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Q: Why doesn’t a Medtech manufacturing job end when the parts, or products, are shipped?

A: Because the job is never done.

Let me explain. For a company serving the medical/healthcare sector, no product design, or delivery, is complete with any finality. Parts and components are merely released to the marketplace, where they begin a new phase of their life. Released from the product development lifecycle, they enter the larger product lifecycle.

And the work of medical contract manufacturers, including their outsourcing contract manufacturing suppliers, continues.

Generally, excellence in customer service translates into greater customer satisfaction and retention. But medical devices and pharmaceutical products vary widely, which results in different measures of service.

Consider the case of a single-use or disposable item, with a high volume of recurring orders. For such products, there are several means of data to record quality, safety, on-time deliveries, and customer satisfaction metrics.

A complex medical device, however, requires a more nuanced approach to service. This applies to manufacturers as well as the contract manufacturer they may use. Particularly for the latter, what exactly is an “after-the-sale” service, and how do we define a “sale?” We don’t; we define a partnership. We partner and collaborate in a multi-disciplinary “gumbo” whose ingredients include material science, design, testing, simulation, manufacturing, and much more.

As a plastic injection molding company, we long ago realized that the job doesn’t end when we help a customer turn a CAD design into a manufactured reality.

Our core functions are indeed focused on traditional project management steps. These include defining project requirements; mold design and fabrication; process development and validation; initial production sampling and customer approval and production of a fully validated product – and beyond.

But the role we serve in the supply chain must also be responsive to post-production handling, shipment of finished goods, on-time delivery, customer satisfaction – and the healthcare providers and patients (OTC customers) they, in turn, serve.

To do the job right, a plastic injection molding service company must define service in the context of the entire product lifecycle, not just the product development cycle.

Baseline requirements for outsourced service

Even a lofty view of customer service must start with the basics. These include compliance with regulations and standards that set the bar with guidelines. These include:

  • 21 CFR Part 820 - Quality System (QS) Regulation/Medical Device Good Manufacturing Practices establishes Current good manufacturing practice (CGMPs) for sets-down requirements for design, manufacture, packaging, labeling, storage, installation, and servicing finished products. Section 820.86, in a nutshell, requires each manufacturer to identify and ensure conformance with acceptance criteria “to ensure that only product which has passed the required acceptance activities is distributed, used, or installed.” Additional sections of the regulation also flesh-out service requirements for finished goods—including vendor-supplied parts in those products. Requirements include Section 820.181 – Device Master Record for installation, maintenance, and servicing a device, and Section 820.200, Subpart N – Servicing, which mandates maintenance instructions and records for all service performed on finished devices.
  • ISO 13485:2016 Medical devices – Quality management systems apply to Medtech manufacturers as well as their outsourced partners, as cited in Section 4.1.5 and (noted in this recent article on the injection molding tools and tips blog). For instance, Medtech manufacturers must track their products after they’re delivered, and contract partners may be asked to help with data on design and manufacturing through packaging and considerations further downstream.

Going beyond what’s expected

Standards and regulations, however, only set the bar, which a good contract partnership must exceed if the goal is a successful, profitable partnership. Examples of going “above and beyond” target continuing improvements, job after job. Examples of such service improvements include:

  • QRM/Quick Response Manufacturing reduces time for market and, in many cases, provides the means for automating work cells to significantly reduce lead times.
  • DFM/Design for Manufacturing provides the discipline to simulate and evaluate part and mold designs for optimal mold flow, part performance, and reliable, repeatable manufacturing.

These two disciplines can be employed for ongoing benefits but are only part of the bigger picture. In a service-oriented partnership, the most important rules are custom-tailored to each need. That is why – and it bears repeating:

To do the job right, a plastic injection molding service company must define service in the context of the entire product lifecycle, not just the product development cycle

The best partnerships are those in which all parties look for new ways to improve. Even for a parts supplier, new ideas can transcend design and process to encompass on-time delivery and logistics. For example, for more than one Medtech customer, Crescent Industries has reduced time to market as well as transportation costs by packing and shipping parts and subassemblies to “the next manufacturer in the chain” who performs final assembly of a given device.

Every outsourcing contract is different because every medical/healthcare product firm has unique needs. However, the common thread for all partnerships, however, is attention to high service levels before, during, and after the job is done – and ready to begin again.

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Topics: contract manufacturing, injection molded tooling, Crescent Injection Molding, custom plastic injection molding, medical device contract manufacturing, purchasing injection molds