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Choosing the right medical injection molding partner is pivotal in the production strategy of your medical device. The success of your medical device depends heavily on the expertise and capabilities of your manufacturing partner. In the highly regulated healthcare industry, making the right choice is crucial for ensuring quality, compliance, and, ultimately, the success of your product. Let’s dive deeper into the key factors that should guide your decision:

1. Quality Assurance: A Cornerstone for Choosing the Right Medical Injection Molding Partner

Medical devices often come into direct contact with the human body, making the highest quality standards non-negotiable.

Look for:

• ISO 13485 Certification: This internationally recognized standard demonstrates a manufacturer’s commitment to a robust quality management system designed specifically for medical devices. Thus, it covers everything from risk management to design control, ensuring a systematic approach to quality throughout the product life cycle.
• FDA Registration: Similarly, FDA registration is a legal requirement for devices intended for the U.S. market. It indicates the manufacturer has met the FDA’s essential requirements for good manufacturing practices (GMP).

2. Certified Clean Room: Protecting Your Product from Contamination

Medical device assembly often requires a controlled environment, known as a clean room, to reduce the risk of contamination from dust, microbes, or other particles. Clean rooms range from ISO Class 8 (least stringent) to ISO Class 1 (most stringent), and not all devices manufacturing require ISO Class 5 or higher clean rooms.

Ask for:

• Evidence of Cleanliness: Request documentation or test results showing the clean room meets required cleanliness levels, whether certified to ISO 14644 or other relevant standards. ISO 14644 certification is widely recognized, but some manufacturers may follow internal procedures or regional guidelines that ensure equivalent cleanliness.
• Maintenance Procedures: Inquire about the manufacturer’s protocols for maintaining the clean room environment, including air filtration, cleaning frequency, and personnel training.

3. Experience: A Proven Track Record in Medical Device Manufacturing

A manufacturer’s experience in the medical device industry strongly indicates their ability to meet your specific needs.

Choose a Partner with:

• Experience in Your Device Type: Look for a manufacturer with expertise in producing devices similar to yours in terms of complexity, materials, and regulatory requirements.
• A Portfolio of Successful Projects: Ask to see examples of their work in the medical field. Their portfolio of projects can give you insight into their capabilities and the quality of their products.

4. Collaborative Design Support: Optimizing Functionality and Manufacturability

Your design team and the manufacturers should work together seamlessly to ensure your device is functional and manufacturable.

Seek a Partner Who:

• Offers Early Design Involvement: The manufacturer should be involved in the design process from the beginning to provide input on material selection, manufacturability, and potential cost savings.
• Has a Dedicated Design Support Team: Equally important, the partner should have expertise in medical device design, materials science, and injection molding processes. They should be able to provide feedback on your design, suggest improvements, and help you navigate any challenges.

Beyond the Basics: Expanding Your Selection Criteria

5. Sustainability: A Growing Priority When Choosing the Right Medical Injection Molding Partner

In today’s environmentally conscious world, sustainable practices are not just nice to have but necessary.

Prioritize Manufacturers Who:

• Practice Energy Efficiency: Inquire about energy-saving measures, such as using renewable energy sources or implementing energy-efficient equipment and processes.
• Use Eco-Friendly Materials: Likewise, ask about their use of recycled or bio-based plastics and their efforts to reduce waste and minimize the environmental impact of their operations.

Choosing the right medical injection molding manufacturer is a strategic decision beyond technical capabilities. It involves finding a partner committed to quality, innovation, and patient safety. They should be able to support you in navigating regulatory complexities, leveraging advanced technologies, and ensuring a sustainable and efficient production process. This guide has outlined key factors to consider, empowering you to make an informed choice that aligns with your goals and sets your medical device on the path to success. Take the next step and contact us for a consultation to find your ideal partner.

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Building client relationships in manufacturing is critical. There are countless reasons why manufacturing companies want to nurture positive relationships with their customers: strong word-of-mouth, higher customer satisfaction, increased client retention, and ultimately, a thriving business. Happy customers often translate to a happy bottom line. But how do you ensure your efforts result in the best possible working relationship?

This comprehensive guide will delve into the strategies that can elevate your manufacturing client relationship management to the next level.

1. Effective Communication with Manufacturing Clients: The Foundation of Success

Open and transparent communication is the cornerstone of any successful partnership. During your initial consultation, set realistic expectations regarding lead times and pricing to avoid misunderstandings down the line. Utilize tools like VISI software or physical prototyping to clearly illustrate your vision for the final product.

Maintain ongoing dialogue to minimize assumptions, clarify expectations, and ensure both parties remain aligned with the shared vision. Schedule regular meetings to keep your client informed and foster a collaborative environment.

Pro Tip: Take the time to understand your client’s business, industry, and market. The more you know about their perspective, the easier it will be to build a strong rapport.

2. Innovative Solutions for Manufacturing Clients: Going Beyond the Expected

As the manufacturing expert, you’re uniquely positioned to offer creative solutions that address your client’s specific needs and constraints. By actively listening to their requirements and maintaining open communication, you can develop innovative approaches that save time and money.

Remember, your insights and experience in manufacturing can provide invaluable guidance to clients who may not have the same level of expertise. Don’t hesitate to challenge assumptions and explore new possibilities to optimize product design and functionality.

3. Delivering Excellent Customer Service in Manufacturing: Exceeding Expectations

Regular meetings and open dialogue are essential, but going the extra mile demonstrates your commitment to client satisfaction. Be responsive to their inquiries and concerns, and prioritize their needs.

Building trust is paramount in any manufacturing partnership. Underscore the mutually beneficial nature of the relationship, emphasize your commitment to their success, and show that you have their back.

Adopting a strategic approach to client relationship management is key. Anticipate potential challenges and address them proactively to prevent costly delays or disruptions.

Remember, treat every client as if they are your most important. By fostering personal, authentic relationships, you can differentiate yourself from other manufacturers and become a valued partner.

4. Producing High-Quality Manufacturing Products: The Ultimate Goal

Ultimately, the true test of a successful manufacturing partnership is delivering high-quality products that meet or exceed client expectations. By listening to their needs, providing innovative solutions, and leveraging your skilled team, you can create products that consistently delight your clients.

If you’re not achieving the desired results, reassess your processes. Are your communication channels effective? Is your staff adequately trained? Are your quality control measures robust? Consider implementing a post-production satisfaction survey to gather valuable feedback from your clients.

In conclusion, building strong, lasting relationships with your manufacturing clients is an investment that yields significant returns. By focusing on effective communication, innovative solutions, exceptional customer service, and high-quality products, you can cultivate partnerships that drive your business forward. Remember, a successful manufacturer is one whose clients are also successful.

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By Miriam Mishkin – HR & Risk Manager, Artemis Plastics

Concepts around the Athena Doctrine and Emotional Quotient (EQ) have been gaining traction in organizations around the world. What implication could the implementation of those ideas have on individual employee performance and the overall productivity of manufacturing companies that employ them? Let’s get a closer look.

In their book The Athena Doctrine, John Gerzema and Michael D’Antonio present findings from their global survey of 64,000 men and women from 13 different countries. The survey asked participants to classify 125 human traits into two big categories: a) gender related characteristics (those traditionally associated with masculine or feminine traits), and b) which traits impact a company’s success. The survey found that traits classified as feminine such as cooperation, empathy, communication, collaboration, flexibility, and patience were most often associated with common indicators of success such as leadership, partnership, morality, and happiness. There is no doubt that there is a growing global trend away from the “winner-takes-all/masculine approach”. Business today needs to become increasingly social, interdependent, and transparent in order to respond to a fast-paced global environment. Thus, feminine traits such as cooperation, empathy, communication, collaboration, flexibility, and patience have become even more important now than ever. The more you master these traits the more agile and better equipped you are to succeed.

Another similar concept that can help boost individual and organizational performance, and is reshaping our view of what it takes to succeed in the workplace, is a person’s level of emotional intelligence, or their Emotional Quotient (EQ). EQ encompasses a person’s ability to understand and manage their own feelings and emotions, as well as those of their team.  This skill has been ranked sixth in the World Economic Forum’s list of the top 10 skills needed by employees who aim to thrive in the workplace. 

While not necessarily a feminine trait, emotional intelligence is comprised of  “softer skills” as opposed to “harder,” or technical skills. Based on a study by Travis Bradberry, author of Emotional Intelligence 2.0, 90% of top performers studied scored higher in EQ. In addition, Dr. Daniel Goleman found that star performance in every field depended more on emotional intelligence (“softer skills”) than on I.Q. or technical skills (“harder skills”). 

How can we leverage these ideas to transform our organization with feminine and emotionally intelligent traits?

One approach is to develop a company culture with core values that mirror feminine traits most associated with success.

At Artemis Plastics, one of our core values is collaboration. We have differentiated ourselves from other manufacturers through strong collaborative structures internally and externally. We believe in building solid relationships with and between our employees, customers, vendors, community members, and all stakeholders. This collaborative culture is part of our company’s DNA, and makes us who we are. 

In addition, we have trained all of our managers on EQ skills and introduced them to the Myers-Briggs Type Indicator (MBTI) test. They now have a broader appreciation for their own perspectives, strengths and challenges as well as those of their peers and teams. We also include many EQ factors on our informal and formal Performance Evaluations.

Building up on our collaborative culture and training our team on Emotional Intelligence have led to happier and more engaged employees who take less sick days, make fewer mistakes, and work together more readily to solve issues before they become problems. For example, Artemis Plastics had zero health and safety incidents during the entire 2019 year.

However, there is still room for improvement. For example, when it comes to providing their ideas, we notice that women mostly choose to post their ideas anonymously in a suggestion box vs. men who are for the most part comfortable sharing  them face to face. This tells us that even though we have made efforts to foster a more collaborative workplace, there are refinements to be made.

Nevertheless, the progress we have seen has been very encouraging, and has motivated us to continue to fully embrace and promote feminine and emotionally intelligent traits at all levels of our company for the benefit of all stakeholders, and particularly, our employees and customers.

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Choosing a medical injection molding manufacturer is an essential element of your medical device’s production strategy. It is undoubtedly a delicate process as it touches the healthcare sector – a sector known for its stricter regulations and guidelines. This is why your future partner should already have mastered the regulations and guidelines associated with medical devices.

Here are four questions you should ask any manufacturing partners to ensure that they meet the minimum manufacturing standard for your plastic molded medical devices.

ISO 13485 Certification: Is Your Medical Injection Molding Manufacturer Qualified? 

Quality assurance is the cornerstone of medical device manufacturing. Medical devices can come in contact with bodily fluids or work to support functions inside our bodies. Therefore, their utilization requires the highest level of quality to avoid contamination and infections. For this reason, you want to select a manufacturing partner with a robust quality assurance process. And a certification is undoubtedly the fastest way for you to evaluate their quality insurance’s credentials. So, to start, check if the manufacturer has a current ISO 13485 certification and FDA registration. 

Clean Room Facilities: Does Your Medical Injection Molding Partner Have the Right Environment? 

In most cases, the assembly of medical devices happens in a clean room. Manufacturers build clean rooms to limit product contamination by airborne particulates, contaminants, and pollutants. Therefore, clean rooms are climate-controlled to reduce the amount of dust and other particles entering the space. Additionally, equipment inside the clean room creates minimal air contamination. Depending on the clean room’s class, personnel could be required to wear garments that cover their hair or their entire body. You should ensure that your medical injection molding manufacturer of choice has a clean room and not just an area separated by a plastic curtain. If you are doubtful or unsure, ask for a form of proof such as clean room certification. 

Experience in Medical Device Injection Molding: Does Your Manufacturer Have a Proven Track Record?

You want to choose a plastic injection molder with prior experience in medical device manufacturing. Preferably, you will select a manufacturer that has successfully produced devices similar to yours in the past. Thus, look for an experienced medical device manufacturer that already has the equipment, facilities, personnel, vendor relationships, design knowledge, and other specialized skills necessary. 

Design Support: Can Your Partner Help You Optimize Your Device?

Your medical injection manufacturer’s design support team should help you add value and functionality to your device. The materials used for production and the techniques used to develop the part must align with the unit’s intended use. For example, specific methods will produce a component that is resistant to heat, while others will provide a part that resists microbes. The wrong choices of raw materials could lead to a disastrous breakdown of the manufacturing process. Medical injection molded device design requires many layers of consideration that will be difficult for an inexperienced supplier to navigate. 

In conclusion, when choosing a medical injection molding manufacturer, prioritize those equipped with the necessary tools, certifications, and experience to produce your device to the highest standards.

Start by getting the initial questions answered in this guide, then consider additional factors important to your business, such as production lead time, price, and services. The right medical injection molding partner can make all the difference in your medical device’s success.

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There are close to 600 plastic injection molders in the United States alone. Choosing your ideal partner can be tricky and time consuming. Here are 10 questions to get you started:

How much experience do they have in your industry?

The amount of time that they have been working as an injection molding manufacturer is important, but equally as important is if they are experienced in serving your industry. An injection molder with experience in your market could help you to design, develop, and improve your product with industry-specific insights. Not only should the manufacturer be versed in your industry, having a diverse portfolio of clients from a wide-range of markets is a great sign of a dynamic team.

Are they equipped to produce your device?

Each injection molding manufacturer is outfitted with different equipment that allows them to deliver differing services to their customers. For example, one important question regarding equipment is if the manufacturer’s presses are capable of producing the size part that you need. Larger presses are able to produce larger items, and smaller presses produce smaller items. Make sure you determine if the manufacturer is equipped to meet the requirements of producing your part before moving too far along in the manufacturing process.

Do they offer prototyping?

In the interest of avoiding a regrettable and costly mistake during production, it is important to get the design of your unit right. Using prototyping techniques such as 3D-Printing, clients can hold the product in their hands before toolmaking even begins. This is a great way to determine if any adjustments need to be made in the design before moving on to tooling.

Do they offer in-house tooling?

Tooling is arguably the most important part of the injection molding process. It’s also the most expensive and time-consuming. This process can be less costly and take less time if your manufacturer utilizes in-house tooling, as opposed to outsourcing this process. Aside from the initial benefits of in-house tooling, this offering boasts other perks such as maintenance options and higher-quality tools.

Do they have a Cleanroom?

Cleanrooms are climate-controlled areas that are built to reduce the amount of dust entering the space, among other things. Depending on the class of cleanroom, personnel are required to wear garb that covers their body in an effort to reduce the amount of particulates entering the room. Cleanrooms are held to high standards because they are used for the production and assembly of sensitive devices, such as those to be used in the medical field. If you need a cleanroom in order to complete your production, also consider how much space they have available to determine if they could handle your demand.

What are their customer service ideals?

You don’t want to find out too late that your partner is a terrible communicator, or that they do not value great customer service. Trust is necessary in any partnership, and especially so in one as important as manufacturing. You can somewhat gauge how the supplier will treat you down the road by evaluating how long it takes for you to hear back from them during initial conversations. If it’s taking a week or two to receive responses during the fact-finding portion of your partnership, then it might be a sign of things to come. The manufacturer should probably also mention, unprompted, that great customer service is one of their priorities.

Are they competitively priced?

The highest-quality product won’t matter if your manufacturing isn’t at a price point that allows you to remain competitive. Ask potential suppliers what their record is for delivering products within a scheduled time-frame. Also, ask what processes they have in place that are meant to save you money; whether that be with product design, value adds, or something else.

Will you have access to a product development or design support team?

In the early stages of development, there is a fair amount of design tweaks and fine-tuning. Choose a manufacturer that offers design support to help add value to your device, or address potential issues that you did not previously recognize. A manufacturer should not only have a team of this kind available to you, but the group should also work well together, be experienced, and highly-talented. After all, the design of your project will only be as good as the team that worked on it.

Do they produce high-quality products?

Determine if you are working with a reputable company by exploring online and asking questions. Try checking out their website, searching for them on the web, reading reviews, and requesting customer testimonials. Another way to determine a quality manufacturer is inquiring about their recent investments in new technologies and equipment. If they show a trend of regular updates and continuous improvements, you can feel more assured that you are dealing with an innovative company that aims to produce quality products.

Are they certified ?

ISO certifications verify that a company is meeting certain regulatory or statutory requirements while also meeting the needs of customers and stakeholders. Check and make sure that your manufacturer is ISO certified, and what other certifications they might hold. This may include FDA registration or Clean Room certified. Even if your project does not require these distinctions, for comparison’s sake, it is good to see which suppliers are capable of meeting strict standards. The manufacturers that have earned these certifications are operating within the highest standards in the industry.

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Sometimes we deal with manufacturing partners that have no in-house tooling services. In those instances, we have no choice but to turn to a third party for our tooling needs, which can lead to additional uncertainty. Fortunately, a growing number of injection molding manufacturers now offers in-house tooling options. Here are several reasons why you should choose a manufacturer with an in-house tooling service:

Cost

Here’s a tip that might give you insight into which manufacturer will becheapest to partner with, even before requesting a quote: do they have in-house tooling, or do they outsource that work?

Tooling is the most important part of the injection molding process. Naturally, it’s also the most expensive, and usually the most time consuming. Choosing a manufacturer with an in-house tooling room instead of one that outsources to make their tools could save you money.

Better communication & more collaboration

Even with advanced technology, miscommunications are bound to occur, which can lead to mistakes. Errors are costly and time-consuming, as reworking a tool can cost several thousand dollars and weeks to complete.

Collaboration between engineers, tool-makers, and inspectors throughout the tool-making process will result in more accurate and higher-quality output. When all parties are under one roof it leads to improved communication and presents the opportunity for problem-solving on the factory floor.

Guaranteed Quality

The quality of components and equipment being used to produce tools can have a substantial effect on the quality of the units the tool will eventually produce.
When tooling is completed in-house, suppliers can guarantee exactly what types of materials are being used, thus, the quality of the tool.

Added value throughout the process

Manufacturers with in-house tooling options often can offer other value-adds by leveraging their design support team. Generally, support team can offer clients key insights on the process and products, and perform tasks such as a DFMA (design for manufacturing analysis) to calculate the viability of the tool design and if any changes should be made for optimal production.

Regular, in-house maintenance

Tools require regular maintenance throughout their life-cycle in order to be at peak operating performance. This maintenance includes fixing damaged tools, as well as scheduled preventative maintenance, such as regular cleaning and inspections. Clients of manufacturers with in-house tooling can enjoy shorter downtimes when compared to outsourcing. This is because preventative maintenance activities can be scheduled at opportune times, and damaged tools can be addressed swiftly. Instead of waiting for shipping time, and the possibility of an extended queue at an outsourced site, on site tool maintenance will require a much shorter time-frame.

Lifetime Value

Many suppliers with an in-house tooling room will offer to hold onto your tool after production has finished. Whenever a client returns to produce more units, the supplier will have the tools on-hand and ready for another run. This ease of access makes an in-house tooling room an incredible value-add for your investment.

Tooling is a vital step in the injection molding process, and the ease of access and flexibility of an in-house tool room will save partners time, money, and circumvent the many risks associated with depending on someone else to develop your tools. Keeping tasks in-house allows for oversight, better communication, and guaranteed quality.

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