Market Entry Readiness Assessment
Please answer the following questions to receive your score and feedback.
Name
*
First Name
Last Name
Email
*
example@example.com
Company
*
Regulatory Readiness
What stage are you at in the UK regulatory process?
No preparation started yet
Research phase/understanding requirements
Technical documentation in preparation
UK CA mark application in progress
UK CA mark obtained
What stage are you at in the EU MDR process?
No preparation started yet
Research phase/understanding requirements
Technical documentation in preparation
CE mark application in progress
CE mark under MDR obtained
Have you established a UK Responsible Person (if based outside UK)?
Not applicable - UK based company
No, not yet considered
Researching options
In discussions with potential partners
Yes, formally established
Have you implemented a Post-Market Surveillance (PMS) system compliant with UK/EU requirements?
No PMS system in place
Basic PMS planning started
PMS system in development
Comprehensive PMS system implemented
Back
Next
Clinical Evidence
What level of clinical evidence have you generated for your device?
Literature review only
Bench/lab testing only
Small feasibility studies
Pivotal clinical trial outside UK/EU
UK/EU-based clinical evidence
Does your clinical evidence address outcomes relevant to the UK healthcare system?
No UK-specific outcomes
Limited UK-relevant endpoints
Some key UK-relevant endpoints included
Comprehensive UK-specific outcomes
Have you developed a PMCF (Post-Market Clinical Follow-up) plan?
No PMCF plan
Basic PMCF concept
PMCF plan in development
Comprehensive PMCF plan with UK sites
Back
Next
Market Access Preparation
Have you developed a health economic value proposition specific to the UK?
No economic analysis
Basic cost analysis
Preliminary health economic model
Comprehensive health economic model with NHS inputs
Have you identified the appropriate NHS procurement frameworks/pathways for your device?
Not yet investigated
Basic research conducted
Potential pathways identified
Specific pathway confirmed with implementation plan
Have you engaged with any UK Key Opinion Leaders (KOLs) or clinical champions?
No KOL engagement
Identified potential KOLs
Initial contact with KOLs
Active engagement with multiple KOLs
Strong KOL relationships with advocacy established
Back
Next
Commercial Strategy
What is your UK market entry approach?
Not yet determined
Planning direct sales model but no implementation
Planning distributor model but no implementation
Distributor identified/contracted
UK team established or advanced distributor relationship
Have you developed UK-specific marketing materials and value propositions?
No UK-specific materials
Basic adaptation of existing materials
UK-specific materials in development
Comprehensive UK-tailored marketing package
Have you identified your target customer segments within the UK healthcare system?
No market segmentation conducted
Basic understanding of potential customers
Detailed segmentation with prioritization
Validated segmentation with customer engagement
Back
Next
Operational Readiness
Do you have a defined budget allocated specifically for UK market entry?
No budget allocated
Preliminary budget estimation
Defined budget but not fully funded
Fully funded UK launch budget
What is your supply chain readiness for serving the UK market?
No supply chain planning for UK
Basic logistics research conducted
Supply chain partners identified
Fully operational UK supply chain
Do you have systems in place to meet UK-specific reporting and compliance requirements?
No systems in place
Basic understanding of requirements
Systems in development
Comprehensive systems implemented
Back
Next
Additional Information
What is your target timeframe for UK market entry?
Already in market seeking growth
0-6 months
7-12 months
13-24 months
More than 24 months
What is your expected annual revenue potential in the UK market?
Less than £100,000
£100,000 - £500,000
£500,000 - £2 million
Over £2 million
Not yet determined
Which clinical specialties or departments will use your device?
What stage of funding/investment is your company at?
Self-funded/Bootstrapped
Seed/Angel funded
Series A or beyond
Publicly traded
Part of larger corporation
What aspects of UK market entry are you most concerned about?
Regulatory approval process
Generating sufficient clinical evidence
Understanding NHS procurement
Building UK sales channels
Health economic justification
Other
Other (please specify):
Calculation
Submit
Should be Empty: