Post market studies

The EU directives for medical devices require that you establish a post market surveillance system for your product.

Nordic Proof can make available test facilities to confirm that the medical device works as intended, and you can receive systematic input about product improvement.

Nordic Proof partners facilitate that KOL’s are involved in designing post market study. A post market study can give valuable data regarding the effectiveness of the product, clinical effect, health economy etc.

A post marked study will also give you insight regarding work flow in the clinic that the use to the product must adapt to.

Product Verification & User need Validation

Product verification
The selected design must be demonstrated to meet the established product requirements, including performance. Depending on the product being a software or a hardware product, or a combination, Nordic Proof can facilitate services which include:

• Clinical evaluation of prototypes
• Functional test
• Integration test
• System Level testing
• Risk analysis
• Demonstrate value based outcome

Nordic Proof can provide access to experts and test facilites where testing can be performed on your prototype(s) to determine whether you designed the medical device right.

In case your medical device is a software we have the expertice available which can perform design verification to ensure that the software is built correctly based on the software requirements (i.e., design inputs), with regard to each task the software must perform (i.e., unit testing), during communication between software modules (i.e., integration testing) and within the overall system architecture (i.e., system level testing)

Risk analysis for evaluating potential problems which could be encountered in connection with using a medical device can be part of the testing regime which you can get performed and documented through Nordic Proof.

Nordic Proof can make available arenas for demonstrating a value based outcome

User Need Validation
Validation is the activities that confirm that the product meets customer requirements consistently (the user needs) through simulated or actual use conditions. Nordic Proof partners has the competence and facilities to be your clinical partner during validation.

• Clinical trial/Clinical investigation
• Confirm intended medical benefit
• Effectiveness / health economy
• Value based outcome
• Ensure the HW/SW design execute on the design concept

For testing of medical devices involving people there are given standards, directives, guidelines and procedures you have to follow.

Once your design transfer is complete and you have available units produced by manufacturing you can utilize Nordic Proof partners to perform various testing to perform your clinical evaluation and clinical investigation. Including hazard analysis.
For software based medical devices the validation shall confirm that the user needs is addressed by the software.

Nordic Proof can benchmark your product in terms of value based outcome

Development & Design Review

Nordic Proof can provide access to Key Opinion Leader (KOLs) who can provide valuable knowledge for some key elements during your development process. KOL’s can be recruited through Nordic Proof to become a formal partner of your review group. Example of for the Nordic Proof partner contribution in this phase:

• Determine if user needs are fulfilled
• Design and development reviews supported by KOLs to increase probability for successful product
• Evaluate early prototypes

The KOL’s can represent a key resource for determining that the design- and development output meet the design and development input with a special focus to determine that user needs are fulfilled, proper use is defined and that the product is safe.

To have E-health software- and/or clinical hardware KOLs in your review team can be an important assett when you evaluate the ability of the results of design and development to meet the product requirements. The KOLs can also advice on necesarry actions to be taken during your product development.

Product requirement & User need

Nordic Proof gives you access to experts and end-users of your product.

You can receive valuable input to your idea prior to finalizing your design and development input and requirement specifications.

This can e.g. be done in a workshop with selected experts from our Nordic Proof partners. The results of such workshops will add input to your product idea with respect to functional, performance, usability, security and safety requirements, according to the intended use.

Cost benefit analysis

Nordic Proof gives you access to health economy experts.

We have experts in our network who can provide you with valuable insight for you to estimate the added value and benefit of your product or solution against the cost of such over time.

Potential topics for a workshop, qualitative interview or quantitative survey :

- Current clinical practice process mapping
- Willingness and ability to pay for product/solution
- Reimbursement strategy & assistance in design of clinical program to support reimbursement goals
- Strategise towards a value based patient centric healthcare model