hsDNA

Martin Bakstad, the Director of the European Division for Design and Development for SteriPack, joins host Justin Starbird on the latest episode of hsDNA.

SteriPack is a contract manufacturer that helps blue-chip companies of this world and with their medical device and pharmaceutical industries. SteriPack preforms contract manufacturing services for class 1, 2, 3 devices and medical class 1, 2, 3 including molding, cleaning, and packaging that helps companies see their concepts through to commercialization and manufacturability.

Martin shared that working through the pandemic was “actually surprisingly easy. Everybody just got the status around working on Microsoft Teams and realized that there was no option to travel. Historically, we were traveling and spending a lot of time, effort and money to meet in-person. Now that there was only one option, white it can never replace a face-to-face meeting, we learned that a lot of people have also loved working from home. It cut out all the travels to and from work which made us more efficient as well.”

Recently his team was also recognized with the 2022 Gold Edison Award for their efforts on the novel Xpress Collect device to test for COVID-19.

As Martin explained, “Xpress Collect is a device that takes away the labor on the backside after testing (for COVID-19). From when the person has been tested, all the way through to a result, is what ur team has optimized with this product. It's a simple device where you take a dry-test and then you liquid without removing the swab which enables you to run high numbers through an automated system. It's novel in the terms that it revolutionized the way that the lab operates because there is literally very little manual labor involved in this.”

Listen as Justin and Martin discuss the challenges and success that came out of working with a global team to solve a pandemic issue with future plans to apply to other testing needs.

Listen to the latest episode of hsDNA, as Michael Quinn, the VP of Design & Engineering for HS Design, joins host Justin Starbird to talk about the how being agile and adhering to regulatory constraints is sometimes in conflict. 

As everyone knows, the medical device development and manufacturing space is highly regulated. Everything has to have a process. Some people may hear agile and think programming or software, but the truth is you have to apply process to every aspect of the design, build, and testing of a new product. As a result, it create an enormous amount of structure that needs to be built. As Mike shares, "There's conflict between that agile methodology of development and the regulations on how to do development and that's where we're really walking a tightrope or a razor's edge between the two."

Mike discusses this conflict with Justin to explain how the HS Design Team have turned these areas that were once headaches, into opportunities. 

Today, we're talking to Bobby Boyer, Director of Product Development for HSD, and talking about the process of strategy and planning. Over the years, the capabilities of HSD have certainly widened, and the scope is a little bit bigger than it has been, but in the true sense, not much has changed either. HSD is still very attentive to the details of the customer, what their needs are, and making sure to build the best product possible. 

The HSD process for strategy and planning is applied to a range of customers. From startups, that have an idea, all the way to Fortune 100 companies that have already created the idea and are about to send it to manufacturing. The process is dependent on what the clients needs are. 

Creating prototypes, getting the industrial design, mechanical engineering factors aspect, are all incorporated into that design. If customers need the backend, which goes into manufacturing, then HSD also provides a design for manufacturing, packaging options, design for packaging, and labeling. 

Listen as Bobby walks host Justin Starbird through each element and collaboration. You are listening to "hsDNA."

On the latest episode of hsDNA, host Justin Starbird is joined by Tor Alden, Global Design Development and Human Factor Lead of HS Design, now a SteriPack company, and Mary Beth Privitera, Principal of Human Factors Engineering for HS Design.

There are a couple of things that are happening in the marketplace that are directly relevant to successful design in the medical device space. Users are getting more complex as they get more used to easy-to-use products in their daily lives. They expect it in their workplace as well, and medical devices fall into that genre.

As Mary Beth points out, "Another thing that's happening is that the regulatory agencies are really looking for strong device design that's validated through usability testings. It's one of the things where if you wait too long and you don't have a significant design, then you run into trouble just in getting over that hurdle. At the heart of it, I think good design is becoming increasingly a customer expectation for medical device users."

Listen as Tor and Mary Beth share their insights and boots-on-the-ground experience of what goes into making an award winning medical device project commercially successful.

At HSD, we are fortunate to work with companies of all sizes. Some of our favorites are start-ups that are just out of the gate. Our passion is working with and teaching entrepreneurs what it takes to start a business and take a product from a concept all the way to commercialization. 

On this episode of the podcast, hsDNA, Bobby Boyer, Director of Product Development joins Justin Starbird to talk about education and the overlaps between teaching and working with startups. In addition to his role here at HSD, Bobby is also an adjunct Professor at Rutgers University where he works with students to walk through the steps necessary to be successful as well as the pitfalls to avoid. We teach as we do here at HSD and continue to be committed to teaching everything from concept to human factors to patent processing and beyond!

Listen now. 

What is the state of medical device design going into 2021? Tor Alden joins host Justin Starbird to discuss as they open Season 2 of the hsDNA Podcast.

Tor shared that, having been been in consultancy for over 20 years, he thought he had seen it all. From corporate outsourcing trends, internalization, recessions, and booms, he had never saw a plague. Now he has! As he looked back on the year, Tor said, "The interesting thing beyond-- if you take COVID out of this year, HSD really had a fantastic year, we have been busy, we've moved into our new building so we've got more space, and we won an IDEA, International Design Award as well."

In Tor's experience from the year, "the real learning curve was how do we (HSD Team) interact with that big Brady Bunch of screen in front of us? Just seeing, how do we get that collaborative-ness. We've done it, but I am fearful in the future for new employees that come on board, they don't get that culture that you have, and you see... how does the industry as a whole or even us continue our HSD culture if we can't get together and interact together?

"We've been spending a lot of time and effort and money on trying to do that virtually. Hopefully we're successful, we hold (together) again. Pity if we can't have more fun and now it’s a little bit tedious. I think the good news is everybody's very caring about each other. Everybody's taking care of each other."

That is what has made HSD so successful this year, has been their ability to hold it together. 

Listen as Tor walks us through what the rest of 2020 looks like and what to expect in 2021.

Process of conducting a human factors validation study and the requirements

As Mary Beth Privitera stated on the most recent edition of the hsDNA podcast, this is one human factors methodology where the agency has done a really good job of communicating what their expectations are. It is also the one method that has some significant rules that must be adhered to in order to have an adequate validation test. The test runs like the other human factors studies where you are going to generate a protocol, you're going to go through the logistics, conduct testing, conduct the root cause analysis and report.

That said, there are some specific requirements that have to be included. For example, if it was a product that was intended to be used by pediatric users and adults, then you'd have 15 pediatric users and 15 adult users that would be in the test. You have to have the final product. The final product must be functional. It must be representative of what's going to go out into the field.

As Mary Beth points out, "The one difference between a validation test, which is also sometimes called a summative versus a formative test are that in a formative test, you don't have a lot of those rules. You can do a little, there's a little bit more wiggle room, but in the validation test, you've got to adhere by strict rules."

"Another strict rule that I didn't mention in the book which is important is that as a human factors evaluator, I cannot interact or assist the user unless I record that I did. It's sort of, I want to be a fly on the wall during this test and let them just use the device and then watch them. Then when they become challenged, I prompt them to say, what would you do if this was a real case? Then eventually, I can intercept or intervene, but I have to mark that and note that. Oftentimes when you do intervene, then that becomes a use error and that gets noted. It's definitely a process that is got a little bit more control to it that must be adhered to."

Mitigating risk in Applied Human Factors In Medical Device Design with Dr. Mary Beth Privitera

Every human factors design firm, in a way, are going to have some area that's dedicated personnel for risk analysis of potential and existing projects. The authors that contributed to this section of the book Applied Human Factors In Medical Device Design, Sophia Kalita and Melissa Lemke, were phenomenal in walking through the process, what to look for, and what is important to mitigate risk. 

As Mary Beth Privitera stated on the most recent episode of hsDNA, "Safety-related risks. I know that it's not one of the most exciting topics but it's certainly one of the most important topics that we've talked about and reviewed. It's one of those approaches that's just inherent, regardless of the medical device. There's always some level of risk and risk that has to be managed. There's quite a number of international standards on risk identification and what that process is to mitigate the risk. The medical device industry has to address the risk and that includes human factors.

Specifically, just in what is the use-related risk analysis. What's the root cause of those problems? Then, once the product's released, how am I going to survey the product as it's being used and what am I going to do about it? How am I going to get that customer input back into the design process?"

Without going through and doing that risk analysis, you're going to have to understand that root cause. First is identifying it and then looking for that root cause of what's going to go on. Mary Beth continued and explained, "Lastly, was the chapter that I authored in regards to no use error and post-market surveillance. That just points down to all of the databases and the research that's available for us to look at."

Our lives would be in peril if risks factors were not incorporated in the release of a device and its' inherent concept. For that, we can be thankful that there are measures in place that help evaluate what is important, what is not, and ways to move forward.

Formative Evaluation, Design and Reporting - Applied Human Factors In Medical Device Design Book Preview | PART 4

Design is the best way to mitigate risks associated with use errors. This section, it's really about human factors in design. When we think about human factors, we always think about the testing. We don't necessarily think about design and how human factors fit into design. The fact of the matter is that if human factors aren't applied in design, then testing is really problematic.

If you look at that historical legacy of work, what is the root of all human factor? It actually goes back to 1997 in this publication that the FDA put out, it was titled Do It By Design. its ethos and its values still ring true and in fact, there's some really nice risk analysis to say, "Hey, you know what, design is the best way to mitigate your risk associated with use errors," said author Dr. Mary Beth Privitera.

This section, covers how human factors is applied in device design, in general, and then it gives a nice overview with specific considerations in designing combination products and then instructions for you. According to Mary Beth, "it is probably one of the most important chapters or sections within the entire book."

To be determined

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.
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.

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.”