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 comme...
May 13, 2022•25 min•Season 2Ep. 6
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, bu...
Mar 16, 2022•26 min
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 ran...
Jan 19, 2022•24 min
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...
Jun 21, 2021•26 min
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 rol...
Dec 04, 2020•20 min•Season 2Ep. 2
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...
Nov 09, 2020•30 min•Season 2Ep. 1
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 prot...
Aug 21, 2020•31 min
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 B...
Aug 21, 2020•26 min
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. I...
May 13, 2020•20 min
To be determined
Apr 07, 2020•29 min
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 ...
Oct 07, 2019•35 min
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...
Sep 18, 2019•23 min
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 fa...
Aug 23, 2019•24 min
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...
Aug 23, 2019•27 min
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 clie...
Aug 10, 2019•22 min
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?
Jul 02, 2019•34 min•Season 1Ep. 5
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.
May 29, 2019•29 min•Season 1Ep. 4
"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 ...
May 14, 2019•29 min•Season 1Ep. 3
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 thei...
May 03, 2019•27 min•Season 1Ep. 2
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 ...
May 03, 2019•31 min•Season 1Ep. 1
