Human Factors Engineering

Human factors expertise embedded in the product development process, from start to FDA approval

Medical Devices Held by Healthcare Professional - Delve Medical Product Development

Medical device design is complicated

Developing a medical device is one of the most risk-filled endeavors a company can undertake.

To mitigate those risks and clear the regulatory hurdles, human factors engineers must complete rigorous formative and validation (summative) studies. We provide expertise early and at key points in the development process based on deep medical device design experience in:

Contextual inquiry
Definition and HF documentation
Formative and validation studies
Design validation studies
HFE/UE reporting
And more

We bring an approach beyond traditional human factors product development

At Delve, we integrate human factors throughout the design process.

With experience in industrial, mechanical, biomedical, psychology, neuroscience and instrumentation engineering, HCI and interaction design, we are comfortable working with designers and engineers throughout the development process.

The process creates devices that are lower risk, cost less to develop, and are ultimately more human-centered to engender brand love and loyalty.

Delve human factors engineering services lab

Are you ready for the FDA?

The FDA expects a certain level of Human Factors work. Not having it will cause costly delays.

We can create documentation for your FDA submission, and you can even use our quality management system. We adapt our multidisciplinary process to the standards your project needs to demonstrate to the FDA that your device is safe for clinicians and patients, including:

ISO 13485
ISO 14971
ISO 11226
AAMI TIR 59
IEC 62366

Learn more about our QMS

Our Work

"The technical innovation in Otoscan combined with unprecedented simplicity makes customization a great experience for our patients and audiologists."

— Lennart Goth & Nils Hampel, Owners of Rhein-Neckar-Akustik

What our clients and users are saying

Featured Case Studies

Laser scanning technology could create a 3D digital image of the complete ear. But to work, a headset placed around the patient’s ear during the scan had to be completely immobile.

Award
Winner

Medical Devices

Dexcom: G6 Continuous Glucose Monitoring System

Users fell in love with the Dexcom G6 because it transformed what had once been an intimidating experience to one that was painless and error-proof.

Medical Devices

ProNova: SC360 Proton Therapy System

Imagine being strapped into a large machine, completely immobilized, for an hour while it delivers high doses of radiation to treat your cancer - every day for six months.

Industrial / Commercial Products

Onity: Disruptive E-Lock Innovation

Delve’s research drove a technical solution that ended up disrupting the electronic locks market for the hospitality industry.

06-Work-Case Study-Bioventus Exogen-H1-1186x667 @2x

Award
Winner

Medical Devices

EXOGEN® Ultrasound Bone Healing System

EXOGEN® is the only FDA-approved bone healing device that uses ultrasound to stimulate the body’s natural healing process.

Award
Winner

Industrial / Commercial Products

D7 Systems: Rugged, Rapid Decontamination

Rugged, versatile BDAS+ is a breakthrough device that helps first responders rapidly and easily neutralize biological threats.

Few medtech companies use human factors the way that makes the most sense.

Instead of being brought in to consult at the end, human factors should be involved throughout a project, directing development at every stage.

— Curt Irwin, Senior Director of Human Factors, Delve

Our Recent Thinking

More insights

Learn the Not-So-Basics

Reducing Medical Device Risk with Usability Testing and uFMEAs

Medical devices are commonly recalled due to usability issues that can be prevented with human factors plans and uFMEAs.

Learn the Not-So-Basics

How Affordance Makes Medical Devices Safer

Affordance is the relationship between what something looks like and how it’s used. The user should be able to figure out how to use something just by looking at it.