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The process to ensure successful Medical Device Assembly for Medical programs begin when the program is accepted.  When you outsource a Medical Device to a Contract Manufacturer, follow these 6 critical steps to guarantee the success of your program once it’s transitioned over to the full-scale assembly phase.

Since each program has unique requirements, steps or processes may overlap depending on a few factors.  These factors include the company, maturity of the build and which tests have been completed before outsourcing the program to the contract manufacturer.

1. medical Device Readiness review

A Contract Manufacturer’s first step when accepting an order to build a Medical Device is to perform a Readiness Review.  This Review is a comprehensive analysis of design and specifications that rare communicated to the Contract Manufacturer by the customer.  The purpose of the review is to determine if the information provided by the customer will lead to a product that is both manufacturable and can meet the intended design and function.  With any new technology, there are likely to be changes and revisions during the first build that can be addressed during the Readiness Review and potentially save time and money by implementing the changes before manufacturing takes place.

The review step also allows the Contract Manufacturer to assess the need for additional resources necessary to complete the build, which can include the acquisition of new equipment and personnel.  It is important that the CM has competent, cross-trained personnel so employees can be deployed as demand increases or decreases.  New manufacturing equipment may also be procured depending on the future needs of the program, which may include machines, or new capabilities added to the organization’s core competencies.

Quality objectives are also established during this stage between the CM and the OEM.  During internal and customer included meetings, the focus is on engineering and manufacturability to lay the groundwork for successful first-time builds.

9ft tall medical mechanical assembly made from metal parts

2. process development

Next, Engineering and Manufacturing groups should begin to develop the process needed to manufacture and build the medical device.  It is in this step where job packages are created.  During this process, deadlines are shared throughout departments.  Managers from each division  work together during these first few internal meetings.  This is so the component parts are completed simultaneously, and the prototype can be built on time according to its deadline. Specialized manufacturing techniques are developed.

The Contract Manufacturer should be certified to ISO 13485 in order to best serve your Medical Device needs.  The certification allows the CM the ability to implement these ISO requirements throughout each stage of manufacturing.

A Quality Control Plan is required for all manufactured Medical Devices and is completed during this step.  The Quality Control Plan allows transparency of all parts and assemblies included on a Medical Device.  If down the road, any part or assembly were to be recalled from the Medical Device, having transparent documents allows for any discrepancy parts to be easily identified and possibly fixed if needed.  The QCP also helps as a tool to manage the product while in it’s manufactured to prevent a non-conformance and any future failures.  This is then used to show that the product met the specifications.

3. Medical Device Component Manufacturing

In this step, component parts are released to the manufacturing floor.  Each stage of manufacturing is monitored so conformance can be verified.  The success of the project relies on the organization’s ability to manage the manufacturing of the product and component parts.

During this process, a cross-functional effort is established between Quality Control and floor personnel to check component parts for a Medical Device program.  If any operations are outsourced to a specialized third-party manufacturer, the parts will be received back by the CM to be reviewed by the Quality Control team before anything is released for assembly.  The CM should also be confident in the ability of the third party vendors they chose when and if they outsource any of their core competencies.  The performance of the third-party must be verified.

Quality Inspector using hand held device, Romer Arm, to inspect a medical machinery part

4. Final test & Verification

The prototype will be tested, if applicable, and checked to ensure it meets the specifications.  These tests are developed by both internal and customer engineering teams to ensure they meet their Quality and Functional requirements.

Once all the parts are on the floor, the prototype or alpha/beta builds can begin.  This vital step, including the ones prior, allow the CM to put together a successful assembly plan once programs are in full-scale production.  The information gained from building 5-piece units will be used down the road for pilot and pre-production builds,  or when the program is moved to full-scale production.

When the builds are completed, initial customer testing may take place so the customer can validate their own technology.  Since FDA regulations apply after the first few builds, these early builds will most likely be used for clinical trials which will determine whether or not the technology can pass FDA regulations.  It is beneficial to find a CM who is familiar with FDA regulations so they can help transition the program to ensure FDA compliance.

3 white machines lined up during our NPI stage before moved to our assembly department. A stool is in the background for scale.

5. Lessons LEarned

After the prototype is finished successfully the engineering group will review lessons learned to revise or update the process to make it suitable for production and to meet the customer’s expectations.  Since PEKO entrusts programs to our New Product Introduction Department for the duration of the first few build sets, we have the capacity to repeat this stage to ensure that we are perfecting builds once they are turned over to our Assembly group.

Important aspects of the program to review after the first round of builds include the following:

  • Optimization of processes to ensure efficiency of future builds
  • Cost-down analysis and decreased lead time assessment
  • Efforts to decrease lead time
  • Reductions in costs for the unit to save the customer money

6. Release for Production

Now the product is ready to be handed off to production.  During this process, supervisors from both the NPI and Assembly divisions will meet internally to ensure that a seamless process is established during the project’s transition.  Assembly floor supervisors will also meet with their team members when creating floor plans for the area so that a smooth, flowing process is put into place and approved upon by the entire team.

The success of a Medical device program relies on the experience of the Contract Manufacturer and the organization’s communication to the OEM.  Ensuring these steps are followed will lay the groundwork for a successful program down the road.

If you are interested in learning more about outsourcing your Medical Device to a Contract Manufacturer, check out this free checklist below to get you started!


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