with ISO 13485 and ISO 14971 standards for medical device development environments.
• Compliance with ISO 27001 is also mentioned as an example of a relevant certification.
• Past experience: Tenderers should ideally demonstrate successful delivery of a minimum of two (2) previous projects in the past five (5) years involving similar projects.
• Personnel: Tenderers must demonstrate access to the minimum number of skilled personnel required for successful delivery. Specific roles and experience levels are not detailed.
• Geographic / facility constraints: Deliveries may be required to any University of Galway location within the Republic of Ireland.

Tenderers may rely on the resources of other entities to meet these requirements, provided they can prove these resources will be at their disposal.

5. Award criteria & scoring

The contract will be awarded on the basis of the most economically advantageous compliant tender, using a combination of qualitative and cost criteria.

• Criterion A (Technical and Professional Ability): Assesses the tenderer's ability to meet the requirement specifications. For Lot 1, this involves demonstrating qualifications and experience in developing cardiovascular medical device prototypes. For Lot 2, it involves expertise in conducting large-animal studies for novel cardiovascular devices.
• Criterion B (Implementation Approach & Delivery Plan): Evaluates the tenderer's proposed approach to project implementation and delivery.
• Criterion C (Price): Assesses the cost of the proposed solution. The lowest cost tender meeting minimum qualitative requirements will receive maximum score.

Tenderers must achieve a minimum score of 2,000 marks for Criterion A and 1,500 marks for Criterion B to remain eligible for evaluation.

6. Submission requirements

Tenderers must submit the following documentation:

• European Single Procurement Document (ESPD): Optional, can be used as evidence for Section 4.2 (a).
• Completed Appendix 2 - COSE1847/2026 Tender Response Document (TRD): This is mandatory and must cover both Qualification Criteria and Award Criteria.
• Appendix 3 - Pricing Schedule Document: This must be submitted as a separate Excel file.
• Declarations:
• Declaration of Bona Fides (as per Art. 57 of Directive 2014/24/EU).
• Declaration regarding compliance with relevant statutory obligations.
• Declaration regarding compliance with EU Regulation 2022/576 (restrictive measures in the context of Russian actions in Ukraine).
• Confirmation of Data Protection Management systems and procedures in line with relevant legislation.
• Confirmation of acceptance of University of Galway Contract Terms and Conditions (Appendix 1).
• Financial Capacity Information: Details on tax compliance, financial standing, and insurance levels.
• Technical Capacity Information: Details on manpower levels, previous experience, quality assurance, and health & safety systems.
• Contract Manager Details: Nomination of a dedicated Contract Manager and deputy, with proposals for contract management, including complaint escalation procedures.

All self-declared information must be provided within five (5) working days of request, prior to award.

7. Key dates & process

The tender validity period is 12 months from the submission deadline.

8. Contract terms that matter

• Term: The framework agreement is for a maximum of four (4) years. Contracts awarded under the framework may extend beyond the expiry date of the agreement.
• Payment terms: Not specified, but contract management reports will include financial payment details.
• SLAs/KPIs: Supplier performance will be monitored quarterly, with clear milestones to be reviewed regularly.
• Liquidated damages: Not specified.
• Termination: The Contracting Authority reserves the right to terminate the framework with one month's notice. Specific termination clauses for individual contracts are detailed in Appendix 1 (Contract Terms and Conditions).
• IP ownership: Not specified.
• Sub-contracting: Not explicitly detailed, but tenderers must provide information on sub-contractors if applicable.
• Guarantees/Bonds: Not specified.

9. Risks, red flags & unusuals

• Framework Value Uncertainty: The maximum framework spend is capped at €370,000, but the initial contract value is estimated between €50,000 and €250,000. This indicates potential variability in project scope and funding allocation across the framework's duration.
• Phased Approach with Funding Contingency: Phases 2 and 3 are explicitly stated as being "Subject to our funding and project progress," introducing a risk of project scope reduction or cancellation if funding is not secured or project milestones are not met.
• Multi-Party Framework: The establishment of a multi-party framework with a minimum of two members suggests potential for competition or collaboration among successful tenderers for subsequent contracts.
• No Guaranteed Expenditure: The tender explicitly states there is "no guaranteed expenditure under the framework agreement," meaning successful tenderers may not receive any work beyond the initial contract.
• Enterprise Ireland Funding: The project is funded by Enterprise Ireland, implying a strong emphasis on innovation, commercialisation, and evidence of market potential.

10. SME fit assessment

This tender is structured as a multi-party framework agreement, encouraging participation from Small and Medium Enterprises (SMEs). SMEs are defined as enterprises with fewer than 250 employees and an annual turnover not exceeding €50 million. The policy explicitly encourages SMEs to form relationships with other SMEs or larger enterprises to meet capacity requirements.

• Credible Bidders: Viable bidders would likely be specialist R&D consultancies or pre-clinical research organisations with proven experience in cardiovascular medical device development or large animal model studies. They would need to demonstrate robust quality assurance and health & safety systems, and ideally possess relevant ISO certifications (e.g., ISO 13485, ISO 14971).
• Consortium/Sub-contracting: Consortium or joint venture bids are permitted. Tenderers can rely on the resources of other entities to meet qualification criteria. A single supplier must be appointed to assume overall responsibility and sign the contract. Sub-contracting is implicitly allowed, though not detailed.
• Indicative Bid-Prep Effort: Preparing a comprehensive bid, including the Tender Response Document (TRD), pricing schedule, and supporting documentation for both technical and qualification criteria, would likely require 10-20 days of effort for a small business, depending on existing documentation and team availability.
• Pwin Signal: The tender is open to multiple bidders for the framework. The "Award to Runner Up" clause suggests a structured process where a successful tenderer might fail to deliver, opening the door for the next highest-scoring tenderer. The presence of Enterprise Ireland funding and the focus on novel medical device development indicate a competitive landscape, potentially favouring firms with strong IP and commercialisation track records.

11. Where to dig deeper

• Source RFT Filename: COSE1847-26 Call for Tender.docx
• eTenders CFT ID: Not specified
• Contact: Via eTenders messaging function only
• Key Attachments:
• Appendix 1 – COSE1847/2026 University of Galway Contract Terms and Conditions
• Appendix 2 - COSE1847/2026 Tender Response Document (TRD)
• Appendix 3 - COSE1847/2026 Pricing Schedule Document