Velentium Blog

Transformational Leadership: Navigating Miracles

Sometimes, your boss or client will ask for a miracle, such as a deliverable before you're ready. Like many of us, you'll probably feel tempted to avoid conflict and nod agreement. Under pressure, this often feels like the easiest way through. But it's fraught with risk: you're risking your reputation, your relationship with your boss, client, and team, and maybe even your job.

Topics: Transformational Leadership

HFE Part Two: Safety Through “Backwards” Priorities

As we resume our discussion of Human Factors Engineering (HFE) for medical devices, it's worth repeating that HFE should be wholly incorporated into the development process. HFE is about thinking ahead to catch and prevent potential user errors before they happen. Ideally, iterative testing against anticipated use-based risk would be scheduled in lockstep with development phases.

Topics: Human Factors Engineering

Transformational Leadership: Challenge Skeptics to Invest

Whether your team is floating new ideas during a brainstorming session or seeking approval on a controversial proposal, skepticism is inevitable. But is skepticism an obstacle... or an opportunity?

Topics: Transformational Leadership

The Root of Trust: Part 1

Welcome to my first blog posting on Embedded Systems Security.

Topics: Root of Trust Embedded Systems Security

Velentium Book Club: The Pixar Touch

Velentium hosts a company-wide monthly book club, seeking to learn from the best in business. This time, we discuss The Pixar Touch: The Making of a Company, by David A. Price.

Topics: Velentium Book Club

Transformational Leadership: Acknowledge Who You're Not

It may feel counter-intuitive, but referring potential clients to companies that operate just outside your specialty or overlap with you can actually be a great way to build your network, develop your brand, and double-down on your strengths.

Topics: Transformational Leadership

HFE, Part One: Integrating Human Factors Engineering for Medical Devices

When it comes to medical device safety, having fully-integrated human factors engineering (HFE) processes in place throughout development is absolutely critical.

Integrating HFE from Day One of development may seem counter-intuitive. The iterative testing process HFE calls for can be frustratingly non-linear, and may appear expensive. But the alternative – taking a product all the way to pre-market testing before identifying potential user error – is much riskier. At that point, when testing reveals use-based safety concerns, you'll be forced to choose between a costly redesign or a hasty, less-than-effective retrofit. The further along in development your product goes before HFE integration, the riskier and more expensive neglecting it becomes.

Broadly speaking, HFE aims at reducing hazard risks arising from user error during normal use of your product. Successful HFE integration forces your whole development team to stay focused on users, use environments, and user interfaces throughout product lifecycle. HFE recognizes that a well-designed user interface (UI) not only encourages correct use of your product, but also discourages incorrect (and potentially hazardous) use errors.
Image Credit: FDA

(The FDA defines UI for medical devices as all elements of the device that a user interacts with – sees, hears, or touches).

It should come as no surprise that modifying product design is more effective at combating user-error hazards than training or labeling. Training is subject to “knowledge decay” – we forget training with time – and we don't necessarily have or take the time to locate and read instructions, especially in urgent medical situations. Users interact with devices primarily on intuition and expectation, biases and instincts which are reactions to product design and influenced by previous interactions with similar products. We've got to anticipate these and keep them constantly in mind in order to “design out” user error.

In general, the FDA believes that user-based medical device safety should be prioritized like this:

  1. Safety Through Design
  2. Protective and Preventative Measures
  3. Safety Information and Training

One of the biggest challenges we face in design is the expectation of simple interfacing. I once heard a microwave repairman claim that they should put only "+30 second" buttons on microwaves instead of all the other numbers because that's the one that malfunctions from overuse.

Topics: Human Factors Engineering