Having a successful medical device on the market is the result of a number of meticulously planned and expertly executed processes. One of these is the manufacturing process.
A growing number of original equipment manufacturers in the medical device industry are choosing to outsource production. In order to optimise this process, it is critical that companies select the right contract manufacturing partner, as this choice has a direct impact on product performance and profitability. One of the key criteria is whether to contract out production to a generalist manufacturing company or one that specialises in the manufacture of medical devices.
What a specialist medical device producer looks like
Your contract medical device manufacturing partner should be a specialist that offers an end-to-end service. This one-stop-shop provision should comprise a range of key services.
To help you make the right decision, we have put together this brief guide to the main services that you should expect from your specialist medical device manufacturer.
What you should expect from a medical device production partner
- Prototyping. The creation of accurate and effective medical equipment prototypes according to bespoke production specifications. A lot of prototyping work is carried out using 3D printing and rapid injection-mould tools that are tailor made for short sample runs.
- Toolmaking. The design and manufacture of new tools or the modification of existing ones for the manufacture of medical devices. Tools range from prototype soft tooling to more sophisticated production tools.
- Injection moulding. Located in a cleanroom to minimise the risk of contamination, injection moulding machines are used to manufacture medical devices in a wide range of materials to customers’ exact specifications.
- Cleanroom assembly. The assembly of medical components and medical supplies is a vital part of the manufacturing process and this service is designed to ensure that your product reaches the end user in perfect condition.
- Catheter manufacturing. This area of medical device manufacturing encompasses catheter tip forming, printing, drilling and skiving, all of which require specialist equipment to ensure that quality standards are met.
- RF welding. Radio frequency welding, or RF welding, is used for the bonding of materials using heat and electromagnetic energy. It creates a super-strong airtight seal that helps ensure product and packaging quality.
- Testing. Medical device testing that spans the entire production process, from the design stage through to the end product stage. Services include packaging, force, pull, in-gauge, shelf-life and product bioburden testing.
- Packaging. The packaging of a wide range of healthcare equipment, all of which has been manufactured and assembled in a cleanroom. Services include medical pouch packaging, procedure packaging, contract packaging and single-process packaging.
- Sterilisation. The management of sterilisation processes, including validated mixed load cycle for EtO sterilisation, which are usually the final stage of production for medical device companies.
- Storage and logistics. Dedicated medical device warehouse, logistics and transport facilities that ensure parts and products are safely stored ready for despatch and delivered on time and undamaged.
These are the key services that a specialist contract medical device manufacturer should offer. This level of capability and the expertise behind it will help ensure that your product is of the highest quality and gets to market when you need it to.
Meridian Medical is an established and experienced contract medical equipment manufacturer, specialising in a wide range of medical device design, development and supply services.
To find out more about how Meridian Medical can help you with your medical product design and manufacture, get in touch today by filling out our online form or contacting us on 01903 732344 or firstname.lastname@example.org.