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Adoption of Medical Devices

NIC Document

Summary

This guide provides an overview of the main factors that influence whether innovations are successfully adopted by health service organisations, looking at areas such as marketing, evaluation and risk management, with real-life examples of good practice from an NHS trust that introduced a new medical device. It is based on a comprehensive review of the literature about adoption, Spreading and Sustaining Good ideas in Healthcare. You can download the full document from: www.netscc.ac.uk.

In Brief

  1. What makes a successful adoption strategy?
  2. Spreading the message
  3. The adoption process
  4. The organisation
  5. Case study
  6. Risk management standards and tools

Introduction

Successfully getting an innovation adopted within health service organisations depends on a number of internal and external factors. Innovators need to take all these aspects into consideration by ensuring that their innovation is presented to match the needs of the organisation and by building in an effective risk management strategy

What makes a successful adoption strategy?

Innovations that are easily adopted tend to offer a clear, unambiguous advantage, such as greater effectiveness, reflecting adopters’ needs or being simple to use. People’s willingness to try out and use new products and services will depend on personal characteristics such as their tolerance of ambiguity, intellectual ability, values and learning style.

Spreading the Message

The most effective way to spread the message about an innovation is through social networks. Within the health service, different groups of potential adopters have different types of networks. For example, doctors tend to operate in informal, horizontal networks, while nurses often have formal, vertical networks. Horizontal networks are most effective for spreading peer influence and supporting people as they work out what the innovation means for them. Vertical networks are more effective for cascading information and passing on authoritative decisions. Key sources of information for clinicians are peer-reviewed journals and trade publications. Conferences are also very important; attending key conferences in your sector can be a very effective way to make contacts and increase awareness of your product. Many companies in the healthcare sector are now using live case studies published on the web to demonstrate a new procedure or product.

The adoption process

It is important to address different concerns and information needs at each stage of the adoption process, including:

  • Awareness – what does the innovation do and how do you use it? How much will it cost?
  • Persuasion –information about how the innovation works and training and support to help people incorporate it into their working life
  • Decision – the consequences of adopting the innovation
  • Implementation – support to help users adapt and refine the innovation to suit individual and local needs.
  • The organisation

    Organisations most likely to successfully adopt innovations share some common characteristics, including:

  • A culture that supports the capturing and sharing of knowledge
  • Project teams with the autonomy to take relevant decisions
  • A climate that encourages experimentation and risk-taking
  • Organisations are ready for change and more likely to adopt an innovation, when:
  • The proposed innovation reflects the organisation’s values, goals and ways of working
  • The innovation’s supporters outnumber its opponents
  • There are systems in place to monitor and evaluate the impact of the innovation
  • Case Study – The adoption of a new medical device into an NHS hospital

    Introduction

    The following case study is an example of how a manufacturer can work with an NHS Trust to support the adoption of a new medical device.

    1. Make the benefits clear

    The Trust’s purchasing team worked closely with the manufacturer to demonstrate the cost/benefit of the device against the current options. The manufacturer and the adoption team also disseminated the results of a relevant practice audit which provided clear evidence of the benefits of the change.

    2. Make use of existing communication channels

    The Trust used its annual hygiene awareness week to launch the new device, giving staff plenty of notice that they would be expected to attend a short mandatory training session.

    3. Target the right people

    Before hygiene awareness week, the Trust informed sisters and charge nurses about the new device and explained how it would affect them and why it was important for them to attend.

    4. Make information widely available

    Information and research findings about the new device are now available on the hospital intranet, giving all staff 24-hour access to information.

    5. Create a sense of occasion

    The Trust set a date for introducing the new device. During that week, the adoption team removed the old stock and made sure that all wards had an adequate supply of the new devices. Ward staff were give training in ordering and supply management. A series of mini road shows were held for all staff.

    Risk Management Standards and Tools

    It is essential to assess the potential risks presented by a project before the design process starts. This includes thinking about the uses that your products may be put to in practice. You also need to assess the nature of the user: who will be operating the device, how much training will be needed, and the environment in which the device will be used. The international standard on risk management, EN ISO 14971:2007 (Medical Devices – Application of Risk Management to Medical Devices) lays out a full risk management process in 13 steps. However, the following four-step process covers the key stages:

  • Analyse the data
  • Evaluate what the data means
  • Control the process
  • Feed back real data to the decision makers
  • ISO 13485:2003 (Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes) sets out the requirements for the quality management systems needed to develop a medical device. This is based on the ISO 9001:200 quality management system as well as the Medical Device Regulations 2002 (see guide ‘Medical Devices: Scope and Definitions’) which define the requirements of a medical device. A number of tools can be used in the risk assessment process, including:

  • Functional analysis – describes the relationships between the inputs and outputs of the most significant functions when developing a new product, including medical devices
  • Fault tree analysis – used in the early stages of development for identifying hazards and their root causes
  • Failure mode effect analysis – where individual components are ‘isolated’ and the effect of them failing is systematically identified, this is more appropriate as a verification tool towards the end of the process, after the design is finalised and/or a prototype is available
  • Hazard and operability study/hazard analysis and critical control point – often used later on in development, this helps to control manufacturing risk