HS Design

Ensera Design is a healthcare-focused product design and development consultancy formed from the merger of Kinneir Dufort and HS Design. The company specializes in bringing medical devices, pharmaceutical products, and consumer health innovations to market with over 30 years of international experience across multiple treatment and therapy areas.

The firm offers end-to-end capabilities spanning research and strategy, human factors engineering, industrial design, digital product design, electronic and software engineering, mechanical engineering, prototyping, and design for manufacture. Their work covers drug delivery systems, surgical devices, diagnostic equipment, connected devices, women's health products, and sustainable medical devices. The company maintains ISO 13485 accreditation for medical device quality management and aligns with FDA and EU MDR standards.

Ensera Design operates studios and in-house prototyping facilities in the UK, New Jersey, and Colorado. As part of the Ensera Group contract manufacturing organization, the company provides integrated design-to-manufacturing pathways for clients seeking scaled production alongside product development services.

Choose Ensera Design when you need a healthcare-specialized consultancy that understands the complete lifecycle from user research through regulatory compliance to manufacturing scale-up. Their integrated approach works particularly well for organizations developing complex medical devices or drug delivery systems that require both innovative design and practical manufacturability.

Expect a collaborative, cross-functional team approach with specialists in human factors, regulatory requirements, and manufacturing readiness working together. The connection to Ensera Group's manufacturing capabilities provides continuity for clients seeking a single partner from concept to commercial production.

Ensera Design operates exclusively in healthcare with specializations across drug delivery, surgical devices, diagnostics, consumer health, medical devices, medical packaging, connected devices, women's health, and sustainable medical device design. The company maintains ISO 13485 certification and designs to FDA and EU MDR standards, with established processes for human factors engineering and regulatory compliance throughout product development.

Their client portfolio spans major pharmaceutical companies, medical device manufacturers, and healthcare startups, with case studies covering products from Tourette Syndrome neurostimulation devices to antimicrobial susceptibility testing platforms and prosthetic limb systems.

Medical device manufacturers, pharmaceutical companies, and healthcare technology startups developing regulated products that require deep understanding of human factors, regulatory pathways, and manufacturing feasibility. Organizations seeking a partner who can navigate complex compliance requirements while maintaining design innovation and commercial viability throughout the development process.