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Defining Your Target Product Profile: Medical Device Products by 8OU78k

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									              Emerging Life Sciences Series




   Defining Your Target Product
  Profile: Medical Device Products
               Workbook Template




Company: <Enter your company name here>

Last updated: <Enter the last update date here>
Table of contents


1. Intended use .................................................................................................................................. 3

2. Device description...................................................................................................................... 3

3. Contraindications ........................................................................................................................ 4

4. Non-clinical testing .................................................................................................................... 5

5. Clinical studies .............................................................................................................................. 5




Emerging Life Sciences Series                                                                                                                     2
Defining Your Target Product Profile: Medical Device Products Template
        1. Intended use

    Target                                           Annotations
    Write a brief response to the following          Complete a summary of completed or
    questions:                                       planned studies that support the targeted
                                                     intended use.
        What are the specific indications for the
         device?                                     List any predicate devices.
        Who are the target patients?
        What anatomical sites does the device
         target?
        Where (e.g. home, clinic, hospital) will
         the device be used?



    Comments:
    If a predicate device(s) will be used in the regulatory strategy, briefly compare the
    intended use statement(s) and highlight any differences.

    Create a summary of the medical devices currently used for diagnosis or treatment in your
    target indication (maximum of four) and write a brief statement on their competitive
    positioning.




        2. Device description

    Target                                           Annotations
    Write a brief response to the following          Supply a summary of completed or planned
    questions:                                       studies that support the effectiveness of
                                                     novel technologies that are incorporated into
        Does the device employ new technology       your medical device.
         or is the technology fundamentally
         similar to a predicate device?
        How many component parts are there to
         the medical device?
        Does the device include software?
        What are the key design features?
        Are any additional devices required to
         achieve the desired clinical outcome?





        Emerging Life Sciences Series                                                       3
        Defining Your Target Product Profile: Medical Device Products Template
Comments:
Summarize the positioning of the scientific basis of your medical device relative to
competitive medical devices.




 3. Contraindications

Target                                           Annotations

In point form, write a brief response to the     List any assumptions regarding the
following question: What conditions would put    contraindications listed for your device.
the patient in a situation where the risk of
your medical device would outweigh the
benefit?




Comments:
How do the contraindications compare with current devices or treatments for the intended
use?




 Emerging Life Sciences Series                                                          4
 Defining Your Target Product Profile: Medical Device Products Template
    4. Non-clinical testing

Target                                            Annotations
Write a brief response to the following           List the completed and planned non-
questions:                                        clinical tests. List any assumptions and
                                                  how they will be tested.
    Will your medical device need to be
     sterile? If yes, how will sterility be
     achieved and confirmed?
    Have the toxicology profiles of the
     component parts of your device been
     reported?
    Will any additional toxicology tests be
     required?
    Will animal models for efficacy and safety
     be required prior to treating patients?
    What are the possible consequences of
     failure of the device?
    How will the device be tested for
     robustness and safety?



Comments:
Identify areas where non-clinical studies would highlight how your medical device has
overcome the limitations of existing devices.




    5. Clinical studies

         Target                                          Annotations
Write a brief response to the following           Prepare a summary of assumptions and
questions:                                        the completed or planned studies that test
                                                  the assumptions.
    What is the clinical evidence to support
     the indication for use?
    What is the safety profile?
    How will the endpoints in the study
     support the competitive positioning and
     marketing strategy for the new device?




    Emerging Life Sciences Series                                                       5
    Defining Your Target Product Profile: Medical Device Products Template
Comments:
Highlight the expected outcomes of clinical studies that will highlight the competitive
advantage of your medical device in comparison with competitive technologies.




 Emerging Life Sciences Series                                                            6
 Defining Your Target Product Profile: Medical Device Products Template

								
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