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Multiple terminologies have created a lot of confusion in the Medical Device Manufacturing landscape. It has become very difficult to differentiate between the OEMs, CDMOs, and Medical Device Manufacturers on Record. Here we analyze how each of these Cemented Carbide Inserts terminologies is different from one another.

Companies willing to shift from being an OEM to a Medical Device brand must have clarity on what steps they should follow to make a smoother transition.

What is Medical Device OEM?

Medical Device OEMs have always played a crucial role in Medical Device Manufacturing. The OEMs do not have ownership of the product or accountability for errors in the product. The OEMs work according to the specifications of the client. The engineers in an OEM organization are “sustainability engineers” who work on the design of the product to optimize cost and make the product more feasible in terms of handling and accessibility. The ownership of the design, accountability to the user, and FDA Regulatory concerns are not owned by the Medical Device OEMs.

BTA deep hole drilling inserts What is a Medical Device Brand?

Medical Device Brand is the recorded brand owner of the device. Accountability, ownership, and end-user concerns are the headache of the brand owner. The engineers and technical team at the brand office are involved in ideating new concepts, putting up their brains in devising new products as per the market demand. The innovation part and actual soul of the product belong to the medical device brand owner.

What is a CDMO (Contract Design & Manufacturing organization)?

Strategic partnership with clients throughout the product lifecycle from design to proto to mass production. They support clients with NPD to achieve lower cost, high quality, and shorter time to market including regulatory.

What are CRAMS (Contract Research & Manufacturing Organization)?

In this case, the company team will take your Medical Device Idea to the final product stage. The Research, Designing, Prototyping, Mass volume production everything will be done by the expert Contract Research and Manufacturing Organization.

Why is there such confusion in terms of Identification?

A company established a long time back must have made some innovation in the beginning but as time passed the innovation became off the line. In the current scenario, the company might only be involved in rendering projects of another brand. This implies the company started as a Medical Device Brand but soon leaned into the OEM and CM territory.

It also happens that a company might have its products as well as cater to other big MedTech firms such as CDMO or OEM.

This way it's often difficult to categorize a Medical Device Manufacturing firm as OEM, CM, CDMO, or Brand.

How do you make a transition from a medical device OEM to Medical Device Brand?

Medical device brand has more responsibilities to bear. For transitioning from OEM to Medical Device Brand these things must be the primary focus.

Transitioning from follower to learner

As an OEM or CM, the task is to follow the instructions and specifications. The approach needs to shift from being a follower to being an active learner. The engineers at your organization need to learn new things to come up with new ideas which fit the user's demands and needs.

Leverage your OEM /CM experience

OEMs might not have new ideas but working on products of other brands has given the team enough skills. To begin with, one can leverage experience in any specific segment to come up with a new product as per market demand.

Assess your strengths and weaknesses

The team, capabilities, and efficiency you currently have as an OEM might require an upgrade while shifting to the brand outlook.

As a “Manufacturer of Record,” you would require enhanced capabilities and strict understanding and compliance to ensure quality products. It's important to check strengths and weaknesses to prevent errors and product recalls as you are the one who will be accountable to FDA for any mishap due to product quality or functionality.

Hire a strong marketing bench

Now, when you are in the brand business everyone must know about you and your product. Also, primary market research for analyzing the actual demand is important. Hiring executives and marketing professionals in digital and offline media is important for both the pre-and post-production success of the product.

Hiring Service Engineers

Once you are the brand owner it is important to keep end-users happy. Especially in Medical Devices of clinical setups that are big-budget and require timely servicing. Hiring service engineers is another important task on the checklist.

As a Global OEM and CM manufacturer Johari ensures an edge over our client's requirements. Sign up with Johari Digital for seamless Medical Device Manufacturing Services.

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