Evaluation of Devices:

1
Evaluation of Devices

• The NHS Innovation Landscape
• SIG Meeting November 2005

2
Background

• First question, posed by Lord Warner against the
  backdrop of the HITF implementation
• is there a clear pathway(s) for medical device
  innovations to follow, such that broad adoption
  by the NHS can be achieved?
• Initial findings
• There are no clear pathways
• DH and NHS organisations work in isolation
• Numerous bottlenecks and inconsistencies in
  approach
• Result
• Clear and consistent pathways cannot be simply
  created
• Therefore, the HITF working group proposed the
  NHS Innovation Landscape Project,
• to be undertaken by the National Innovation
  Centre in the Technology Product
• Directorate of the NHS Institute, in conjunction
  with the wider stakeholder group

3
The NHS Innovation landscape project

• Project principles
• A holistic approach rather than silo mentality is
  required to solve the problem due to its
  complexity
• The project must first address the problem
  without reference to organisational boundaries
• The project will not duplicate effort or
  re-create unnecessary bureaucracy
• Full buy-in to project outcomes by all
  landscape stakeholders is required
• Project delivery team
• The National Innovation Centre at the NHS
  Institute for Innovation and Improvement
• Commercial Directorate, DH Industry Sponsorship
  team
• Faraday (KTN) Partnership, PASA, CEP, RRP RDD
• Expected project outcomes
• Pathways and how2 guides for innovators,
  published on the NIC and other DH websites
• Clear NHS entry points and routes to follow for
  innovators
• Operational mechanisms to manage the innovation
  landscape
• Co-ordinated policy across the NHS innovation
  landscape

4
Project overview
May 05 September 05
Are there consistent Innovation Pathways?
NO
November 05 March 06
October 05
April 06
Inform SIG
Update SIG
Phase 1 Analysis
Phase 2 Business process mapping
Phase 3 Implementation by NIC

• How should an innovation landscape work in
  principle?
• Who does what in an innovation landscape?
• Align stakeholders

• What would an innovation landscape do?
• What are the essential parts of the innovation
  landscape?
• Agree stakeholders

• Implement and build delivery mechanisms
• Monitor progress
• Iterate as required

5
Phase 1 outcomes

• Approach
• Build on work undertaken to date
• Treat the Innovations Landscape as a virtual
  organisation
• Use a rigorous business process modelling method
• Workshop held with key DH agencies
• Initiating wider engagement with service,
  industry and academic stakeholders
• Achievements
• Firm stakeholder buy-in to the business process
  methodology
• Confirmation of three domains on landscape
• - Pre-market not quite products
• - Post-market products (CEP PASA involved)
• - Landscape management where do they fit?
• Framework developed for mapping processes

6
Project metrics
Phase
Deliverable
Milestones
Phase
Deliverable
Milestones
Phase 1

• Deliverable

• Milestones

Phase 1

• Stakeholder Reference Group established
• Phase 1 Report
• Stakeholder analysis
• Current state assessment
• Process architecture
• Illustrative cases

• End Nov 05

Phase 2

• Deliverable

• Milestones

Phase 3

• Deliverable

• Milestones

Phase 2

• Phase 2 Report including
• Role-activity diagrams
• Worked examples
• Stakeholder workshop walkthrough
• Briefing update for SIG

• End Mar 06

Phase 3

• Stakeholder alignment on implementation plan
• Landscape paths operational

• May 06

7
Next steps

• Brief SIG November 2005 on project purpose,
  desired outcomes and methodology
• Kick off phase 2
• Brief SIG April 2006
• Landscape operational May 2006