REQUEST FOR INFORMATION (RFI)

Handheld OCT Solutions for Ophthalmic Imaging

1. Introduction

St Eriks Eyes Hospital is conducting a market assessment regarding handheld Optical Coherence Tomography (OCT) systems for ophthalmic imaging.

The purpose of this Request for Information (RFI) is to identify available handheld OCT solutions suitable for imaging of pediatric, sedated, bedridden, and non-cooperative patients in ophthalmology.

This RFI is intended for information gathering only and does not constitute a procurement commitment.

2. Clinical Areas of Interest

We are particularly interested in handheld OCT systems suitable for:

·       Pediatric ophthalmology

·       Imaging under anesthesia (EUA)

·       Premature infants / ROP screening

·       Bedside imaging

·       ICU / NICU use

·       Operating room use

·       Retina imaging

·       Anterior segment imaging

·       Patients unable to use tabletop OCT systems

3. Requested Information

A. Company Information

Please provide:

·       Company name

·       Headquarters location

·       Local distributor/support organization in Sweden and/or Europe

·       Contact person

·       Website

B. Product Information

Please provide detailed information regarding:

·       Product name and model

·       Intended clinical use

·       Regulatory approvals:

·       CE mark

·       OCT technology:

·       Spectral-domain OCT

·       Swept-source OCT

·       Other

·       Supported imaging modalities

·       Retina and/or anterior segment capability

·       Image resolution

·       Scan speed

·       Field of view

·       Real-time imaging capabilities

·       3D imaging capabilities

·       AI-supported analysis functions (if applicable)

C. Handheld and Bedside Functionality

Please describe:

·       Handheld ergonomics

·       Weight and dimensions

·       Battery operation

·       Mobility/cart solutions

·       Ease of use during anesthesia/sedation

·       Suitability for pediatric imaging

·       Imaging of supine patients

·       Use in ICU/NICU environments

·       Operating room compatibility

·       Integration with surgical microscopes (if applicable)

D. Connectivity and IT Integration

Please provide information regarding:

·       DICOM compatibility

·       EMR/EHR integration

·       PACS integration

·       Cloud capabilities

·       Remote review/telemedicine support

·       Data export formats

E. Clinical Validation

Please include:

·       Clinical publications

·       Validation studies

·       Reference hospitals

·       Existing installations in:

ü  Sweden, or

ü  Nordic countries

ü  Europe

ü  Global university hospitals / eye hospitals

F. Service and Commercial Information

Please provide:

·       Estimated pricing structure

·       Service agreements

·       Warranty terms

·       Preventive maintenance requirements

·       Training programs

·       Delivery lead times

·       Local technical support availability

4. Submission Instructions

Please submit responses electronically in PDF format.

Preferred language: English or Swedish

Interested parties may submit responses in the form of a freely structured document containing comments, recommendations, advantages and disadvantages, and any other relevant information.

5. Disclaimer

This external Request for Information (RFI) is conducted for the purpose of gathering information and feedback from the market in preparation for a potential future procurement process. The material provided within this RFI is preliminary and may be subject to change.

The contracting authority reserves the right to amend, supplement, revise, or otherwise modify the procurement documentation and requirements based on what is deemed most appropriate. Submitted feedback and comments will be considered where relevant and appropriate; however, no guarantees are given that proposed changes or suggestions will be implemented.

This RFI does not constitute a commitment to proceed with a procurement in its current form, nor does it constitute any obligation to conduct a procurement process at all.

6. Confidentiality

Region Stockholm applies the provisions of the Swedish Public Access to Information and Secrecy Act (2009:400).

Documents and information submitted within the framework of this RFI generally become official documents and may be subject to disclosure upon request. In the event of a request for disclosure, a confidentiality assessment will always be carried out in accordance with applicable legislation.

Region Stockholm aims to ensure that information covered by confidentiality, such as sensitive business or commercial information, is protected from disclosure where permitted by law.

Suppliers are therefore requested to clearly identify any information or sections of their response that they consider confidential and provide a brief justification for such confidentiality.

Please note that such identification does not guarantee confidentiality, as an independent legal assessment will always be conducted in connection with any request for disclosure.