The success of a medical device development project is dependent on running an efficient development program. In many cases, using local expert engineering talent can greatly improve the time to market and your competitive advantage in the marketplace. 

Leveraging local expert support can augment your team’s capabilities and provide a focused effort in problem-solving, prototyping, and testing. When outsourcing product development you don’t just benefit from that team’s internal resources, you can be connected with an international network of proven vendors. 

It’s critical to select a strong partner with deep experience in sourcing, cost estimating, and design transfer to the right manufacturer. Having a trusted expert with a full spectrum of capabilities and expertise will empower your team to execute a program at the right time and at the right price. 

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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.”

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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.”

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The healthcare industry has been trending toward health monitoring in the home environment, and since COVID-19, this trend has significantly increased. Medical device manufacturers are experiencing many new opportunities and additional challenges in designing medical devices for a more diverse user population and less controlled use environment.

In this Sunrise Labs podcast, Alex Therrien, Director of User-Centered Design, and Kelly Catale, Principal Human Factors Engineer, explain how taking a User-Centered Approach to design home-use medical devices will lead to a more successful medical product.

Starting the medical device design process from the standpoint of empathy will ensure that the new device will fit into the end user’s life and is more likely to be adopted. User adoption and therapy adherence will determine the success of the product for all stakeholders.

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Which came first, manufacturing or design? For Eric Soederberg, CEO at Sunrise Labs, the answer is simple. Design always comes first.

In this episode of “Making Bright Ideas Work,” Soederberg explains that if you choose a manufacturer to design your product, you may lose the ability to take a fresh look at your design.

The time to select the most appropriate contract manufacturer is after the design is defined. You then have the flexibility to compare the offerings from more than one contract manufacturer with a clearer view of your needs.

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Building a company culture of continuous improvement and investing for the future sounds like an obvious recipe for success, but it is easier said than done. Eric Soederberg, CEO of Sunrise Labs, joined Tyler Kern on this episode of the Sunrise Podcast to talk about the importance of creating the right work environment for continuous improvement and the investments required to bring that culture to life.

“Continuous improvement is an investment,” Soederberg said. “When someone comes into your office and says they have a great idea, but they need to buy something or take a particular class to make it happen, it requires you to say yes.”

Soederberg’s philosophy is to foster an environment where employees are comfortable coming to managers for things they want or need. When Soederberg first came to Sunrise Labs, people were not asking for stuff, and they made do with existing equipment that was sometimes up to 20 years old.

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No one is an expert at everything, which is why hiring a product development team to get your medical product off the ground can determine whether it will ultimately sink or swim. Product development team expert at Sunrise Labs, Laurin Noel, joins Making Bright Ides Work to discuss what components lead to a successful group of product developers.

With over 27 years of experience in the medical product development business, Sunrise Labs has seen a thing or two. Noel cautions startups and established businesses alike on what to avoid when outsourcing product development. Her leading cautionary tale is to not drop the project on the team and walk away. Remember to dedicate time to your outsource partner, she said. Allocate extra resources and over-estimate the time it may take to fully realize the product through multiple revisions.

“Think of the project holistically,” Noel said, “in order to use time and money efficiently.”

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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.

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