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Medical Device Contract Manufacturing

Easy Guide To Medical Device Contract Manufacturing

Contract manufacturing is an agreement between a contract manufacturer and a company to make certain products within a specific period. Some businesses usually hire another organization for the production of goods for their business. In simple words contract manufacturing is a form of outsourcing that helps business manufacture their products and goods.

It is also common for medical device manufacturers to outsource the manufacture of medical devices and components, which are later sold to a third party. The category of medical devices is broad ranging from the products found in the operating rooms and intensive care units to local pharmacies.

What is Medical Device according to FDA?

In the USA selling medical devices is regulated by FDA (Food and Drug Administration).

According to FDA, the medical device can be defined as an instrument, apparatus, machine, implement, implant, contrivance, in vitro reagent, or other similar related articles including a part or accessory that is recognized as a Pharmaceutics and supplements intended to diagnose, cure, or prevent diseases, or to affect the structure of the body of humans or animals.

Medical device contract manufacturing can provide cost optimization, device upgrade, regulatory guidance, and consistent quality improvement.

What Does a Complete Medical Device Manufacturing Company Offer?

There are a few consistent aspects of medical device contract manufacturing definitions, despite their broad scope. The complete medical contractual manufacturing services must include:

  • Creating the manufacturing process design
  • Quality Assurance
  • Sterilization Management
  • Final Packaging and Labelling for shipment
  • Sterilization Management
  • Rapid Prototyping Process
  • Device Assembly
  • Package Testing and Validation
  • ISO Certified Cleanroom Manufacturing

Benefits of Medical Device Contract Manufacturers for Medical Device Industry

Let us now take a look at the different benefits of taking the help of medical device producers on contract basis.

Launching a Product Quickly

The speed of medical device commercialization is a critical component. The companies offering multiple services of medical device contract manufacturing under one roof have turned the concept of a one-stop shop into a reality.

It may be more effective and efficient for medical device companies to partner with a resource with key capabilities in-house for their manufacturing needs. Long ago the concept of a one-stop-shop for medical device outsourcing didn’t exist that always caused considerable delay in launching a medical product in the market, as they were supposed to outsource multiple companies for assembly, packaging, testing, and sterilization.

For launching a product quickly, it is essential to choose a medical device manufacturing partner on a contract basis that complies with regulatory manufacturing and provides all the necessary capabilities under one roof. As your efficiency increases, you can better deal your clients.

Cost-Optimization with Quality Assurance

Contractual manufacturing for medical devices can be cost-optimizing as it saves you the cost of procurement, capability, resource, and machinery. Multiple benefits can be derived from manufacturing cost savings. These savings can be channeled into other important areas, such as marketing and branding that ultimately determine the return on investment. 

Hiring a well-reputed contractual manufacturing company for medical devices ensures quality and verifies that internal standards are met. It also oversees and manages operations to meet general and local requirements. Moreover, the company is liable for maintaining the quality to ensure patient health and safety.

Regulated Assistance and Services

A medical device contract manufacturing company offers regulated services such as quality management systems, sterilization management, testing and validation, and ISO-certified cleanrooms.

A medical device company must ensure that its contract manufacturing partner offers compliant regulated services.

The contract manufacturer can also assist you in taking your product to the global market with their extensive knowledge and experience. Therefore, approaching a contract manufacturer for your medical devices can help you expand your product’s reach across the globe relatively more quickly.

Manufacturing with Lean Principles

Lean manufacturing is a methodology of manufacturing product in a way that minimizes waste and maximize productivity.

By implementing Lean Manufacturing, contract manufacturing facilities are improving their turnaround time and getting the products to market faster and more efficiently. The core goals of manufacturing with lean principles are to improve efficiency, yield increment, reduce WIP (work in progress), and ensure quality.

Criteria to Consider Appropriate Medical Device Contract Manufacturing Company

Before signing up for the agreement with the manufacturing company on a contractual basis, medical device and equipment manufacturers must consider the following important factors to ensure the accurate contract manufacturer selection for your project.

Certification or Qualification of Contract Manufacturers

The term medical device refers to a wide range of equipment such as surgical instruments, diagnostic instruments, wearable medical instruments, anesthetic instruments, etc. Hence, medical device manufacturers must evaluate the qualification or certification for producing medical devices.

A key component for choosing a company from the manufacturing industry is that the contractual manufacturing company is audited by the third-party registrar, as well as by their customers, to assess their compliance with ISI 9001 and ISO 13485 requirements.

More importantly, it should be an FDA-registered company as well. This is quite a substantial requirement to take care of. Without FDA approval, companies may not be fit to produce the right medical devices.

Capability to Meet Delivery Deadline

Medical device companies in the medical device industry must be persistent in their commitment to meet the scheduled deadlines. The manufacturer must be able to demonstrate how technology can be leveraged to ensure the smooth flow of a program from conception to creation.

Through the manufacturing process, the manufacturer needs to know how to adapt to unforeseen changes driven by the customer. It should also have a reasonable supply chain and should be able to meet orders timely. You can ask them for details about their medical devices sold to see if they have enough expertise, equipment, and resources to fulfill your order.

Providing Technical Specifications for Medical Devices

Maintaining a schedule is essential to achieving technical specifications and milestones. To meet the technical specifications of the medical device industry, the contractual manufacturer must know about applying the QA procedures, tools, and equipment.

The manufacturing company should be accountable for executing both schedule and technical requirements. Also, check if they observe current good manufacturing practices and observe regulatory requirements by examining their processes, or getting details about them.


Medical device contract manufacturing is outsourcing a manufacturing company for producing medical devices and equipment. Approaching a manufacturing company on a contractual basis for medical devices can save you a lot of energy, time, and money that you can utilize on increasing your organization’s growth. You can get all the services from packaging and labeling to testing and verification under one roof.

Before considering any manufacturing company for your medical devices on a contract basis, you must evaluate their authentication and certification. Make sure that the company you are going to finalize an agreement with, undergo best industry practices, takes care of quality control, and abides by all the rule and regulations passed by the government and FDA.

Moreover, the contract manufacturing company must be reliable enough to support you when you need it. It is best to opt for medical device manufacturing companies that have been in the industry for 2 to 3 years and have considerable experience in medical device development.

Make sure to conduct your background search on the contract partner before entering into an agreement with them. If you can connect to industry experts, that would be the ideal scenario.

About the author

Jamie Moses

Jamie Moses founded Artvoice in 1990

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