What is Medical Device Contract Manufacturing?

Medical Device Contract Manufacturing is a process where a MedTech company that owns the idea (sole proprietorship) outsources manufacturing to another Medical device manufacturing firm. The product is developed according to the specifications sent by the OEM company in compliance with ISO:13485 and FDA guidelines. The core purpose for which medical device companies outsource manufacturing can be cost optimization, device upgrade, regulatory guidance or expansion.

Medical device contract manufacturing definition scope can be broad, a few consistent aspects are:

  • Medical Device Design and Development for Manufacturing Process
  • Device assembly
  • Testing and Validation
  • Quality Assurance
  • Regulatory Assistance
  • Packaging for shipment

How can Medical Device OEM benefit from a Contract Manufacturer?

Contract Manufacturing has many benefits as it gives the benefit of cost and experience at once. Signing up with a contract manufacturer you have these benefits mentioned below:

  1. Cost-optimized Manufacturing
  2. Experience and technology expertise
  3. Fast Go-To-Market
  4. Increased access across geographies
  5. Regulatory assistance to take products in Global market

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#1. Cost-Optimized Manufacturing

Contract Manufacturers are experienced to optimize costs at various levels. You save on procurement costs, resource costs, capability costs, and machinery. Savings on the manufacturing end entails multiple benefits, the savings can be allocated to other important segments like marketing and branding that eventually decide the ROI you’ll get from the investments. 

#2. Experience and technology expertise

Contract Manufacturers work on numerous projects, this brings a wide range of experience. Signing up with a Contract Manufacturer you get expertise across various segments that you can utilize to upscale the project.

#3. Fast Go-To-Market

Go-To-Market is a very serious issue for new start-ups as well as experienced MedTech giants. With FDA and ISO: 13485 certified manufacturing and stepwise documentation the Go-To-Market speed is never compromised. It’s essential to choose a contract manufacturing partner with effective regulatory compliant manufacturing.

#4. Increased access across Geographies

When you sign up with a Medical Device Contract Manufacturer from different geographies, you unlock enormous benefits. You get numerous networks that you can utilize to expand your product’s reach across multiple geographies.

#5. Regulatory assistance to take products in Global market

The contract manufacturer with a wide range of experience can help you take your product to the global markets. The CM works with multiple clients across different geographies and therefore they can guide you to take your product to different global markets with relevant certifications.

Sign up with Johari Medical Device Manufacturing Services for Regulatory Compliant, Cost-optimized and Speedy Contract Manufacturing of Medical Devices

Johari Digital Healthcare Ltd. is a 40+ years of Medical Device Manufacturing organization with deep understanding of industry dynamics and regulatory norms. We adopt your idea in our canvas to deliver innovations for better healthcare. Our customized protocols and strategic planning from day 1 are the key ingredients for success over 40+ years. We have solutions catering to multiple segments including life sciences, diagnostics, biotechnology and Therapeutic devices. With our efficient supply chain capabilities and understanding of global market demands we can also assist you to enter untapped markets and beyond.

Have a revolutionary MedTech idea, we are the ones you’ve been looking for !

Schedule a Free Consultation with Johari Digital Healthcare for seamless Contract Manufacturing services at the lowest cost.


What is a Medical Device Contract Manufacturing company?

Medical Device Contract Manufacturing company refers to an organization where the manufacturing is done for another company that owns rights over the design and technology.

What are the types of manufacturing on the basis of scale?

On the basis of the scale of manufacturing, there are three types of manufacturing including make to stock (MTS), make to assemble (MTA), and make to order (MTO).

How can contract manufacturers help in regulatory approvals and assistance?

Authentic Contract Manufacturers have a regulatory compliant manufacturing facility. Also, working with multiple clients on different complex projects they have an idea about which segment would require special attention to get fast regulatory approval. A contract manufacturer can you in availing relevant certifications to expand your product’s reach to multiple geographies.

What is the estimated growth in the medical device contract manufacturing market?

The Global Medical Device Contract Manufacturing market is estimated to reach USD 113.3 Billion USD by 2026 from USD 65.9 Billion USD in 2021 at a CAGR of 11.5%. (Source: Precedence Research)

Why should a startup/ large OEM sign up with a Contract Manufacturer?

A fresh start-up has minimal experience and knowledge on different aspects of Manufacturing. They also lack the resources and networks required for optimizing cost. Signing up with a Contract Manufacturer you get cost-optimized manufacturing along with relevant timely guidance to fast-track your product to market.



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