RFP - Supply of medical devices used in the prevention of venous thromboembolisms

Hospital devices

RFP Closed

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PHARMAC invites proposals for the supply of medical devices used in the prevention of venous thromboembolisms (VTEs) to DHB hospitals in New Zealand.

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

All proposals must be submitted to PHARMAC via the Government Electronic Tenders Services (GETS) (www.gets.govt.nz(external link)) no later than 5.00 p.m. on 30 June 2016

If you have any questions about this RFP, please submit questions through GETS. Alternatively, contact Ryan Graves (Device Category Manager) by email ryan.graves@pharmac.govt.nz at PHARMAC.

Answers to questions will be provided through the Government Electronic Tenders Service (GETS). PHARMAC will also post any addenda through GETS. We encourage interested suppliers to register with GETS and subscribe to this RFP to be kept up to date.

We look forward to receiving your proposal.

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

1. Medical Devices

PHARMAC is interested in considering any proposal from suppliers of medical devices used in the prevention of venous thromboembolisms (VTEs), such as Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) for use in DHB Hospitals. These devices include:

  • Graduated Compression Stockings (GCS);
  • Intermittent Pneumatic Compression (IPC) devices;
  • Venous Foot Pump (VFP) devices;
  • Mobile Vascular Compression devices (portable, battery powered IPC devices);
  • Neuromuscular Electrical Stimulation (NMES) devices; and
  • associated consumables and related products required to be used with these devices.

2. Background to RFP

The background to this RFP is as follows:

(a) PHARMAC’s role in Medical devices used in the prevention of VTEs

PHARMAC sought feedback from stakeholders in May 2013 on a number of identified medical device categories to commence initial procurement. The ‘mechanical compression devices’ and ‘anti-embolism hosiery’ categories were two of the categories identified. These categories have been combined, with the addition of other devices used in this indication, into a single category to encompass the range of medical devices used in the prevention of venous thromboembolisms (VTEs).

(b) Reasons for running the RFP

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.

(c) Impact of RFP

PHARMAC intends to establish listing agreements (National Contracts) with suppliers to gain the best price for medical devices used in the prevention of venous thromboembolisms used in District Health Board hospitals. It is expected that medical devices subject to a listing agreement will be listed in the Schedule. It is also anticipated that multiple suppliers of equivalent products will be listed, where appropriate.

3. Expected outcome of the RFP

4. Types of proposals sought

Schedule 2: RFP process

1. Submission

  1. You may submit more than one proposal. Each proposal will be considered as a separate proposal.
  2. All proposals must be submitted to PHARMAC via GETS no later than 5pm (New Zealand time) on 28 30 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.
  3. You cannot withdraw your proposal, once submitted, while the RFP process is continuing.
  4. If you have any enquiries about this RFP you should submit questions through GETS (www.gets.govt.nz(external link)) or alternatively contact Ryan Graves, (ryan.graves@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. The following information should be included in or form part of your proposal:

(a) details of all your medical devices used in the prevention of VTEs and associated products currently available as set out in Attachment 1;

(b) information on usage and expenditure by each DHB Hospital as set out in Attachment 1;

(c) indicative pricing (GST exclusive, free into store), including any related conditions or proposed terms affecting cost for PHARMAC as set out in Attachment 1;

(d) information about management and technical skills of your staff;

(e) 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);

(f) describe proposed distribution and supply arrangements for your medical devices and associated products (this includes any information regarding freight or delivery costs to DHBs);

(g) explain your current or proposed complaints management processes, including ability to recall stock, refund or credit for damaged or faulty goods;

(h) demonstration of experience and knowledge within the healthcare sector, and specifically with District Health Board hospitals;

(i) detail the availability of a comprehensive training, ongoing education and product and customer support package.

(j) describe how you envisage working with PHARMAC and other key stakeholders;

2. Product Information requirements

(a) Please confirm your ability to meet the following requirements and provide documented evidence where required:

Requirement Evidence requirement is met Response

All products must be WAND registered

WAND registration number must be provided as set out in Attachment 1.

Mandatory

International compliance

Evidence of international compliance certificates must be provided (e.g. ARTG, CE Mark) as set out in Attachment 1.

Mandatory

Safety and performance standards

Evidence of standards must be provided (for relevant product items)

Mandatory

DHB current usage data

Provide usage and current pricing information by DHB for the period

1 April 2015 – 31 March 2016 for all line items submitted as set out in Attachment 1.

Mandatory

Current contract status

Provide information on active DHB hospital contracts with expiry date.

Mandatory

Supply chain arrangements you would have in place to support NZ market requirements

Information relating to continuity of supply of products in New Zealand. This should include information on:

  • distribution arrangements and 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.

Mandatory

Consignment stock arrangements you would have in place to support NZ market requirements

Describe your current consignment stock management system including but not limited to;

  • risk and liability arrangements;
  • responsibility for stock management; and
  • auditing arrangements.

Provide information relating to your ability to support consignment products and associated instruments if a DHB hospital required that service.

Mandatory

Custom-sizing supply

Describe your ability to source and supply custom made Graduated Compression Stockings or IPC garments for individual patients. Please include where these are sourced from and the lead time to delivery of these products.

Desirable

Change management process

Detailed plan to support DHBs during any product swap out. Provide details of the process you would follow to support a DHB if they were interested in changing to your product range, including but not limited to:

  • establishing requirements;
  • timelines for change;
  • forecasting to meet increased demands; and
  • training & education provided.

Mandatory

Gs1 status

Provide GTIN codes for items.

Desirable

UNSPSC

Provide UNSPSC codes for items.

Desirable

Does the manufacturer operate a waste reduction policy? Is there a recycling process for their products in New Zealand?

Please give details.

Desirable

N.B. Mandatory response requirements: Where provision of a response to a requirement is indicated as mandatory in the above table a response to that requirement must be submitted, otherwise the proposal may not be able to be considered.

3. Declaration

(a) 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.

Schedule 4: Proposal form

An electronic version of this form is available on PHARMAC’s website and on GETS (www.gets.govt.nz(external link)). You should expand the boxes as necessary.

[Supplier to insert date]

Director of Operations
PHARMAC
C/- Ryan Graves
Device Category Manager

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

Dear Sir/Madam

Proposal for the supply of Medical devices used in the prevention of venous thromboembolisms

In response to your request for proposals (RFP) dated 25 May 2016 we put forward the following proposal in respect of Medical devices used in the prevention of venous thromboembolisms.

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

Set out below is further information in support of our proposal.

(a) Our contact details:

Full legal trading name in NZ

 

Key Contact person

 

Address

 

Phone

 

Facsimile

 

Email address

 

(b) Key features of our proposal and associated services available:

(c) Information about management and technical skills of your staff:

(d) Information about the availability of a comprehensive training, ongoing education and product and customer support package.

(e) Details of our services provided for maintenance, servicing and calibration; please detail service agreements including, but not limited to:

Service Product Name Service detail

Frequency of calibration and maintenance

   

Performed by DHB clinical engineers on-site (and training of engineers), or off-site service centre

   

Replacement / repair policies, and holding of replacement parts

   

Cost of respective services, including within the warranty period and following the expiry of the warranty period

   

Specialist equipment or manuals required (include cost)

   

Training of DHB staff (e.g. clinical engineers)

   

[Other]

   

(f) Information relating to pricing ($NZ, GST exclusive), including any related conditions or proposed terms affecting cost for DHBs (e.g. reference price protection, risk sharing mechanisms, price linking to other products outside of this category etc.):

(g) Evidence of market approval and any other required consents:

WAND registration details supplied against line items in Attachment 1

[yes/no]

TGA/FDA/CE details supplied against line items in Attachment 1

[yes/no]

(h) Evidence of safety and performance standards for relevant product items:

AS/NZS IEC 60601-1 - Medical electrical equipment

[yes/no]

AS/NZS 3200.1.1: Collateral Standard: Safety requirements for medical electrical systems or IEC 60601-1-1: Collateral Standard: Safety requirements for medical electrical Systems

[yes/no] and state which standard

AS/NZS 3200.1.2: General requirements for safety—Collateral standard: Electromagnetic compatibility- Requirements and tests or IEC 60601-1-2:2004 General requirements for safety—Collateral standard: Electromagnetic compatibility- Requirements and tests

[yes/no] and state which standard.

AS/NZS 3551:2012 Management programs for medical equipment

[yes/no]

Quality Management Systems in place (e.g. ISO 13485:2003)

State as applicable

(i) Information about our proposed distribution and supply arrangements for your medical devices and associated products (this includes any information regarding freight or delivery costs to DHBs for none-routine orders such as urgent orders or returns):

(j) Information about our current supply arrangements, supply volumes and relevant supply terms in other major markets including recent tenders awarded in New Zealand and/or other countries (N.B.: site references show which products are supplied to these sites, and referees are available to contact):

(k) Information about our supply chain arrangements in the NZ market. This includes information relating to continuity of supply of products, distribution arrangements and stockholding in NZ, minimum order size, delivery frequency and lead times. We have also included specific measures that we will take to secure stock for New Zealand from international production:

(l) Information about our consignment stock arrangements that we would have in place to support NZ market requirements:

(m) Information about our current or proposed complaints management processes, including ability to recall stock, refund or credit for damaged or faulty goods:

(n) Information about our supply of custom-sized Graduated Compression Stockings or IPC garments for individual patients:

(o) Information about our plan to support a DHB if they were interested in changing to our product range, including but not limited to establishing requirements, timelines for change, forecasting to meet increased demands; and training & education provided:

(p) Information about our experience and knowledge within the healthcare sector, and specifically with District Health Board hospitals:

(q) Information about a waste reduction policy and, recycling processes for our products in New Zealand:

(r) Proposals/suggestions (e.g. pricing, risk sharing arrangements, etc.) regarding the medical devices not expressly identified in this RFP that we would like PHARMAC to consider as part of our proposal:

(s) Reasons why PHARMAC should accept our proposal, and how we envisage working with PHARMAC and other key stakeholders:

(t) Additional information that PHARMAC should consider when evaluating our proposal:

(u) 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: