There is no doubt that the current environment for medical device innovation is riddled with risks and challenges. Market fluctuations have affected material availability, while supply chain hiccups, cost pressures, and high-demands from insurers can adversely affect time to market. But in this ever-evolving landscape there is one thing that has remained the same — if you’re not first to market ahead of your competition, you’re last.
Now more than ever, taking your medical device innovation from design to delivery requires a partnership that not only has expertise in your specific device area, but can provide more value-added services such as product and process development, component manufacturing, assembly, and packaging to help streamline the process. To ensure your device maintains a competitive edge, it’s important to seek out these services in addition to risk mitigation to avoid the typical derailments at every stage.
Here are the 5 key steps to ensure speed and success from design through manufacturing:
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Establish a Solid Supply Chain
Even the best medical innovations can get stalled if the proper supply chain isn’t in place ahead of time. Most supply partners vary in their ability to design, develop, test and improve OEM designs. Having these services adds discrete value throughout the product life cycle. Therefore, understanding your partner’s capabilities and making sure they have a strong network with priority access to materials will ensure there are no manufacturing disruptions. Partners with multiple locations could add redundancy as well as provide the option to be closer to your facilities or within lower-cost manufacturing countries. That flexibility, along with global reach will help mitigate risk.
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Choose & Source the Right Materials for the Job
Specialty materials are a key part of devices and packaging. Therefore, partners with priority access to these materials are fundamental to ensure availability and uninterrupted supply. From these relationships, your supplier needs to be able to provide solutions to highly challenging designs. The result should be an optimized material ready to perform to your specific requirements. Minimum order quantities, lead times and availability of pre-qualified medical grade materials are crucial when making design decisions that might be difficult to change later, affecting timing and cost. For single-use devices that utilize foams or films, a proficiency in precision molding of complex foam components or combining hard to join films to create failsafe bonds, is crucial in creating solutions that are reliable. Raw materials are ‘raw.’ A supply partner that can manage the adaptation of the material to your product is essential. Partners that are pro-active in managing material suppliers will help increase value across the board, and protect the OEM from having to manage potential challenges along the product lifecycle.
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Set Up a Quality Management System
It is essential to have a Medical Quality Management System (QMS) in place, led by a team of experienced quality personnel. Having these established processes and experts accessible, while understanding the critical requirements for the production of the device, will help foresee any problems as you move beyond a prototype. You will need a QMS that is proven and repeatable to ensure products are manufactured to the strictest levels of quality to mitigate risk. Specifically for sterile packaging for Class III medical devices, it’s important to look for a partner who has experience with thermoplastic polyurethane (TPU) films, which are ideal for use in medical device packaging due to their cut and abrasion resistance, biocompatibility, USP Class VI certification, and compatibility with various sterilization methods.
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Be Ready to Scale Production as Necessary
In high-demand applications like Robotic Surgery, it’s important to understand the level of production required in order to meet the need of your customers. Having a partner with deep expertise in designing and manufacturing, along with other full-service capabilities, and in particular the ability to scale, will make for fast-turnarounds on custom designs, and efficient manufacturing. Make sure your supply partners can demonstrate previous experience with managing steep ramps or changes in business conditions. Ask a lot of questions, get referrals, and ask for specifics. In the market of Minimally Invasive Surgery (MIS), procedures have experienced tremendous growth due to their benefits of less trauma, shorter hospital stays, minimal scarring, and improved outcomes. Having a partner with numerous solutions to scale, like access ports, tissue containment, stroke treatment devices, organ positioners, and packaging for guidewires and catheters, will ensure your ability to meet the MIS procedure demand.
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Usability in the Field & Business Condition Flexibility
When time is critical, precision is paramount. Even at the very first stages of your project, it’s important to be efficient and accurate, not rushed. Look for a supplier that is flexible and can react quickly to changing business conditions. New to market devices experience a multitude of accelerations and delays during launch and serial production. Employing design and engineering experts to act as an extension of your in-house team from day one, will provide a better understanding of the applications, materials, and processes needed to get your device or packaging to market quickly without sacrificing quality. A device or packaging system that’s difficult to use can lead to errors and compromise patient safety. Creating functional prototypes and performing rigorous usability testing will help mitigate these risks.
When considering a manufacturer who has specific expertise in your project, you should also consider these 5 checkpoints for success, and whether the manufacturer can carry out value-added services such as assembly, testing, packaging, or supply chain management. UFP MedTech is a full-service partner that provides these key areas of support along with product and process development, component manufacturing, and full-scale production at a global scale.
If you are in the process of developing your next medical device innovation, make sure you are first to market. Contact UFP MedTech to get started today.
