What Quality Really Means in MedTech: A Conversation with Kim Tetuan

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How do you and your team really build
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the quality and regulatory consideration
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into each step of the product
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development process? Welcome back to
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Beyond the Light, the podcast where we
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explore the stories, innovations, and
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people driving the future of medical
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lighting and technology. I'm your host,
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Lindsay Jenovic, and today I'm excited
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to be joined by Kim Tetuan, our director
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of regulatory affairs and quality here
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at Lumatex. Kim has been instrumental in
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guiding how we meet and exceed the
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rigorous standards with that come with
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developing lighting for medical devices.
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Kim, thank you so much for joining
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today.
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Yeah, thanks for having me.
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Let's dive right in. Let's talk about
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regulatory compliance and how it just
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plays such a key role in the medtech
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world. Can you share how Lumatex ensures
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our lighting components meet FDA
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requirements and our quality standards?
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Sure. Yeah, we ensure that the
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regulatory team is involved right from
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the beginning when we get a new customer
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or or a new product um when it's
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officially kicked off. We create an
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entire regulatory strategy from each
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product to ensure we fully understand
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the requirements of the customer where
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they want to distribute the product and
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the product itself. The strategy ensures
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that we adequately plan for the
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regulatory compliance of that new
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product. Um Lumitex also has some defined
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product families already. Um, so we're
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able to utilize those products and those
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registrations if the new product meets
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that defined intended use of the
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product. So that allows us to leverage
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those registrations and get that product
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to market faster. Um, if they fit within
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that product family,
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it sounds like that makes it a lot
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easier for our customers, especially
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because we have such a rich history of
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doing it already.
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Absolutely. Yeah. And if that product
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fits within that defined family or we
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have a new product registration, we have
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that defined regulatory team who has
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that extensive knowledge on different
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lighting medical devices um technologies
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to assist our customers in completing
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that regulatory compliance activity and
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obtain that product approval quicker.
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Well, that's great. It takes a lot off
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of our customers plate.
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Absolutely. Yeah. I mean, Kim, I I know
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how much quality means to you. I know
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it's it's at the heart of every medical
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device. How do you and your team really
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build the quality and regulatory
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considerations into each step of the
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product development process?
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Yeah, so anyone who who designs and
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manufactures medical devices, it's an
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extremely regulated process and it has a
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pretty structured defined design control
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process. So to ensure that we build the
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quality and regulatory into that defined
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process, we ensure we have a defined
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crossf functional team from the very
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beginning of the design controls
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process. quality and regulatory are
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included from the very beginning to
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ensure we have that regulatory strategy
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um and that's fully understood as well
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as ensuring that the product is being
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designed with quality in mind. We have
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the quality team ensuring that we're
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able to measure or test the equipment or
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and product at every step of the
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production process to ensure the
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products at the highest quality when
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shipping to our customers.
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Yeah, that's definitely key and very
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important to tackle these things early
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on in the process. It sounds like as
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early as possible starting to consider
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these things.
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Absolutely. And lighting is very
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important as it uh directly relates to
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the human factors and usability of a
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product. So you want to ensure that
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lighting is considered as early as in
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the process as possible to ensure that
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the product is used appropriately and
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understood by the user. So important. I
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feel like that's that's something we
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can't stress enough to our customers.
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Yeah.
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Kim, this is something that's so
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exciting for you. You recently recently
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implemented a new electronic quality
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management system. Congratulations, by
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the way. That's so exciting.
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Yes, it's a very special project to me.
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It really is. I know it's been a long
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time coming.
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There are a lot of aspects to this, but
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overall, can you talk about how this
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upgrade has improved our internal
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processes and then how does that make a
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better experience for our customers?
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Yeah. Yeah, the electronic QM is
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definitely a special project. has been a
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labor of love the last couple of years
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for me. As Zumatex continues to grow as
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a company, we want to ensure that our
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processes are able to grow with us. So,
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starting this electronic QM, we're able
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to to leverage electronic processes to
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streamline how we work as a business and
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in turn get quality product to the
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market quicker. We're able to
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collaborate easier, utilize electronic
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processes to be able to more to be able
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to work more efficiently as we continue
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to add more capabilities into our
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electronic QM. It will only continue to
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streamline how we work as a business
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even more.
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That's so exciting. What are the next
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stages in 2026 for this QM?
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Yeah, so we are starting to implement
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all of our quality processes into the
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EQMS. includes our kappa process, how we
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monitor all of our complaints, our
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inspections, our non-conformances,
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internal auditing, how we work
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qualitywise in electronic QM. And then
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after that, we'll be implementing a PLM
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and all of our drawings into the EQMS to
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have um a database that has all of our
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drawings in there. So, we're able to
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collaborate a lot easier as well as our
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design controls process. So, we're able
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to make that more efficient and get our
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product to market faster. That's
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wonderful. Um really excited to see how
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that develops and you know I know from
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working with you just how near and dear
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all of this is to you and how seriously
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you take it for our customers. So thank
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you for being such a crucial part of
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what we do um for our customers here at
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Limit.
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Thank you very much.
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It's clear that quality and compliance
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aren't just boxes to check at Lumatex.
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They are truly embedded in everything
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that we do. I want to thank Kim for
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joining us today. And to our viewers,
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thank you for listening. If you enjoyed
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this conversation, be sure to follow
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Beyond the Light for more stories from
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the people driving the future of medical
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lighting and technology. And until next
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time, keep pushing boundaries and keep
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improving life with light. Thank you.
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