Ventus Medical Ventus Medical
  • Home
  • About
  • Quality
  • Our Work
  • Pillars
  • Mission
  • News
  • NRT
  • Contact
Ventus Medical

Julia Day

07Dec

Our Quality Testing Process

December 7, 2020 Julia Day Uncategorized 106

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.

Read more
23Nov

The regulatory implications of NRT

November 23, 2020 Julia Day Uncategorized 112

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.

Read more
06Nov

How we use compliance standards to improve quality at Ventus

November 6, 2020 Julia Day Ventus Medical 114

As an innovative company focused on developing products with the potential to benefit public health, quality is ingrained in everything we do. In order to maintain and promote the highest level of quality in our work, our various compliance standards ensure that our processes are in accordance with the recommended guidelines and are always improving.

The standards below are created and upheld by the British Standards Institute, who are the national standards body and are on a mission to “share knowledge, innovation and best practice to help people and organisations make excellence a habit.”

ISO9001 – Quality Management Systems

ISO 9001 sets out guidelines to help businesses to create and implement Quality Management Systems which help to improve the way they work by improving their products and services, provide a better service to clients and make their work practices and processes as efficient as possible by implementing the management system set out in the standard. Certification is achieved through a formal assessment by the British Standards Institution (BSI).

For Ventus Medical, complying with ISO 9001 ensures that we are able to conduct our work in the most effective, high quality manner possible. 

ISO13485 – Quality Management Systems for Medical Device Manufacturers

Similarly to ISO9001, ISO 13485 helps businesses to perform better and more efficiently by setting our regulations for Quality Management Systems, however it requires a stricter system and is designed specifically for regulatory compliance with “Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.”

As we are in the business of developing medical devices to make nicotine safer to consumers and the general public, it’s crucial that our systems and procedures are effective while also complying with the standards required to make our products safe.

Good Manufacturing Practice (GMP) QC Release 

All medicinal products which are intended for human use are required to be manufactured under GMP. GMP extends not only to the manufacturing of such products but also to the testing and release. Our internal laboratory is currently undergoing assessment for GMP licensing in order to fully internalise the company activities in relation to the conduct of clinical studies on our developments as well as enabling product release testing for future products entering the market. 

ISO14001 – Environmental Management

At Ventus Medical, we work hard to ensure that our environmental footprint and impact on the planet are kept as low as possible. We demonstrate our commitment to environmental responsibility through our certification to ISO14001, which ensures that not only our working practices are considered to the environment but that our innovation is guided by a principle of environmental sustainability.

In addition to these compliance standards, we also uphold our high level of quality by following a quality testing process and continuously working to innovate and improve our work.

Read more
21Sep

Why it’s so difficult to stop smoking

September 21, 2020 Julia Day Ventus Medical 128

Thousands of people attempt to stop smoking every year in the UK, and yet for many it seems like an impossible feat. You may go a few days, or even a few weeks, without picking up a cigarette, and yet the desire to smoke can remain strong.

If you’re struggling to give up cigarettes, you are not alone. Here are some of the reasons why it’s so difficult to stop smoking and a few helpful tips to help you give it up for good

Nicotine is highly addictive

Nicotine is one of the most addictive chemicals on the planet, and its effects impact you both mentally and psychologically. Plus, the more nicotine you’re used to, the more you need to recreate the “buzz” you get when you smoke.

As with most addictions, giving up nicotine can cause a lot of unpleasant side effects including headaches, hunger and anxiety. These effects make it incredibly hard not to give in to your cigarette cravings.

It’s part of your routine

When you smoke, particularly if you’ve been a smoker for a long period of time, it becomes part of your routine – things like having a cup of tea or coffee, going out with friends and taking a break at work feel strange without a cigarette involved.

Because of this, parts of your daily routine will “trigger” you to crave a cigarette as you would usually smoke at this time or during this activity, which makes it difficult to quit. It takes time and resilience to overcome this trigger so you don’t feel that urge to smoke while going about your day normally.

People don’t seek help to stop smoking

There is so much help available to help you to stop smoking, yet many people feel that they need to do it alone or simply aren’t aware of the support available to them. There is no shame in seeking help to give up smoking, and the NHS offers free Stop Smoking Services around the UK to help you do just that.

You can also share your goal to quit smoking with your friends and family so they can help you, or if you aren’t comfortable telling people in person yet, there are plenty of support groups online where you can get support from others who are doing the same.

Nicotine replacement therapy is often overlooked

In addition to this, there are lots of products on the market to help you to stop smoking by providing a small amount of nicotine which eases the side effects of nicotine withdrawal, including patches, gum and inhalers.

These are all types of nicotine replacement therapy, or NRT, a tool to reduce the harm caused by smoking. NRTs provide nicotine without having to smoke cigarettes, which helps to reduce the withdrawal symptoms and cravings often associated with quitting smoking, and can even help you to reduce your nicotine intake.

While stopping smoking is a tough thing to do, it certainly isn’t impossible and understanding why it’s so tricky to give up this addiction is the first step in putting the cigarettes down for good.

Read more
17Aug

Four tips to help you stop smoking

August 17, 2020 Julia Day News 146

According to the Gov.UK website one person quits smoking every 80 seconds in the UK, and 390,400 managed to stop smoking in 2017. Yet quitting smoking can be extremely difficult. After all, it’s an addiction and nicotine withdrawal symptoms can cause both psychological and physical issues. Here are our top tips to help you stop smoking permanently.

Use a local Stop Smoking Service

Stop Smoking Service centres are all over the country, and there will more than likely be one near where you live. These services are free and offer one-to-one support and medicines to aid you with your attempt to quit smoking. Your trained advisor will help you to create a plan to keep you smoke-free.These services are very successful and 9 out of 10 ex-smokers who have used the service would recommend it to others.

Get support from the people around you

It’s always helpful to talk about how you’re feeling with others – after all, a problem shared is a problem solved.

If you’re in the process of stopping smoking, let your friends and family know so they can support you, especially if they’ve quit smoking themselves in the past so they can offer guidance.

There are also lots of stop smoking communities both in person and online, made up of other people trying to quit who will support and cheer you on.

Nicotine replacement therapy

Nicotine replacement therapy works by supplying a small amount of nicotine to help you manage cravings while you are in the process of quitting smoking and to ease the negative withdrawal symptoms. Combined with a plan, nicotine replacement therapy can be an incredibly effective way to stop smoking.

Nicotine replacement therapy products include nicotine patches, gum, medication, inhalers and nasal sprays.

Keep yourself busy

One of the things that makes it so hard to stop smoking is how ingrained it becomes in your routine. To tackle this, make sure that you keep busy and try introducing new, healthy hobbies such as exercise, socialising with friends or getting creative.

Many smokers struggle with not having anything in their hands or mouth, so try hobbies which use your hands, fidget devices or holding your drink in the hand you would usually hold a cigarette in when you’re out. You can also try chewing gum to keep your mouth busy.

In conclusion, it may be difficult to stop smoking, but there are many ways you can make it easier for yourself. Getting support and using the resources available to help you stop smoking will give you the best chance of giving up cigarettes for good.

Read more
10Aug

How we bring innovation to our work at Ventus Medical

August 10, 2020 Julia Day Ventus Medical 128

As a medical development company, Ventus Medical is committed to creating high-quality, effective, products which offer new and unique ways to benefit public health and pharmaceutical innovation.

We’re developing the next generation of safer nicotine products

Smoking is a risk to public health, and we’re currently working on products which shake up the industry and provide a safer way for smokers to consume nicotine and ultimately quit smoking.

Our first product, ENHALE, has been CE marked as a medical device in the European Union under the Medical Devices Directive and is currently undergoing regulatory approval as a form of Nicotine Replacement Therapy. 

Our extensive research into nicotine delivery, stability and aerosol science has allowed us to develop innovative solutions for a safe and effective way to deliver nicotine.

We’re focused on public health

Public health is at the forefront of our work as we develop new tools which improve the quality of life of the population and reduce morbidity and mortality.

Quality is one of our core values, and all of our devices undergo rigorous quality testing to ensure that they are safe and effective. The quality of the work we do is certified by the British Standards Institution (BSI) to the international standards ISO9001 and ISO13485. These standards guide our working practices and ensure that our development and innovations are guided by the best possible working practices.

Our varied team and agile development strategy promote innovation

With a varied team of specialists in different areas of science and technology, we bring together the expertise needed to create, develop and protect the most innovative products with the goal of protecting public health.

We take a uniquely agile approach to our work, fostering a creative environment built on quality to ensure that we are able to deliver groundbreaking products and technologies.

Read more
05Aug

How nicotine addiction works

August 5, 2020 Julia Day News 143

Nicotine is a highly addictive chemical found in tobacco products such as cigarettes. One of the most common effects of smoking is the “buzz” which is caused by the neurotransmitter adrenaline being released due to nicotine stimulating your nervous system.

Nicotine is one of the most addictive stimulants in the world and can be difficult, though not impossible to quit. Here’s how nicotine addiction works.

The effects of nicotine on your body and mind

Nicotine affects users both physically and psychologically.

While many people find that smoking makes them feel nauseous or lightheaded when they first smoke, the body quickly becomes used to the effect of nicotine. It enters the bloodstream and causes the release of various hormones and neurotransmitters which change the way you feel, including the “happy” hormone, dopamine.

As smoking becomes a habit, you start to associate it with your daily activities and routine. For example, if you often smoke while drinking your morning coffee, this will become a “trigger” making it hard to get through this part of your day without a cigarette.

Your body and mind both become dependent on nicotine, and ceasing to smoke can cause withdrawal symptoms.

How do you know if you have a nicotine addiction?

As with many addictive substances, the more nicotine you are used to, the more you need to feel its effects due to the body’s adaptation. 

Smoking can cause many health issues including various cancers, lung disease, heart disease, gum disease and more. However, nicotine addiction means that despite knowing the risks associated with smoking, you are unable to quit.

You are most likely addicted to nicotine if you have unsuccessfully attempted to quit before, you experience withdrawal symptoms when you stop smoking for a period of time and you avoid situations where you are not allowed to smoke. 

What are the withdrawal symptoms of quitting nicotine?

The symptoms of giving up nicotine are what make it so difficult to quit.

Nicotine withdrawal symptoms can be both physical and psychological and include:

  • Irritability
  • Anxiety
  • Low mood
  • Increased appetite/weight gain
  • Difficulty concentrating
  • Constipation/diarrhoea 
  • Headaches

If you are struggling to quit smoking, it’s recommended that you visit your GP to help you come up with a plan to help you quit for good. This may involve the use of a combination of Nicotine Replacement Therapy and behavioural support.

Read more
  • Home
  • About
  • Quality
  • Our Work
  • Pillars
  • Mission
  • News
  • NRT
  • Contact

The Matchworks, Speke Rd, Liverpool L19 2RF

©2023 Ventus Medical – Website by Fat Cow Media