Taking the decision to outsource your medical device manufacturing to a third-party manufacturer can be a difficult decision to take. While it is relatively easy for other industries to consider outsourcing, in the case of medical device industry, careful consideration needs to be given.

Questions such as process quality of the third-party manufacturer, documentation, manufacturing quality standards and protocols should be considered. It is therefore critical that any medical equipment carrying your brand name must be produced in the highest quality standards befitting your company.

Before taking the final decision of selecting the right vendor for your outsourcing, companies should take into consideration the following 10 key critical steps.

1. Production Capabilities

Understand the production capabilities of the proposed manufacturer that you are considering for outsourcing. Typically, these companies that provide contract manufacturing have better access to technology, state of the art manufacturing processes and supply chain that OEM’s may not have.

2. Documentation

This is a very critical component to consider before outsourcing your medical device manufacturing. The adherence to documentation is critical. In some cases, your contract manufacturer may control the documentations or the OEM may choose to retain control. The important thing is to define the scope and responsibility and clearly delineate where one responsibility ends and the other begins.

3. Device Expertise

Does your potential contract manufacturer have the device expertise to manufacture your class of medial device? Have they the requisite experience, industry and technical knowledge about your class to fully understand the regulatory framework in which your product will be sold? Knowledge or the lack of it will impact your product finish positively or adversely.

4. Quality Certifications

If your medical device is going to be marketed and sold in the US, it is paramount that you select a vendor who has a FDA certification. Similarly, if you are looking to explore markets like Canada and the US or markets like India, Brazil, you will be well off to tie up with a contract manufacturer who is MDSAP certified. Quality certifications help not only in being assured of certain high standards of manufacturing standards; it also ensures that your product will find a faster go-to-market

5. Supply Chain Management

Always remember to choose a vendor with good supply chain management systems in place. In the case of medical equipment, HLAs (High Level Assemblies) are integrated from a wide variety of components and the best contract manufacturer is one that has the ability to quickly, easily and economically obtain the required components to build your medical device.

6. Design Engineering Capabilities

Your contract manufacturer should ideally be able to provide full-service design engineering support to you. This could include device development, prototyping as well as production support. Look for a vendor that is able to bring all of this as part of the scope of work.

7. Regulatory Guidance

By virtue of being FDA approved, your contract manufacturer should be able to play in role in offering a portfolio of medical device production and testing experience. They should also have the appropriate certifications and on-going processes to support DHR (Device History Record) documentation. Understanding the regulatory framework under which your medical device will ultimately operate is critical knowledge that your CM must have.

8. Manufacturing Services

What kind of manufacturing services does the proposed CM have to offer? Does he for instance provide process validation? Does he provide sterile release management? Warehousing? Inventory Management? Software management support? Every CM has a several key skills and services and a better understanding of the key services that your CM can provide you is important to understand.

9. Business Fit & Experience

How long has the CM been in business providing the kind of manufacturing outsourcing operations you are considering? The lower the number of years, the lower the combined experience that comes with it. Contract manufacturers specializing in medical equipment, who have been in business for long have a varied and unique experience that will come in use

10. Costs

Last, but not the least how economically reasonable is your medical device to outsource? Does it fit into what the market can afford to buy? Ultimately finding the right medical device contract manufacturer who offers the most economically reasonable cost for your device is the goal when you look for outsourcing.

As one of the leading contract manufacturer for medical devices, Johari Digital has been serving the medical healthcare industry in equipment manufacturing for the past 40 years. We are a single point of contact for many medical device requirements. Johari’s Research and Development teams include highly qualified and experienced professionals who are focused on applying leading edge innovation and technology to your medical product concepts.

Our R&D staff can contribute to your success through their strong engineering capacities in circuit design, PCB layout, software development, test engineering and product development. We offer complete end – to – end medical equipment manufacturing services, allowing our customers to gain the benefit of supply chain consolidation, manufacturing efficiency and lower costs. We are constantly integrating innovative technologies and processes with forward – thinking ideas cultivated in our own labs and in collaboration with outside partners.



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