Context-driven design approach

Currently, almost all equipment is designed and manufactured
with a main focus on the context in high income countries. The
context in low-and-middle income countries in which surgical
equipment is used, differs from high income countries, especially
in terms of financial resources and access to maintenance, spare
parts and consumables.

We developed a roadmap for design of
surgical equipment for global use.

We believe that designers should strive for design that is of the
same quality and complies with the same safety regulations as
equipment designed for HICs. In this way user and patient safety
can be assured in any setting worldwide. And we advocate for
surgical equipment that fits the context optimally.

We published a design paper about the development of a context-specific electrosurgical unit for global surgery that extensively describes the use of this design method.

Four phases

Phase 0: Define a clear need

Before the start
of a design project, a clear need for certain surgical equipment
should be identified. Medical needs identified by
scientific research, NGOs or local end-user could all act as a
starting point for a design project

Phase 1: Understanding the context

This phase consists of 3 parts to get a good understanding of the context-of use.

Phase 2: Determining design requirements

In this phase the contextual findings are translated into functional design requirements.

Phase 3: Prototyping

In this phase the prototyping starts, we advocate for consulting end users for feedback during each iteration.

Phase 1: Understanding the context of global surgery

Mapping the context of global surgery can be conducted invarious ways. Examples are using the Capability Driven Design method developed by A. Mink or qualitative research methods like surveys, semi-structured interviews and site visits. Surgical barriers, the structure of the health care system and aspects of safe surgery should be researched.

This phase consists of 3 parts:

1. Phase 1.1: Determine the cultural, financial and structural barriers for patients seeking care in LMICs

2. Phase 1.2: Determine the structures of the health care system (levels, private, public, NGO etc.)

3. Phase 1.3: Evaluate aspects involved in providing safe surgery (processes, team, cleaning, maintenance, consumables etc.)

Phase 2: Determine the implementation strategy and the design requirements

After understanding the context and choosing an
implementation strategy, a list of design requirements can be
drawn up.

There are some requirements that are common for
many LMICs settings such as :

• Low costs
• Easy to use and maintain (low training needs)
• Compact and portable
• Flexible in terms of required accessories (option to
use different brands of accessories/types of
monitors)
• Robust (able to withstand high temperatures,
humidity, power fluctuations)

Phase 3: Prototyping and rapid feedback

When the need, the context, the implementation strategy and
the design requirements, are established, the design team can
start to design, prototype and test the equipment.

It should be recognized
that co-creative design processes involving local stakeholders
generate the most effective global health solutions, we therefore advocate for collaborating with end-users and consult them for feedback during each iteration.

Please note that context specific medical device design often requires resourcefulness
and creativity rather than technical sophistication.

One way of involving local stakeholders could be by
establishing partnerships with local universities, NGOs, or local
hospitals.