RFP - Supply of single use instruments

Hospital devices

RFP Closed

PHARMAC invites proposals for the supply of single use instrument medical devices (“single use instruments”) to DHB hospitals in New Zealand (“DHBs”).

On this page

This request for proposals (RFP) letter incorporates the following schedules:

All proposals must be submitted to PHARMAC via the Government Electronic Tenders Services (GETS) no later than 5.00 p.m. on Thursday 23 June 2016.

If you have any enquiries about this RFP, please submit questions through GETS: www.gets.govt.nz(external link)

The contact for this RFP is Rob Turner by email: rob.turner@pharmac.govt.nz

We look forward to receiving your proposal.

Schedule 1: Medical Devices, background to RFP and types of proposals sought

1. Background to RFP

1.1 PHARMAC’s role in medical devices

PHARMAC is taking a greater role in medical devices to manage the assessment, standardisation, prioritisation and procurement of medical devices for the District Health Boards. The objective of this activity is to help achieve national consistency in managing medical devices, improve transparency of decision-making and improve the cost-effectiveness of public spending to generate savings for re-investment into health.

1.2 Reasons for running this RFP

PHARMAC sought feedback from stakeholders in May 2013 on a number of identified medical device categories to commence initial procurement.

The Single Use Instruments category is one of the categories identified.

1.3 Expected outcomes of this RFP

2. Types of Proposal Sought

2.1 PHARMAC is willing to consider the following types of proposals for listing in Part III of Section H of the Pharmaceutical Schedule for use by DHBs:

2.2 PHARMAC is not willing to consider proposals that are submitted in response to this RFP for any other medical devices, including the medical devices set out in clause 4.1 as out of scope.

2.3 Proposals must meet all the requirements as set out in Schedule 3.

3. Scope

3.1 In Scope for the Single Use Instruments Category:

PHARMAC invites suppliers of Single Use Instruments to submit its range of products as applicable to the categories set out below. All instruments are to be intended for a single use, or use on a single patient during a procedure in a hospital ward, clinic or theatre/surgery.

A full list of product details required, specifications and pricing requirements, and in-scope descriptions, are listed in the attached spreadsheet under the following sub-categories:

  • BLADES, SURGICAL CUTTING INSTRUMENTS, SNARES AND RELATED PRODUCTS
    • Curettes
    • Blades
    • Scalpels
    • Blunt-Blunt Scissors
    • Sharp-Blunt Scissors
    • Sharp-Sharp Scissors
    • Snares
    • Dental Burrs
    • Bandage Scissors
    • Newborn Umbilical Cord Scissors
    • Other blades, surgical cutting instruments, snare and related products
  • CLAMPS, CLIPS AND FORCEPS
    • Artery Forceps
    • Extracting Forceps
    • Grasping Forceps
    • Needle Holders
    • Obstetric Forceps
    • Newborn Umbiilcal Cord Clamp
    • Thumb Forceps
    • Other Clamps, Clips and Forceps
  • HOOKS, PROBES AND BIOPSY PUNCHES
    • Amnio Hooks
    • Probes
    • Biopsy Punches
    • Other Hooks and Probes
  • SPECULUMS
    • Sigmoidoscopes
    • Ear/Otoscope Speculums
    • Nasal Speculums
    • Vaginal Speculums
    • Other Speculums
  • DISSECTORS, ELEVATORS, PICKS AND RELATED PRODUCTS
    • Dental Picks
    • Surgical Dissectors
    • Surgical Elevators or Levers
    • Surgical Lifters
    • Other Dissectors, Elevators, Picks or Related products
  • RETRACTORS
    • Surgical Retractors
    • Surgical Retractor Rings
    • Surgical Retraction Hooks
    • Surgical Retractor Sets
    • Other Retractors
  • SIMPLE INSTRUMENT KITS
    • Suture Kits
    • Other Instrument Kits

3.2 Out of Scope Single Use Instruments Categories

PHARMAC is not seeking proposals for products in these areas as part of this RFP process, but may consider them at a later date.

  1. Instruments designed specifically for use in laparoscopic or orthopaedic procedures
  2. Consumables/accessories used with reusable instruments
  3. Reusable instruments
  4. Reposable instruments (i.e. designed for limited reuse)
  5. Packs containing reusable instruments
  6. Plastic ware (Bowls, basins and jugs)
  7. Custom Procedure packs

Schedule 2: RFP process

1. Submission

  1. Proposals must be submitted to PHARMAC via the Government Electronic Tenders Service (GETS).
  2. You may submit more than one proposal. Each proposal will be considered as a separate proposal.
  3. Proposals must be submitted no later than 5pm (New Zealand time) on Thursday, 23 June 2016. Late proposals will only be considered at PHARMAC’s discretion, taking into account the need for fairness to other suppliers and integrity of the RFP process.
  4. You cannot withdraw your proposal, once submitted, while the RFP process is continuing.
  5. If you have any enquiries about this RFP, please submit questions through GETS www.gets.govt.nz(external link).
  6. PHARMAC’s Devices Category Manager for this RFP is Rob Turner rob.turner@pharmac.govt.nz

2. Evaluation

3. PHARMAC may request further information

4. Negotiation

  1. PHARMAC may negotiate with the suppliers of one or more preferred proposals, in the latter case whether or not the acceptance of either supplier’s proposal would exclude acceptance of the other proposal.
  2. Negotiations will proceed on the basis that PHARMAC’s standard terms and conditions for supply of medical devices, which are available from GETS, will apply.
  3. Given that PHARMAC expects your proposal to be the best you can offer, PHARMAC does not intend to initiate negotiation with you on price. However, PHARMAC does not exclude the possibility that the final price agreed will be different from the price put forward in your proposal, as a result of the impact that other negotiated terms may have on price.
  4. PHARMAC may negotiate and enter into provisional agreement(s) with a preferred supplier(s) on whatever special terms, in addition to PHARMAC’s standard terms and conditions, PHARMAC considers appropriate.
  5. If PHARMAC and the supplier(s) are unable to reach a provisional agreement within what PHARMAC considers being a reasonable time, PHARMAC may terminate those negotiations and negotiate with a different supplier(s).

5. Consultation and approval

6. Miscellaneous

7. Anticipated timetable

8. Governing Law

This RFP is governed by New Zealand law, and the New Zealand courts have exclusive jurisdiction in all matters relating to this RFP.

Schedule 3: Information to be included in your proposal

1. Schedule of Single Use Instrument Categories Spreadsheet

A spreadsheet is separately attached on GETS and must be completed and submitted as part of a supplier’s response.

When completing the spreadsheet, please ensure the instructions below are followed:

  • Please do not alter the spreadsheet format.
  • In the submission please list all models, versions or sizes in the range of products on a separate line.
  • All prices to be submitted in $NZ
  • Please submit the spreadsheet in an excel format document (not pdf).

2. Supplier Proposal Form

A supplier proposal form (available on GETS and attached as Appendix 1 to this RFP) requires completing and submitting as part of this RFP process.

The following information should be included in or form part of your proposal:

a) Organisation details

i) full legal name of supplier;

ii) key contact person;

iii) contact details (including but not limited to physical address, telephone and email addresses);

iv) organisational infrastructure, including legal status;

b) Product details

Requirement Details Required?
(i) Single Use Instrument Details
  • Details as per the attached spreadsheet
  • Details of any marking to identify the instruments as single-use rather than reusable (such as colour of handles, and details noted on packaging)
Mandatory
  • Details of instrument traceability processes including the marking of instruments/packaging with batch numbers/serial numbers (if any)
  • Global Trade Item Numbers (GS1 GTINs), (if available)
  • UNSPSC Codes, (if available)
Desirable
(ii) DHB Experience
  • Volumes for period 1 April 2015 to 31 March 2016
  • Details of any existing DHB contracts, including expiry dates
Mandatory (if DHBs are using your products)
(iii) Current Pricing (GST exclusive)
  • Details of your current pricing model(s), and which DHBs have accessed the pricing model(s) in the period 1 April 2015 to 31 March 2016
Mandatory (if DHBs are using your products)
(iv) Proposed Pricing (GST exclusive)
  • Details of your proposed pricing model(s), include any related conditions or proposed terms
  • Alternative pricing models (if any)
Mandatory
(v) Impact Analysis
  • Provide financial impact analysis of your proposal for DHBs based on current usage patterns
Mandatory (if DHBs are using your products)
(vi) Quality/Standards Compliance
  • A copy of registration in one of the following foreign jurisdictions: Europe, the United States, Canada, Australia. For example, if product is registered in Australia, a copy of the Australian Register of Therapeutic Goods (ARTG) certificate
  • Conformance to relevant standards and regulatory requirements. All Single Use Instruments would require WAND notification before being considered. WAND registration number must be provided
Mandatory

c) Operational Details

Requirement Details Required?
(i) Supply arrangements
  • Information relating to continuity of supply of Single Use Instruments in New Zealand. This should include information on
    • stockholding in New Zealand and overseas,
    • country of origin for the instruments supplied,
    • minimum order size,
    • delivery frequency and lead times for a stable demand situation, in the event of supply disruptions and when there is an unexpected surge in demand for your Single Use Instruments,
    • Please include any specific measures you will take to secure stock for New Zealand from international production
    • Describe your current supply arrangements, supply volumes and relevant supply terms in other major markets including recent tenders awarded (in New Zealand and/or other countries)
    • Describe proposed distribution and supply arrangements for the Single Use Instruments (this includes any information regarding freight or delivery costs to DHBs)
Mandatory
(ii) Complaints and Recalls
  • Explain your current or proposed complaints management processes, including ability to recall stock, refund or credit for damaged or faulty goods
Mandatory
(iii) Business Continuity Plan
  • Brief summary, including confirmation that any parties who will be supplying products have a business continuity plan(s) with a brief summary of the plan(s)
Mandatory
(iv) Experience (if any)
  • Demonstration of experience and knowledge within the healthcare sector, and specifically with DHBs
  • Details of any overseas market (including site referees) please indicate which products are supplied to these sites
Mandatory
(v) Sustainability
  • Details of relevant programmes for:
    • Waste reduction
    • Recycling
    • Other sustainability programmes
Optional
(vi) Associated Services
  • Availability of training, education and product support
Optional

d) evidence of how the supplier envisages working with PHARMAC and other key stakeholders;

e) the supplier’s own rationale for why it considers PHARMAC should accept its proposal;

f) any particular information that the supplier considers PHARMAC should take into account when assessing its proposal; and

g) a declaration of any conflicts of interest that the supplier or an associated person or organisation may have that could affect or compromise the supplier or PHARMAC in relation to this RFP process or performance under any listing agreement if successful.

Appendix 1: Supplier Proposal Form – Single Use Instruments RFP

An electronic version of this form is available on GETS.

You should expand the boxes as necessary.

You must also include information as outlined in Schedule 3 and Attachment 1 (Excel spreadsheet) as part of your proposal.

[Supplier to insert date]

Director of Operations
PHARMAC C/- Rob Turner
Devices Category Manager

By electronic transfer using GETS (www.gets.govt.nz(external link))

Dear Sir/Madam

Proposal for the supply of Single Use Instruments

In response to your request for proposals (RFP) dated 25 May 2016, we put forward the following proposal in respect of Single Use Instruments.

Set out below is further information in support of our proposal. Note that additional information is set out in the spreadsheet.

a) Organisation details

i) full legal name of supplier;

 

ii) contact person;

 

iii) physical address

 

telephone

 

email addresses

 

iv) organisational infrastructure, including legal status;

 

b) Product details

i) Details

Complete Attachment 1 (spreadsheet)

Details of any marking to identify the instruments as single-use rather than reusable (such as colour of handles, and details noted on packaging):

Details of instrument traceability processes including the marking of instruments/packaging with batch numbers/serial numbers (if any):

ii) DHB Experience

Volumes for period 1 April 20015 to 31 March 2016

See Attachment 1 (spreadsheet)

Details of any existing DHB contracts, including expiry dates

 

iii) Current Pricing (GST exclusive),

Details of your current pricing model(s), and which DHBs have accessed the pricing model(s) in the period 1 April 2015 to 31 March 2016

See Attachment 1 (spreadsheet)

iv) Proposed Pricing (GST exclusive)

Details of your proposed pricing model(s), include any related conditions or proposed terms;

Include on Attachment 1 (spreadsheet) where appropriate

Alternative pricing models (if any)

Include on Attachment 1 (spreadsheet) where appropriate

v) Impact Analysis

Provide financial impact analysis of your proposal for DHBs based on current usage patterns

Include in Attachment 1 (spreadsheet) where appropriate

vi) Quality/Standards Compliance

 Conformance to any relevant standards and regulatory requirements

 

A copy of registration in one of the following foreign jurisdictions: Europe, the United States, Canada, Australia.

For example, if product is registered in Australia, a copy of the Australian Register of Therapeutic Goods (ARTG) certificate and/or evidence of a third party conformity assessment demonstrating the product complies with the International Medical Device Regulators Forum (IMDRF) Essential Principles for Safety and Performance;

 

All products would require WAND notification before being considered. WAND registration number must be provided;

See Attachment 1 (spreadsheet)

c) Operational Details

i) Supply arrangements

Information relating to continuity of supply of Single Use Instruments in New Zealand. This should include information on

  • Stockholding in New Zealand,
 
  • Minimum order size,
 
  • delivery frequency and lead times:
    • for a stable demand situation,
    • in the event of supply disruptions, and
    • when there is an unexpected surge in demand for your product.
 
  • Please include any specific measures you will take to secure stock for New Zealand from international production;
 
  • Other
 

Describe your current supply arrangements, supply volumes and relevant supply terms in other major markets including recent tenders awarded (in New Zealand and/or other countries);

Describe proposed distribution and supply arrangements for the Single Use Instruments (this includes any information regarding freight or delivery costs to DHBs)

ii) Complaints and Recalls

Explain your current or proposed complaints management processes, including ability to recall stock, refund or credit for damaged or faulty goods

iii) Business Continuity Plan

Brief summary, including confirmation that any parties who will be supplying Single Use Instruments have a business continuity plan(s) with a brief summary of the plan(s)

iv) Experience (if any)

Demonstration of experience and knowledge within the healthcare sector, and specifically with District Health Board hospitals

Details of any overseas market (including site referees) please indicate which Single Use Instruments are supplied to these sites;

v) Sustainability

Details of relevant programmes for:

  • Waste reduction
  • Recycling
  • Other sustainability programmes

vi) Associated Services

Availability of training, education and product support

d) evidence of how the supplier envisages working with PHARMAC and other key stakeholders;

e) the supplier’s own rationale for why it considers PHARMAC should accept its proposal;

f) any particular information that the supplier considers PHARMAC should take into account when assessing its proposal; and

g) a declaration of any conflicts of interest that the supplier or an associated person or organisation may have that could affect or compromise the supplier or PHARMAC in relation to this RFP process or performance under any listing agreement if successful.