Five Essential Strategies for Risk Mitigation in Medical Molding Outsourcing

For medical product manufacturers, success is measured by the health and safety of patients and end users. Given the critical nature of your device, equipment, or product, throughout the design, development, and manufacturing process, there is no room for risk.

Throughout your supply chain, risk can take many forms. You may experience the threat of missing a launch deadline due to defective parts from a supplier. You could be in danger of rising costs due to issues with your part design not discovered until the production floor. You could be partnering with suppliers for your materials, sub-components, or equipment that aren’t moving with the same understanding of product performance. However, the biggest risk is the potential harm that can be caused if your final product does not perform as intended.

As a medical product manufacturer, you are rightly concerned about minimizing risk wherever possible — particularly in the careful selection of dependable supply chain partners. This becomes particularly critical during the launch of a new product or when scaling up the production of an existing one. The reliability of these suppliers, including custom injection molders, plays a pivotal role. It is imperative that these partners not only meet but surpass the highest standards for quality and reliability.

Whether you are manufacturing test kits, in-home diagnostic equipment, surgical equipment, or any other medical-related product, your plastic parts need to perform exactly as designed when being used in hospitals, doctor’s offices, at home, and beyond.

With thousands of custom injection molders in business today, the decision of who to partner with can be a challenge. Here are five key characteristics to look for to build and maintain a strong, long-term custom molder partnership.

Look for an innovative custom injection molder that is dedicated to getting ahead of manufacturing challenges, new regulations and customer demands to enhance product design, functionality and sustainability. Image courtesy of Hoffer Plastics.

1. Technical expertise

It goes without saying that your medical supply chain partners need to be technically excellent. The tight tolerances, complex geometries, and challenging materials often seen in medical devices, products, and equipment require a greater level of sophistication than a standard widget. By choosing a contract molder or manufacturer without specialized and proven technical skills, you could be facing delayed timelines, added costs, and unnecessary risks to your product functionality and integrity.

From design engineering and micro-molding to post-molding sterilization, your program may call for advanced expertise from one or multiple partners. Seeking a custom manufacturer that offers a full range of competencies that align with your program needs can make a significant positive impact on your program. You can mitigate risk by bringing together a cross-functional team of engineering and manufacturing experts on one team, under one roof, to evaluate your product and design from every angle, providing support for your program from start to finish. That way, your team can focus on what it does best — ideating new products that address unmet critical patient needs in the market — while your custom molder manages the details.

2. Forward-thinking innovation

What can your supplier do to enhance your part or product design for safer, easier use? Can they improve materials and processes to reduce costs? Find more sustainable solutions for your part to lessen your environmental footprint? You can eliminate the risk of losing market share, and reputation, with the right innovative and forward-thinking partner.

Beyond consistently delivering high-quality parts, medical product manufacturers need to ideate new products or enhance existing technologies to stay ahead of the competition. In a field where challenges, regulations, and customer demand constantly evolve, an innovative custom molder can help you translate these potential risks into better product design, functionality, and sustainability. When you are facing a potential delay due to a seemingly insurmountable challenge, a contract manufacturing partner who is not afraid to think differently about your specific program can ultimately lead to new developments — in materials, part design or process — that accelerate your growth beyond what you had imagined.

As you seek your next supply chain partner, consider one that embodies a spirit of entrepreneurship and innovation that can quickly help you launch new products or make your next-generation product even better.

3. Financial stability

Are your suppliers on solid ground? Is an ownership change, and all the disruption that comes with it, on the horizon? Will your partner need to shutter its doors due to poor performance? Asking yourself these questions when selecting an injection molder can save you a lot of time and stress throughout the validation and approval process and beyond.

For you, working with a financially stable medical device manufacturer will bring peace of mind, and can also have a major impact on your own financial stability as well. Avoiding the negative financial impacts of regulatory compliance issues and rework, supply chain disruptions, and potential legal ramifications of product failure are all positive results of a partnership with a stable contract manufacturer.

The healthcare industry demands stringent adherence to changing regulatory standards and commitment to producing high-quality products. A medical molder’s ability to keep up is also dependent on strategic investments in processes, technologies and equipment to drive near-constant innovation. Without the ability to financially support this continued growth, your partner may fall behind. These strategic investments can be a key driver that sustains the long-term viability, quality, and innovation capabilities of a medical contract manufacturer.

When it comes to critical medical components, good is not good enough. From initial program discussion through final product delivery, ensure your custom manufacturing partner embodies a quality culture that enables safe, consistent, high-quality production of medically oriented parts. Image courtesy of Hoffer Plastics.

4.  Verified quality

An unwavering dedication to maintaining consistent quality is a fundamental characteristic that you must share with your supply chain partners. In order to protect end-users, partners must embody a quality culture at every stage — from initial program discussions through final product delivery.

Seek out suppliers that take ownership and accountability for quality. Your partner should hold certifications such as MedAccred — an industry-managed oversight program that verifies strict adherence to standards and processes that enable safe, consistent, high-quality production of medically oriented parts. Medical contract manufacturers that undergo an annual MedAccred audit and review must prove that processes and practices are always on point and up to date. It’s worth the effort to bring you greater peace of mind about protecting patient safety.

Other certifications, like Safe Quality Food (SQF) which is a Global Food Safety Initiative (GFSI) to benchmark food safety standards, may not have a direct application to your product. Yet, it can help you get a clearer picture of a company’s prioritization of quality.

There’s no such thing as “good enough” when it comes to patient safety and your reputation. Seek a custom molder that embodies a true commitment to quality and product integrity, going above and beyond to minimize your risks.

5. Proactive communication and continuous improvement

Your business doesn’t stand still. Especially in the medical products industry where speed-to-market is the name of the game. You’re always looking for ways to do what you do better. So should your suppliers.

Transparency and communication serve as powerful shields against potential risks. By fostering an environment where challenges are openly communicated, addressed promptly and transformed into opportunities, you create a resilient partnership. This approach not only mitigates risks associated with unforeseen challenges but also establishes a foundation for trust and collaboration.

Selecting a custom medical manufacturer that prioritizes continuous improvement and proactive communication propels your products to market faster while significantly minimizing risk. This forward-looking partnership is fundamental in navigating the complexities of the medical industry.

Taking your next steps
These key factors collectively contribute to the production of high-quality medical products, safeguarding patient safety and maintaining the integrity of manufacturers in the ever-evolving medical industry. Choosing a custom injection molder is not merely a business decision, it signifies a commitment to ensuring the seamless performance of medical products, safeguarding patient well-being, and preventing any potential failures in the field. Take the first step towards ensuring the success and reliability of your medical products by partnering with a custom injection molder that is focused on accelerating your success.