How to Choose the Perfect Manufacturer for Your Medical Device Prototype Development

If you’re a medical device inventor, developer, or start-up with an innovative medical device idea, choosing the perfect medical device contract manufacturer is essential to the success of your product. It’s important to make sure that the contract manufacturer you choose is capable of meeting your needs. All medical device contract manufacturers are not created equal. Some may specialize in certain areas while others are much more diversified. The role of a manufacturer isn’t only to produce your product but also to help you navigate the complexities of the medical device industry. Priming your medical device for success in the market means understanding the needs of healthcare providers and patients, accurately estimating demand, and navigating the intricate regulatory world of the medical device industry.  

A medical device contract manufacturer should help you through the complete lifecycle of your product. Experienced manufacturers have a wealth of resources to effectively and efficiently bring any product through development, testing, validation, verification, manufacturing, and finally to the marketplace. The perfect device manufacturer consists of expert teams of designers, engineers, marketers, and regulatory experts to help you and your product navigate the process from beginning to delivery. The best way to find the right one for your product is by exploring all of your options and doing thorough research before making a decision. It is essential that you have a clear understanding of what your product’s needs are before choosing any particular manufacturer. Depending on your unique device, you can better choose a medical device contract manufacturer whose expertise and experience closely align with the needs of your device.

Don’t Underestimate Industry Standards Knowledge and Experience

Medical device manufacturers make an investment in your medical device or component once the contracts are signed. Equally, you make an investment in the manufacturer so that they can lead you and your product to success. It’s essential to put your trust in a manufacturer that can manage the regulatory and compliance processes of manufacturing. Hiccups in these processes can result in costly delays, fines, and the possibility of your product never reaching the marketplace. Familiarize yourself with a manufacturer’s regulatory experience before committing to anything.

The Food and Drug Administration (FDA) regulates medical devices to confirm that they are not only safe for use but also effective at completing their intended function. The FDA classifies medical devices with one of three distinct labels: Class 1, Class 2, or Class 3. Classifications determine the degree of regulatory control necessary for devices, which directly influences the processes of your product’s manufacturer. Regulatory control is more stringent as the class number increases. Navigating the complex world of the FDA regulation process is easier with an experienced, knowledgeable medical device contract manufacturer to help you along the way. 

Underestimating the importance of experience in the processes can place your product in serious jeopardy. This is a part of the manufacturing process in which Pathway NPI excels. Pathway NPI complies with ISO Standards for Medical Device Development in FDA-compliant facilities, which seamlessly works with regulatory bodies to design, validate, and produce compliant medical device solutions. If your product is classified as a Class 2 or Class 3 medical device, it’s also important to consider that when choosing a medical device contract manufacturer. If your chosen manufacturer doesn’t have experience manufacturing Class 2 medical devices, for example, that presents unknowns that may affect their ability to properly manage the regulatory and manufacturing process.

Efficiency Throughout the Manufacturing Process

If you’re looking to bring your revolutionary medical device to the marketplace, utilizing a cost-effective manufacturer is the biggest incentive to collaborate. Manufacturers rely on streamlined development and manufacturing processes to save money and time for their clients. Pathway NPI, for example, employs expert teams of designers, engineers, and regulatory experts to standardize processes and efficiently move products from concept to delivery. 

By monitoring the trends of the medical device industry and understanding the regulatory necessities for compliance, Pathway NPI can anticipate and deliver on the needs of any specific product or client. Merging vast resources and innovative technologies, such as additive manufacturing and cloud based medical devices systems, allows an experienced device manufacturer like Pathway NPI to produce high-quality devices and components with minimal waste. Additionally, a quality control system is needed to establish device design controls. Not only is process and documentation necessary to receive FDA clearance for medical devices, but they also dictate the practices used in the development and manufacturing processes. Failure to establish these device design controls can result in FDA disapproval. Choosing a manufacturer with a well-documented and iterative approach can make for an efficient and streamlined manufacturing process. 

Responsiveness and Honest Communication are Invaluable

The willingness and ability of a contract manufacturer to prioritize communication with a client cannot be undervalued. Clear and prompt communication from a manufacturer can be indicative of important qualities in their structure and processes. Their ability to communicate and invite discussion about the device or component offers valuable insight into the development process. Take note of the communication, especially early in the process, to get a better sense of how the manufacturer will operate throughout the rest of the partnership. Internal communication is often a glimpse into the inner workings of the company as well. If you’re meeting with multiple team members, all of which are knowledgeable and communicative about your device’s unique needs, problems, and applications, it’s a sign that you’re dealing with a well-organized and open manufacturer.

Pathway NPI prioritizes communication with our clients through our expert teams of designers, engineers, and regulatory specialists. Are you an entrepreneur, inventor, or start-up with the next big medical device idea? Pathway NPI can help you develop your medical device, navigate the regulatory process, and push your product through to the marketplace. We’re a one-stop-shop for medical device design, development, and manufacturing. Our multidisciplinary team has top-level experience and knows how to turn your vision into reality. 

Contact us today to learn more about how Pathway NPI can help turn your innovative medical device design into the next big success!

About the Author

​​Arthur Deptala
LinkedIn
CEO of Pathway NPI

I’m the CEO of Pathway NPI, where we’re impacting the evolution of healthcare by streamlining medical device development, manufacturing, and commercialization.

Specifically, Pathway NPI partners with early-stage medical device companies, enabling them to leverage our umbrella of certifications, audits, and manufacturing technologies to expedite their time to market while focusing exclusively on selling their product. This solution in turn allows better use of startup capital and compresses the startup timeframe.