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This workshop will provide insights on successfully using prototype mock-ups to collect user input and usability insights from the inception stage, and dives into creating a strategy to use these approaches to effectively and systematically de-risk a new drug delivery device project and ultimately pass summative usability testing.

You will earn:

  • How to process inputs from all the stakeholders and identify key areas to focus for patient-centric device development without sacrificing compliance, time or budget.
  • Ways of deliberately and systematically experimenting with features, experiences, environments, and systems that produce design inputs linked directly to user data and insights
  • Be able to present a clear value proposition to your management to support early stage prototyping efforts as part of usability testing
  • Develop practical experience in creating a cohesive tangible strategy that maximizes the value generated by user testing
  • Get to master insights generation with respect to users' physical and cognitive capabilities as well preferences to increase both product safety, ease-of-use and UX
  • Learn to prioritize and accelerate different kinds of testing based on project risks unique to a particular drug delivery application
  • Take away practical methods for rapidly generating effective objects and experiences to support usability testing
  • Meet people, make stuff, have fun!

Executives, Directors, VPs, Heads, Principals, Managers of:

Pre-Filled Syringes/ PFS
Autoinjectors
Device/ Device Engineering
Human Factor
Scientist
CMC
Product
Injectables
Sterile Manufacturing
Packaging
Regulatory Affairs
or anyone who works with Pre-Filled Syringes/ Autoinjectors within pharmaceutical, biotech and solution providers.


 

Abbott Laboratories; Alkermes; Allergan; Amgen; Anteris Medical GmbH; Baxalta; Baxter Healthcare; Bayer Healthcare; Bayer HealthCare AG; BCM Group LLC; Biogen Inc; Boehringer Ingelheim; Boehringer Ingelheim Pharmaceuticals Incorporated; Bosch Packaging Technology; Bristol-Myers Squibb Co; Cambridge Consultants Ltd; Centurion Medical Products; DDL; Eli Lilly ; Emergent BioSolutions Inc.; ENCO Pharmaceutical Development, Inc. (EPDI); Epione BioPharmaceuticals; FDA; Genentech; Genentech, Inc.; Getinge A B; Gilead Sciences; Gilead Sciences Inc; Insulet Corp; IntraCellular Therapies Inc; Ionis Pharmaceuticals, Inc.; KBI Biopharma; LoneStar Heart Inc; Maeda industry Co Ltd; Merck, Sharp & Dohme Corp.; MITSUBISHI GAS CHEMICAL COMPANY, INC; Mitsubishi Gas Chemical Singapore Pte Ltd; Noxilizer, Inc.; PAREXEL International; Pfizer; Pfizer CentreOne; Pharmacircle; Shire; Shire US Inc; Steris Corp; STERIS FINN-AQUA; Takeda Pharmaceuticals; Teleflex; Terumo Americas Holding, Inc; Terumo Medical Corporation; Terumo Pharmaceutical Solutions; Teva Pharamceuticals; Teva Pharmaceuticals; UserWise; Versartis, Inc.; W.L. Gore & Associates, Inc.; Xcelthera; Xeris Pharmaceuticals; Xeris Pharmaceuticals, Inc.; ZebraSCI; zebrasci inc; Zeon Chemicals L.P.;
 

Workshop LEADER

keynote-img

Kate Stephenson

Academic Partnerships and Business Development, iO Lifesciences

Between obtaining her MS in Biomechanical Engineering and returning to Stanford University to complete a Mechanical Engineering PhD, Dr Stephenson spent ten years in the medical device industry as a Senior Design Engineer and Project Manager. She has worked on over eighteen different devices, ranging from insulin pumps to annuloplasty rings. During her PhD she taught course in design and entrepreneurship as part of Stanford's world class design program. She also completed a two-year stint as the Resident Clinical Bioengineer at Stanford Children's Hospital Gait and Motion Lab, where she advised on complex orthopaedic surgery cases and worked directly with patients. She has recently joined iO Life Science, where she works with early stage medical device companies on their design and manufacturing strategies. Her current role at iO is in business development and academic partnerships.

iO Lifesciences

iO Life Science is a combination product design and development firm, dedicated to transforming lives through the innovation of smart, connected and patient-centric devices. We actively partner with healthcare companies focused on creating breakthrough therapeutic solutions to unmet patient needs and do so by transforming our client's technologies into innovative products, always with the needs of the user at the fore. As appropriate, we work within the framework of our agile and ISO13485 certified QMS.

Workshop programme

8:30 Workshop Registration & Coffee

9:00 Workshop Leader Introduction and Opening Remarks

Kate Stephenson

Kate Stephenson, Academic Partnerships and Business Development, iO Lifesciences
View Bio

Maria Lund Jensen

Maria Lund Jensen, Lead, Human Factors Engineering, iO Lifesciences
View Bio

9:15 Segment 1 - Usability testing: Context and Challenges

9:30 Segment 2: Overview of building tangibles for usability

  • Build Smart - Defining a clear strategy based on de-risking projects
  • Build Early - How to use tangible experiences to drive design from the earliest stages
  • Build Fast - Minimize extra cost to your project by leveraging efficient and creative ways of creating tangibles
  • Kate Stephenson

    Kate Stephenson, Academic Partnerships and Business Development, iO Lifesciences
    View Bio

    Maria Lund Jensen

    Maria Lund Jensen, Lead, Human Factors Engineering, iO Lifesciences
    View Bio

    10:30 Morning Coffee and Networking Break

    11:00 Practical applications of concepts and case studies

  • Build a tangibles strategy to complete user testing for a specific drug delivery application
  • Map out user test milestones from early concept to summative testing for the case study
  • Practice rapid building techniques to generate prototypes to collect usability data
  • Test artifacts by conducting tests on members from other teams
  • Kate Stephenson

    Kate Stephenson, Academic Partnerships and Business Development, iO Lifesciences
    View Bio

    Maria Lund Jensen

    Maria Lund Jensen, Lead, Human Factors Engineering, iO Lifesciences
    View Bio

    12:00 Group review of strategies and insights learned

    Kate Stephenson

    Kate Stephenson, Academic Partnerships and Business Development, iO Lifesciences
    View Bio

    Maria Lund Jensen

    Maria Lund Jensen, Lead, Human Factors Engineering, iO Lifesciences
    View Bio

    12:15 Closing Remarks from Workshop Leader and Close of Workshop

    +

    VENUE

    Crowne Plaza San Diego - Mission Valley

    2270 Hotel Circle North, San Diego, CA, USA

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    Crowne Plaza San Diego - Mission Valley

    2270 Hotel Circle North
    San Diego 92108
    USA

    Crowne Plaza San Diego - Mission Valley

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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