We caught up with Andrew DiMeo ahead of his educational discussion for MD&M Minneapolis. DiMeo is an Innovation and Design Coach with Trig and we asked him about human-centric design, prototyping challenges prototypers to deal with, and negative design patterns in med-tech.

DiMeo’s presentation is titled The Art & Science of Prototyping on the Path to Approving Great Products.

 

Andrew DiMeo
Andrew DiMeo, Innovation & Design Coach with Trig

Q&A With Andrew DiMeo, Innovation & Design Coach w/ Trig.

As consumers and providers demand smaller packages and more functionality, what are some unexpected prototypes challenges that have come about?

Andrew DiMeo: This question/answer will not be a focus of the particular panel in question. However, here are our thoughts from our team at Trig: Replicating the intended final material properties, such as flexibility, durometer, transparency, color, texture, and dimensional requirements can be difficult. What may be unexpected is the significant time and effort to design a prototype constructed for feedback specific to these properties. Knowledge of both prototype material properties and the intended final material selection for intended use is critical to the process.

 

What are the biggest giveaways a device or product hasn’t focused on human-centric design?

Andrew DiMeo: The biggest giveaway is if the device is used improperly. If proper use is dependent on reading the instructions for use, that’s a telltale sign of not doing human-centered design (HCD). Some other giveaways for a lack of focus on HCD include:

  • It only works well for the demographic of people that designed it
  • It’s only existed in CAD before going to commercialization
  • It is dependent on the user being in an ideal environment

It’s impossible for there to be a perfect representation of the user on your product design team, and for there to be a perfect representation of the use environment. Connecting with the users in their use environment and embracing their needs and context is critical to doing HCD.

 

Are there any patterns in prototyping, problem solving and collaboration in med-tech design that never seem to go away?

Andrew DiMeo: Some of the patterns that exist in medical device product design include:

  • Lack of iteration due to a perceived requirement for a stage-gate design process
  • Prototypes thought of as one ever-increasing version of a final product, rather than many prototypes designed to answer a specific question
  • Optimization for scale versus optimization for user experience
  • Starting with a technology rather than a need

A common pattern in medical device design is a lack of iteration due to a perceived requirement for a linear stage-gated process as a regulatory requirement. While stage-gate is an important business process, it doesn’t need to be baked into the design process. Additionally, nowhere in the regulations (such as the FDA’s QSR) nor standards (such as ISO 13485) is there a requirement for stage-gate. This is indeed a misinterpretation, proliferated by taking a process map (the Waterfall Diagram found in the FDA’s Guidance Document on Design Controls) and translating it into a standard operating procedure. This topic will be discussed in detail during the panel session, “The Art & Science of Prototyping on the Path to Approving Great Products,” at the MD&M Show in Minneapolis.

With respect to prototypes being thought of as one ever-increasing version of a final product, rather than many prototypes, consider ergonomics as just one example. We may have a complex device with mechanical, electrical, and user interface attributes. As we build one prototype the capture all of the technology, it provides limited feedback with respect to ergonomics.

Rather, an ergonomics only prototype may be considered, such as a 2-D prototype that a user can physically interact with. Making a dozen such prototypes of various sizes is a rapid and affordable way to attain valuable information with the intended users on ergonomics. This is the type of HCD that the regulatory bodies are looking for in Human Factors Engineering requirements for design controls. It also demonstrates the first point, that iteration is critical to the process.

Focusing on the users, embracing their context, and resolving their unmet needs as the foundation for design are keys to developing medical devices that are used properly, increase health outcomes, reduce the cost of care, and improve the clinical experience.

 

Sign Up For Andrew DiMeo’s Session

MD&M Minneapolis which is October 23-24th at the Minneapolis Convention Center. Make sure to register for Andrew DiMeo’s session, The Art & Science of Prototyping on the Path to Approving Great Products. Learn more about Trig and Andrew DiMeo by clicking here or you can sign up for Trig’s newsletter here.

We also caught up with Audrey Turley of Nelson Labs who will also be presenting at MD&M Minneapolis. That Q&A is Available here.

 


Accumold is a world leader in medical micro molding and we love to highlight the most innovative minds in the field. If you have specific micro-molding questions or want us to produce a micro-injected part for you. Reach out here.