Selecting an IVD contract manufacturer is an important but daunting task. The complexity arises not just from the technical nuances, but also from the contractual and logistic intricacies that come into play. As a product manager, your choices can make or break the project. The stakes are high, so a disciplined approach to choosing your manufacturing partner is pivotal.
Before signing on the dotted line with a contract manufacturer, there are several important factors to consider.
Does the Provider Have Expertise Beyond Prototyping?
Prototyping is a pivotal step, but it’s just the beginning. A manufacturer should be able to guide the project from initial sketches to full-scale production. To achieve this, the provider must (not should) possess robust engineering capabilities. That’s because advanced engineering skills are critical for navigating the challenges that arise between prototype and market-ready product stages.
With a dedicated team of over 100 engineers, Enplas offers comprehensive analysis and innovative solutions to ensure that your product doesn’t just reach the market but excels in it. Our unique blend of engineering acumen, material knowledge, and precision in injection molding allows us to provide commercial-scale diagnostic device production of the highest quality.
This engineering capability significantly streamlines the transition from prototype to market, setting us apart as a valuable partner for IVD product managers.
Is the Provider Competent in Commercial Production?
While many manufacturers can handle prototypes, not all can manage the rigors of commercial production. Inadequate preparation for high-volume production can cause logistical nightmares, such as disruptions in supply or spiraling costs that can devastate the project’s budget. This not only puts immense stress on your team but can also damage your company’s reputation.
With expertise in engineering, material knowledge, precision injection molding, automation, and quality control, Enplas is a trusted supplier of high-quality, commercial volume diagnostic device production. Our ability to supply millions of copies of microfluidic devices with channel depth variation of ± 1um or less speaks to the precision we achieve with our production. Our established track record in commercial-volume diagnostic device production makes Enplas a reliable long-term partner for your business, offering scalability and stability for future growth.
Do They Harness the Advantage of In-House Tooling?
Outsourcing tooling operations may seem cost effective, but it can become a burden in the long run. It can lead to issues like production delays, inconsistent quality, and increased costs due to back-and-forth communication and transport. In-house tooling ensures the manufacturer has complete control over quality and timelines.
Enplas’s integrated approach to in-house tooling offers benefits in these aspects. We control the priority of your mold, ensuring faster, more efficient product delivery.
Moreover, our in-house team has comprehensive expertise in plastics manufacturing, which allows for high-quality, quick-turnaround molds. We specialize in making precision hardened-steel cavity and core prototype tools, offering both quality consistency and the flexibility for revisions. This minimizes both the cost and stress of having to buy new molds due to unsatisfactory results or inconsistent part quality.
When it comes to scaling, we shine as well. Our on-site tool shop enables seamless transitions from single or two-cavity prototype molds to multi-cavity production molds. All of this occurs without the loss of time and information, making the progression smooth and cost-effective.
Do They Have Unique Capabilities for IVD Manufacturing?
In the realm of IVD products, certain specialized manufacturing capabilities can set a contract manufacturer apart. Skills in reagent handling, microfluidics, and elastomer fluid seals, for instance, are often paramount. Enplas offers a broad range of specialized capabilities that extend beyond typical plastic manufacturing, such as micro-machining and cleanroom assembly. Our portfolio serves as an invaluable resource, allowing product managers to make informed decisions.
Enplas provides:
- Lyophilizing, packing, and preloading reagents, with temperature-controlled and monitored reagent storage.
- Automated liquid reagent filling and quality control by weight.
- Precision in plastic microfluidics production.
- Expertise in elastomer fluid seals.
- A host of secondary processes like pouch making, tube cutting, bonding, assembly, kitting, and packaging.
These services take place in meticulously controlled environments that meet the industry’s highest standards, including ISO class 6 or 7 cleanrooms and humidity-controlled chambers
How Robust is their Supply Chain Management?
In today’s globalized world, supply chain disruptions are not a matter of if but when. Whether it’s natural disasters or geopolitical tensions, many factors can derail your manufacturing timeline.
Enplas mitigates these risks with robust business continuity plans and a global manufacturing network, ensuring minimal disruptions to the supply chain. Our global operations and close relationships with suppliers enable a robust material supply for polymers, as well—in fact, we work with almost all polymer material suppliers around the world. Dual-sourcing polymer materials can also help mitigate disruption risks. Enplas can provide recommendations and support on selecting and evaluating alternative materials that can maintain required device performance and manufacturability. Our global tooling capacity (including in the U.S.) enables us to manufacture more than thirty molds in-house monthly, and we have various material supply sources to maintain production. Given the dynamic needs of established OEM’s or growing start-ups, Enplas’s flexible and robust supply chain management system can adapt quickly to scale production up or down as your business needs evolve.
Do They Have a Culture of Transparent Communication?
Transparency and open communication are invaluable in any successful partnership. With contract manufacturing, this becomes even more important. Failure to communicate clearly and effectively can lead to misunderstandings, delayed timelines, and even compromised quality. Always choose a partner that values open dialogue, keeps you updated on every stage of production, and listens to your concerns.
Enplas doesn’t just manufacture; we partner. Flexibility is our cornerstone: we adapt swiftly to project changes to safeguard timelines and milestones. When challenges arise, our hands-on problem-solving approach transcends conventional supplier limitations to overcome any obstacle. And good, clear, and proactive communication isn’t just a value—it’s a key determinant in the success of your project. When Enplas commits to a culture of communication, we’re essentially committing to minimizing delays, reducing unnecessary costs, and achieving your project goals effectively.
Conclusion
Choosing an IVD contract manufacturer is a complex yet critical process. The success of your project hinges on your ability to make informed, judicious decisions. By asking the right questions and focusing on the key considerations outlined here, you can mitigate risks and set the stage for a fruitful partnership.
For a partner that aligns with your manufacturing goals across all these critical dimensions, consider Enplas. Learn more about how Enplas can elevate your manufacturing processes and help you navigate the complexities with ease.