Medasil product ranges are intended to provide sufficient variety to satisfy clinical preference, but Health Care Professionals (HCPs) may sometimes conclude that certain adjustments to the usual design or presentation of a specific device may prove clinically advantageous.

HCPs may also wish to pursue a new and innovative concept that requires full support from initial product design to the eventual production schedule.

As part of an expanding Medasil service that also develops prototypes and novel components for new and existing business partners, all such request for Special Orders is assessed on an individual basis.

 

SPECIAL ORDERS

The highly skilled and experienced production staff at Medasil can accommodate a wide variety of customer ‘Special Order’ product requirements, including:

• Non-stock products: Minor variations from the existing Medasil product portfolio
• “Made to Order” products: Devices commissioned for periodic orders, to meet specific customer criteria
• Custom fabrication: Bespoke, “one-off”, and limited quantity specialist devices
• Innovative design projects: Drawing, design, prototype and manufacture of novel product developments
• Component manufacture: Development and production of specialised silicone components
• Assembly – full or partial fabrication of the finished product from individual components
• Commercial partnerships – collaborative arrangements with OEM partners

 

EVALUATION CRITERIA

Each Special Order proposal is evaluated independently, with process feasibility, project viability, overall time frame and eventual unit pricing determined by consideration of all appropriate criteria including, but not limited to, the following:

• A relative degree of modification from an existing catalogue product (eg colour, radio-opacity, length)
• Any additional manufacturing processing phases involved (eg packaging, sterilisation)
• Compliance with existing manufacturing requirements (eg CE, labelling, Quality Control. And Regulatory)
• The complexity of design, where appropriate (eg novel product designs and prototypes)
• Additional tooling requirements and costs
• Design, drawing and development costs
• The quantity of the item(s) required
• Frequency and volume of future demand, if appropriate
• Initial order and agreement – see the following section

 

PROCEDURE

The Customer initially confirms either:

• The proposed modifications to an existing Medasil product, or
• The specific design features of the new product*

*Note: To assist the full consideration of the proposal, this information should be as comprehensive as possible. Especially relating to any key details of the product that affect functionality, or are critical to the end-user.

The Customer confirms the expected quantity and frequency of demand for the proposed product.

For Special Order requirements that have been assessed and are suitable for the manufacture, Medasil will prepare and submit an official quotation for approval by the Customer in the first instance.

Once the quotation has been accepted, a more detailed Commercial Agreement will then be prepared and issued. This agreement will be binding and will confirm all salient details of the project, including:

• Development and tooling costs (where appropriate)
• Design details
• Order quantities
• Delivery schedules
• Product pricing

The Commercial Agreement must be completed by the Customer, prior to initiation of the manufacturing phase of the project by Medasil.

 

CONDITIONS

All Special Orders must be supported by a binding Commercial Agreement.

Finished devices developed outside the usual scope of the established Medasil product portfolio, are by definition, unique or bespoke products that reflect the individual requirements and expectations of the originating Customer, and therefore unlikely to be suitable elsewhere.

If any requested modification or Special Order is processed by Medasil, but the agreed order quantities specified in the Commercial Agreement are subsequently not fulfilled by the organization Customer, the Customer will remain liable for the value of the full quantity of products manufactured to this specification under the terms of the Agreement.

Once an initial Commercial Agreement has been fulfilled and all deliveries are complete, any subsequent order requirements by the Customer for precisely the same product(s) may be simplified and accelerated by quoting the reference number of the original Agreement.