Digital health solutions - achieving commercial goals and meeting regulatory requirements

Partner Content
Pre-Filled Syringes East Coast conference

SMi Group reports:  For anyone thinking about bringing digital health solutions to market, the workshop - Human factors for connected drug delivery systems, hosted by Cambridge Consultants (April 10, Boston) - will identify the considerations that need to be addressed when designing a comprehensive Human Factors engineering process for a system which contains both physical and digital elements, and how to leverage the tools, methodologies and best practices across device development, User Interface (UI), and User Experience (UX) development.


This workshop will show how to achieve both commercial goals and meet regulatory requirements. The Human Factors engineering process and regulatory requirements for traditional medical device development are fairly well established and will be reviewed to ensure there is a common understanding of the current landscape. Workshop leaders will then explore how to adapt this process to meet the needs and requirements for a system which includes digital as well as physical elements.


The workshop is part of the Pre-Filled Syringes East Coast conference (April 11 – 12, Boston) and will be run by Melanie Turieo, Director, Human Factors Engineering and Karen Unterman, Group Leader, Human Factors Engineering at Cambridge Consultants Ltd


Workshop leaders:

  • Melanie has over 20 years' experience providing human factors expertise to the design and development of regulated and safety-critical items, including medical, military and consumer products. She has extensive experience in the development of drug delivery systems from early stage needs assessment and product definition through concept generation, detailed development, and HF validation
  • Karen’s experience is in performing human factors activities throughout the development process, including: ethnographic research, translating stakeholder needs into measurable, technical requirements, facilitating creative workshops, assessing product risk, and designing, conducting and analyzing Formative and Validation usability studies.


You can attend both Pre-Filled Syringes East Coast conference and this Interactive Workshop by booking at



LinkedIn – search 'SMi Pharma'

Twitter – @SMIpharm and #smipfsusa



Pre-Filled Syringes East Coast | April 11 – 12, 2018 | Boston, USA


profile mask

Lyudmyla Durneva

15 March, 2018