hsDNA

Ian Culverhouse of Rebus Medical and Melissa Lemke of Agilis Consulting Group join Justin Starbird and Dr. Mary Beth Privitera, Principal of HFE/Research for HS Design and the Co-Chair of AAMI Human Engineering Committee to talk about their contributions to the new book Applied Human Factors in Medical Device Design. 

Ian discussed how "...contextual inquiry is a really, really powerful technique that looks beyond looking just at the device at a task level, but it looks to better understand the world in which that device or the system would used in."

Melissa talked at length that "...task analysis, is one of the most important and beneficial human factors tools that we have to work with. It's a systematic hierarchical breakdown of user performance, or device used steps. Importantly, we take a step back from thinking about the device user interface and we look at it from the user perspective. We start documenting what are the user interactions that are required to reach some outcome, perform some function or use the features of the product or device.

Bobby Boyer joins Justin Starbird on the latest episode of "The hsDNA Podcast to talk about the importance of a product champion.

As Bobby shares, "The product champion is someone that is devoted to the success of the product itself. They are going to be the ones that are driving the decision to make sure that the product is the best it can be. A lot of times that means they have to juggle a lot of different things. They have to juggle between the aesthetics, which the designers care a lot about. They have to deal with the mechanical systems where it needs to function properly. Same thing with the electrical aspects.

Then they need to look at it also on the business side of things of those startups and those fortune 100 companies where there's business needs. Keeping the cost down and keeping all that moving forward. Most importantly, it's also about having the user needs and caring about, what does the user eventually need in this product? At the end of the day, that product champion is really that person that's devoted to working on all those pieces and taking some aspects. Knowing that they're going to lose on other aspects, but understanding that, at the end of the day it's going to meet all of those needs all together and create the best product possible."

Dr. Mary Beth Privitera, Research and Human Factors Principal at HS Design and Co-Chair of the AAMI Human Engineering Committee joins Justin Starbird to kickoff a 7-part podcast series on this episode of hsDNA. She speaks with Justin to give an overview of section one where she defines Human Factors and how to use the new resource book.

The goal and challenge was to create one title which would clear the air and provide direction while highlighting the major areas within the practice of human factors

Dr. Mary Beth Privitera, Research and Human Factors Principal at HS Design and Co-Chair of the AAMI Human Engineering Committee joins hsDNA to introduce her new book titled Applied Human Factors in Medical Device Design. The book began with a recognition of the new human factors guidance coming out between the FDA, MHRA, and the IUC and understanding how it all fits together. It dawned on Dr. Privitera that there wasn't a comprehensive methodology.

When discussing the topic of certification for a design firm and the process you have to go through there is quite a bit of rigor that goes into creating, maintaining and showing compliance to the quality systems. While that overhead will naturally be absorbed into the hourly rate or retainer, in the long run, certification actually makes things less expensive.

The reason why a design firm, like HS Design of Gladstone, NJ maintains it is because it brings a tremendous amount of value to our clients. Readers may have heard of the term “right the first time.” When you are talking product development, engineers chuckle because there are always multiple design iterations. But there are design iterations and then there are major setbacks.

The Importance of Design in Medical Equipment. Listen as we walk through what goes into the design of Medical Equipment. What steps are followed? What are the most overlooked elements?

For this episode of hsDNA,  we have Michael Quinn from HS Design to talk to us about a topic that, for a lot of folks, this topic can mean a couple of different things. We're here to clear up what is Six Sigma and how does that apply to design and innovation for device design and how HS Design implements that into their process.

"Back in the day, human factors was just a course that we took where we essentially, looking for, how do people interact with the objects?" Explained Mary Beth Privitera, Human Factors Principal at HS Design from her office in Cincinnati. When she got her start, Human Factors Engineering or Human Factor Design were not professions in and of themselves. 

Today, if you look at human factors professionals that go get a degree in human factors, it essentially applies theoretical principles, data and methods in order to optimize the design for the purposes of well-being and overall system performance.

Human Factors really about answering, 'how do we interact with products and systems?' Or 'how do we interact with ourselves?' 

It gets down to when work within the human factors scope is getting done, it's the tools, it's the tasks, it's the environment and taking that all into consideration so that we have a little easier time doing our everyday tasks or when we're on the job or our jobs, the tasks that we have to do related to a job.

For a product development firm to engage with a start-up group, they could come in at any stage really. How a start-up is engaged depends on the goals of the companies that come in. For startups specifically, it could mean that they need help taking their idea or their prototype to develop it into a viable, commercialized solution for the end users. 

Many times, the startups looking for product development services come out of labs, or from universities. Others come from a tinkerer that's in their garage trying to put together something. Regardless of how they get to a product design firm, when they come in, they don't really know what the development cycle is or how they can bring it out. Bobby Boyer, Director of Product Development for HS Design in New Jersey explains, “These start-ups come in and just say, ‘I have this prototype. It works. What's next?’"

Industrial design as a whole, is a wide open and diverse field that touches lives every day in nearly every activity. The big differentiation between industrial design in consumer product development and medical product development are the certification processes and quality. Each of which is super important to how products are brought to commercialization.

For the very best design firms, they will even go one step further than that and bring back to the doctors and nurses the updated prototype for what HS Design of New Jersey calls, “formative evaluations” and “formative tests.” Alden states, “We will bring these concepts to them, maybe in prototype forms, maybe in a wireframe, depending on the sophistication of the product. It may be a picture, and if it's simple enough, we'll have prototypes for them to hold and talk through. We'll actually get their insight on which is their preferred, and we do that in a quantitative method where we'll have an actual ranking and result of the preferences.”

The added benefit of going into such depth is that this process also gets through the full documentation process that the FDA likes to see. Having done such heavy lifting as the process is underway, when the approved product goes into market or production and the final validation called the summative test is administered, the product will be brought to those users which participated on the front end, as well as new users using it for the first time. The users will be watched in use, making sure that they can operate the new product. The Summative Test will grade whether the product has a training curve or whether it has instructions for use, but the goal is to have the users maneuver the product inherently on their own, without use error. To Tor Alden, “...that really is the differentiation in a nutshell between medical product development and a consumer, for example. If a consumer product fails, the user might get frustrated. In a medical product, the user might die.”