Overview of the medical device industry

Medical Device Industry is growing at a fast pace. Globally, technological advancement, favorable healthcare government policies, rise in demand for accessible healthcare, and active per capita healthcare expenditure are guiding factors for fast-paced growth in the segment. The global medical device market stood at 495.46 billion in 2022 and is expected to reach 718.92 billion by 2027.

Unlike other segments of the economy, healthcare is extremely dynamic. Every now & then a newly emerging disease or infection affects specific geography. A global health pandemic leaves a deep impact on the economy.

Globally manufacturers are investing in their infrastructure, regulatory certifications, capabilities, and talent pool to develop an ecosystem for Full Turn Key Medical Device Manufacturing.

Importance of Medical Device Outsourcing Partners

  • Cost Optimized Manufacturing is the ultimate benefit of Medical Device outsourcing. When you outsource manufacturing most of the operations and tasks are handled at the contract manufacturer’s end.
  • Focus on branding and marketing is another significant merit to be considered. Subletting manufacturing operations gives enough space and room to plan branding and marketing of the device or idea.
  • Assistance in penetrating global markets with experienced manufacturing partners is another added advantage. Contract Manufacturers work on numerous projects along the way. They have experience in handling multiple categories of projects in different geographies. Signing up with an experienced manufacturer brings in-depth expertise for documentation to enter global markets.
  • A skilled workforce at the manufacturer’s end saves ample investment in the workforce for handling the manufacturing floor.
  • Post-market design & engineering assistance at manufacturer’s end helps in eliminating extra overhead costs involved in complying with global regulatory guidelines.
  • Outsourcing manufacturing has a lesser chance of errors & redoes as your contract manufacturer is handling manufacturing operations. Dedicated efforts in a single direction assure that production is completed within timelines without hassle and errors.

Purpose of the guide

Here we clearly outline the key benefits of outsourcing Medical Device Manufacturing. The guide also exposes parameters to keep in mind while outsourcing Medical Device Manufacturing.

Understanding the types Medical Device Contract Manufacturing

Contract Manufacturing refers to subletting manufacturing of a part or entire product to another company in exchange of an agreed capital. In the Medical Device Development Industry, Contract Manufacturing is a process of outsourcing a part of a service to a relevant person or party in exchange for a certain amount of investment. Being a highly regulated industry the process of outsourcing Medical Devices is complex. Choosing the right manufacturer is necessary to ensure the successful Go-To-Market of the device.

Private Label Manufacturing

Private label manufacturing refers to delivering the finished product to the store. In case of private labeling design, technology and everything is transferred from the brand owner to the contract manufacturer. The Contract Manufacturer’s task is to combine parts and accelerate the final product to market.

Component Manufacturing

Component manufacturing as the name suggests refers to hiring a manufacturer for a specific component or part manufacturing. Medical Devices are highly regulated and each component plays a significant role. This means that even if you are subletting a component manufacturing its mandatory to ensure that your manufacturer is regulatory compliant.

Labor or service contracting

Often you can just hire a workforce to assemble things. This kind of arrangement refers to Labor or service contracting. The arrangement saves you time in handling team, training them, and paying them extra for assembly and production operations.

Finding the right contract manufacturer for your medical breakthroughs

Criteria for selecting a contract manufacturer

1.) Capabilities

Capabilities comprise everything from machinery to workforce. A Contract Manufacturer must have a trained or skilled workforce, relevant infrastructure, and an environment suitable for the development & manufacturing of a specific type of medical device.

2.) Certifications

Medical Device Industry is highly regulated. Keeping in mind all the regulatory requirements a manufacturer must exhibit relevant certifications. These certifications ensure that Medical Devices being manufactured in the facility comply with Global Regulatory Requirements.

3.) Expertise

It’s also important to know that your manufacturer has the right capabilities for your project. It’s important to analyze that the project that you’re assigning to a manufacturer has been on their table before.

Outsourcing manufacturing to someone who doesn’t have any prior experience brings no value. Checking on experience ensures that the manufacturer will surely add some value to your product and help you scale and improve efficiently.

4.) Supply Chain

Manufacturing entirely depends on procurement. The strength of the supply chain determines the timeline & quality of the Medical device. The quality of Medical devices eventually determines the success in the market.

Sample questions to ask your potential contract manufacturer

  1. How many years of experience does a contract manufacturer have?
  2. What are the most recent technologies on which the contract manufacturer has worked?
  3. How strong is the regulatory team at Contract Manufacturer’s end?
  4. Does your manufacturer offer post-market design assistance?
  5. What is the team efficiency of the contract manufacturer?
  6. How much cost optimization does the Contract Manufacturer offer?
  7. Is the Contract Manufacturer capable of expanding existing capabilities when the demand grows?
  8. Does the Contract Manufacturer have relevant setup and protocols for IP protection?

If answers to all the above questions is yes, then you are good to go!

Managing a Contract Manufacturer Relationship

Like every business relationship, a contract manufacturer’s relationship also requires continual nurturing. There are multiple ways to ensure that your manufacturer is on the same page as you.

1.) Communication & Collaboration

Transparent communication about suppliers, vendors, and other key decisions concerning the project is important for a strong Contract Manufacturer relationship.

2.) Quality control & Regulatory Compliance

A manufacturer must comply with the regulatory requirements of the country where you’re targeting your product. In cases where the contract manufacturer misses on regulatory everything may round up to zero.

3.) Intellectual Property Protection

A Contract Manufacturer must ensure that the product’s original identity is protected. At the manufacturer’s end your IPs must stay protected.

4.) Managing Change & Scaling Production

May be you are starting with low volume production but how soon do you see the demand growing needs a careful evaluation. Efficiency of your manufacturer in fulfilling growing requirements in future is must. Also, it’s an added bonus if your manufacturer can support you with changes in design. A good design team at manufacturer’s end gives you an extra hand to deal with post market design feedbacks and changes.

Navigating Common Challenges

Quality control issues

Medical Devices unlike any other commodity of consumption deal with human lives. A minor glitch can have serious repercussions for the user & manufacturer. It’s extremely important that your manufacturer has strong Quality Management System for safe Medical Devices. Also, in case of any incidence where you need to prove that manufacturing & development were in sync with standard guidelines your manufacturer must have proper documents of each step from design up to manufacturing. These include DHR, DFM and more.

Delays and production problems

During COVID 19 manufacturing experienced numerous supply chain hurdles due to which shipments & deliveries were delayed. In such circumstances the developers must understand the reasons for delay & support contract manufacturer in every possible manner.

Intellectual property disputes

IPs need protection at both developers & manufacturers end. Often language barriers and communication gaps lead to misinterpretation or infringement of data. Its recommended bridge the language barriers to ensure proper channelized communication.  minimum ensure IPs are safe at both ends.

We’re the ones you’ve been looking for accelerated Go-To-Market of your Medical Devices!

With 40+ years of industry experience we help you successfully take your product to market. From complicated engineering services to mass volume production, we ace the art of New Product Introduction.

Critical analysis & sketching of the processes

We make sure that all the processes required are in sync with the specific product requirements.

Long term association with Global Med-Tech’s

We’ve been working closely with Global Med-Tech Companies to accelerate their products successfully to the market.

Multiple Assembly lines

We have multiple assembly lines to strategically manage assembly of multiple products at once. From small hand-held products to Clinical Models, we ensure time-bound project management.

Continual Risk Analysis

Every Medical Device has a certain level of risks associated with it. Continual risk analysis from stage 1 to final commercialization stage makes sure that device offers efficient functionality as per the industry standards.

Lean Sigma Manufacturing

Eliminating unnecessary repetitive tasks with automation or any activity that promotes waste production is our main manufacturing principle. Some key aspects that we focus on eliminating while lean sigma manufacturing are defects, overproduction, waiting, non-utilized talent, transportation, inventory, motion, and extra processing.

Collaborate with us to explore seamless manufacturing services. Sign up with us to accelerate your product to market.



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