Stimulate Product Innovation
WHO aims to consistently improve the quality and reliability of immunization products. To achieve this, it engages with WHO Member States and national immunization programmes to understand the evolving needs of product end-users and to define desirable future product characteristics that will better satisfy operational and programmatic needs. These characteristics are described in target product profiles (TPPs). This process also helps to support a healthy and competitive market place, as well as stimulate innovation and the development of new technologies for immunization products. WHO also provides guidance for the field-testing of products, which is a prequalification prerequisite or some products.
Challenges for immunization products
WHO immunization programmes operate in settings that are often low- or unreliably-resourced, creating tough challenges for vaccine transport, storage and delivery. The purpose of Target Product Profiles (TPPs) is to propose product or device enhancements that better address the challenges faced in operating environments, resolve performance or safety issues, or meet an identified technical or operational need.
The development of a TTP also initiates a consultation process with industry which will further support the revision of performance specifications and verification protocols and also, therefore, the design of products with improved overall performance.
TPPs are a key element of WHO's work to evolve product standards. They help to drive an ongoing process of product development that leads to evermore fit-for-purpose and quality products for immunization programmes. By clarifying the desired product characteristics, a well-designed TPP process helps to mitigate the risk of product development failures. In this way, TPPs also help to make the product development process more efficient. Products that better meet the needs of low-resource operating environments, and even new and emerging challenges, serve to extend the reach, reliability and impact of immunization programmes.
Product innovation process
WHO has a four-step cycle that drives innovation:
- Clearly identified needs of national immunization programmes
- Development of TPPs
- Development of performance specifications
- Field monitoring of products.
This cycle is both iterative and interactive.
Target product profiles
A Target Product Profile (TPP) is a document that contains a detailed description of desirable future product characteristics, features or functions. It explains the reason for each desirable characteristic and states the date by which the feature must be included in products seeking to achieve or to maintain prequalified status.
The full list of current TPPs is available here.
TPPs capture new and evolving user needs via the feedback and input of immunization programme healthcare staff in operating environment. TPPs list desirable new product characteristics and are intended to stimulate further feedback and dialogue with (prospective) Prequalification Holders. TPPs are not proscriptive: they do not dictate how the performance characteristics they contain should be met. Rather they are intended to stimulate new technical solutions to meet these programme needs.
A TPP does not impose any implicit or explicit obligation on the prospective Prequalification Holder to achieve all of the desirable product characteristics. For example, during the dialogue process it may emerge that some of these characteristics are technically difficult to achieve or may drive up costs. In such circumstances, these characteristics may appear as optional performance requirements in the final WHO specification. Prospective Prequalification Holders who are able to satisfy these optional requirements may be at a competitive advantage, and serve as an incentive to other prospective Prequalification Holders to reach the same level of performance.
TPP linkages with standards and norms
A successful TPP process facilitates the drafting of a realistic and technically-achievable performance specification and verification protocols that are acceptable to all interested parties. Performance specifications and verification protocols remain the basis for prequalification because they define the specific characteristics that each prequalified product must demonstrate.
TPPs can inform these documents by initiating:
- improvements or changes to an existing product or product type: The TPP addresses a known technical or operational shortcoming based on field performance data and user feedback from national immunization programmes. The TPP process invites feedback from industry and Prequalification Holders, leading to revision of an existing performance specification and its companion verification protocol(s), followed by a further cycle of product development and prequalification.
- development of an entirely new product or product type: The TPP addresses a new technical or operational need based on field performance data and user feedback from national immunization programmes. The TPP attracts an initial response from industry and Prequalification Holders. This leads to the development of a new specification and verification protocol and a new cycle of product development and prequalification.
TPP linkages with field monitoring and performance feedback
User feedback supplies valuable information on equipment performance under field conditions. It also facilitates identification of emerging vaccine transport, delivery or storage needs that are not yet (fully) met by existing products or devices. Comprehensive field performance data is gathered from UNICEF, from WHO country and regional offices, and from current Prequalification Holders. Quantitative field performance data can be obtained from management reporting systems, as well as from field inspections carried out by review teams during exercises such as programme reviews and Effective Vaccine Management inspections.
Data collection
WHO IMD-PQS collects field performance data to inform the revision of TPPs or the creation of new TPPs in various ways:
- spontaneous user-driven electronic reporting via the User Feedback Form
- sourcing data from country-level management reporting systems via WHO national immunization programmes
- Prequalification Holder product defect reporting and analysis of technology issues or product defect information received by Prequalification Holders directly from product users (WHO IMD-PQS post-market monitoring)
- annual product review: an opportunity for WHO and Prequalification Holders to analyse and address the root-causes of technology issues or product defects
- prequalification field-testing: manufacturer-led field testing of products that are safety-critical or to be used in high volumes.