Human-Centered Design of Medical Devices for …Human Centered Design Beyond Products > Key...
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Human-Centered Design of Medical Devices for Global Users Beth Kolko, PhD Professor, Department of Human Centered Design & Engineering University of Washington Seattle, USA
Transcript of Human-Centered Design of Medical Devices for …Human Centered Design Beyond Products > Key...
Human-Centered Design of Medical Devices for Global Users Beth Kolko, PhD Professor, Department of Human Centered Design & Engineering University of Washington Seattle, USA
HCD as Research Methodology and Institutional Strategy
> HCD is a powerful toolset to view the world
> HCD provides visibility into power dynamics
> HCD uncovers contextual pressures
> HCD is well proven as a tool for product & service design
However, we need more than products.
> Impact depends on what comes next: manufacturing,
regulatory approvals, reaching customers
> Sustainable innovations must be able to scale while
maintaining commitments to driving ideals and goals
HCD can help get us there.
Leveraging the full potential of HCD
Background: Academic Projects
HCD as a Framework for Product and Service Design
Bottom-up engagement throughout the process
> Initial user research which provides a 360° assessment > Stakeholder engagement via partnership or direct collaboration
> User interviews that are iterative and qualitatively analyzed
> Observations in the field which can inform quantitative assessments
> Design sketches to produce an initial
> Rapid iteration and generating multiple possibilities (Yes, and)
> Different modalities/technologies
> Wizard-of-Oz usability/mockups > Enable quick feedback loops
> Prototype development
> Usability research > Enable quick feedback loops, considering user response and
contextual issues, acceptability by users, etc.
Traditional Medical Device Design Approaches
Design methodologies driven by top-down frameworks
> Intellectual property “moats” > Barriers to competition
> Market prioritization
> Reimbursement-driven device development
> Device innovation built around fee schedules, not technology costs
> Narrow market applicability to ease product introduction > Focus on clinical indication to engage KOLs, etc.
Navigating the Cultural Gap Between HCD and Global Health
Global health is tied to Public Health and relies on articulated goals and
agendas
HCD is by definition a bottom-up approach
that engages with multiple user communities
Negotiating top-down and bottom-up practices to achieve shared goals
Using Bottom-Up Approaches After the Prototype
> Moving from prototype to product to market requires
ongoing compromise
> For global health, HCD can help maintain focus on the
ultimate goal and guide decision-making
> Tradeoffs during commercialization are inevitable
> Who guides the choices? What are their goals? How do
we keep focus on users? Approaching commercialization as a university researcher
Approaching commercialization as an industry entity
Building a great product isn’t enough
Using HCD to Drive Innovation through the Valley of Death and the Trough of Sorrow
Trough of Sorrow
Valley of Death
Source: Paul Graham
Scale is Non-negotiable
> Great products don’t scale. Great organizations do.
> Impact relies on reaching your stakeholders. Which stakeholder is more important? The clinician? The patient?
The policymaker?
Many shades of sustainability
An HCD Approach for a Hypothetical Device
> Device manufacturability
> Pricing
> Durability and replacement cycles
> Consumables as part of a business model
> Procurement processes
> Clinical evidence
> Regulatory approvals
> Patent applications
> Distribution strategy
> Packaging
> Local sourcing and/or manufacturing
> Maintenance and support schedules
> Training programmes
How do we decide:
Some Decisions Made
> Device manufacturability
> Clinical evidence
> Durability and replacement cycles
> Procurement processes
> Distribution strategy
> Local sourcing and/or manufacturing
> Maintenance and support schedules
> Training programmes
How is HCD used throughout the process
Human Centered Design Beyond Products
> Key takeaways: • Closing healthcare gaps requires attention not just to the
devices we build, but how we share them with patients and
clinicians around the world.
• Devices brought to market using HCD principles are more likely
to succeed in the field and have greater value to end users.
• Looking for partners who integrate HCD into business models
as well as device design can increase long-term impact.
Going from prototype to scale requires ongoing commitment to HCD
Disclosures
> I am a Professor at the University of Washington. My
participation in this presentation has been paid for with
university related funds.
> Some of the research reported here is the result of first-
hand experience in the course of my work as CEO of a
medical device startup. I receive compensation in that
role, although it is unrelated to the research reported
here.
