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
Human factor designed pieces on a board
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

Our Work

Natus otometrics
"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
Otoscan-Glamour-Shot-1-1
Award
Winner
Otometrics: Otoscan
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.
Dexcom in use cropped touch up
Award
Winner
Dexcom: G6 Continuous Glucose Monitoring System
While users of the previous Dexcom system greatly valued its enhanced ability to monitor their glucose levels, applying the subcutaneous Dexcom sensor to their bodies was an obvious pain point that was a barrier to wider adoption.
06 Work Case Study Pro Nova H1 @2X
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.
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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
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.
BDAS Hero
Award
Winner
D7 Systems: Rugged, Rapid Decontamination
Rugged, versatile BDAS+ is a breakthrough device that helps first responders rapidly and easily neutralize biological threats.

The stakes are higher in medical product design

Winnie Lee THUMB
"If an auto-injector's design makes it unclear to a user how to inject themselves, the user could suffer from a needle stick injury. If it’s unclear to nurses how to stop an infusion pump from delivering medication, it could cause harm to the patient."
Winnie Lee, Human Factors Engineer, Delve
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A Chronically Underutilized Role in New Medical Device Development
Utilizing this role to its fullest could minimize project risk and speed your product to market.
2023 10 Reducing Med Device Risk HERO
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.
2023 11 27 Using the PCA Method HERO
Using the PCA Method To Assess Use Errors in Medical Usability Testing
The PCA (perception, cognition, action) method recommended by the FDA helps researchers assess and understand why a use error has occurred.
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How Design for Misuse Creates Safer Products
Users often go rogue, using products in ways they weren’t designed to be used. Design for misuse is a way to counteract this.
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The Role of Human Factors in Product Design
A primer on what, how and when the discipline of human factors is used in the design and development of products.
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How Root Cause Probing Improves Medical Device Design
Often, users don’t know why they made a mistake. Human Factors researches use the art of Root Cause Probing to uncover what went wrong.

Our Human Factors Engineering Team

Our Human Factors Engineering Services

  • Contextual inquiry (ethnographic research)
  • Task analysis
  • Workflow and experience mapping
  • Literature searches
  • Anthropometric studies
  • Form studies
  • Concept development
  • Heuristic evaluation
  • Digital interface information hierarchy and information architecture
  • Digital interface wireframing
  • Concept preference testing
  • Use error risk analysis
  • Formative usability studies
  • Validation usability testing
  • HFE/UE Reports for FDA submissions

Let's build something together.