There are a lot of options and a lot of potential (and costly) mistakes you can make along the way – especially when it comes to medical components. Your contract manufacturing partner needs to meet the highest standards to ensure you end up with a reliable, quality product.
Finding the right partner isn’t easy. Here are five important questions you will need to ask before choosing a partner to guide your project through production.
The manufacturing of medical components is highly controlled and held to the utmost standards. The appropriate certification in the medical industry is ISO 13485, which sets out the requirements for quality and compliance, as well as defining approved manufacturing processes. If you are looking for a partner to manufacture medical components, give serious consideration to a company with a ISO 13485 certification – but don’t necessarily rule out those that don’t if your products don’t require it, as it will raise your costs.
Other ISO (International Standards Organization) certifications include ISO 9000 and 9001, which stipulate international quality management system (QMS) standards and guidelines, ISO 14001, which is the standard for environmental management systems (EMS), and there are many, many more. Make sure your prospective manufacturer has all the relevant certifications for your project.
For medical devices, federal approval will likely be required, such as FDA (Food and Drug Administration approval in the United States or compliance with Canada’s Food and Drugs Act for Medical Instruments. Other market certifications can also come into play, such as CSA (Canadian Standards Association) or UL (Underwriters Lab) if you’re planning to sell in Canada. In Europe, products may require the CE mark, which certifies that they have been assessed to meet high safety, health, and environmental protection requirements.
If your partner’s facility is approved to these standards and certifications, then they know that representatives from these agencies can conduct surprise audits. A partner experienced in dealing with these agencies will not deviate from the approved processes and ensure any audit runs smoothly. They will also have the experience to work with the investigator to resolve any issues.
More and more companies are outsourcing portions of their medical device engineering and manufacturing. It can be a complex process due to the industry’s many regulations, so relevant experience is essential.
In addition to being subject to stringent protocols and regulatory standards, the manufacture of your product may also require testing facilities, a proven testing process, and skilled, experienced staff. The partner you choose should have people, both in-house and in the factory, who are intimately knowledgeable about medical component manufacturing. You can’t take the risk of having them learn the ropes on your project.
Ensure your contract manufacturing partner has confidentiality agreements, and that they extend to all third parties, as well. It might be beneficial to consult with an attorney who specializes in international trade and intellectual property (IP) protection. They can ensure you don’t get caught up in IP entanglements that can limit your future plans. If your manufacturing partner has facilities offshore, make sure they have team members in-country who understand the local business culture and keep your products and ideas secure.
Are you looking for the full array of design, engineering, and manufacturing – or a subset? Here, again, experience in medical components is a must. An engineering team that also understands the regulatory documentation and submission process can properly prepare your medical project for hand-off to manufacturing. An experienced manufacturing team can then ensure those regulatory requirements are met and ensure a safe, reliable component and satisfied end customer.
Ideally, you should select your contract manufacturer as early in the process as possible and include them in every project phase. If you choose a company that offers turnkey medical engineering and manufacturing, you will benefit from fully developed, standardized and compliant processes, whether you’re starting from scratch or just need to outsource the manufacturing.
There are advantages to taking manufacturing offshore, and an inexpensive workforce is a big one. On the other hand, factors like punitive tariffs need also be considered, such as the US tariffs on certain medical goods manufactured in China. That’s one reason it’s smart to select a partner that understands customs and logistics associated with offshore manufacturing, and can assign the proper HS codes to avoid issues with tariffs altogether.
Note that the majority of medical products manufactured in China are not subject to these tariffs, which is why large medical companies are still choosing to manufacture there. Perhaps it’s because, outside of the US, China has more FDA-registered medical manufacturing facilities than any other country. Manufacturers like Roche and Johnson & Johnson – and soon Bayer and Novartis – have moved production to China, so they must be confident that quality and profitability will be maintained. (You can take a deeper look into this topic here.)
China is the hub of global manufacturing, and besides delivering electronic products around the world, they also have a thriving domestic medical device market of close to $79 billion, which has been growing in double-digits over the past decade. Western companies can leverage their knowledgeable, affordable workforce, healthy supply chain and cost-effective raw materials in a country focused on innovation.
The list above is by no means exhaustive, but it can help you sift through the sea of candidates to evaluate both what they say they can do and what you should be looking for.
If you have a medical product design, Kingstec can assist you on your journey through engineering and manufacturing. Our experienced logistics team can continue that support straight through to delivery, getting finished products to your door quickly and without hassle.
If you want to discuss this further, we would be happy to help.
