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This article will offer considerations and best practices for selecting the right partner for your medical device development project.
May 13, 2021
By: Ashley Turrell
Director of Strategy, Natech Plastics
When designing a new or novel product, a key piece of your product development success is your manufacturing supply chain. It may not necessarily be hard to find a contract manufacturer for your project; the real challenge is finding the right manufacturer for your project. Selecting the right companies to partner with means enhanced functionality for your product and elevated success for your company. Your manufacturing partner impacts everything from mold design, part functionality, part aesthetics, and material usage to piece price, part quality, and overall speed to market. Get it right early on in your design process, and you are setting yourself and your team up for success. Getting it wrong can mean increased costs, longer lead times, lower quality, and increased risks. There are thousands of contract manufacturers just in the United States and selecting the right one can be an overwhelming process. This article will help you understand how to select the right manufacturing partner the first time. Five Signs You Found the Right Manufacturer 1. They are responsive from the beginning. Decide early on what you are looking for from your manufacturing partner and what type of partnership you want. Do you want someone to be with you from design to final product? Are you looking for a long-term partnership? If you answered yes to either of these questions, then pay close attention to the company’s overall responsiveness and eagerness to work with you from day one. A manufacturer interested in a long-term partnership will be collaborative, responsive, and eager to work with you from your very first outreach. If they are delayed in getting back to your emails or calls, seem pushy or distracted in the beginning, then beware. This behavior likely won’t change once they’ve won your business. Early stage collaboration is an indication of their overall investment in your project’s success. Companies interested in truly being a collaborator and partner will show you this through their interactions with you from the very beginning. 2. They hold industry certifications and quality systems. Depending on your product’s application, you may need your manufacturer to follow some required industry standards and certifications. These certifications are issued by independent bodies, such as the International Standards Organization (ISO) or the Food & Drug Administration (FDA). Receiving these standards are optional and require a dedication to continual improvement, customer service, and quality. Manufacturers that carry these standards have a proven track record of quality, efficiency, and compliance. Achieving and maintaining these certifications can give you confidence your manufacturer has proven they are proficient in specific manufacturing and quality practices. At a minimum, look for a manufacturer with ISO 9001 certification. This certification outlines their quality management system and demonstrates their commitment to providing quality products. Beyond that, specific products, especially in the medical field, likely require you to work with a manufacturer who is ISO 13485 certified and/or an FDA-registered manufacturer. 3. They have experience serving your industry. Seek a partner who has experience in your product’s specific market. This will allow you to work with someone who understands your needs, potential product risks, technology applications, and recommend suppliers to help your product along the way. Some companies specialize in just one or two industries, while others serve broader markets. Depending on your product, you want a manufacturer who has the right experience to help you. For instance, if you have a medical device, you will want a manufacturer who has developed, designed, and manufactured medical devices in the past. If you are a startup or are new to partnering with a contract manufacturer, you want a partnership with a company who has worked with other startups in the past to launch their products. Ask about their experience with products or markets like yours. They should be able to provide case studies and examples to showcase their expertise. 4. They offer a suite of engineering and manufacturing services. When you approach a potential manufacturer to discuss your project, they should help you walk through their manufacturing process and explain how they can assist you through the product development process. Some companies offer only injection molding, while others can help you in early stages during design and into the post-manufacturing steps, such as a decorating, assembling, filling, sealing, and packaging. The suite of manufacturing services offered should match your product’s needs and eliminate the need for more complex or unreliable supply chains. Additionally, a reputable manufacturer will be able to recommend companies for any services they are not able to provide. 5. Their values align with yours. Based on your company’s values, both companies’ core values should align for a perfect partnership. Look for overall company values alignment. Ask potential manufacturing partners about their company’s core values. After which, ask for examples of how they maintain and live those values through their daily working interactions. A company who values innovation should be able to share how they support and execute on innovative ideas, continued learning, and new technologies. They will also be able to provide you with client testimonials and success stories that further highlight their core values in practice. When your values align with your supplier’s values, you have a higher chance at success, better communication, and increase the trust between your two organizations. A values misalignment could lead to trouble down the road in terms of sourcing, quality issues, missed deadlines, and miscommunication.
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