The process of designing and producing a medical device is more complicated that it is for many consumer items. Today, it involves not a single company or individual but an entire group of specialists and experts. While an OEM may be responsible for the concept, the actual work may be farmed out to contract medical manufacturing firms. They will provide the necessary support while ensuring the product is viable and falls within the parameters of the budget for that particular medical device or devices.
Issues Facing Medical Manufacturing Contractors
Preparing a new medical device for the market is not as simple as other types of equipment. Contract medical manufacturing companies have to address many issues, some of them common to all manufacturing ventures; others unique to the production and assembly of medical devices and instruments. These contract companies must consider:
- Feasibility
- Functionality
- Design – must be adaptable for both manufacturing and assembly
- Biocompatibility
- Sterilization
- FDA regulations
While many OEMs may decide to handle everything, including the complex design development, in-house, most rely on contract manufacturing firms to take care of various aspects of the process. While some third party companies may address the design, others may handle engineering the device for functionality. Other contractors may take care of the assembly of the medical instruments as well as its packaging and shipping.
Why Use Contract Medical Manufacturing Firms?
The growing product complexity of medical devices, the need to create partnerships with experts and experienced individuals, creates a demand for outsourcing to contractors. A lot is at stake for OEM. They need to get the product market-ready quickly. They cannot do so without expertise, access to the newest type of materials and the use of the latest technology. No one company can usually afford to do this. However, by contracting the work to contract medical manufacturing concerns that are out to specialists in this area, an OEM can achieve its goals.
