A Case for Placing a Higher Priority on Human Factors in Your Medical Device Design Process

I may be a new engineer to the medical device field, but the discussion I’ve observed in the industry over the past few years indicates the landscape is changing quickly. Some examples of recent changes that we’ve already seen include the emergence of digital medicine, robotically assisted surgeries, additive manufacturing for patient-specific implants, and consolidation of entire hospital systems in an effort to cut costs without compromising quality of care. Some large players in the medical device industry are even starting to push for healthcare reimbursement policy that’s a function of patient outcomes (‘Value-Based Healthcare’ – see JnJ, Medtronic, Stryker, Boston Scientific) vs. reimbursement per procedure or device used with no tie to outcomes, which has been the traditional reimbursement structure to-date.

I recently read an article from the February 2018 issue of Medical Design Technology (MDT) Magazine that summarized the results of a reader poll they had done focused on Value-based healthcare and data-driven medicine. There were some interesting counter-points brought up by the readers related to the challenges of implementing this type of policy, such as: “Will healthcare providers be more reluctant to take on patients with lower odds of positive outcomes”, and “How does one differentiate between success and failure… pay if the life is saved, no pay if not?”. Despite these challenges, more than 60% of those polled felt that outcome-based strategies will play a significant role in how patients are treated and how insurance providers compensate healthcare providers in the near future [1].

Ok, so what’s this all mean? From a commercial standpoint, I think it means that those bringing medical devices to market must be able to make a stronger case than ever for the value they bring if entire hospital systems are to have the confidence to make the switch. I would argue that a heavier investment in human factors as part of a medical device development program is a great way to differentiate. One of our largest (and most expensive) issues from a national healthcare perspective is the occurrence of preventable medical errors, which are the third leading cause of death in the United States [2]. There have been numerous studies done that looked at implementing systems as simple as using a checklist in the Operating Room to avoid common mistakes and missteps, with some studies finding the occurrence of preventable errors being cut by nearly half after implementing the checklist [3]. We can borrow this perspective to shift more of our focus and effort to human factors in our product development process, which involves developing an understanding the user, the user interface, and the environment to drive design and use decisions. Doing so will not only help in the ultimate goal of your device improving patient outcomes, but will also make your device more attractive in the marketplace. And if the reimbursement policy does shift to a higher priority on outcomes, you and your human factors-savvy device will be ready.

The author, Mike Chambers, is a Product Development Engineer at the Design & Development Center of EG-GILERO

Resources:
FDA Guidance Document: Applying Human Factors and Usability Engineering to Medical Devices

References:

  1. Goldberg, Lee. “A Crowd-Sourced Crystal Ball.” Medical Design Technology, vol. February 2018, pp. 6–8.
  2. Makary, Martin A., and Michael Daniel. “Medical Error—the Third Leading Cause of Death in the US.” BMJ, vol. 353, May 2016, p. i2139. www.bmj.com, doi:10.1136/bmj.i2139.
  3. Treadwell, Jonathan R., et al. “Surgical Checklists: A Systematic Review of Impacts and Implementation.” BMJ Quality & Safety, vol. 23, no. 4, Apr. 2014, pp. 299–318. PubMed Central, doi:10.1136/bmjqs-2012-001797.