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Overview of the workshop:
Workshop attendees will learn
1. Principles of design that are key for developing medical products or selecting drug delivery devices for new drugs, and
2. Best practices for how to conduct an expert review to uncover design flaws even before entering into usability testing.
 

A review will be presented on numerous examples of Good vs. Bad Design and delegates will be trained on how to best select the drug delivery platform for a specific product as well as use principles of informal use error analysis, IEC 62366 PCA task analysis, and use-related risk analysis to uncover use errors that could negatively impact usability testing results and ultimate product success.
 

About the workshop leader
Shannon E. Clark is founder and CEO of UserWise, a consultancy that helps medical device manufacturers and start-ups to design safe and easy-to-use medical devices. The consultants at UserWise conduct usability testing for a variety of medical devices ranging from surgical robots to home-use injection platforms. UserWise consultants also perform safety assessments to comply with U.S. and international regulations related to Human Factors. Before founding UserWise in 2015, Shannon was a Human Factors Engineer at Intuitive Surgical and Abbott Laboratories. Shannon graduated from UCLA with a B.S. in Mechanical Engineering and a technical breadth in Technology Management. Shannon is additionally a Certified Processional Industrial Engineer, holds two patents, and has written and published three books.

 

Uncovering design flaws late in the development cycle can be costly and catastrophic to meeting a medical product’s commercialization deadline. Workshop attendees will learn how to uncover use errors early in the design process to avoid unacceptable use errors surfacing during late stage usability testing.
 

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

Pre-Filled Syringes/ PFS
Autoinjectors
Device/ Device Engineering
Human Factor
Container Closure Integrity
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; AbbVie; Advanced Molding Technologies; Aegerion Pharmaceuticals; Ajinomoto Althea, Inc.; Allergan; Allergen Inc; Almac Group; Amgen; Antares Pharma; Aptar Pharma; Baxter Healthcare; BCM Group LLC; BioMarin; Boehringer Ingelheim; Connecticut Spring & Stamping; Credence MedSystems; Execution Metrics, Inc; Ferring Pharmaceuticals; Fresenius-Kabi; Genentech; Genentech, Inc.; Gilead Sciences; Glenmark Pharmaceuticals; Harro Höfliger; Inovio Pharmaceuticals; iO Lifesciences; Ionis Pharmaceuticals, Inc.; Matchstick; MedImmune; MedImmune Inc; MedImmune LLC; Medizap; Medtronic; Merck & Co.; Mitsubishi Gas Chemical America Inc; MITSUBISHI GAS CHEMICAL COMPANY, INC; Nemera; Nipro PharmaPackaging; NOVO Engineering, Inc.; Novo Nordisk; Novo Nordisk A/S; One World DMG; Owen Mumford; Pfenex; Pfenex Inc; Pfizer CentreOne; RAUMEDIC INC; Regeneron; Regeneron Pharmaceuticals; Regeneron Pharmaceuticals, Inc.; Shire; Smithers Rapra; Steri-Tek; Stevanato Group S.p.A; Subcuject ApS; Suttons Creek Inc; Terumo Corporation; Terumo Medical Corporation; Terumo Pharmaceutical Solutions; UserWise, Inc.; W. L. Gore & Associates, Inc.; West Pharmaceutical Services,; West Pharmaceutical Services, Inc.; West Pharmaceuticals Services Inc; Worrell; Xeris Pharmaceuticals; ZebraSCI; zebrasci inc; ZEON; ZEON CORPORATION; Zeon Specialty Materials Inc;
 

Workshop programme

8:30 Registration & Coffee

9:00 Opening Remarks and Introductions

Shannon  E. Clark

Shannon E. Clark, Principal, UserWise, Inc.

9:10 Principles of Design

Shannon  E. Clark

Shannon E. Clark, Principal, UserWise, Inc.

  • What are the guiding principles of designing a new medical product or selecting a drug delivery device for your new drug?
  • How do I conduct an expert review to uncover design flaws even before entering into usability testing?

     

  •  

    9:50 Good vs. Bad Design

    Shannon  E. Clark

    Shannon E. Clark, Principal, UserWise, Inc.

  • Study numerous examples of Good vs. Bad Design and start training delegates to see the patterns of good vs. bad design
  • Review the principles of comparative expert reviews - How do I select the best drug delivery platform for my product?
  • Review the principles of informal use error analysis, IEC 62366 PCA task analysis, and use-related risk analysis to uncover use errors
  • 10:30 Morning Coffee

    11:00 Interactive Expert Reviews

    Shannon  E. Clark

    Shannon E. Clark, Principal, UserWise, Inc.

  • Delegates will be presented with different real-life medical product prototypes and concepts, and they'll be tasked with conducting an expert review
  • Discuss the principles of identifying whether the product is "optimized" and ready for testing

     

  • 11:40 Closing Remarks from Workshop Leader and End of Workshop

    Shannon  E. Clark

    Shannon E. Clark, Principal, UserWise, Inc.

    +

    VENUE

    Hyatt Regency Mission Bay

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    Experience the epitome of California coastal chic at Hyatt Regency Mission Bay Spa and Marina San Diego vacation resort near SeaWorld San Diego. Expect the best at this remarkable San Diego vacation resort offering incredible ocean views, waterfront dining, a contemporary poolside lounge, eco-friendly spa, and redesigned hotel rooms and suites and meeting rooms. The only resort hotel in San Diego with multiple water slides, you'll delight in a water playground with three new pools, waterfront health club, and a full-service marina with jet skis, sailboats, kayaks, sportfishing and whale excursions.

    An unparalleled choice for discerning travelers, you’ll find everything you could wish for at our premier Mission Bay hotel near famous San Diego,CA attractions such as SeaWorld San Diego.

    A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
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    Hyatt Regency Mission Bay

    1441 Quivira Road
    San Diego 92109
    USA

    Hyatt Regency Mission Bay

    Experience the epitome of California coastal chic at Hyatt Regency Mission Bay Spa and Marina San Diego vacation resort near SeaWorld San Diego. Expect the best at this remarkable San Diego vacation resort offering incredible ocean views, waterfront dining, a contemporary poolside lounge, eco-friendly spa, and redesigned hotel rooms and suites and meeting rooms. The only resort hotel in San Diego with multiple water slides, you'll delight in a water playground with three new pools, waterfront health club, and a full-service marina with jet skis, sailboats, kayaks, sportfishing and whale excursions.

    An unparalleled choice for discerning travelers, you’ll find everything you could wish for at our premier Mission Bay hotel near famous San Diego,CA attractions such as SeaWorld San Diego.

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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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