Medical Device Development
Categories Preclinical Research

Medical Device Development: Design Validation and Preclinical Research

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?”

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

A Step-by-Step Guide:

1) Review the current industry standards to plan your preclinical research.

2) Consider the following aspects for your research:

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.

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. The manufacturing methods can also change during the post-market phase of the device development. Thus, consider its possibility during the preclinical phase.

Factors such as packaging/sterilization, manufacturing storage instructions, shelf life, transport, and target population should also be considered.

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

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. The duration of the study is the next point of consideration as this will determine the number of termination intervals needed, which can range from a couple of weeks to several months.

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

e) Packaging and 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.  This will help you avoid choosing materials for the device that are incompatible with the packaging and sterilization, and thus, save time.

f) Sterilization validation: 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:

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

Different methods have different effects on the device material. For example, Ethylene oxide residuals can be toxic, gamma sterilisation can increase cross-linking in polymers, high temperatures may soften or oxidise the material.

Thus, while choosing the device materials, consider its sterilisation method also.

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

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

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.

Preclinical Study
Categories Preclinical Research

How to Design a Preclinical Study that makes a Difference?

Many preclinical studies are conducted and thousands of research papers are published every year. However, these publications fail to provide clear information on how the study was designed, conducted, and analysed. They lack the standards of scientific rigour and transparency in their reports. As a result, they lose their value in informing future scientific studies, designing drugs and making policy decisions.

In such a scenario, you can be a role model and increase the potential of your preclinical research by designing robust preclinical studies.

You must plan your experiment before starting. So, here are the tips on how to design a powerful experiment and detect biologically important results.

1) Minimize bias

There’s always the potential for bias when assessing the results of your study, especially if a subjective element is involved.

Therefore, perform the experiment in such a way that the researchers are “blind” to the division of the animals to treatment groups and mouse genotypes.

2) Housing and husbandry considerations

If you use mice with different genotypes in your study, generate similar housing conditions for all. This ensures comparable environment and maternal influences on your animal models.

3) Report your methods and results accurately

Check out Animal Research Reporting of In Vivo Experiments (ARRIVE) guidelines to report your animal research completely and accurately.

Take these fundamental steps to develop robust preclinical studies that use mouse models of human diseases and make a difference in the world of clinical research.

Common Barriers to Preclinical Studies
Categories Preclinical Research

Common Barriers to Preclinical Studies and How to Overcome Them

The scientists, physicians, and academicians who investigate the preclinical studies are busy individuals. They do not involve themselves in one study at a time but in multiple studies. Plus, they have their own clinical duties and responsibilities. This gives them little time to stay engaged in any of the preclinical studies. Thus, a preclinical research study suffers from a poor engagement by its investigators and its progress gets delayed. It can further impact the quality of the research results negatively.

So, how can you improve the investigator’s engagement in the preclinical studies?

Let us first see what are the common barriers to the investigator’s engagement in preclinical studies?

  1. Conflicting demands of multiple job duties
  2. Lack of enjoyment in preclinical studies
  3. Lack of a sound and supportive research infrastructure
  4. Complexities associated with the preclinical research

A comprehensive solution to preclinical research barriers

1) Outsource your lab services to a Contract Research Organization (CRO)

An experienced and a competent contract research organization have the necessary tools and resources to process your research study with accuracy and on time. Thus, investigators who are busy and unable to devote much time to their preclinical studies can avail the services offered by CRO.

However, choose an organisation which has a minimum of 10 years experience in handling scientific research in every domain, can strike a perfect balance between the quality of results and their timely delivery, and observe the best practices and ethics of research.

2) Use a mobile platform to access the research data

In the era of smartphones, investigators can use their personal mobile devices to access the research data and communicate with their team quickly and as per their convenience.

3) Take part in online study-specific communities

Online forums dedicated to your specific research area are available to discuss the research results, share ideas, and stay connected with other like-minded people. They are an excellent medium to share preclinical research data between the institutions and prevent duplicate research.

4) Hire a courier service to pick up study materials

Hire a courier service which can retrieve the study materials from your place and deliver it the off-site for professional processing. After the process is complete, the courier returns the materials to your facility along with a report of the study results. This can save yours and your team’s time so you can focus on your preclinical studies.

The best way to overcome the barriers of your preclinical research study is to take the help of the leading preclinical research services or CRO. Make a list of the services offered by the CRO in your area. By doing so, you can drive maximum engagement from the research investigators and improve your research results.