Stimulator

Description

12/01/2018    S8    - - Supplies - Prior information notice without call for competition - Not applicable 

United Kingdom-Normanton: Stimulator

2018/S 008-013070

Prior information notice

This notice is for prior information only

Supplies

Directive 2014/24/EU

Section I: Contracting authority

I.1)Name and addresses
NHS Supply Chain acting as agent for NHS Business Services Authority
Foxbridge Way
Normanton
WF6 1TL
United Kingdom
Contact person: Kevin Long
Telephone: +44 7802862570
E-mail: kevin.Long@supplychain.nhs.uk
Fax: +44 1924328744
NUTS code: UKE4

Internet address(es):

Main address: www.supplychain.nhs.uk

I.2)Joint procurement
The contract is awarded by a central purchasing body
I.3)Communication
Additional information can be obtained from the abovementioned address
Electronic communication requires the use of tools and devices that are not generally available. Unrestricted and full direct access to these tools and devices is possible, free of charge, at: http://procurement.supplychain.nhs.uk/ISS
I.4)Type of the contracting authority
National or federal agency/office
I.5)Main activity
Health

Section II: Object

II.1)Scope of the procurement
II.1.1)Title:

Neuromodulation Devices Consumables and associated Products including Intrathecal Drug Delivery Pumps

II.1.2)Main CPV code
33158210
II.1.3)Type of contract
Supplies
II.1.4)Short description:

Non-exclusive framework agreement for the supply to the NHS Supply Chain customer base via the E-Direct Route. Product range to include, but not limited to:

— Spinal cord stimulation,

— Deep brain stimulation,

— Intrathecal drug pumps,

— Sacral nerve stimulation,

— Vagal nerve stimulation,

— Peripheral nerve stimulation,

— Occipital nerve stimulation,

— Dorsal root ganglion stimulation.

However, NHSSC may be interested in capturing other procedures or products that potential suppliers may consider relevant to the overarching requirement for devices, consumables and other products that are associated with neuromodulation procedures.

Precise quantities are unknown. It is anticipated that initial expenditure will be in the region of £30m to £52m in the first year of this FAG; however, this is approximate only and the values may vary depending on the requirements of those bodies purchasing under the FAG. The estimated value over the total FAG term (including any extension options) is £280m.

II.1.5)Estimated total value
Value excluding VAT: 280 000 000.00 GBP
II.1.6)Information about lots
This contract is divided into lots: yes
II.2)Description
II.2.1)Title:

Deep Brain Stimulation

Lot No: 1
II.2.2)Additional CPV code(s)
33158210
31711140
33100000
33124100
33124130
33140000
33141200
33141210
33141240
33141310
33141320
33141620
33190000
33698000
38434540
42122410
33141323
II.2.3)Place of performance
NUTS code: UK
II.2.4)Description of the procurement:

Deep brain stimulation is a neurosurgical procedure involving the implantation of a medical device called a neurostimulator, which sends electrical impulses through implanted electrodes to specific targets in the brain for the treatment of movement and neuropsychiatric disorders. This surgery benefits patients with the following symptons: Parkinson"s disease, essential tremor, dystonia, chronic pain, major depression, obsessive–compulsive disorder and others. Deep brain stimulation directly changes brain activity in a controlled manner, its effects are reversible. The deep brain stimulation system consists of three components: the implanted pulse generator (IPG), the lead and an extension.

II.2.14)Additional information

Precise quantities are unknown. It is anticipated that initial expenditure will be in the region of £9,500,000 to £11,500,000 in the first year of this framework agreement; however, this is approximate only and the values may vary depending on the requirements of those bodies purchasing under the framework agreement.

II.2)Description
II.2.1)Title:

Sacral Nerve Stimulation

Lot No: 2
II.2.2)Additional CPV code(s)
33158210
31711140
33100000
33124100
33124130
33140000
33141200
33141210
33141240
33141310
33141320
33141620
33190000
33698000
38434540
42122410
33141323
II.2.3)Place of performance
NUTS code: UK
II.2.4)Description of the procurement:

Sacral nerve stimulation typically involves the implantation of a programmable stimulator subcutaneously, which delivers low amplitude electrical stimulation via a lead to the sacral nerve, usually accessed via the S3 foramen. In the event that the nerves and the brain are no longer communicating effectively, resulting in a bowel/bladder disorder, this type of treatment is designed to imitate a signal sent via the central nervous system. The sacral nerve stimulation system consists of three components: the implanted pulse generator (IPG), the lead, and patient remote.

II.2.14)Additional information

Precise quantities are unknown. It is anticipated that initial expenditure will be in the region of £8,000,000 to £10,000,000 in the first year of this framework agreement; however, this is approximate only and the values may vary depending on the requirements of those bodies purchasing under the framework agreement.

II.2)Description
II.2.1)Title:

Spinal Cord Stimulation

Lot No: 3
II.2.2)Additional CPV code(s)
33158210
31711140
33100000
33124100
33124130
33140000
33141200
33141210
33141240
33141310
33141320
33141620
33190000
33698000
38434540
42122410
33141323
II.2.3)Place of performance
NUTS code: UK
II.2.4)Description of the procurement:

Spinal cord stimulator or dorsal column stimulator is a type of implantable neuromodulation device that is used to send electrical signals to select areas of the spinal cord (dorsal columns) for the treatment of certain pain conditions. Spinal cord stimulation is a consideration for people who have a pain condition that has not responded to more conservative therapy. The spinal cord stimulation system consists of three components: the implanted pulse generator (IPG), the lead, and patient remote.

II.2.14)Additional information

Precise quantities are unknown. It is anticipated that initial expenditure will be in the region of £21,000,000 to £25,000,000 in the first year of this framework agreement; however, this is approximate only and the values may vary depending on the requirements of those bodies purchasing under the framework agreement.

II.2)Description
II.2.1)Title:

Dorsal Root Ganglion

Lot No: 4
II.2.2)Additional CPV code(s)
33158210
31711140
33100000
33124100
33124130
33140000
33141200
33141210
33141240
33141310
33141320
33141620
33190000
33698000
38434540
42122410
33141323
II.2.3)Place of performance
NUTS code: UK
II.2.4)Description of the procurement:

Dorsal root ganglion (DRG) therapy is a new type of neurostimulation therapy designed to manage difficult-to-treat chronic pain in specific areas of the lower body, such as the foot, knee, hip or groin. If you suffer from this kind of pain, DRG therapy may work where other therapies have not — or may have provided only partial relief. The dorsal root ganglion system consists of three components: the implanted pulse generator (IPG), the lead and patient remote.

II.2.14)Additional information

Precise quantities are unknown. It is anticipated that initial expenditure will be in the region of £2,000,000 to £2,500,000 in the first year of this framework agreement; however, this is approximate only and the values may vary depending on the requirements of those bodies purchasing under the framework agreement.

II.2)Description
II.2.1)Title:

Vagal Nerve Stimulation

Lot No: 5
II.2.2)Additional CPV code(s)
33158210
31711140
33100000
33124100
33124130
33140000
33141200
33141210
33141240
33141310
33141320
33141620
33190000
33698000
38434540
42122410
33141323
II.2.3)Place of performance
NUTS code: UK
II.2.4)Description of the procurement:

The vagal nerve stimulation therapy system uses a surgically implanted medical device that delivers pulsed electrical signals to the vagus nerve. It is used as an adjunctive treatment for certain types of intractable epilepsy and treatment-resistant depression as well as other medical conditions. The vagal nerve stimulation system consists of three components: the implanted pulse generator (IPG), the lead and patient remote.

II.2.14)Additional information

Precise quantities are unknown. It is anticipated that initial expenditure will be in the region of £6,000,000 to £7,200,000 in the first year of this framework agreement; however, this is approximate only and the values may vary depending on the requirements of those bodies purchasing under the framework agreement.

II.2)Description
II.2.1)Title:

Peripheral Nerve Stimulation

Lot No: 6
II.2.2)Additional CPV code(s)
33158210
31711140
33100000
33124100
33124130
33140000
33141200
33141210
33141240
33141310
33141320
33141620
33190000
33698000
38434540
42122410
33141323
II.2.3)Place of performance
NUTS code: UK
II.2.4)Description of the procurement:

Peripheral nerve stimulation is a commonly used approach to treat chronic pain. It involves surgery that places a small electrical device (a wire-like electrode) next to one of the peripheral nerves.

II.2.14)Additional information

Precise quantities are unknown. It is anticipated that initial expenditure will be in the region of £1,050,000 to £1,300,000 in the first year of this framework agreement; however, this is approximate only and the values may vary depending on the requirements of those bodies purchasing under the framework agreement.

II.2)Description
II.2.1)Title:

Occipital Nerve Stimulation

Lot No: 7
II.2.2)Additional CPV code(s)
33158210
31711140
33100000
33124100
33124130
33140000
33141200
33141210
33141240
33141310
33141320
33141620
33190000
33698000
38434540
42122410
33141323
II.2.3)Place of performance
NUTS code: UK
II.2.4)Description of the procurement:

Occipital nerve stimulation is a form of neuromodulation therapy aimed at treating headache and craniofacial pain. This therapy involves an implantable device composed of an electrode and pulse generator.

II.2.14)Additional information

Precise quantities are unknown. It is anticipated that initial expenditure will be in the region of £2,000,000 to £2,500,000 in the first year of this framework agreement; however, this is approximate only and the values may vary depending on the requirements of those bodies purchasing under the framework agreement.

II.2)Description
II.2.1)Title:

Intrathecal Drug Delivery Pumps

Lot No: 8
II.2.2)Additional CPV code(s)
33141200
42122410
33100000
33190000
33141620
II.2.3)Place of performance
NUTS code: UK
II.2.4)Description of the procurement:

Intrathecal drug delivery is introduced directly to the spinal fluid (intrathecal space) through a drug delivery system comprised of a pump and catheter. The intrathecal space is usually accessed from the lumbar region of the lower back.

II.2.14)Additional information

Precise quantities are unknown. It is anticipated that initial expenditure will be in the region of £500,000 to £600,000 in the first year of this framework agreement; however, this is approximate only and the values may vary depending on the requirements of those bodies purchasing under the framework agreement.

II.3)Estimated date of publication of contract notice:
01/04/2018

Section IV: Procedure

IV.1)Description
IV.1.8)Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: yes

Section VI: Complementary information

VI.3)Additional information:

The following certification will be a requirement of the upcoming tender exercise and applicants will be required to include evidence of this with their tender submission.

— ISO 9001:2015 or equivalent externally accredited and up-to-date quality standard certificate(s) to cover all segments of the applicant"s (and the product"s) supply chain. This should include but not be limited to manufacturing storage and distribution. Further information in respect of certification requirements will be set out in the notice for the forthcoming procurement. If such certificates are not in the name of the applicant, then the applicant must supply a copy of agreements setting out the authority and responsibilities of all parties in the supply chain.

The purpose of this notice is to draw attention to a procurement that NHSSC intends to commence during the subsequent 12 months. The invitation to tender will be the subject of a separate notice to which potential suppliers will need to respond at the appropriate time.

Whilst it is anticipated that initial expenditure under any forthcoming procurement will be in the region of £240m to £280m for this contract award, this is an approximate only.

NHSSC expects to provide successful suppliers with the opportunity to offer additional savings to customers through the provision of discounted pricing, value added offerings and commitment/bulk buy initiatives.

The framework agreement will be between NHSSC and the supplier; however, NHSSC; any NHS Trust; any other NHS entity; any government department, agency or other statutory body and/or any private sector entity active in the UK healthcare sector will be able to enter into a direct contract with the supplier for any of the supplies and/or services under the framework.

The supplier will be required to report to and pay a direct contract management fee to NHSSC as detailed in the tender documents.

NHSSC is currently considering the use of lots for this procurement. However, it reserves the right not to as part of any future tender process. Further information in respect of the lot strategy will be set out in the notice for the forthcoming procurement.

As part of its pre-tender strategy, NHSSC would also like to engage with suppliers of these products via a Request for Information (RFI). If you would like to complete the Request for Information document in respect of the products which are the subject of this procurement, then please follow the below instructions:

Candidates wishing to complete the Request for Information must register their expression of interest. The Request for Information document will then be sent via the Intenda Messaging Centre.

Registration:

1) Use URL http://procurement.supplychain.nhs.uk/ISS/ to access the NHSSC Procurement portal;

2) If not yet registered:

(a) Click on the "Not Registered Yet" link to access the registration page;

(b) Complete the registration pages as guided by the mini guide found on the landing page.

Portal Access:

If registration has been completed:

1) Login with URL http://procurement.supplychain.nhs.uk/ISS/

2) Click on the "Applicant Dashboard" icon to open the list of new procurement events.

Expression of Interest:

1) View PIN content by clicking on the "View Notice" button for the procurement event. This opens a PDF document;

2) Express an interest by clicking on the "Express Interest" button.

Request for Information Document:

1) The Request for Information document will then be sent to you via the Intenda Messaging Centre;

2) Applicants will then have 5 weeks from the dispatch of this notice to complete and return the Request for Information document.

NHSSC anticipates holding pre-tender meetings with suppliers during March 2018. If you would like to attend this event, please contact Kevin Long via http://procurement.supplychain.nhs.uk/ISS to register your attendance.

VI.5)Date of dispatch of this notice:
10/01/2018

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