Medical Device Design

Human Factors & Usability Engineering

PRODUCT DESIGN

PROTOTYPING

MANUFACTURE SUPPORT

USABILITY ENGINEERING

GUI DESIGN

VERIFICATION SUPPORT

PDR – International Centre for Design and Research is an award-winning multidisciplinary product development centre.

PDR has over 20 years’ experience of working with world-leading healthcare providers and international medical device companies alongside innovative start-ups and other specialised device manufacturers.

Clients Include:

Medical Device Design

Human Factors andUsability Engineering

• SPECIFICATION & FEASIBILITY ANALYSIS

• CONCEPTUAL DESIGN & VISUALISATION

• DESIGN FOR MANUFACTURE

• BROAD MANUFACTURING EXPERIENCE

• REGULATORY COMPLIANCE SUPPORT & TECHNICAL FILE

CONSTRUCTION

• DESIGN, PROCESS & USER FMEA’S

• FINITE ELEMENT ANALYSIS

• HIGH FIDELITY RAPID PROTOTYPING

• MOULDFLOW & TOOLING SUPPORT

• LOW VOLUME RAPID MANUFACTURING

PDR has significant experience in medical device development in all classifications from disability devices and medical furniture through to complex diagnostic tools and drug delivery systems.

PDR combines expert user-centred research, product design and development, interaction design, regulatory compliance and introductory manufacturing services to produce robust and commercially successful solutions. A profound understanding of both user and clinical needs acts as the foundation of PDR’s reliable and proven product development and risk reduction process.

The Centre’s award-winning product design and development path takes the client from concept through to manufacturing handover and uses robust design tools and methodologies to produce high quality designs and clear regulatory data output.

Medical Device Design

Robust Design

Across Concept Design, Design Inputs, Outputs, Verification and Validation stages PDR integrates a flexible controlled approach that incorporates best practice HF/UE from the outset.

PDR’s approach to device design is a robust and reliable, human centred design control process. This allows creativity and innovation to flourish whilst remaining compliant with ISO13485 and CFR820.30.

PDR can provide complete Design History File support - from briefing and requirements identification through to manufacturing implementation and new product introduction. Where projects only require light touch support, PDR utilises one-off interventions in conceptual design or proof of concept to support in-house teams.

“PDR’s professional and rigorous approach to product testing and user insight, translating into new developments drew a clear path for product innovations which has allowed us to create a product that best fits the user’s needs”

GE HEALTHCARE

Human Factors and Usability Engineering

• FORMATIVE DEVELOPMENT STUDIES

• SUMMATIVE USABILITY VALIDATION STUDIES

• USABILITY ENGINEERING FILE DOCUMENTATION

• CONTEXTUAL INQUIRY

• PARTICIPATORY DESIGN

• AESTHETICS / VISUAL BRAND LANGUAGE RESEARCH

• TIME AND MOTION STUDIES

• INSTRUCTIONS FOR USE

• HEURISTIC EVALUATION

• EXPERT REVIEW

• COMPARATIVE AND FUNCTIONAL ANALYSIS

• EYE TRACKING AND GAZE ANALYSIS

• RAPID ETHNOGRAPHIC VIDEO ANALYSIS

• USER PREFERENCE AND ACCEPTANCE RESEARCH

• RAPID INTERACTIVE PROTOTYPING

• GUI DESIGN AND PROTOTYPING

• USER-RELATED RISK ASSESSMENT

Usability Engineering

PDRs approach to Human Factors is based upon maximising user contact to inform, specify, refine and test products.

We have developed an end-to-end system from initial generative tasks identifying how and why your solution should exist, through iterative formative studies, culminating in larger scale summative studies assessing the final product for usability and risk. This process is rapid and cost effective providing you with clear insight and design suggestions to enhance the product.

PDR has vast experience in the development of protocols to assess primary and frequently used operating functions alongside the key safety related features important for the reduction of risk.

Our in-house observation facility fitted with 360 CCTV and audio recording facilities allow us to run user studies on-site and hand the cost saving directly to our clients. Such studies provide an effective mechanism for documenting evidence of user involvement throughout the design process which is a key factor in helping companies meet their legislative requirements.

“The UCD team at PDR are friendly and a pleasure to work with. Working on the design a touchscreen interface their user insight has been vital in decision making and they have directly translated the insight into beautiful and usable design concepts.”

DELTEX MEDICAL

“The design of a usable medical device is a challenging endeavour, yet many organizations treat it as if it were just common sense. The design of the user interface to achieve adequate (safe) usability requires a very different skill set that that of the technical implementation of that interface”

ISO 62366:2008

Usability Standards

For more than ten years the FDA has been emphasising the use of ‘human factors’, or, ‘usability engineering’ as a design requirement for medical devices. During this time, several standards have been developed to aid medical device manufacturers when incorporating usability into the design process.

Human factors engineering sees knowledge of human capabilities applied to the design and development of products and systems, utilising both behavioural science and engineering methodologies.

This maintains a focus on the skills and limitations (physical, sensory, emotional and intellectual) of all the end-solutions’ users throughout the design process.

The most recent standards governing the application of human factors are IEC 62366:2008 recognised by the FDA and harmonised in Europe as well as ANSI standard HE75:2009, though these are built upon a long history of supporting documents.

These standards detail the process and documentation required to ensure the product is both appropriate and safe for use.

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ISO 14971-1:2007 Medical Devices Application of Risk Management to Medical Devices

AAMI / ANSI HE75:2009 Human Factor Engineering – Design of Medical Devices (General)

IEC 60601-1-6:2010 Medical Electrical Equipment Part 1-8: General Requirements for Safety – Collateral Standard: Alarm Systems – Requirement, Test and Guidance – General Requirements and Guidelines for Alarm Systems in Medical Equipment (General)

ISO 62366 Medical Devices Application of Usability Engineering to Medical Devices

User Experience and Graphic User Interface Design

Ensuring users are able to develop a clear and accurate mental model of how a product works is a critical requirement in relation to medical devices.

The user experience extends beyond the interface displayed on a product’s screen. PDR consider UX design to fundamentally be about developing a dialogue between a user and a product. Understanding how people behave is essential to design products that are intuitive, elegant, pleasurable and above all, safe to use.

Graphical user interfaces are often integral to this experience. PDR utilise a wide range of tools and methods in a structured approach to develop GUIs that reduce risk and increase patient safety whilst also providing the user with the information they need in a manner that is efficient and easy to use.

This user centred process includes: creating user journeys, information architectures, participatory design, paper prototyping, storyboarding, prototyping interactive UIs, usability testing and heuristic evaluations.

Prototyping

Producing accurate, reliable and functional parts and assemblies is essential in reducing development risk.

Rapid production of design data in three dimensions, and using this for user or market testing, reducing design risk or in support of new product introduction; is an essential part of an efficient and effective verification and validation strategy.

For over 20 years, PDR has been a leading prototyping, 3D printing and rapid, low volume batch manufacturing facility to the medical and life science industry. Seen as a pioneer at the start of the additive manufacturing revolution, PDR remains at the leading edge of technology and practice.

PDR’s extensive in-house facilities include various advanced 3D printing technologies that utilise a range of materials, extensive model making and finishing workshops. Low volume silicone tooling and polymer cast technologies enable low volume production runs of high quality, market ready parts.

• RAPID PROTOTYPING (SLA, PROJET HD 3000PLUS)

• 3D PRINTING

• HAND FABRICATION AND MODELMAKING

• FULL COSMETIC SPRAYING AND FINISHING

• GRAPHICS AND BRANDING

• PACKAGING MOCK UP AND FABRICATION

• PANTONE AND RAL COLOUR MATCHING

• VACUUM CASTING AND LOW VOLUME POLYMER PART

MANUFACTURE

• HAND FINISHING, ASSEMBLY AND PACK

‘PDR’s staff are experienced and hardworking, they have guided Magstim through medical product usability regulations with superior knowledge and friendliness’ MAGSTIM

Manufacturing Implementation

New product introduction (NPI) is an essential and often underestimated component of successful device development.

To stay competitive, a company should have all manufacturing options available. From low volume, simple single cavity tooling in aluminium and soft steels through to multi cavity, high volume, zero defect production. PDR has a highly experienced team with a strong record of manufacture implementation and support across various technologies, processes and supply chains.

PDR’s approach is integral to the overall project’s risk management process, with process FMEA activity running alongside user and design FMEA activity. This early identification and elimination of problems forms the foundation of an effective design for manufacture methodology.

PDR has expertise in a wide range of tooling and manufacturing technologies, with partnerships in the UK, Europe and the Far East. This gives a deep understanding of the advantages, disadvantages and costs. A strong design for manufacture perspective gives PDR the ability to effectively advise on, support and manage tooling and NPI.

• SUPPLIER SOURCING AND BEST VALUE ACTIVITY

• TOOLING APPROVAL AND MANAGEMENT

• TOOL TRIAL MANAGEMENT AND VERIFICATION

• PROTOTYPE AND PRE-PRODUCTION BUILD SUPPORT

• BUILD, ASSEMBLY AND MANUFACTURE DOCUMENTATION

• VALIDATION AND VERIFICATION SUPPORT

• DHF INTEGRATION

“What we universally heard, and this was often unsolicited, was how good the look and feel was. That has to be congratulations and thanks to your team in Cardiff”ACTICHECK

PDRCardiff Metropolitan UniversityCardiff, United KingdomCF5 2YB

Tel: +44 (0) 29 2041 6725Fax: +44 (0) 29 2041 6973Email: info@pdronline.co.ukWeb: www.pdronline.co.uk