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Medical & Wellness Product Development and Manufacturing
As consumers and healthcare providers place greater emphasis on safety, quality, and performance, the design and manufacturing of medical and wellness products demand exceptional precision and care.
At Klugonyx, we specialize in navigating the complexities of developing innovative, compliant, and effective health-related products. Whether you're launching a new wellness device or developing a Class I medical product, we guide you through material safety, regulatory requirements, usability, and every stage of the design and manufacturing process.
Phi Health
With a mission to harmonize nature and technology, Phi sought designing, engineering, and manufacturing of custom packaging for its Stack supplements that not only embodied a sleek, futuristic aesthetic but was also eco-friendly and 100% recyclable.
Read full case study.
Wellness Product Development Work Examples
FAQs
You've got questions? We've got answers:
Designing a wellness or medical product involves user research, ergonomic design, prototyping, and engineering with strict attention to safety and compliance. Unlike general consumer products, medical and wellness items often require additional documentation, testing, and validation to meet regulatory standards before they can be manufactured and sold.
The requirements depend on the product type and market. In the U.S., FDA clearance or registration may be required for medical devices, along with ISO 13485 certification for manufacturers. For wellness products (like fitness devices, supplements, or therapeutic tools), compliance may include FCC, CE, RoHS, or biocompatibility testing. Ensuring regulatory approval early in development is critical.
Costs vary widely depending on complexity and classification. A simple wellness accessory could cost just a few dollars per unit, while an FDA Class II medical device may require hundreds of thousands in upfront investment for tooling, safety testing, and regulatory approval before production. Ongoing quality-control processes also add to manufacturing costs.
Most wellness and medical devices are manufactured in China, Mexico, Vietnam, and India, but many brands also keep some production in the U.S. or Europe due to stricter quality requirements and faster regulatory alignment. Selecting a manufacturer with ISO 13485 certification and experience in healthcare products is essential to ensure compliance and product safety.