Product Design & Engineering Services

Built with Speed, Designed to Empower

Leverage our full suite of capabilities to acceleration your product to realization.

Your Agile Healthcare Product Innovation Partner

Our services will help you strategically allocate investments, accelerate the realization of your products, and allow you to deliver meaningful outcomes for your business, healthcare practitioners, and patients.

OUR CAPABILITIES

Through utilizing our research, design, engineering, and commercialization capabilities, we can build out personalized teams to extend your internal expertise and get you where you want to go, fast.

We transform revolutionary ideas into reality.

 

Research & Strategy
K
L

Our research and strategy services help you understand your target market, identify unmet needs, and develop a product roadmap that aligns your business goals to user needs.

We identify opportunities for our partners to improve healthcare outcomes through their products and services. Our access to healthcare facilities around the world allows us to study and empathize with the diverse patient populations and healthcare practitioners.

Human-Centered Design
K
L

Our human-centered design services use empathy and user feedback to create healthcare products that are intuitive, accessible, and effective for patients and healthcare practitioners. Human centered design is at the heart of everything we do. We use our passion to accelerate your product into the hands of patients and healthcare practitioners.

Engineering & Development
K
L

Our engineering and development services actualize your product concept into functional products using cutting-edge technology and years of healthcare industry expertise. We follow our own innovation process to build robust solutions customized to your targeted market and user. We provide world class design experience that caters to your healthcare specialty with comprehensive services that span the continuum of product development.

Human Factors
K
L

Our Human Factors Services ensure your healthcare product meets regulatory requirements, is safe for use, and enhances the user experience. We cover the entire spectrum of the Human Factors process as defined by 62366-1, HE-75 and guidance from the regulatory bodies. From gap analysis, formative and summative testing, and labeling and IFU services, our teams are ready to ensure success of your product’s usability and safety of combination products, SaMDs and medical devices by continuously observing and implementing user feedback into design.

Manufacturing Solutions
K
L

Our manufacturing solutions reduce your time to market and create options as you grow your business. Capitalize on our experience to get the job done right and on time. Our QMS (Quality Management System) facilities, and services are designed to support both low-volume and high-volume manufacturing.

Program Management
K
L

An integral part of our Design and Development success comes from our highly collaborative program management team. You can rely on our experts to provide you with technical leadership while leveraging financial acuity to guide strategic decisions for your project and achieve your goals.

We Are Better Together

Our product design and engineering team was built from three legacy companies — Fusion Biotec, Worrell, and Ximedica. With more than 35 years of experience designing, developing, and realizing revolutionary products for healthcare, we’re committed to understanding your goals and advising you on a tailored approach that expedites the development process. From discovery and definition of concept, to tapping into industrial design and human factors, to creating manufacturing transfer plans — we have extensive depth and breadth of services to complete your initiative.

Certifications

Find our certifications on our certification page.

PD&E

OUR LOCATIONS

United States

Plymouth, MN
2840 Vicksburg Ln N
Plymouth MN 55447
United States

Philadelphia, PA
3675 Market Street
7th Floor
Philadelphia PA 19104
United States

Orange, CA
160 S. Cypress St.
Suite 400
Orange CA 92866
United States

Europe

London, UK
23 Curtain Rd
3rd Floor
London EC2A3LT
United Kingdom

United States

Minneapolis, MN
1414 Marshall Street NE
Minneapolis MN 55119
United States

Providence, RI
55 Dupont Drive
Providence RI 02907
United States

San Francisco, CA
595 Pacific Avenue
Floor 5
San Francisco CA 94133
United States

Asia Pacific

Hong Kong, China
5 Science Park West Avenue
Unit 505, 5/F., Enterprise Place,
Hong Kong

LEARN ABOUT

OUR OTHER SERVICES

Preclinical Services

Global Clinical Research

Product Design & Engineering

Regulatory Affairs & Quality Management

Commercial Strategy & Market Access

Clinical Data Services