Making Bright Ideas Work

Sunrise Labs
Making Bright Ideas Work

Join Sunrise Labs on the Making Bright Ideas Work podcast to discuss the ins and outs of bringing medical devices to life, and their impact on the industry and beyond.

  1. 01/09/2021

    Continuous Integration & Automated Testing; When, Where, Why, and How ~ with Jim Turner and Mike Goulet

    No one loved group projects in school, but working together as a team is important at any level of business. Working in a team always can be complicated, but that’s especially true when developing engineering services for medical devices, said Mike Goulet, Program Manager and Principal Software Engineer at Sunrise Labs. That’s why developing processes that run on their own, like continuous integration and automated testing, is critical. “One benefit and one real challenge in medical device development is … controlling the tools that are used to develop the software. One of the projects I was on recently, I think there must be 20, 30, 40 maybe 50 if you add it all up – [there were] so many tools involved in that build of software between compilers, handwritten tools, off-the-shelf products, repositories, testing tools,” Goulet said. “When you’ve got 20 developers, and you say, ‘This is how you’re supposed to develop the software, and these are the tools and configurations you’re supposed to use,’ it’s really, really important you do it in a very specific way because we have to control the inputs and outputs.” That’s especially true in an industry like the heavily regulated medical device space. With continuous integration, all members of the team can find the right tools all in one place. Keeping everyone on the same page and making sure the software stays in compliance is among the benefits of deploying continuous integration and automated testing, and, as Jim Turner, Director of Software Engineering at Sunrise Labs, noted, it’s an opportunity to make sure work isn’t repeated or undone, saving time and money for the client. “The concept is not too hard, but entropy is at work. You get developers, you get five people together, and you don’t have control over what they’re going to do – you’ll have a mess on your hands very shortly,” Turner said. “So, think about the universe wanting to break apart. So does your code, ultimately, so you’ve got to put the processes together to bring it back.” Follow us @SunriseLabsInc, LinkedIn, YouTube Email Us: info@sunriselabs.com Thanks for listening!

    36 min
  2. Quality Assurance Teams and Building a Foundation of Trust ~ with Spenser Zawasky and Trisha Bouthout

    11/10/2020

    Quality Assurance Teams and Building a Foundation of Trust ~ with Spenser Zawasky and Trisha Bouthout

    Quality assurance is a critical component in the product development and manufacturing process. For medical devices, it’s paramount. Sunrise Labs’ Spencer Zawasky, Principal Quality Engineer and Test Manager, and Trisha Bouthot, Director of Quality & Test, spoke about the importance of building a foundation of trust within quality assurance teams and with clients. Bouthot said there are many factors involved to build a foundation of trust within a quality assurance team. Idea and knowledge sharing are critical components in this team trust formula. “As an organization, we share a lot of knowledge. We have many lunch and learns and technical sharing sessions. And as a quality department, we meet multiple times a week and share in our experiences. There is so much power in knowledge transfer,” Bouthot said. “It really helps our team to be efficient.” Empowerment is another element Bouthot said helps build trust within a team. “Allowing people within a team to own their tasks and own their responsibilities puts forth a better product,” Bouthot said, “than they would if it was, say, me directing them to do something my way. I feel like it’s my job to guide them and remove obstacles for them so that they can be much more productive.” Trust built the medical device industry. “A quality assurance team enforces that trust,” Zawasky said. “We’re the ones who have to honor that trust in a way I don’t think is quite as prominent to the developers in an organization.” Follow us @SunriseLabsInc, LinkedIn, YouTube Email Us: info@sunriselabs.com Thanks for listening!

    37 min
  3. 10/25/2019

    How Do You Define a User Need ~ with Nick Lesniewski-Laas, Director of Electrical Engineering

    The fundamental question that comes with designing new MedTech devices is this one: What are the user needs and requirements? The questions feel simple enough, but it’s far from simple. With that question comes others: Who is the user? What makes a good requirement? How do you actually test these requirements? For a MedTech designer like Nick Lesniewski-Laas, Director of Electrical Engineering for Sunrise Labs, these questions can often inhibit his ability to deliver on quality products if the communication between all parties isn’t consistent and straight-forward. “I’m in the business of designing medical devices because I want to help people and I want to make sure that the devices I design are best able to do that,” Lesniewski-Laas said. “So, a lot of guidelines around requirements writing are aimed toward that but don’t really hit the mark in my opinion.” On today’s Healthcare podcast, Lesniewski-Laas digs into this multi-layered question of delivering on user needs and defining needs versus requirements versus actual mandated FDA requirements. “By far the most important things to me are ‘unambiguous’ and ‘testable,’ or ‘verifiable,'” Lesniewski-Laas said. He breaks down the importance of atomicity, the way user needs affect everyone from the manufacturers to the patients, and his process for getting everyone involved on the same page so the potentially life-saving product can make its way efficiently to market. Follow us @SunriseLabsInc, LinkedIn, YouTube Email Us: info@sunriselabs.com Thanks for listening!

    24 min

About

Join Sunrise Labs on the Making Bright Ideas Work podcast to discuss the ins and outs of bringing medical devices to life, and their impact on the industry and beyond.

To listen to explicit episodes, sign in.

Stay up to date with this show

Sign in or sign up to follow shows, save episodes, and get the latest updates.

Select a country or region

Africa, Middle East, and India

Asia Pacific

Europe

Latin America and the Caribbean

The United States and Canada