If you’re working on a healthcare product – whether it’s a connected medical device, digital health app or new drug – you need to consider not just whether it works, but whether it is compliant.
Many products take years to get on the market due to the need for rigorous testing and trialling. In this post, we’ll take a look at some of the different compliance checks you may need to make.
Initial testing
When designing your product, initial tests need to be made to make sure that your drug or device meets the most basic safety standards. These must be passed before you can think about clinical trials or user testing.
In the case of drug discovery, this could include looking into lab capabilities like analytical solutions for peptide research to help maintain purity and stability across batches.
With gadgets, you need to consider aspects like electrical safety and electromagnetic compatibility. There are specialist companies that can carry out these electrical safety tests.
Initial testing eliminates the biggest dangers first like acute poisoning or electrical shock. You can then move onto detecting the more hidden hazards.
Clinical trials and investigations
All healthcare products need to undergo trials or investigations on human volunteers before they can be put forward for regulatory approval. This stage involves testing for unpleasant side effects in medication or making sure that a device is comfortable and user-friendly.
Drugs typically must undergo pre-clinical trials (tests on organic tissue and then animals), followed by clinical trials (tests on humans). Clinical trials are made up of three phases on increasingly larger focus groups.
Clinical investigations for devices are typically smaller in scale. Class III devices (like heart valves and implants) require the most stringent tests.
Regulatory submission and approval
Results of clinical trials and investigations are then sent to a national regulatory body such as the FDA or MHRA. These should be accompanied by detailed information on the product and instructions for use.
Regulatory bodies pour over this information and then decide whether to approve a healthcare product. Some products are rejected due to insufficient testing or results showing risks that are too high. Others are approved but must be sold under certain conditions (such as containing specific warning labels). Only a few healthcare products are approved with no strings attached.
Staying compliant after launch
The compliance checks don’t stop after a product has been approved. Regulatory bodies like the FDA constantly monitor drugs on the market to make sure that no new side effects have emerged or that they continue to comply with emerging laws. In the cases of healthcare gadgets and apps, it could be important to keep updating software to comply with new cybersecurity standards.
All of this compliance testing is of course vital for making sure that your product doesn’t harm anyone. Instead of seeing it as a nuisance, see these compliance checks as rewarding goals to work towards – you want your product to help people and to be recommended by others, so it needs to be safe and effective.
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