Company insight
The benefits of partnering with a one-stop shop CMO
When first considering whether to outsource production of medical devices it is important to understand the options available, while also assessing the benefits of each. Working with a one-stop shop contract manufacturer such as Mi3 can present a range of benefits to even the largest of medical device companies.
utsourcing the development and manufacturing processes of a medical device can seem like an obvious decision, especially for innovative start-ups that don’t have the infrastructure to support such a multifaceted end-to-end process. Yet, the decision may not be so obvious for larger organisations or those deciding whether to partner with a contract manufacturer that offers a complete range of services or outsource just a few steps in the process. It is a decision that can have a significant impact on many aspects of a business, all potentially affecting the overall performance and, more importantly, profitability. Selecting the right partner should result in having an extension to in-house facilities, rather than complicated dealings with multiple suppliers. Mi3 are experts in designing, developing, and manufacturing end-to-end advanced medical and surgical solutions – providing the range of benefits discussed below when outsourcing medical device manufacturing. Mi3 takes
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expert and companies will benefit from a specially trained workforce on hand to advise, manage and potentially troubleshoot requirements from start to finish.
Supply chain consolidation Outsourcing the manufacturing of a medical device saves significant time and resources, sourcing materials and qualifying suppliers. Mi3 has an established network of trusted suppliers and relationships, so costs and overall supply chain risks will diminish significantly. Having dedicated production lines can also be costly. Not only does one need to recruit, train and retain skilled staff, expensive capital equipment, specialist materials or sterilisation services may also be required. Mi3 manufacture, assemble and package using the latest technology and equipment, so its customers don’t incur any of these costs as well as benefiting from the economies of scale that comes from purchasing materials in bulk. All resulting in an overall positive impact on the bottom line.
“Mi3 are experts in designing, developing, and manufacturing end-to-end advanced medical and surgical solutions – providing the range of benefits discussed below when outsourcing medical device manufacturing.”
a product idea from consultation to concept, to production, and works alongside its customers to bring medical innovations to life.
Expertise
The breadth of the engineering and manufacturing experience available when engaging a contract manufacturer far surpasses what is available to in-house. As a specialist contract manufacturer, Mi3 is an
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Latest regulatory know-how Getting a medical device to market can be a manufacturing challenge on its own, but ensuring the device is registered under the correct classification and the technical file is submitted correctly can be a different challenge if unfamiliar with the current industry standards and regulatory requirements. Mi3 offers comprehensive regulatory consulting services, and with quality management systems certified and
audited to ISO 13485:2016 via the Medical Device Single Audit Programme (MDSAP), resulting in products being complaint for launch across the globe.
Greater capacity for NPD and innovation
When sourcing and validating material, suppliers or commissioning new pieces of capital equipment doesn’t need significant time and budget allocated, companies will find themselves and their staff freed up to let those creative juices flow. Increased capacity will allow focus on core activities or develop new medical devices.
Improved timelines
In an industry driven by innovation and scientific/technological advancements reducing product life cycles seemingly overnight, getting products to market in a timely fashion is crucial, both for project plans as well as generating a quick return on investment (ROI). By utilising a complete service, end-to-end contract manufacturing organisation, companies can capitalise on the expertise and resources to get their product to market quickly without the delays of moving processes between different suppliers, thus providing a larger window of opportunity when the product hits the market. With digital platforms making the global marketplace even smaller and increasingly competitive, partnering with an experienced contract manufacturing organisation – offering the full complement of services required to get medical devices from design concept all the way through to production – can provide better all-round service delivery, seamless processes and a high quality regulatory compliant product in a timely and cost-effective manner, giving the desired market advantage. ●
www.mi-3.co.uk Medical Device Developments /
www.nsmedicaldevices.com
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