Product Design & Development for the
Healthcare Industry
Innovative, Compliant, and Human-Centered Medical Product Design Solutions by Shark Design
Elevating Healthcare Through Smart Product Design
At Shark Design, we specialize in designing and developing healthcare and medical products that are safe, intuitive, and commercially viable. From wearable health tech to diagnostic tools and digital health interfaces, we help medical startups, healthcare professionals, and OEMs transform ideas into fully compliant, manufacturable products.
We fuse industrial design, engineering, and regulatory know-how to bring life-changing healthcare innovations to market — efficiently and affordably.
Why Healthcare Product Design Demands More
Designing for the healthcare industry isn’t like designing for any other sector. You’re building products that could save lives, enhance comfort, reduce medical errors, and transform clinical outcomes. Whether it’s a home-use medical device or hospital-grade equipment, the stakes are high — and so are the standards.
At Shark Design, we deliver medical product design that meets:
FDA and ISO
FDA and ISO 13485 requirements
1
Ergonomic
Ergonomic and human-factor considerations
2
Accessibility
End-user usability and accessibility
3
Sustainability
Sustainable material selection and waste reduction
4
Consumer Product Design
We handle every stage of medical device design and development — from early-stage concepts to production-ready prototypes and regulatory support.
Concept Development & Feasibility
We begin by identifying your product’s core purpose, functionality, and market fit. Our team conducts research, sketches initial concepts, and maps out product requirements aligned with industry regulations.
Industrial Design & Human Factors
We design products that are not only beautiful but also safe and user-friendly — especially in high-stress environments like clinics and hospitals. Every button, curve, or interaction is guided by real user behavior.
Engineering Development
Mechanical, electrical, and embedded software components are engineered with precision. We ensure that your device meets both technical specs and regulatory standards without compromising design.
Prototyping & Usability Testing
Using rapid prototyping tools (3D printing, CNC, soft tooling), we turn designs into functional physical models. These are tested with real users for form, function, and usability.
Regulatory Guidance
We work closely with your team to ensure that your healthcare product design meets the regulatory requirements in your target market (FDA, CE, ISO 13485, etc.).
Manufacturing Support
From DFM (Design for Manufacturing) to sourcing medical-grade components, we help bridge the gap between design and full-scale production with vetted manufacturing partners.
Types of Healthcare Products We Design
Shark Design has extensive experience in designing and developing a wide range of healthcare products, including:
Wearable Medical Devices
- (e.g. smart patches, glucose monitors, biosensors)
Digital Health & Telemedicine Devices
- (e.g. connected diagnostic tools, mobile app-integrated devices)
Surgical Tools and Equipment
- (e.g. ergonomic instruments, patient-monitoring systems)
Home Healthcare Devices
- (e.g. pill dispensers, mobility aids, smart reminders)
Human-Centered Design That Puts Patients First
We Design Products That Drive Commercial Success
Great healthcare product design starts with empathy. We take the time to understand the people using your product — doctors, nurses, caregivers, and patients — and their needs in real environments.
We follow inclusive design principles and ergonomic research to make sure the final product works for people of all ages, abilities, and backgrounds.
Regulatory Compliance, Built Into Every Step
Our development process is built to meet the stringent demands of the medical industry. We maintain full traceability and documentation across each design phase.
We help ensure compliance with:
- FDA Class I & II device requirements
- ISO 13485 Quality Management Systems
- IEC 60601 for electrical medical devices
- HIPAA for connected health tech
- CE Marking for EU distribution
Why Choose Shark Design?
We’re not just industrial designers — we’re problem solvers for the healthcare world. With experience spanning across digital health, medtech startups, and large-scale device manufacturers, we bring deep expertise, agile development, and a user-first mindset to every project.
What sets us apart:
What sets us apart:
- FDA-compliant medical product design workflows
- On-site prototyping with medical-grade materials
- Cross-functional team (designers, engineers, UX experts, QA)
- Strong network of ISO-certified manufacturers
- End-to-end service — from ideation to production
