WORRELL China Capabilities 2015

MEDICAL DEVICE DESIGN FOR EMERGING MARKETS
Since 1976, WORRELL has partnered with global industry leaders to bring clarity to the fuzzy front end of new
medical device development. In 2007, WORRELL China was established to bring these world-class user-centric
design service offerings to companies seeking to develop tailored medical device & healthcare product solutions
for emerging markets.
EXPERTISE
Research & Strategy
Recruiting
Design Research & Strategy
Co-Creation & Visualization
Concept Testing
Design & Engineering
Industrial Design (ID)
User Experience Design (UX)
Design Language
Rapid Prototyping
Feasibility Engineering
Design Engineering
Transfer to Manufacturing
Human Factors Engineering
Preliminary Analysis
Formative Testing
Summative Testing
Minneapolis, MN
1976
Shanghai, China
2007
2/F, 127 An Yuan Road, Jing An District, Shanghai, 200041
For further info please contact: bd@worrell.com

RESEARCH &
STRATEGY
RECRUITING
We offer single and double blind recruiting, screening and logistics services for
all types of heath care professionals (HCP) and patients. Blinded recruiting and
screening helps to mitigate the confirmation bias that tends to happen when
companies recruit through established commercial channels and only observe
and interact with their best customers.
DESIGN RESEARCH & STRATEGY
Qualitative ethnographic research methodologies and highly visual outputs help
the project team gain a deep understanding and build empathy for customers
and stakeholders. Research methodologies such as Clinical Observation,
Shadowing, In-Depth-Interviews and Camera Studies are designed to uncover
the “why” behind the “what” and yield strategic insights that can be visualized,
mapped and prioritized in order to clarify design objectives and fuel innovation.
CO-CREATION & VISUALIZATION
This is where intellectual property and ideas begin to germinate.
Co-creation sessions create an opportunity for curated cross-functional
teams to meet, review research outputs, ask questions, generate new
ideas, expand on existing ideas and bring energy and diverse
perspectives to the design process. WORRELL designers will catalog
and map all of the ideas that emerge and visualize the most promising
ones by sketch, illustration or mockup so that the broader team can
review and comment with a mutual understanding.
CONCEPT TESTING
Industrial Designers are experts at envisioning and visualizing a variety
of systematic design directions. Through various collaborative
brainstorming and mapping exercises, our cross-functional team will
create a diverse range of use case scenarios and concept iterations/
configurations for testing and validation with internal and external
stakeholders in order to gain early and valuable feedback on possible
design directions.
Surgeon & Nurse Patient
Co-creation session in Shanghai studio.
Concept validation with cardiologists.

USER EXPERIENCE DESIGN (UX)
The best digital interfaces enable users to accomplish defined directives with
confidence and ease. The WORRELL UX team applies an iterative prototyping
process to digital interfaces using semi-functional mock-ups. These tools
identify the optimal design language and information architecture for use in your
digital interface.
DESIGN LANGUAGE
Design language is an overarching scheme or style that guides the design of a
family of products. WORRELL designers develop a unique and consistent visual
language that can describe choices for design aspects such as form, proportion,
surface transitions, materials, color schemes, shapes, patterns, textures, layouts
and even audio signatures. The design language document becomes a guide for
how the visual, tactile & audible “DNA” of a family of products should be
considered and implemented in order to establish brand consistency.
INDUSTRIAL DESIGN (ID)
Designers take a user-centric approach to creating numerous low-fidelity
concept solutions directly linked to opportunities and insights discovered during
Research and Co-Creation. The Design team will explore different options for
system layouts based on the use case scenarios identified. Concepts will also
address usability, ergonomics, aesthetics, business objectives,
manufacturability, etc… The project team will then review concepts against the
customer requirements, use case scenarios and research insights in order to
select the best features and elements from the concepts. We then create and
refine a select few concepts for higher fidelity refinement and further evaluation
and testing.
DESIGN &
ENGINEERING
Rendered ID concept image.
Semi-functional UX prototypes.

PROTOTYPING
Prototyping is an integral part of our design and engineering process. We build
numerous rounds of prototypes because they are invaluable tools for
effectively evaluating a design. WORRELL can provide many different
prototyping methods depending on the objective - 3D printing (SLA, SLS,
FDM, etc…), CNC machining, silicone molding, sheet metal fabrication,
small-run injection molding, etc… We build early stage mock-ups, appearance
models, semi-functional models and even small-run pre-production models for
testing and evaluation.
FEASIBILITY ENGINEERING
WORRELL Engineers work closely with your team to build a system engineering
plan and requirements document by defining performance specifications while
exploring the feasibility and risk of multiple concept directions.
TRANSFER TO MANUFACTURING
Design Engineers work closely with Manufacturing to ensure that the product
or device can be manufactured efficiently and cost effectively. We help to
navigate the cost/benefit tradeoffs that inevitably occur late in the
development process without jeopardizing the design intent. These services
may involve design reviews, factory visits, first article inspections,
troubleshooting, etc…
DESIGN ENGINEERING
Design Engineers work closely with our Designers to engineer solutions that
maintain the integrity of the design intent while reducing cost and complexity.
DESIGN &
ENGINEERING
Design engineers work in ProE & SolidWorks.
Engineers work closely with manufacturing to test & develop
processes.

* Conducted in compliance with IEC 62366: 2007
— Application of Usability Engineering to Medical
Devices and the FDA Guidance Applying Human
Factors and Usability Engineering to Optimize
Medical Device Design.
HUMAN FACTORS
ENGINEERING*
PRELIMINARY ANALYSIS
An immersive understanding of all users, stakeholders, environments, and
intended uses for a device is the foundation for a successful human factors
assessment. WORRELL maps the task flows and various use case scenarios
around your device to create an exhaustive list of potential risks. We analyze
these risks using specialized tools. The data is then used to inform the
Design team of potential implications for human factors and usability in order
to create a foundation for successive formative and summative testing.
FORMATIVE TESTING
Formative verification testing reduces potential risks early in the design process.
In these tests, we build upon deep user awareness with iterative rounds of
product design and usability testing with physical and/or digital models. This
human factors framework allows our designers to focus their creativity by
eliminating assumptions, establishing initial ergonomic requirements,
addressing accessibility as well as potential cultural nuances.
SUMMATIVE TESTING
Final testing against all identified use case scenarios and potential risks
means there should be no surprises during validation. WORRELL is vigilant
about generating protocols matching all risk-related tasks with the proper
user sample. A final report for regulatory submission is generated at this
point.
Task analysis & documentation.

RELEVANT
EXPERIENCE
FEATURED CLIENTS
GEOGRAPHIC EXPERIENCE
User-centric design requires a deep understanding of needs, wants and limitations for a specified group of stakeholders.
WORRELL routinely conducts Ethnographic Research and Co-Creation Sessions around the world in order to build empathy
and immerse the project team in the unique challenges and opportunities that these geographies present.
CATEGORY EXPERIENCE
Auto-Injection
Cardiac Surgery
Colorectal Surgery
CRM
Diabetes Management – Type I&II
ENT Surgery
ESRD – Peritoneal Dialysis
General Surgery
Heart Failure Management
Hernia Repair
Interventional Cardiology
IV Therapy
Neuromodulation
OBGYN
Orthopedics
Sports Medicine (Soft Tissue Repair)
Thoracic Surgery
Vascular Therapy
Wound Care
Wound Closure

FEATURED
PROJECTS
TENSION-FREE INGUINAL HERNIA REPAIR
SOLUTION
Recruiting, Design Research & Strategy, Co-Creation &
Visualization, Concept Testing, Industrial Design (ID), Rapid
Prototyping
SINGLE CHANNEL ADVANCED ENERGY SURGICAL
GENERATOR
Visualization, Concept Testing, Industrial Design (ID), User
Experience Design (UX), Rapid Prototyping, Feasibility
Engineering, Design Engineering, Transfer to Manufacturing
KNEE REPAIR INSTRUMENT SET DESIGN
LANGUAGE
Industrial Design (ID), Design Language, Rapid Prototyping
VALUE SEGMENT KNEE REPAIR INSTRUMENT SET
Co-Creation & Visualization, Concept Testing, Industrial Design
(ID), Rapid Prototyping
PRIMARY HIP REPAIR IN CHINA
Visualization, Concept Testing
HIP REVISION IN CHINA
KNEE SOFT TISSUE REPAIR IN CHINA
Prototyping
CLOSED IV CATHETER SYSTEM
Prototyping
VALUE SEGMENT IV PUMP SOLUTION
Experience Design (UX), Rapid Prototyping
WARD-LEVEL ADMIXING SOLUTION
Experience Design (UX), Rapid Prototyping, Design
Engineering, Transfer to Manufacturing, Preliminary Analysis
MOBILE ADMIXING FACILITY
(ID), User Experience Design (UX), Preliminary Analysis,
Formative Testing
HEART FAILURE MANAGEMENT IN CHINA
Experience Design (UX)
BLOOD GLUCOSE METER UI DEVELOPMENT
Recruiting, Design Research & Strategy, User Experience
Design (UX), Rapid Prototyping
KNEE REPAIR INSTRUMENT SET
(ID), Rapid Prototyping
REUSABLE SURGICAL LINEAR STAPLER
(ID), Rapid Prototyping, Design Engineering, Transfer to
Manufacturing
RESPOSABLE TROCAR SET
Co-Creation & Visualization, Industrial Design (ID), Rapid
Prototyping
RESPOSABLE ADVANCED ENERGY LIGATION
DEVICE
Prototyping, Feasibility Engineering, Design Engineering, Transfer
to Manufacturing
CARDIO PULMINARY BYPASS MEMBRANE
OXYGENATOR
to Manufacturing
CARDIO-PULMINARY BYPASS RESERVOIR &
MOUNTING SYSTEM
to Manufacturing
THORACIC SURGICAL LINEAR STAPLER/CUTTER
Prototyping
ENT SURGICAL ADVANCED ENERGY DEVICE
Recruiting, Design Research & Strategy, Concept Testing
PD CATHETER PLACEMENT
LIVER ABLATION GENERATOR & HANDPIECE
Industrial Design (ID), User Experience Design (UX), Rapid
Prototyping
CARDIOVASCULAR ABLATION GENERATOR
Experience Design (UX), Rapid Prototyping
CARDIAC MITRAL VALVE REPAIR DEVICE
(ID), User Experience Design (UX), Rapid Prototyping, Feasibility
DYNAMIC SPINE STABILIZATION SYSTEM
INSTRUMENTATION
Prototyping, Design Engineering, Transfer to Manufacturing
EPINEPHRINE AUTOINJECTOR
NUCLEAR MEDICINE INFUSION CART
RESPOSABLE HERNIA MESH TACKING DEVICE
(ID), Prototyping
BALOON ANGIOPLASTI INFLATION SYRINGE
to Manufacturing, Preliminary Analysis, Formative Testing
WOUND CLOSURE IN CHINA
OBGYN SURGICAL INSTRUMENTATION
(ID), Design Language, Rapid Prototyping, Design Engineering
SERVO-ELECTRIC LOAD FRAME MATERIAL
TESTING SYSTEM
Industrial Design (ID), Design Language, Rapid Prototyping,
Transfer to Manufacturing
SERVO-HYDRAULIC LOAD FRAME MATERIAL
TESTING SYSTEM
Design Research & Strategy, Co-Creation & Visualization,
Industrial Design (ID), Rapid Prototyping
ACTIVITY TRACKING DEVICE
Design (ID), User Experience Design (UX), Rapid Prototyping,
Feasibility Engineering, Design Engineering, Transfer to
Manufacturing
EMERGENCY CPR KIT
PATIENT WARMING SYSTEM
Industrial Design (ID), Rapid Prototyping, Feasibility Engineering,
Design Engineering, Transfer to Manufacturing
BIO-ADHESIVE MIXING & APPLICATION SYSTEM
Recruiting, Preliminary Analysis, Formative Testing
NEURO STIMULATION PATIENT CONTROLLER
Industrial Design (ID), User Experience Design (UX), Rapid
Prototyping, Preliminary Analysis
MOBILE PATIENT MONITORING DEVICE (CRM)
Engineering, Transfer to Manufacturing
IVD LAB EQUIPMENT
Feasibility Engineering, Design Engineering, Transfer to
Manufacturing
LOW-COST RENAL DENERVATION
TRANSCATHETER DEVICE
Prototyping, Feasibility Engineering, Design Engineering
MICRO NEEDLE ARRAY AUTO-INJECTOR PATCH
(ID), Rapid Prototyping, Feasibility Engineering, Design
Engineering
OVER ACTIVE BLADDER PATIENT STUDY
Visualization, Concept Testing, Industrial Design (ID)
DISPOSABLE VALUE SEGMENT SURGICAL
CIRCULAR STAPLER
Industrial Design (ID), Rapid Prototyping

WORRELL China Capabilities 2015

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