As we develop ENHALE, the first of our medicinal products, our quality testing process means that we conduct various tests and analysis to ensure that the device is of the highest quality and complies with regulatory standards.

In this post, we’re sharing some of our quality testing processes and why these are so important for medicines. 

Why quality testing is important

Any product which is being developed with the intention of being sold to as a medicine must adhere to strict regulatory standards and industry guidelines, particularly if it has the goal of improving consumers’ health. We follow both the standards required by European Directives and UK Regulations as well as our own stringent internal quality criteria.

Testing of the medical device and its components and analysing the results allows us to ensure that they are safe for people to use and work correctly. Furthermore, the testing of all raw materials used in the manufacture of any medicine is critical to ensuring product safety.

Our quality testing process

The process of developing ENHALE is split into various “blocks” in order to maintain an agile development process, so we can quickly resolve issues as they arise.

At the start of each block, we plan out which tests need to be completed, which order they need to be completed in and the results we are looking for in order to be able to move forward. Testing is carried out on samples of the device, the results are analysed and any necessary adjustments are made. 

Everything is documented thoroughly and once testing is complete, we review the results and any conclusions reached before starting to plan the next block of testing.

What happens after testing

Once testing has been carried out, we analyse the results in order to check that they match what was expected and if not, to understand why that is. Often, we will test various components or materials together to see which performs better with the device so we can select that component to move forward with.

Ultimately, our goal with quality testing is to ensure that our product is safe to use, complies with regulatory requirements and is designed to the highest standards possible.

Contact us today to learn more about ENHALE.

As we prepare ENHALE for clinical study; a nicotine inhaler and the first of our products, we have had to carefully consider the regulatory implications of NRT (nicotine replacement therapy) as NRT is subject to some stringent regulations in order to be considered NRT rather than an e-cigarette or similar products. 

What are the regulatory implications of NRT?

It is important to note that e-cigarettes are not considered to be NRT. They are not officially recommended by the NHS or doctors to quit smoking, whereas NRT such as nicotine inhalers, gum and patches are.

NRT and other products promoted with the goal of aiding consumers to quit smoking are classified as medicinal products and can only be placed on the UK market when they are granted authorisation from the licensing authority or European Commission, in accordance with The Human Medicines Regulations 2012 (S.I. 2012/1916).

How are we addressing these with ENHALE?

In order to obtain marketing authorisation for ENHALE, we are currently conducting extensive testing to ensure that it is safe to use and meets the requirements set out by The Human Medicines Regulations 2012 (S.I. 2012/1916), including:

• Product and design development: ENHALE has been carefully conceptualised and designed to help consumers quit smoking, so when developing the design of the product, we made sure that it is able to solve the problem it was intended to, and is user-friendly, both important elements if the ENHALE is to improve a smoker’s chance of quitting.

• CE marking: ENHALE has been CE marked as a medical device, showing that the device conforms with regulations and is fit for its intended purpose. We are committed to making this innovative product a safer option for consuming nicotine.

• Drug safety and stability: in order to ensure the safety of ENHALE, we carry out safety and product stability tests to confirm the product’s shelf life and determine the effect of environmental conditions on product quality over time.

• Clinical studies: Ventus has conducted various clinical trials in order to determine things such as device efficiency, ease of use, taste and risk of use.

• Submission and approval from the European Union to market ENHALE as a medical device

In summary, there are many regulatory implications of developing an NRT, and here at Ventus Medical we are working to ensure that ENHALE meets all regulatory requirements so we can help people to stop smoking safely.

To learn more about NRT and the work we’re doing, click here to read our blog or get in touch – we’d love to hear from you.

Amongst all of the negative statistics coming out of the COVID-19 pandemic, a recent survey carried out by the charity Action on Smoking and Health (Ash) has revealed more than 1 million smokers have quit during the pandemic.

This has also been backed up by the University College London (UCL). The UCL has reported that more smokers have quit this year than any previous year since they started keeping a record.

Interestingly, around half of those who quit said the pandemic influenced their decision. For the majority of people, it’s not known exactly why. The government did issue advice saying smokers are at higher risk of more severe COVID symptoms, so that’s likely to have played a part.

There’s also the anecdotal effect of smokers who have contracted the virus experiencing serious health scares.

Are smokers more at risk during the pandemic?

Researchers at Guy’s and St Thomas’ hospitals and King’s College London have developed an app to track COVID symptoms.

So far, they have collected data from more than 2.4 million participants in the UK. Analysing this data, they can see that from patients with a positive COVID-19 test, those who smoke are more than twice as likely to need hospital care.

This ties up with information from a study carried out in the U.S. showing that smokers there are 1.8 times more likely to die than a non-smoker when hospitalised with symptoms.

Conversely, there have also been studies carried out globally that suggest smoking may also help protect against coronavirus.

It’s thought the reason for these results is that nicotine, the stimulant, and highly addictive compound in cigarettes, might be blocking receptors in the body that the virus uses to get into a patient’s cells.

Even if smoking did block or help reduce the symptoms of COVID, the health risks associated with smoking still outweigh any of these potential “benefits”.

While these stats do seem to start revealing more about coronavirus, it’s important to remember that it’s early days and the sample size of patients is still small.

In regard to the health risks associated with smoking, it’s also important to pay attention to the Public Health England’s guidelines on the topic:

“There is strong evidence that smoking tobacco is generally associated with an increased risk of developing respiratory viral infections.

“Smoking causes damage to the lungs and airways and harms the immune system, reducing your ability to fight infection.”