Clonallon are proud to announce a new venture with a US firm, YourBio Health. Despite Brexit uncertainty and Covid-19 challenges, Clonallon have agreed a multi-million-pound deal. We are now one of the most established businesses on the island of Ireland within the medical devices industry. Major challenges have had to be overcome in recent times to ensure the continued success of the business, namely Brexit and Covid-19.

Regarding Brexit, Clonallon were proactive from the beginning and made several key decisions to allow trade to continue uninterrupted. With supply chains spanning several continents and customers in the UK, the EU and beyond, Clonallon had to ensure that come what may they were fully prepared. Clonallon dedicated large resources to tackling the issues surrounding Brexit and key changes were made to the operations of the business. Gaining full understanding of new customs arrangements, changes to regulations and applying those rules to the practicalities of the business was a complex process. In hindsight the company absolutely made the correct decision to address this issue head on, subsequently putting them in a position to prosper. Other companies in the sector who have not made the same investment are still struggling with the idea of Brexit and therefore aren’t able to take advantage of the new rules where possible.

As a medical device supplier to several large hospital groups Covid-19 was particularly challenging, especially at the beginning of the pandemic. Clonallon’s entire staff felt not only a contractual duty but a moral duty to continue to supply goods to the hospitals during this difficult time. Despite global shortages of raw materials and costs reaching incredibly high levels never seen before Clonallon worked well with senior personnel in the healthcare industry. As soon as word filtered through that global supply chains were being impacted by the pandemic, Clonallon reached out to their customer base to work closely with them to ensure their needs would be met. Countless late nights were spent by Clonallon staff utilising their supply chain network to ensure any disruption was mitigated. Clonallon were transparent with its end-users and feel a sound outcome was achieved for all parties involved. The company has also taken measures to ensure its employees work in a safe environment.

Clonallons’ relationship with YourBio Health developed while working on manufacturing blood collection kits. YourBio Health developed a unique patented microneedle blood collection device, called the TAP II, which allows a consumer to simply, conveniently, and painlessly collect their own blood into a small tube which can be safely sent to the laboratory for processing.  YourBio Health is here to put your health into your hands. As a direct-to-consumer brand that believes knowledge is power, YourBio Health offers convenient at-home testing so you can easily monitor your personal health information and make informed decisions about how you live your everyday life. Backed by the latest science, technology, and certified laboratories to guarantee best-in-class test results, the YourBio Health goal is for you to feel safe, confident, educated and in control of your short and long-term health.

The current standard of care for blood collection is phlebotomy, which requires medical professionals, large needles, and in-person appointments to collect blood. However, TAP II can be used in place of traditional venepuncture or fingerstick blood collection for many applications in both professional and at-home settings. With CE mark clearance for TAP II, YourBio Health’s mission is to make blood collection simple, convenient, and more comfortable for UK and European customers.

YourBio Health is based near Boston, USA, comprised of experienced and passionate individuals working together to design, develop, and manufacture innovative blood collection technologies, services, and solutions that meet the needs of the patients, providers, labs, and everyone else impacted by their products.

Clonallon has secured the contract for kit assembly and fulfilment services for use throughout the UK. This will result in the creation of up to 12 new jobs in the first year and increasing thereafter. Manufacture of these kits will be carried out in Clonallons’ modern facility in validated Class 7 cleanrooms. Clonallons’ processes and quality management systems are accredited to ISO13485:2016 and MDD 93/42/EC. Stephen Lennon, Quality Manager of Clonallon led this project from its inception and played a crucial role in securing the business for the company by ensuring that all targets and challenges were met and resolved.

Dermot Dempster stated that “We are delighted to be working with likeminded individuals from YourBio Health. The dedication of professionalism and sheer hard work by Clonallon staff has resulted in securing this business and plays to our key strengths of clinical problem solving, manufacturing and logistics. Our presence in Northern Ireland gives us a unique opportunity to distribute this product range to both the UK and European markets.”

 

Key Management Staff

Dermot Dempster – Manging Director

Dermot holds B.Sc. in Microbiology & Biochemistry and an MBA in International Business. Dermot has been the Managing Director of Clonallon Laboratories for 20 years and has a wealth of experience in the medical devices industry. Dermot has worked with Johnson & Johnson and ICON clinical research specialising in clinical trials.

Michael Sands – Finance Director

Michael has been a member of Chartered Accountants Ireland since 2015 and this was achieved alongside fulltime employment with ASM Chartered Accountants while studying for professional exams. Michael is the Finance Director of Clonallon Laboratories and is responsible for the overall profitable running of the business. Michael joined Clonallon in 2016.

Aiveen Mackle – Production Director

Aiveen is the Production Director of Clonallon Laboratories and has 20 years’ experience in the medical devices industry. She is well versed in the procurement of necessary materials to allow for market demands and fluctuating production schedules with minimum wastage. Her role is essential in ensuring adequate production and material resources are allocated.

Stephen Lennon – Quality Manager

Stephen is responsible for quality assurance throughout the entire organisation. He is a vital resource in managing key objectives to ensure continued regulatory approval. Stephen has over 10 years’ experience in the medical devices and pharmaceutical industries in a quality capacity.