Contract Manufacturing
Why Contract Manufacturing
Constantly spiraling costs, regulatory demands, industry consolidation, combination products, and engineering and product management talent shortages are forcing Original Equipment Manufacturers (OEMs) of medical devices to rethink their strategies. To maintain their competitive edge and deliver optimal solutions at a reduced price, they are engaging Contract Manufacturers (CMs) for the design and production of cost-effective, branded solutions.
This consolidation delivers cost reductions on individual components and assemblies, particularly with CMs who can offer several component and assembly verticals. It also enables OEMs to reduce their overall number of individual suppliers.
Sky medical is offering of production services for a range of products, from single-use medical devices to the assembly of complex, integrated devices, according to the regulatory demands medical and healthcare industries.
Production Services
Product development & manufacturing
We offer a range of products, from single-use medical devices to the assembly of complex, integrated devices, all produced according to the regulatory demands of medical and healthcare industries. We have an ISO Class 7 validated cleanroom which enables us to ensure the quality and sterility of every product that we manufacture, and we provide full-scale project management and technical support services to manage transfer processes. Examples of our range of medical devices and products include:
Complex Tubing Sets
Sky Medical is specializing in production of complex tubing sets for various medical procedures, we have full capabilities for assembly, cutting, bonding, testing and packing tubing sets from different materials and tubing dimensions. We have the knowhow and production capabilities for tubing systems such as:
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Physiology pressure transducer sets
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Total Parenteral Nutrition sets
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Contrast media delivery sets
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Fluid transfer sets, connecting lines and administration sets
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Heart perfusion
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Enteral feeding
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Pharmacy assemblies and others
Catheters Processing
Sky medical offers production services for catheter processing for different medical procedures, including the following production expertise:
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Hub over-molding
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Catheter Printing
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Catheter Tip forming
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Designing the final catheter kit / packaging
Packaging & Labelling
To ensure safe and sterile medical devices, we use a range of packaging materials, including pouches and rigid packaging materials that maintain product integrity. We also have extensive experience in designing dedicated packaging for specific products, and work in close cooperation with leading thermoforming companies, ensuring that our customers receive their products packaged and validated according to all the relevant standards.
Sterilization
To ensure safe and sterile medical devices, we use a range of packaging materials, including pouches and rigid packaging materials that maintain product integrity. We also have extensive experience in designing dedicated packaging for specific products, and work in close cooperation with leading thermoforming companies, ensuring that our customers receive their products packaged and validated according to all the relevant standards.
Selecting a CM Partner
Price is not the only consideration when selecting a CM partner.
The following are the 6 key factors that every medical device OEM should consider before outsourcing to a CM:
Size
Large CMs are burdened with bureaucracy and high overheads. Mid-size CMs are agile and responsive, offer robust quality control, and have sufficient presence to provide significant cost reductions. Small CMs lack the ability for volume ramp-up and global scale cost reductions.
Responsiveness & Communication
Good CMs offer fast responses and direct access to an appropriate point of contact throughout product development, manufacture and delivery. First impressions are an indication of how business will operate throughout the partnership
Production Focus
Vertically-integrated CMs deliver significant value through consolidated supply chains and integrated teams delivering total value to the product. Singularly-focused CMs are valuable for niche processes, or when they are experts in a singular commodity process field.
Level of Quality
CMs with robust, accredited quality systems in combination with risk mitigation plans are very valuable, since this almost always reduces expenditure of time, money, and effort.
Location
CM location and country of manufacture significantly affects the price-per-unit, access and timeliness to distribution channels, and overhead rates.
Understanding of Goals
It is critical that the CM clearly understands why an OEM is outsourcing, e.g., reduce costs, reduce wholly-owned space, create flexible models for expansion.