The demand for innovative healthcare solutions continues to rise, putting extra pressure on the scalability of medical devices. Even mature start-ups find themselves scrambling to figure out how quickly their products can be available and how widely they can be deployed.
Most scalability challenges stem from two common roadblocks:
1) the manufacturability of the product design and
2) a lack of an established supplier network.
Designing for Manufacturability
Product designs go through multiple iterations from concept to first article. When a product incorporates new technology, and needs to meet aggressive deadlines, engineers often source components that are the most accessible. This will often include consumer or gaming grade components that are convenient to source in small volumes, easy to purchase, and are familiar brands.
The issues with these types of components arise as one moves from proof of concept and early prototype stage to production. Medical devices are subject to stringent regulatory standards to ensure patient safety and product efficacy. Long production life, revision controlled components are critical. Components that were not designed or produced with medical devices in mind will not provide the predictable availability and revision control over a long period of time driving costly validation, regulatory and other distractions to a business that hamper their ability to scale manufacturing.
It’s crucial to use components specifically designed and tested for healthcare applications, meeting the highest standards of safety and reliability, long term availability and revision control to ensure the success of medical device manufacturing. It can be more difficult to do this from the proof of concept and prototype stage and require more investment in identifying and sourcing the components, but it will build a solid foundation for managing the product through regulatory submittal/approval and production.
Which leads to the second roadblock – finding a supplier that works with smaller medical device companies and startups.
Establishing a Supplier Network
Component suppliers support customers worldwide across all industries. The higher the quality or popularity in the industrial market, the harder a smaller order volume will be to find. Medical device startups may find themselves in a dilemma where they know the components and suppliers they need for manufacturability but are unable to work with them early in their development process due to low volumes and budgets.
Unfortunately, medical device startups have a few disadvantages while they are in the beginning phases of development when it comes to finding a supplier. A startup’s limited brand recognition, lack of track record for making consistent and timely payments, and low and/or fluctuating order volumes make them appear to be a risky venture.
Medical device startups can overcome these challenges by establishing partnerships with other startups or leveraging their manufacturer’s supplier relationships since they can vouch for their credibility. These collaborations can support the startup as it builds a reputation for reliability and steady growth.
Remove Roadblocks
There are many ways for medical device startups to navigate these roadblocks on their own. They can be removed altogether by partnering with a manufacturer who is experienced in scalability, has worked for years to establish a trusted supplier network, and can remain a partner for the long-term, even as the startup grows and matures.
EmbedTek takes a system-level, holistic approach to designing a solution based on initial requirements from the customer. We leverage proven technologies, common building blocks components, and existing supply chains whenever possible. Our engineering and production teams incorporate and validate the technical, ergonomic, business, environmental, and regulatory dynamics of a project at each step of design. Our manufacturing process and quality system is agile, flexible, automated, and adaptable to reduce the burden on our customers and eliminate errors.
When medical device startups partner with EmbedTek, they are supported throughout the lifecycle of the product. EmbedTek knows how to manage long-term cycles by leveraging our supplier network to accommodate smaller volumes. Thanks to our many active accounts, we can combine multiple customer orders to buy in high volumes and minimize costs.
Because of our many years working with medical device startups, EmbedTek has the engineering and electronic design expertise to scale a project as demand increases. We are registered with the U.S. Food and Drug Administration (FDA) as a Contract Manufacturer of Medical Devices. This status provides medical device companies with the operational infrastructure they need to grow while preserving capital to apply to their own R&D, maximize ROI, and focus on what they do best.
