What To Look for in a Medical Device Manufacturing Team
Choosing your business partners is a crucial process. You want to take your time evaluating your choices, learning more about certain companies, and choosing a team that will serve your specific needs with quality, efficiency, and passion.
When it’s time to search for a development and manufacturing team to bring your medical device to market, prepare a list of qualities and values you want in your partner. This checklist will inform questions you have and research you perform on your potential associate.
When you know what to look for in a medical device manufacturing team, you can narrow down your search and find the best company for your specific project. As you begin reaching out to potential manufacturers, keep an eye out for these valuable traits and assets.
Experience and Relevant Case Studies
A company can be phenomenal at its specialty, but if that specialty has nothing to do with your project, that team might not be able to serve you. Experience and relevance are crucial when finding a manufacturing partner. Take the time to learn about your potential partners and their history in the industry. How long have they been in manufacturing? How has their team grown over the years?
At the same time, look into their specialties and services. Case studies are a great resource for learning more about a manufacturer’s services. Look at the projects they’ve done in the past, how they completed the job, and what kind of results they achieved. Don’t be afraid to ask questions about a company’s history in your field. The more relevant experience they have, the better they’ll be able to serve you.
Material and Supply Chain Expertise
Materials are a major part of a device’s cost and success. The right material will enable a product to work flawlessly, while the wrong material can contaminate samples, alter results, and even cause safety concerns for end users and patients. A lot rides on your manufacturer’s ability to choose the right material for your device. As such, you must work with a team that has experience and expertise in material selection.
Knowing which materials to use and why isn’t enough, however. A good manufacturer will also know how to reliably source materials. A solid supply chain and good relationships with vendors makes development a faster and easier process for everyone involved. Furthermore, a dependable supply chain should display clear quality control practices. Ask your potential manufacturers how they work with their vendors to ensure they use only high-quality materials that are right for each specific project.
Turnkey Manufacturing Abilities
Turnkey manufacturing is when a single company oversees all steps of the manufacturing process. From sketching initial designs to putting products on the market, a turnkey manufacturing partner handles every step along the way. While it’s not always necessary to choose a partner with turnkey manufacturing capabilities, there are clear advantages to it.
Turnkey manufacturing means shorter production times. When all your various teams and processes are under the same roof, communication and collaboration becomes much smoother. Turnkey manufacturing leaves less room for miscommunication, delayed work, and other signs of disorganization. More efficient manufacturing, in turn, means a more cost-effective process for you.
A consolidated team also leads to clearer intent and a unified dynamic when working on your project. Instead of several teams trying to coordinate over every small change in the design, your manufacturers are all working together as part of one big team. In addition to streamlined communication among the manufacturing team, you’ll also be able to work with a single point of contact to ask questions and receive updates about your project.
Proven Quality Assurance Processes
When you entrust your design to someone, you want to know that they’ll make a high-quality product that serves its purpose and meets end users’ needs. That’s why quality assurance is one of the most important things to look for in a medical device manufacturing team.
In medical device manufacturing, much of quality control revolves around verification and validation. Design verification determines whether the device meets all its requirements. Verification guarantees that specifications such as efficiency or portability exist in the final product. Meanwhile, design validation determines whether a device fulfills the goal you initially set out with. Validation guarantees that the final product is safe, effective, and beneficial for your target audience.
While verification and validation are crucial steps in the manufacturing process, quality assurance must be more than just a single phase of development. Quality should be a priority every step of the way. Always ask your potential manufacturing partners how they assure quality throughout the design, development, and manufacturing process. Look for hard evidence such as testing data, device history reports, and more.
Industry Compliances and Certifications
The manufacturing partner you choose must have experience in navigating industrial, federal, and international standards of compliance. When learning more about your options, always look for companies’ statements on ISO and IEC compliance.
Medical device manufacturing companies must follow guidelines set by ISO 13485 and ISO 14971, which outline quality control and risk management requirements, respectively. Additionally, IEC 60601 establishes internationally recognized standards for medical device developers to follow.
These guidelines are the basis for reliable quality assurance and risk management in the development process, so pay close attention to how companies address and follow these compliances.
Transparency is an essential part of any business partnership. You should be able to discuss the details of pricing, timelines, and challenges from the beginning of the process. The manufacturing partner you choose must be up front and honest with the specifics of how your project fits into their practices. Honest collaboration and clear communication from the early stages of your project make the entire process easier.
Look for transparency and excellent communication early on. A partner who is open and honest with you from the beginning—even before you decide to work with them—will be much easier to work with if any problems or challenges arise throughout the project.
At Gener8, we bring the utmost precision, talent, and care to every project we take on. We’re committed to bringing your designs to life with equal amounts of quality and efficiency. Our molecular diagnostic capital equipment development and manufacturing teams deliver all of the above attributes and more to your idea. From early designs to market release, Gener8 strives to bring the best results to your project.