Your Single Solution for Medical Device Contract Manufacturing


Posted Thu, 7th May 2020

It can be an arduous process, creating something from scratch.

So: your business has an innovative new idea for a medical device – where do you start? As these questions begin to mount and you begin to do research, you can see that you actually need a handful of different specialised companies to create your products. Wouldn’t you rather have a single company that can assist you through the whole process? Because of our internal capabilities, we can offer end-to-end service with the design, manufacturing, and shipping of your medical devices – an innovative method in our industry that can save you time, complexity, and money. Our simple and transparent process can turn that inspired lightbulb moment into a real product in a few defined steps. Here we share the stages involved in our ‘end to end’ process.

1 – The process begins with design. PolarSeal uses the most advanced computer-aided design software paired with an innovative team of designers to bring you fast and accurate designs for whatever your needs. The fact that our designers are in-house and familiar with the materials, process, and capabilities ensures greater specificity and a more thorough understanding of how exactly your project will turn out. With extensive experience from diverse projects around the globe, we’re confident that our design team can create the solution you are looking for.

2 – Sometimes a design can only go so far, and before progressing to creating new biomedical products, a prototype is required. Our in-house laboratory and R&D department lead at this stage. Our R&D experts can quickly and efficiently produce prototypes to test and refine products before they go to market. Product efficiency and usefulness is key, especially in the medical device industry, so we encourage you to make use of our prototyping to suss out any issues that need fixing with your design.

3 – The next step in this process is choosing your materials – potentially the most important part of your product. How breathable does it need to be? How flexible? How sticky? For your product, second-best just isn’t going to cut it, so you can rely on our unrivalled stock of high-grade materials to get the job done. Medical device contract manufacturing is not a one-size-fits-all business, so we make sure we have a variety of different materials to suit the needs of your particular project. 

4 – Design, research, material diversity… all of these are fundamentals of a successful product, but what about industry regulations? For devices that are used in a medical capacity, CE Marking is essential  in ensuring the highest industry standards of care in terms of health, safety, and the environment. Rest assured that we are fully accredited by the FDA and the European Notified Bodies, and audited regularly to make sure our processes meet the requirements. We have the capabilities to CE mark all your medical products. As far as the impact of Brexit goes, it is a fluid situation. However, we remain committed to bringing the highest-quality industry standard for medical devices used in Europe and abroad.

5 – Once your product is ready to be manufactured on a large scale, the designs are brought to either of our two production facilities in Suffolk and Surrey. We maintain identical machinery operating at each of our cleanrooms, meaning that we can streamline the manufacturing process by creating your product in double-time. Our machinery is of the highest standard and can be used for material conversion on all levels. Need exacting standards when it comes to lamination? Want multi-layered final products? Our facilities are guaranteed to accomplish what you require.

6 – Once your product has been manufactured, the next step is precise packaging. A medical device is only as effective as the packaging – for which a sterile environment is crucial. That’s why we take great care in our packing process, using a high-grade pouch packing machine to ensure that your product has a strong seal. Our packaging materials are varied to offer you different options to suit your project’s needs, and we also have in-house printing capabilities to print your packaging which your exact requirements.

7 – The journey between the cleanroom and the operating room can be a nasty place for a clean, new biomedical product. While that may be the case for other companies, we know that our facility has dealt with wound care products, fixation devices, diagnostic tools, electro-medical products, and dozens of other medical devices and can therefore circumvent any of the last-step contamination risks that are present.  If you require sterile products, our experienced quality team looks after the entire process with our sterilisation partners. Unsurprisingly, our success in creating and manufacturing this plethora of products that require a sterile environment has led us to maintain the highest standard of care when it comes to the cleanliness of every single item we ship from our facilities.

8 – Lastly, once we have triple-checked your products and they are ready to go, we deal with all of the logistics and transportation. While using a different carrier or logistical company is understandable, we know the care that has gone into creating these products from design to delivery, and we take great care in handling and shipping the products we have helped you bring into being. We pride ourselves in being swift and punctual with every delivery.

As you can see from our ‘design to delivery’ process, there’s nothing that falls outside of our remit. Anything you can dream up in the field of medical devices or equipment, we can manage. If you think that this simple, streamlined solution is right for you, we encourage you to drop us a line by calling +44 1252 726000 or emailing info@polarseal.net today to discuss the specifics you’d like for your project.