Medical Device Development

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 doesnt give sufficient
  information about a products 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 devices 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, its important to
  identify the product packaging. 

10
f) Sterilization Validation
For devices that will be sold and used sterile,
or cleaned between uses, its imperative to
choose and validate their sterilization method.
This is because sterilization methods can also
affect the products safety and efficacy. Some of
the common sterilization methods are

• Ethylene oxide
• Steam
• Dry heat
• Irradiation (gamma, x-ray, or e-beam)

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
Contact Us

• E-mail project_at_cognibrain.com
• Phone [phone]
• URL https//www.cognibrain.com/