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Stage – ID4: Demonstrate the Benefits

At this stage evidence needs to be presented that the prototype is viable and meets planned design requirements. Building on this evidence, the business plan needs to be finalized and further funding needs to be sourced.

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Task Overview

Launching your product well and planning its scale-up can make a big to its future success.

What you need to do:

  • Plan what type of launch you want – it could be low-key, with identified first-adopter customers, or with a big fanfare and advertising, exhibition and distribution.
  • Make sure products and support are available and working. Launching an incomplete or unevaluated product can be very damaging.
  • Develop a full package of training resources, patient advice, promotional materials, maintenance manuals, etc for product support. Satisfaction with a product is often dependent on initial training and expectations, so this package (and any instrumentation) can be as important as the product itself.
  • Establish close contact with the appropriate purchasing and pricing agencies (reimbursement) in the healthcare markets so that your product reaches the patient at a sustainable price for the business. If necessary, engage in initial volume and cost/benefit analyses and discussions. Some form of health technology assessment or clinical evaluation may be required. Specialist advice is likely to be needed for overseas markets. Approval from a national reimbursement agency will allow widespread use of the product and strengthen its market position.
  • By this stage your product should:
    • Shown success in pre-production tests as identified by the risk analyses.
    • Received regulatory approval, perhaps in the form of CE marking.
    • Undergone validated transfer from product design and development, to process design and development, and to full manufacture.
    • Acquired the support of a full package of product and associated instrumentation, marketing activity and training materials.
  • The core technical value will be enhanced though the reduction in risk of commercial or clinical failure. This should have been achieved by establishing a database showing that the product works as intended. Whilst the technical value still predominantly resides in the product IP, there is further generation of value in the production ‘know-how’ process.

Do not proceed to the next stage without first having demonstrated the value above (i.e. if regulatory authorities have not provided full safety approval for your product, it would be unwise to proceed to product launch only to have to stall the process at a later date pending a decision).

  • Once a prototype has been tested and the final amendments made for documentation of any changes to the manufacturing process, you must deal with scale-up for production issues. But you must overcome a number of barriers:
    • Validate production process, which may include: process flow documentation and creation of associated validated production routes: sampling and in-production testing must be defined, and the set-up processes quantified.
    • Identify and validate supply chains; raw materials and sub-contract processes should conform to any necessary regulatory requirements.
    • Seek final confirmation that product manufacture can be achieved within maximum cost limits.
    • Set up final tooling for the production run, which can be a time-consuming and expensive stage. This stage will not easily accommodate later design changes, so it’s vital to make sure the design is frozen and formally validated .
    • Validate the process if you have a sterile product (often a good reason for outsourcing this step).
    • Seek quality assurance – it is important in any product, but in medical devices it is integral to the licence to sell the product.
  • It’s important that the manufacture satisfies the regulatory requirements of all target markets. The manufacturer is responsible for the safety and performance of its medical devices. For EU countries, there is a formal signing of a Declaration of Conformity to the appropriate regulatory requirements to enable the product to be CE-marked. Each country is slightly different, so ensure the manufacturing process conforms throughout.

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