Intraoperative Navigation System (Spinal)

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 contract requires the supply, installation, and ongoing support of an intraoperative navigation system specifically for paediatric spinal surgery. This system is intended for use at Children's Health Ireland (CHI) at Crumlin, with a future transfer to the new National Children's Hospital Ireland (NCHI). The system will be integral to supporting surgical workflows within these facilities.

Key activities and components include:

• System Supply: Provision of the intraoperative navigation system hardware and associated software.
• Installation: Installation of the system at the designated CHI facility.
• Support and Maintenance: Ongoing technical support, maintenance, and potential upgrades for the system throughout the contract term.
• Future Transfer: Planning and execution of the system's transfer to the new National Children's Hospital Ireland (NCHI).
• Compliance: The system must conform to relevant medical device regulations and standards, including EN60601 series, ISO 13485, and ISO 14971.
• ICT Standards: The system must align with CHI's ICT Standards for New Systems and Applications, as detailed in Appendix 3 of the RFT.
• Minimum Features: Bidders must detail a minimum of three main features and their associated clinical/technical benefits.
• Sterilisation: The system must be capable of steam sterilisation at 134° - 137° for a minimum of 3 minutes, and at 121° for a minimum of 15 minutes.
• Spare Parts: Genuine or equivalent spare parts must be available for a minimum of nine years from the date of purchase.
• End-of-Life Notification: A minimum of two years' notice will be provided before a product or service is declared "Out Of Service" or reaches its "End of Life".

3. Background & buyer context

Children's Health Ireland (CHI) is procuring this intraoperative navigation system to enhance paediatric spinal surgery capabilities. The initiative aligns with the ongoing development and integration of healthcare services under the CHI umbrella, culminating in the establishment of the new National Children's Hospital Ireland (NCHI). The system is intended to support advanced surgical workflows and is subject to funding availability. The procurement follows an open procedure, indicating a competitive process for selecting a supplier.

4. Eligibility & selection criteria

Bidders must meet the following minimum requirements to be considered:

• Turnover requirement: A minimum average annual turnover of €2,000,000 for the past three years, evidenced by an auditor's letter and a bank statement confirming the account is in good standing.
• Insurance:
• Employer's Liability: €12.7 million
• Public Liability: €6.5 million
• Environmental Indemnity: €2.0 million
• Certifications: Not explicitly stated as mandatory for initial submission, but compliance with medical device standards (EN60601, ISO 13485, ISO 14971) is required for the system. Waste management requirements may necessitate ISO14001 certification.
• Past experience: Not specified as a distinct criterion in the provided extract, but technical and professional ability will be assessed as part of the award criteria.
• Personnel: Not specified as a distinct criterion.
• Geographic / facility constraints: Not specified, beyond the system being for use in Ireland.

5. Award criteria & scoring

The contract will be awarded based on the Most Economically Advantageous Tender (MEAT), with a split of 70% for Quality and 30% for Cost.

A minimum score of 60% must be achieved in each quality sub-section for the tender to be considered compliant. Failure to meet this threshold in any quality sub-section will result in an automatic fail.

6. Submission requirements

Bidders must submit the following:

• European Single Procurement Document (eESPD): Electronic version.
• All required documentation: As specified in the RFT.
• Tenderer's Statement: Signed copy on letterhead, confirming acceptance of contract terms.
• Pricing Schedule: Completed as per Appendix 2.
• Declarations:
• eESPD confirming no mandatory grounds for exclusion or evidence of remedial measures.
• Declaration regarding personal circumstances (Appendix 4).
• Tax Clearance Access Number and Tax Reference Number.
• Declaration of independent tender preparation.
• Supporting Documentation: As requested for selection criteria verification.
• Presentation: Tenderers may be required to deliver a presentation.
• Format: Tenders must be submitted in English, preferably as ZIP file(s), in PDF format, and uploaded via the eTenders electronic tenderbox.

7. Key dates & process

8. Contract terms that matter

• Term: 5 years, with an option to extend for up to 4 additional years on an annual basis.
• Pricing: Prices are fixed for the first three years. Subsequent increases are permitted annually, capped by the Irish Consumer Price Index (CPI) increase, and require Contracting Authority approval.
• Payment: Subject to the terms in Appendix 5 (Services Contract).
• Insurance: Mandatory for the term of the contract, including Employer's Liability (€12.7m), Public Liability (€6.5m), and Environmental Indemnity (€2.0m).
• Sub-contracting: If subcontractors are used, their capacity must be demonstrated, and they must also meet relevant requirements.
• Confidentiality: Tenderers must treat all information disclosed by CHI as confidential.
• Tax Compliance: Successful tenderers must comply with all applicable EU and domestic tax laws.

9. Risks, red flags & unusuals

• Funding Contingency: The contract is explicitly stated to be "subject to funding," introducing a risk of cancellation or delay if funding is not secured.
• Future Transfer Complexity: The requirement for the system to transfer to the new NCHI implies a need for robust planning and potential compatibility considerations, which could be a challenge for non-incumbent suppliers.
• Strict Submission Portal: Tenders must be submitted exclusively via the eTenders electronic tenderbox, with strict file size limits and a mandatory "Submit" button click. Late or improperly submitted tenders will not be considered.
• No Lowest Price Award: The contracting authority explicitly states it is not bound to accept the lowest priced tender, emphasizing the importance of the quality criteria.
• Medical Device Regulations: The tender operates within the stringent framework of EU medical device regulations (MDR/IVDR), requiring a thorough understanding of compliance.

10. SME fit assessment

This tender is open to a range of suppliers, but the technical specifications and regulatory requirements suggest a need for specialised expertise in medical technology and surgical navigation systems.

• Viable Bidders: Likely to be established medical device suppliers with proven experience in providing and supporting complex surgical navigation systems, particularly for paediatric spinal surgery. Companies with a strong track record in meeting stringent medical device regulatory requirements (e.g., EN60601, ISO 13485) are well-positioned.
• Consortium/Sub-contracting: While not explicitly forbidden, the requirement for a single nominated entity to represent a group of undertakings and a designated "Prime Contractor" suggests that consortia or subcontracting arrangements are permissible. SMEs are encouraged to form relationships with larger enterprises or other SMEs if the scope exceeds their individual capacity.
• Indicative Bid-Prep Effort: Significant effort is anticipated due to the technical specifications, regulatory compliance, detailed pricing schedule, and the need to demonstrate robust quality and after-sales support. A minimum of 10-15 working days for a dedicated bid team is a reasonable estimate, potentially more if significant customisation or complex consortium arrangements are involved.
• Pwin Signal: The tender is an open procedure, indicating it is not a sole-supplier framework. However, the specialised nature of the equipment and the need for specific medical device compliance may favour suppliers with existing relationships or established product lines in this niche. The future transfer to NCHI could also favour an incumbent if one exists, though this is not stated.

11. Where to dig deeper

• Source RFT: RFT Intraoperative Navigation System (Spinal) Final.docx
• eTenders CFT ID: Not specified in the provided text.
• Contact: Queries must be directed via the messaging facility on www.etenders.gov.ie.
• Key Attachments:
• Appendix 1: Requirements and Specifications
• Appendix 2: Pricing Schedule
• Appendix 5: Services Contract