Every day the world is waking up to a new reality. How are businesses pivoting? What changes are they making to not get left behind? During every great set-back there is an enormous opportunity to learn and make giant steps forward. In the medical device design and development space, the set backs have resulted in need to make changes to what was status quo. Listen to Tor Alden & Mary Beth Privitera talk in great detail about how Human Factors studies are changing every day and what is necessary to overcome.

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 about how "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 returns to the hsDNA Podcast to join host Justin Starbird to talk about the importance of a product champion when developing a project.

Listen as Bobby explains how... "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.”

The product champion needs to look at the project from the business side of things as well. This is super important for startups as well as those in the Fortune 100 where the stake holder expectations can be heavy. The product champion is also tasked with keeping the cost down and keeping the user needs in mind.

At the end of the day, the product champion is really the one individual that is devoted to working on all those pieces and 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.

Read more about the Product Champion here (https://hs-design.com/blog/product-champion/)

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.

Buy her new book (https://Amazon.com)

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.

Applied Human Factors in Medical Device Design describes the contents of a human factors toolbox with in-depth descriptions of both empirical and analytical methodologies. The book begins with an overview of the design control process, integrating human factors as directed by AAMI TIR 59 and experienced practice. It then explains each method, describing why each method is important, its potential impact, when it's ideal to use, and related challenges. Also discussed are other barriers, such as communication breakdowns between users and design teams. This book is an excellent reference for professionals working in human factors, design, engineering, marketing and regulation.

-->Focuses on meeting agency requirements as it pertains to the application of human factors in the medical device development process in both the US and the European Union (EU)

-->Explains technology development and the application of human factors throughout the development process

-->Covers FDA and MHRA regulations

-->Includes case examples with each method

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.

You can BUY HER NEW BOOK HERE (https://Amazon.com)

When discussing the topic of certification for a design firm, certification does not mean a lack of creativity. Good design firms have been able to tailor quality systems, standard operating procedures, and work instructions to reflect the type of work that needs to be completed. The process you have to go through to get to proper certification is quite rigorous and there are many elements that go into creating, maintaining and showing compliance to the quality systems.

It is imperative for any quality manager, especially at a creative firm, to look at the ISO standard and tailor their processes to not only be compliant but to be useful to the development teams and their clients. 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 maintains ISO 13485 certification is because it brings a tremendous amount of value to our clients. Listeners 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.

You can read more about the importance of ISO 13485 here (https://hs-design.com/blog/hsdna-iso-13485/)

Tor Alden, Principal of HS Design, comes back to the hsDNA Podcast to talk about his passion for design. From the outside, Tor says that... “it seems obvious that design would be nearly as important as function. Yet for a long time, industrial design has always been considered an afterthought because either engineering or marketing would work to contain or put boundaries on what was possible. At its worst, design became an “add-on” for if there was extra money in the budget then design could put some styling on or get a different look just for the sake of differentiation. It was not a core piece of the puzzle.”

Today, Tor talks about the design inclusively of industrial design, UI, but more importantly, the user experience, and that product is perceived from the out of box experience all the way to its end of life of the product.

Read about the importance of design here (https://hs-design.com/blog/importance-of-design/)

Michael Quinn VP of Design & Engineering of HS Design joins host Justin Starbird to talk Six Sigma. Certainly, this topic has many different meanings. Michael is here to clear up what Six Sigma IS and how does that apply to design and innovation for device design. He also shares how HS Design implements Six Sigma into their process.

Michael explains, “Six Sigma is a method that provides organizations tools to improve the capability of their business processes. This increase in performance and decrease in process variation helps lead to defect reduction and improvement in the design to commercialization process.”

Not only can Michael speak to the specifics of Six Sigma, he is also Certified Design for Six Sigma (DFSS) Expert engineer and adept at producing need-driven, innovative designs for the medical field.

Read More (https://hs-design.com/blog/michael-quinn-talks-six-sigma-design/)

Human Factors, at their root, are about helping designers answer, 'how do we interact with products and systems?' and 'how do we interact with ourselves?'

The two most fundamental questions when it comes to how a proposed device will function and be used. "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. Without dating her, MBP shares that when she got her start, “Human Factors Engineering or Human Factor Design were not professions in and of themselves.” She professes we are all as young as we feel!

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.

The process of understanding Human Factors gets down to when work within the human factors scope is getting done, it's the tools, it is 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.

Read More (https://hs-design.com/blog/podcast-human-factors-blog/)

hsDNA Ep2: I have a prototype. It works! Now what?

Bobby Boyer joins host Justin Starbird for the second episode of the “hsDNA Podcast” to talk product development. For start-ups and new companies, this is the beginning of what could be a global game changer!

Product Development Firms can engage with a start-up group at any stage in the process. But HOW a start-up company is engaged to the Product Development Firm, depends on their end goals. For startups specifically, they need to evaluate which stage of commercialization they are in and where they can use the specialization. As Bobby explains, “For example, if a company needs assistance taking their idea or their prototype to development versus another start-up that needs help taking a viable product to a commercialized solution for the end users, will be treated differently at HS Design with different folks helping manage the project.”

For some on the HSD team the excitement comes from the different types of companies that they get to work with. 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?’"

Read more about Product Development (https://hs-design.com/blog/podcast-prototype-works-now/)