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.”

Making Bright Ideas Work

Quality Assurance Teams and Building a Foundation of Trust

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 designing 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.

Empathy is Key to Home Use Medical Device Success with Alex Therrien and Kelly Catale

Which came first, manufacturing or design? For Eric Soederberg, CEO at Sunrise Labs, the answer is simple. Design always comes first. But, as more manufacturing companies gobble up small, independent medical device design firms in a merging technique to make investors money, design becomes an accessory to the product instead of the impetus. On this episode of “Making Bright Ideas Work,” Soederberg explained why this practice is bad for clients and consumers and why design firms are better off remaining independent from manufacturing firms. Medical device creation begins with the end-user. Clients first come to design firms to request a new product. The designers work on creating the best, most efficient product. Once designed, they choose the applicable manufacturing plant that is equipped to build out their new design. But when the two parties are already holding hands, the best, most efficient product is not produced. Rather, designers create for the manufacturer’s capabilities instead of the client’s needs. Though buying out design companies can lead to fast growth, Soederberg said, it more often leads to low quality in the end. You won’t find everything you need under one roof, said Soederberg regarding the niche knowledge of designers coupled with the specific capabilities of a manufacturer. As medical devices are usually complex, sometimes involving electronics and coding or acute knowledge of chemistry, it is rare to find a coupled up design and manufacturing pairing that suits all of a client’s needs.

Does Consolidating Manufacturing and Design Really Work?

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. It was important for Soederberg to change the culture into one where people felt they were trusted to make the right decisions to improve their performance and that of the company. “People are happier when they are working toward a better life for themselves, better processes and more efficient ways of doing things,” Soederberg said. To make improvements in a company, sometimes taking a risk and going beyond the comfort zone is required. As Soederberg put it, “You can take a risk, and you might fail, or you could not take a risk, and you will fail."

Continuous Improvement and Investing in Your Company’s Future with Eric Soederberg

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 third-party employees, 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."With years of experience and anecdotes, Noel educates listeners on common roadblocks in outsourcing product development, and how to avoid them. Above all, she explained the need to keep communicating with the team. Revisit the responsibilities of everyone involved, from system engineer to copywriter, as the product moves through development. Above all, assume positive intent of all team members and approach problems with a willingness and openness to hearing different opinions.For the latest news, videos, and podcasts in the Healthcare Industry, be sure to subscribe to our industry publication.Follow us on social media for the latest updates in B2B!Twitter – @MarketScaleFacebook – facebook.com/marketscaleLinkedIn – linkedin.com/company/marketscale

The Keys to Successfully Outsourcing Product Development with Laurin Noel

For all the discussion about process improvement, company culture, and team member morale, you might forget that Sunrise Labs is a medical laboratories company offering a broad spectrum of clinical laboratory testing. That's because Sunrise Labs was founded to be different, and that's evident in everything they do down to the way they run their daily operations. Today on Making Bright Ideas Work, the Sunrise Podcast powered by Sunrise Labs, we sat down with Program Manager Joe McCluskey to discuss how agile project management is more than methodology -- it's about people. "Personal ownership means that you really take pride and you want to deliver the best you can," McCluskey said. "Individual contributions help the team, like the building blocks, to create a better widget when you combine all those personal ownership items." While the team at Sunrise uses agile methodology, most commonly used in software development, and a daily scrum in its everyday operations, they take a very personal approach to project management. Scrum is a methodology that allows a team to self-organize with daily information exchanges and make changes quickly, in accordance with agile principles. "Anybody can make a document and check a list, but the dynamics of a project excel when there's personal ownership and human stimulation," McCluskey said. "There's also humanization of the project itself. If it's a pilot build, personalize the name of the pilot or deliverable. Call it a name. Everybody can connect to a name."

Project Management is Most Successful When it's Personal with Joe McCluskey of Sunrise Labs

Perhaps no state is more renowned for medicine than Massachusetts. The Commonwealth is host to leading hospitals, medical centers, and medical device companies that are maturing next generation technologies. But medtech enterprises large and small need representatives to ensure that innovations in the space can thrive. That’s where Brian Johnson comes in. He is President of the Massachusetts Medical Device Industry Council (MassMEDIC) and on this week’s episode of Making Bright Ideas Work, a Sunrise Labs podcast, he shared insights into his advocacy work. “We help maintain a healthy environment for medical device innovators,” Johnson said. Medicine is a highly regulated industry so his trade group works with government partners to streamline processes and ensure a healthy ecosystem that fosters innovation. Whether its pushing for the repeal of the medical device tax or staying atop of Brexit and its complications for medical device companies, MassMEDIC is there looking out for its members and the medtech community as a whole. “Massachusetts continues to be a robust environment in this space,” he contended, and cited Sunrise Labs as one of the leaders pushing medtech forward. He also works with a number of startups disrupting the industry, and advises that novice CEOs should focus less energy on raising money and more on their plan to go from zero to commercialization. “You need to think about the entire lifespan of this company as a founder," Johnson said. As a former company founder himself, Brian feels passionately about helping other founders. It’s why he’s become a personal champion of MassMEDIC IGNITE, which provides the medtech startup community with training, mentorship, and networking. “I really love medtech,” Johnson confessed, and said that the innovations advanced by medical device companies are on par with those of the space program. He is proud and amazed at the medical advances that come out of the Commonwealth. The first surgery with anesthesia was done in Massachusetts and now leading hospitals in the state are performing surgeries using advanced robotics or remote surgeons.

Making Bright Ideas Work: The Trade Group Looking Out for the MedTech Community

With healthy growth rates projected for the medical technology and devices industry globally, MedTech careers are in high demand. On this episode of Making Bright Ideas Work, we break down how two open positions in the software and product development field at Sunrise Labs are affecting medical change on an industry level. To share their insight, host Daniel Litwin sat down with Jim Turner, director of software development, and Mike Goulet, program manager & software technical lead. “We have a lot of opportunities here at Sunrise,” Turner said. Sunrise Labs has been delivering medical device design and engineering expertise for more than 25 years. The Embedded Software Engineer is tasked with leading the company forward into new product markets, bringing deep C or C++ skills, Linux applications experience, and wireless protocol experience. Personality-wise, Sunrise is looking for someone with a strong, driving desire to bring cutting-edge products to the table, Goulet said. In addition, Sunrise is seeking a Software Architect who’ll be tasked with architecting, leading, and developing medical device software, including embedded software. They'll lead a software development team, provide project direction using agile development methods, and write detailed software design descriptions. The key to success in these positions, Turner said, is the unparalleled ability for employees to express themselves well. That’s because both these positions will have a hand in crafting important, industry-affecting devices that improve real patients’ lives. Give this a listen to learn more about the culture at Sunrise Labs, why their energy draws parallels to Hamilton the Musical, and what you should do to prepare for the interview. If you'd like to apply for either position, click here.

Impact Medical Technology as a Software Engineer & Architect with Jim Turner & Mike Goulet

What are the keys to a successful business? Many will claim that businesses can stay ahead by keeping up with current trends, being innovative, and offering competitive price points, but what about other competitive advantages? What about a high level of respect for your employees and the same amount of integrity? Eric Soederberg, President of Sunrise Labs, joins today’s MarketScale podcast to discuss corporate culture as a competitive advantage. Soederberg says that “high respect and high integrity are the only things that are going to get you long-term success as main ingredients,” and that it starts with letting employees know that they are fully trusted. This also includes admitting when a mistake has been made. “I took a class on participative leadership connected with my church, and in class, the instructor told a story of a minister who had 4 words tattooed to his forearm where he couldn’t overlook them,” says Soederberg. What were the words? “I might be wrong.” By assuming always that employees have positive intent, and asking (and listening) when workers explain why they did things a certain way, managers will realize that employees often had perfectly sane and rational reasons, of which perhaps they weren't previously aware. There is a whole attitude that has to change, and this culture is one of “let’s work on this together to make a better product because none of us are perfect. Let’s work together and make it as good as it can be.” 

Company Culture Eats Strategy for Breakfast with Eric Soederberg

Having a "Eureka!" moment and coming up with a new idea is only the first step in a lengthy and sometimes tedious process known as medical device development. David Hibbard of Sunrise Labs has worked in medical technology development for over 25 years, so David knows a thing or two about navigating this process. In today's episode he explains what a successful commercial launch looks like.

Med Tech: From Mind to Market with David Hibbard of Sunrise Labs

Getting a medical product to market is no simple task. From conception, to development, to marketing to appeal to audiences worldwide, every step has its speed bumps, and like a speed bump, and put in place for good measure. Quality control for feasibility and engineering tests both play a part in making sure that the product is functional, viable, and in many cases, FDA approved. On today's episode of The Sunrise Podcast, Adam Jacobs, Chief Technology Officer at Sunrise Labs reeducates on how products are submitted and certified by the FDA and what kind of things need to be done during product development, including ISO 13485 certification for medical devices. It's a long and necessary process, especially when the product needs to be manufactured so that it’s reliable and economically sound for the consumer, but also profitable, and that’s where complications often come in. Many companies may work on a single product for long periods of time and end up not getting exposure, and everyone wants to “get to profitability as quickly as they can,” according to Jacobs. “We probably have 20 or so projects at any given time, and as CTO I’m lucky and get to be exposed to most of them,” Jacobs said, which also means that he sees the products that weren’t put together well. “Getting a mature vision of what you want it to be is often one of the best things that you can do,” because otherwise medtech companies may have to change their products or production process downstream, an expensive and time-consuming mistake.

Avoiding the Pain Points of Getting MedTech to Market, with Adam Jacobs

The fundamental question that comes with designing new MedTech devices is this one: What are the user needs and requirements? The questions feels 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."

In MedTech, How Do You Define a User Need? with Nick Lesniewski-Laas of Sunrise Labs

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.

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Making Bright Ideas Work

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