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Medical & Wellness Product Development and Manufacturing
As consumers and healthcare providers place greater emphasis on safety, quality, and performance, medical and wellness product design and manufacturing demand exceptional precision and care. Every decision, from materials and ergonomics to labeling and instructions, must consider patient safety, user experience, and regulatory requirements.
At Klugonyx, we specialize in navigating the complexities of medical and wellness product development. Whether you’re launching a new wellness device, developing a Class I medical product, or creating health-focused consumer goods, we guide you through material safety, regulatory awareness, usability, and every stage of medical and wellness product design, engineering, and manufacturing.
Medical & Wellness Product Design and Development Services
Product Design & Engineering
As a product development company, Klugonyx unites product design and product engineering from day one. We focus on consumer product design backed by practical product engineering services like DFM, CAD, and functional prototypes. By aligning design and engineering early, we cut rework, speed timelines, and make sure your product is truly ready for manufacturing, not just a nice rendering.
Factory Sourcing & Manufacturing
When your design is ready, we take over factory sourcing and supply chain management so you’re not guessing your way through overseas manufacturing. Klugonyx provides factory sourcing services across China, Vietnam, Mexico, and other key regions, connecting you with reliable manufacturing partners. We manage quoting, sampling, quality control, and global sourcing so production runs smoothly and can scale with your brand.
Medical & Wellness Product Design Case Study: Phi Health – Stack
With a mission to harmonize nature and technology, Phi partnered with Klugonyx for the design, 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. Through close collaboration, we developed high-end capsules and packaging that align with Phi’s wellness mission while being optimized for efficient manufacturing and filling.
Read full case study.
Wellness Product Development Examples
These medical and wellness product design and development examples show how Klugonyx helps brands bring health-focused products to market. From wellness devices and consumer health products to medical-adjacent packaging and accessories, each project reflects our integrated approach to medical and wellness product design, engineering, and manufacturing.
Medical & Wellness Product Design and Development FAQs
Common questions we hear from founders and brands about medical and wellness product design, development, and manufacturing.
Designing a wellness or medical product starts with understanding the user, the clinical or wellness context, and any applicable regulations. We typically begin with product strategy, user research, and early industrial design concepts, then move into engineering, prototyping, and design for manufacturing. Unlike general consumer products, medical and wellness items often require formal documentation, risk assessments, and validation testing before they can be manufactured and sold. Throughout medical and wellness product development, we keep usability, safety, and manufacturability aligned.
Requirements depend on the product type, intended use, and target markets. In the U.S., certain medical devices may require FDA registration, listing, or clearance, and manufacturers often operate under ISO 13485 quality systems. Wellness products such as fitness devices, therapeutic tools, or connected health products may also need to address FCC, CE, RoHS, biocompatibility, or other standards. As part of medical and wellness product design and development, we help you think through likely regulatory pathways and coordinate with specialized regulatory and testing partners.
Costs vary widely based on complexity and classification. A simple wellness accessory might require a moderate design and tooling budget, while an FDA-regulated medical device can involve significant investment in engineering, prototypes, safety testing, regulatory work, and quality systems before production. On the manufacturing side, unit costs depend on materials, processes, order quantities, and where you produce. During the medical and wellness product development process, we help you estimate both upfront and ongoing costs so you can make informed decisions.
Timelines depend on how complex your product is and how strict the regulatory requirements are. Some wellness-focused products can move from concept to production in several months, while regulated medical devices may take a year or more to fully design, test, and validate. We build realistic schedules that account for design, engineering, prototyping, potential testing, and manufacturing lead times, and adjust as needed based on feedback and regulatory milestones.
Yes. Many clients come to us with an early prototype, sketch, or previous design work and need help refining it for regulatory expectations and manufacturing. We can review what you have, identify risks or gaps in your current medical and wellness product design, and then provide recommendations for engineering, materials, testing plans, and factory readiness. From there, we support you through additional prototypes, design updates, and preparation for production.
Medical and wellness products are often manufactured in regions such as China, Mexico, Vietnam, India, and sometimes domestically, depending on product type and regulatory needs. For certain medical devices, it’s important to work with manufacturers who are experienced in healthcare products and may be ISO 13485 certified. Klugonyx can help you evaluate manufacturing regions, identify and vet suitable factories, coordinate quotes and samples, and set up quality control processes so your medical and wellness product manufacturing strategy supports both compliance and scale.
