Established medical device manufacturers, start-ups, growing medical device companies, and OEMs are increasingly benefiting from the advanced and highly specialised solutions offered by contract manufacturing companies.
The biggest gains can be made when the contract manufacturing partner has medical device expertise and experience, ideally in a specific component or product area relevant to your product.
In this blog, we’ll explore the main benefits of partnering with a medical device contract manufacturing organisation.
Contract Manufacturing Benefits for Medical Device Businesses
Cost Benefits
Working with a contract manufacturing partner reduces upfront costs while also lowering costs over the medium and long term.
You will have a significantly reduced or eliminated need for upfront capital expenditure on equipment, machinery, software, and other key components of medical device manufacturing lines.
At Arrotek, we also deliver cost savings for our client through the use of lean manufacturing methodologies that eliminate waste, improve quality, and reduce production lead times.
There are also ongoing cost savings. For example, equipment maintenance costs will be the responsibility of your contract manufacturing partner. You can also benefit from economies of scale as a medical device contract manufacturer will work with several customers. This improves critical manufacturing metrics such as OEE (overall equipment effectiveness), producing savings that can be passed onto your business.
Resource Benefits
Recruiting and retaining staff for medical device manufacturing is challenging. Medical device production line operators, technicians, and engineers need specific skills, and ongoing training is required. Contract manufacturers have established, skilled, and well-trained teams, eliminating the need for you to recruit, retain, and train new resources.
At Arrotek, for example, we have SMEs (subject matter experts) in medical device design, supply chain management, manufacturing, engineering, quality assurance, and compliance.
Investment Benefits
Using a medical device contract manufacturing partner means your capital won’t be tied up in equipment and labour, giving you more scope to invest in other areas such as marketing and product promotion, R&D, and product development.
Time to Market Benefits
Working with a contract manufacturing partner will reduce time-to-market for your medical device product, as contract manufacturers have established teams, production facilities, and production processes (for example, design transfer processes, tooling design/manufacture, etc).
A contract manufacturer can, for example, become a strategic geographic partner for established medical device organisations, unlocking new markets without the need for a facility in the target location.
For companies with minimal (or zero) manufacturing facilities, the reduction in time-to-market timescales can be significant. This is because it takes considerable time to, for example, build and achieve certification for cleanroom manufacturing facilities. It also takes time to design production processes, purchase machinery, integrate equipment, design SOPs (standard operating procedures), install equipment, commission equipment, validate equipment/lines/processes, and train staff.
A contract manufacturing partner will have all of this in place and ready to use, from certified cleanrooms to validated and operational production lines to trained staff.
Expertise Benefits
Specialist medical device contact manufacturers such as Arrotek possess a wealth of knowledge across multiple skillsets. As a result, partnering with an experienced manufacturer will give you access to highly specialised project managers, technicians, operators, and engineers. This includes expertise in materials and specialist components, as well as production processes, assembly, and quality control.
You will also benefit from expertise in project management, supply chain optimisation, logistics, compliance, and lifecycle product management. The latter includes continuous improvement in manufacturing processes, cost of manufacturing, product quality, and product safety.
Quality Benefits
Achieving consistent standards of quality that meet the high bar required in the medical device industry requires expertise and experience. A contract manufacturing partner will not only bring quality expertise but will also be committed to continuous quality improvements. This helps prevent everything from scrapped production batches and batch release delays to adverse incidents and product recalls.
Specialist Manufacturing Process Benefits
For medical device products and components that require specialised manufacturing processes, there are additional benefits that contract manufacturing can bring. This is because it is not possible to quickly develop capabilities in specialist areas, even with available capital.
Contract manufacturing will give you immediate – or close to immediate – access to the specialist manufacturing processes that your product requires.
For example, at Arrotek, we have highly advanced metal manufacturing capabilities at our facility in Boston. This means we can quickly and cost-effectively deliver contract manufacturing solutions even when components have micro dimensions, complex geometries, and/or intricate design features.
We can offer similar levels of expertise for polymer-based components at our European manufacturing facility in Ireland, plus we have high-volume manufacturing capabilities in Costa Rica. This global manufacturing footprint allows us to tap into expert knowledge quickly and efficiently.
Finished Device Benefits
There are multiple approaches you can take to produce your finished medical device product. You can handle some of the manufacturing and assembly processes in-house while allocating specific components to a contract manufacturer. You could also buy in components from an OEM (original equipment manufacturer – a company that supplies off-the-shelf medical device products and components that can be adapted and incorporated into your product).
That said, often the most streamlined and cost-effective approach is to partner with a contract manufacturing company that can offer you finished product capabilities, i.e., a manufacturing partner that can produce all components and handle all parts of the process.
Risk Mitigation Benefits
With a contract manufacturing partner, some of the risks involved in manufacturing a medical device product can be shared, especially in relation to supply chain management (through strong relationships with critical material suppliers) and the management of essential production KPIs (OEE, batch changeover times, throughput, etc).
Flexibility in production schedules and utilisation of manufacturing equipment also mitigates risks by reducing lead times.
Furthermore, a specialist medical device manufacturing organisation will have a well-established quality management system with robust and effective NC (nonconformance) and CAPA (corrective and preventative actions) processes to reduce quality and compliance risks.
Compliance Benefits
It is essential to maintain compliance throughout the product’s lifecycle. An experienced contract manufacturing partner will have audited production facilities and well-established processes that are in line with ISO 13485, GMP, and other regulatory standards and industry best practices. These processes can be adapted to your requirements, streamlining adherence to regulations.
At Arrotek, for example, our quality management system has a proven track record of streamlining regulatory audit processes while remaining flexible during iterative product development phases of a project.
Scalability Benefits
Setting up production capabilities for a new product being launched in a specific market is one thing. Being able to scale up production to meet growing customer demand is another.
By working with an experienced contract manufacturing partner that prioritises capacity building, you will be able to quickly scale output to meet customer demand without massive investments in new equipment or labour and without compromising quality or compliance.
At Arrotek, for example, we continuously invest in our manufacturing capacity, including opening new cleanrooms.
Diversification Benefits
It is easier to diversify and innovate beyond your current product range when you work with a manufacturing partner. Examples include diversifying into a new product area or developing a new innovation on an existing product. By working with the right contract manufacturing partner, you can move to the manufacturing phase in situations like these without significant increases in resources or large capital investments.
IP Benefits
Working with a contract manufacturing company like Arrotek means you retain full control and ownership over the intellectual property of your business and product.
Whole Device and Product Lifecycle Benefits
You might need support with a specific component or aspect of your product, but a contract manufacturing partner might be able to offer a wider range of solutions covering the entire product and/or the full product lifecycle. This additional support can reduce costs and complexities even further.
Competitiveness Benefits
A contract manufacturing partner will free up your time and resources to focus on value-adding tasks and initiatives, improving business agility and making it easier for you to quickly and positively respond to opportunities and evolving market trends.
Contract Manufacturing at Arrotek
At Arrotek, we have specialist experience and extensive manufacturing capabilities that can benefit your medical device company and product. We have an advanced manufacturing facility in Ireland, a Metals Centre of Excellence manufacturing facility in Boston, USA, and a high-volume, high-speed manufacturing facility in Costa Rica. We work with companies across the entire spectrum of the medical device industry, from exciting start-ups to the biggest and most established corporations. To discuss your medical device contract manufacturing requirements, please get in touch with us today.
