Medical technology development is a unique game.

Enormous investment

Prototyping of a medical device is an enormous undertaking

The technologies themselves are highly complex and often extremely delicate, there are deep regulatory considerations not faced in other industries, and the legal ecosystem surrounding intellectual property can be convoluted.

Prototyping of a medical device is an enormous undertaking, and our team’s ability to expertly manage such complex projects is as valuable to your success as the wizardry we perform on the shop floor. So, when it comes to medical device development, there really is no better partner to have in your corner than PEP. Our team has consistently demonstrated the ability to take on the most complex medical device prototyping projects and to deliver them on-time and on-budget, every time, under even the most extreme time crunches. That unmatched track record of success is what our team promises to bring to your team every step of the way when you partner with PEP.



There is a lot at stake.

When it comes to designing and developing medical devices, there is a lot at stake.

Not only do new medical devices represent enormous investments, but they’re also potential life-changers for the end patients that will use them. As such, failure isn’t an option, and it’s imperative to get things right throughout every step of the development, especially the prototyping stage.

Prototyping medical devices is a complex and specialized process, and it’s also the most crucial link between ideas and market-ready products.

When you partner with PEP, you can enjoy the comfort of knowing your device is in the hands of the most professional team of American engineers and machinists in the industry, leaving your team free to do what you do best – coming up with the next idea for game-changing medical technology.

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Pre-Production Medical Device Prototyping

all about verifying your design

Pre-production prototyping is all about verifying your design, your materials, and your manufacturing processes by creating prototypes that are as close to the final production product as possible without the logistical complexity or cost associated with large-scale manufacturing. That ability to create a near-production testbed is extremely beneficial across all product categories, as it helps eliminate the possibility of problems and expensive rework emerging in full production, but it’s especially important in the medical field, where FDA approval often requires extensive clinical studies.

Pre-production prototyping allows medical device developers to simultaneously verify and refine their designs while also creating user-ready versions of their devices for use in those all-important clinical trials. That not only cuts down on costs, it also cuts down on time to market by enabling trials to be performed prior to having a 100%-production model. In an industry where speed to market is so important, that makes the benefits of pre-production prototyping hard to overstate.

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At PEP, our technical staff all experts in Design for Manufacturing and Assembly (DFMA). DFMA is a process designed to look beyond your original designs, considering every factor in the manufacturing and assembly process in addition to a product’s final use in order to find untapped potential for increased efficiency. That refinement of materials and processes ensures that the design that goes to final production is fully optimized for your manufacturing partners as well as for your end-users. The result is a smoother, more efficient, and more cost-effective journey from concept to market.

DFMA is a specialized skill that not all manufacturing or prototyping firms can offer. With PEP, you can rest assured that our engineers and machinists are constantly applying a highly trained eye in pursuit of innovative new ways to improve your product and lower your overall manufacturing costs. And when it comes to highly complex products like medical devices, sometimes even the smallest improvements in manufacturing efficiency can represent major savings.

Choose your Manufacturing Services  

Quick Turn CNC Machining

Let PEP turn your machining projects around with industry-leading speed and professionalism, no matter how complex the requirements.

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Pre-Production Prototypes

Ensure your product is ready for mass production and the market with the help of PEP’s pre-production prototyping services.

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Low-Volume Manufacturing

From high-tolerance tooling to initial production batches designed to test market adoption, PEP offers complete low-volume manufacturing solutions with quality and service levels our offshore competitors just can’t match.

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At PEP Prototypes, we’re on the cutting edge of medical device prototyping, and we’re the leaders in affordable, 100% American-made manufacturing solutions. We’d love the chance to speak with you about the unmatched experience, expertise, and track record of success in medical device development that PEP can bring to your project, so take the first step and contact us today to find out more about how our team can become a part of yours.

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