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This workshop is aimed at anyone who needs to commission Human Factors work (including formative and summative studies) containing digital elements in the overall offering. The regulatory process for 'traditional HF' (device only) is fairly well established and will be reviewed to ensure there is both a common understanding of the current landscape and also how the landscape is changing to accommodate more iterative and agile work streams that sit alongside. The workshop will allow participants to plan and execute these different work streams when designing their next HF program.

For anyone starting to think about bringing digital health solutions to market, this workshop will allow you to understand how traditional HF studies are changing and how the 'agile' and iterative world of digital testing can work alongside the more structured, 'waterfall' world of device HF. This is key when designing studies that comply with FDA and other regulatory bodies.

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

3P INNOVATION LTD; AbbVie Ltd; addey and stanhope school; Affibody AB; Aptar; APTAR PHARMA; Ascendis Pharma GmbH; Aspen Pharmacare; AstraZeneca; B. Brauná; BA Consultancy; BAUMANN SPRINGS LTD; Bayer Pharma AG; Becton Dickinson; Bespak Innovation; Biocorp; Biopharm Insight; Boehringer Ingelheim; Boehringer Ingelheim GmbH; Cambridge Consultants Ltd; Colwill Health Ltd.; Consillient Health; DATWYLER PHARMA PACKAGING INTERNATIONAL NV; Datwyler Schweiz AG; DTP Holding; E3D ACA Ltd; F. Hoffmann-La Roche Ltd.; Formycon AG; FRUH VERPACKUNGSTECHNIK AG; Galderma; GALDERMA R&D; Genentech, Inc.; Gerresheimer; Glenmark Pharmaceuticals S A; GROUPE JBT; GSK; GSK R&D; Guerbet; Intertek (Schweiz) AG; Laboratoire Aguettant; LEO Pharma; LEO Pharma A/S; LFB Biotechnologies; LRQA; Medical Device Usability Ltd; MET; MHRA; Midatech Pharma; Mikron S A Boudry; MINAKEM SAS; MITSUBISHI GAS CHEMICAL COMPANY, INC; Mylan; Mylan, Inc.; Nemera; New Injection Systems Ltd; Nipro Europe NV; Nolato Medical; Novartis; Novartis Pharma AG; Octapharma; Owen Mumford; Owen Mumford Ltd.; Pfizer; PFIZER CenterOne; Pharmaceutical Systems; Pharmacircle; Pharmis Biofarmaceutica Lda; Phillips-Medisize; Pliva; Roche; Samedan Ltd ; Sandoz; Sanofi S A; Sanofi-Aventis; SCHOTT; SCHOTT AG; SCHOTT Schweiz AG; Shire; SiO2 Medical Products; teamtechnik Maschinen & Anlagen GmbH; Terumo ; Terumo Europe; Terumo Europe N.V.; Terumo Europe NV; Teva-Pliva; TOPAS Advanced Polymers GmbH; Trinseo Deutschland GmbH; UCB; UCB Celltech; Vetter Pharma International GmbH; W.L. Gore & Associates, Inc.; Weidmann Medical Technology AG; West Pharmaceutical Services; West Pharmaceutical Services Deutschland GmbH & Co. KG; Worrell; Ypsomed AG; Zeon Europe GmbH; Zwick Testing Machines Limited;

Workshop LEADER


Jaquie Finn

Head of Digital Health , Cambridge Consultants Ltd

Jaquie is Head of Digital Health at Cambridge Consultants and leads the initiative to provide guidance and support to clients within the healthcare industry who are looking to transition their business model to digital product and service-led innovation. Jaquie has a BSc in Applied Biology, 10 years' experience in Molecular Biology and 15 years' experience of Product Management and Marketing software, hardware and digital services in the medical and life science industries.

Cambridge Consultants Ltd

Cambridge Consultants develops breakthrough products, creates and licenses intellectual property, and provides business consultancy in technology-critical issues for clients worldwide. For more than 50 years, the company has been helping its clients turn business opportunities into commercial successes, whether they are launching first-to-market products, entering new markets or expanding existing markets through the introduction of new technologies. With a team of 750 staff, including engineers, scientists, mathematicians and designers, in offices in Cambridge (UK), Boston (USA) and Singapore, Cambridge Consultants offers solutions across a diverse range of industries including medical technology, industrial and consumer products, digital health, oil and gas, and wireless communications.

Workshop programme

8:30 Workshop Registration & Morning Coffee

9:00 Workshop Leader Introduction

Jaquie  Finn

Jaquie Finn , Head of Digital Health , Cambridge Consultants Ltd
View Bio

9:10 Overview of the Digital Landscape and the FDA

Jaquie  Finn

Jaquie Finn , Head of Digital Health , Cambridge Consultants Ltd
View Bio

  • Is it a medical system or not?
  • Overview of Consumer Digital systems
  • Overview of Medical Digital systems
  • 9:40 What is UX and how is it interpreted for 'hybrid' sytems?

    Jaquie  Finn

    Jaquie Finn , Head of Digital Health , Cambridge Consultants Ltd
    View Bio

  • The sub-sections of UX
  • How does regulated Human Factors methodology play with other aspects of UX?
  • 10:30 Morning Coffee and Networking Break

    11:00 Bringing digital into traditional Human Factors - how does it change the process?

    Jaquie  Finn

    Jaquie Finn , Head of Digital Health , Cambridge Consultants Ltd
    View Bio

  • Agile vs. Waterfall methodologies
  • How to merge the two
  • What is the delta?
  • 11:30 Design of the UI(s)

    Jaquie  Finn

    Jaquie Finn , Head of Digital Health , Cambridge Consultants Ltd
    View Bio

  • ADA and WC3
  • 12:00 Validation of digital system

    Jaquie  Finn

    Jaquie Finn , Head of Digital Health , Cambridge Consultants Ltd
    View Bio

  • Merging methodologies
  • 12:30 Closing Remarks and End of Workshop


    Copthorne Tara Hotel

    Scarsdale Place
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.




    speaker image






    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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