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As part of SMi’s leading Injectables series, this year’s event will address the key drivers of the pre-filled syringes and combination products industry to give a comprehensive insight into the latest device innovations, regulatory updates and future insights for the coming year. With the global market for prefilled syringes estimated to exceed $9.7bn by 2025, the field is evolving at an exponential rate with connectivity and digital health strategies for devices and studies at the forefront. Furthermore, this event will delve into the key takeaways following the global pandemic and discover how this will be used to enhance future drug delivery device development.


Shannon Clark has conducted numerous workshops on human factors and usability testing throughout the world, from Stockholm to Shanghai. This workshop will discuss the U.S. FDA Human Factors Engineering Process in the context of digital health and connected devices, as well as unique U.S. FDA regulatory hurdles related to this domain. The workshop will include case studies related to emergent digital health innovations currently coming out of Silicon Valley, software apps connected to drug delivery platforms, and new applications for medical software

  • Review all applications for connected devices
  • Discuss the unique U.S. FDA regulatory requirements related to phone applications and connected devices
  • Discover common software and device development pitfalls related to connected devices and digital health
  • Walk through the unique considerations for your human factors strategy and the details of usability testing for Apps and connected device


  • Drug-delivery developers
  • Medical Device Engineers
  • Primary Packaging material designers
  • Secondary packagers
  • Smart device developers
  • Training device developers
  • Device-safety solution providers
  • Drug developers

Previous attendees include:

3P Innovation Ltd; Alexion Pharmaceuticals; American Regent Inc; Amgen; Amgen Incorporated; Aptar Pharma; AstraZeneca; BCM Group LLC; BD / Becton, Dickinson and Company; Biogeneral Incorporated; BMS; Bristol Myers Squibb; Bristol-Meyers Squibb; Bristol-Myers Squibb; Celanese Corporation ; Celgene; Connecticut Spring & Stamping; Credence MedSystems, Inc.; Elektrofi; Eli Lilly and Company; Emd Serono; FDA; Ferring Pharmaceuticals; Flexion Therapeutics; Gerresheimer; Grifols; GSK; GSK Pharma; Harro Hofliger Verpackungsmaschinen GmbH; Imbrium Therapeutics; Janssen; Janssen Pharmaceutical Incorporated; Janssen Supply Chain, Johnson & Johnson; kaleo, Inc.; Key Tech; Kiniksa Pharmaceuticals; Lonstruff AG; MedImmune; Merck; Mitsubishi Gas Chemical Company, Inc; Mitsubishi Gas Chemical Singapore Pte Ltd; Momenta Pharmaceuticals; Nipro PharmaPackaging; NN Life Sciences; Nypro; Owen Mumford; Pfizer; Pfizer Inc; Pfizer Inc.; Pharmacircle; PHC Corporation of North America; Plastic Ingenuity Inc; Polyplastics, USA; Purdue Pharma; Regeneron Pharmaceuticals; RheoSense, Inc; Sagentia Ltd; Sanofi; Sanofi Pasteur; Sanofi Pharmaceuticals; Sanofi US; Schott AG; SCHOTT AG - Pharmaceutical; Smithers Rapra; Steri-Tek; Sumitomo Rubber; Takeda; Takeda Pharma Ceuticals International; Terumo Solutions; Teva Pharmaceuticals; Topas Advanced Polymers; Uhlmann; W.L. Gore & Associates, Inc.; West Pharmaceutical Services; zebrasci inc; Zeon Specialty Materials ; Zeon Specialty Materials Inc

Workshop programme

8:30 Registration & Coffee

9:00 Opening Remarks and Introductions

Shannon Clark

Shannon Clark, CEO, UserWise, Inc.
View Bio

9:10 Connected devices and digital Health - Current and future Applications

Shannon Clark

Shannon Clark, CEO, UserWise, Inc.
View Bio

  • What’s the digital health landscape and latest buzz in Silicon Valley, California, as well as the rest of the world?
  • What innovations are currently tackling issues of medication adherence, medical product adherence, clinical decision support, and remote patient monitoring?
  • How are innovators solving patient needs via usercentered design of digital health apps?
  • 9:50 Overview of Applicable U.S. FDA Usability Engineering Requirements & Regulatory Requirements for Connected Devices and Digital Health

    Shannon Clark

    Shannon Clark, CEO, UserWise, Inc.
    View Bio

  • What U.S. FDA Regulations and Guidance do we need to know about when developing connected devices and digital health applications?
  • What digital health applications are NOT governed by the U.S. FDA
  • 10:30 Morning Coffee

    11:00 Review Unique Usability Engineering Considerations Related to Connected Devices

    Shannon Clark

    Shannon Clark, CEO, UserWise, Inc.
    View Bio

  • Case Study: What are some unique human factors and usability engineering considerations when developing an app and connected device?
  • Case Study: What are some best practices and design considerations (i.e. heuristics) to take into account when developing digital health applications and connected devices?
  • Looking Ahead: What can we expect in 2029?
  • 11:40 Q&A

    Shannon Clark

    Shannon Clark, CEO, UserWise, Inc.
    View Bio

    12:20 Closing Remarks

    Shannon Clark

    Shannon Clark, CEO, UserWise, Inc.
    View Bio

    12:30 End of Workshop



    Shannon Clark

    Shannon Clark

    CEO, UserWise, Inc.

    Shannon Clark

    CEO, UserWise, Inc.
    Shannon Clark

    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 2014, 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 Professional Industrial Engineer, holds two patents, and has written and published three books.


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    Hyatt Centric Fisherman’s Wharf San Francisco

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    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.


    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.


    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.


    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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