This document provides guidance on planning preclinical testing for medical device development. It outlines key aspects to consider, including material selection, manufacturing methods, biocompatibility testing, study design, packaging and sterilization validation. Manufacturers are advised to review industry standards, evaluate all potential impacts to safety and performance, and plan timelines for all required activities and documentation. Attention to these details at the preclinical stage will help ensure a successful medical device design validation process.

1. Medical Device Development
Design Validation and Preclinical Research

2. Preclinical Testing of Medical Device
 For medical device manufacturers, the preclinical testing
of medical device development is most crucial. This is the
stage in which they set the design of the product including
its functionality and safety aspects and validate the
selected materials.
 However, their major dilemmas are “When to plan the
preclinical stage of the device development?” and “What
aspects to consider?”

3. So, here we answer
the questions to help
the medical device
manufacturers in
their preclinical
research and design
validation.

4. A Step-by-Step Guide
 Review the current industry standards to plan
your preclinical research.
 Consider the following aspects for your research:

5. a) Material Selection
 Carefully select the material to be used in
the device keeping in mind the factors like
its mechanical, physical, chemical, and
toxicological properties.
 Review the current literature to get
information about the standard tests, purity,
and bio-compatibility studies of the raw
material.

6. b) Manufacturing Methods
 Since manufacturing processes affect the safety
and performance of the device, get as much
information as possible on the manufacturing
processes.
 Evaluate any changes in the manufacturing
methods made during the preclinical phase
irrespective of whether it will or will not impact
the timing of the testing of the device.
 Factors such as packaging/sterilization,
manufacturing storage instructions, shelf life,
transport, and target population should also be
considered.

7. c) Biocompatibility Tests
 If existing literature doesn’t give
sufficient information about a product’s
safety, then preclinical biocompatibility
testing is also needed.

8. d) Preclinical Study Design
 After considering the materials, manufacturing
methods, and biocompatibility, the
manufacturer must also test its performance.
 First, determine the purpose, aim, and endpoints
of the study.
 If you only look at the device’s functionality,
histopathology of the implant site is sufficient.
 But, if you plan to prove its safety, it will
require body and organ weights, target organ
pathology, and a statistical analysis of the data

9. e) Packaging & Sterilization
 Select the packaging material based on the
product integrity, sterilization method, and
product functionality.
 Your aim is to design a packaging system that
is easy to access and protects the product
from internal or external breaches in sterility.
 It is important to consider packaging
materials and sterilization methods early in
the design process. Before validation, it’s
important to identify the product packaging.

10. f) Sterilization Validation
• Ethylene oxide
• Steam
• Dry heat
• Irradiation (gamma, x-ray, or e-beam)
For devices that will be sold and used sterile, or
cleaned between uses, it’s imperative to choose
and validate their sterilization method. This is
because sterilization methods can also affect
the product’s safety and efficacy. Some of the
common sterilization methods are:

11. Finally, before planning
your preclinical study, also
plan out the following to
avoid unnecessary delays

12.  Where to submit
 When to submit
 Timelines for all activities like biocompatibility
and preclinical studies, sterilisation validation,
and written evaluation of existing materials.
 Compilation of all documents and data

13. If you pay attention to all these aspects
and plan well in advance, your preclinical
design validation stage of medical device
development will be a great success.

14. • E-mail: project@cognibrain.com
• Phone: 044-49595223
• URL: https://www.cognibrain.com/
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