Sean Fenske, Editor-in-Chief11.14.22
It’s been quite the hiatus since attending the Medica and CompaMed trade shows in Dusseldorf, Germany. My last visit to the event was 2019, prior to all the disruption created by the COVID-19 pandemic. With renewed enthusiasm, I was anxious to get back onto the show floor to meet with those companies attending the 2022 event. In anticipation of my visit, I reached out to a number of companies to get the scoop directly from them on what they are showcasing at the event, what challenges customers have brought them, and where they see their role within the industry in aiding medical device manufacturers. With that in mind, Dr. Sean Lynn, senior director of engineering of Teleflex Medical OEM, shared the following insights to help you determine if the firm should be a potential services partner for you in 2023 or beyond.
Sean Fenske: What technology or service are you emphasizing at Medica/CompaMed this year?
Dr. Sean Lynn: At Teleflex Medical OEM, we understand the need to progress through the early stages of the device development process quickly but still take advantage of the opportunity for learning and developing a deep understanding of how best to meet the device’s key user needs. We have observed that the customers who develop very successful products tend to spend these early stages prototyping numerous different concepts and ideas to learn and iterate their design quickly. Much of our efforts at developing technology and services over the last seven years are around making it easier for our customer to progress their device designs in a faster time frame. We have strengthened our development groups and development capacity at our various sites. As a vertically integrated company, we buy very few outside components. This allows us to be very responsive.
At Medica/Compamed, we are emphasizing the WaySteer quick-turn steerable handle platform. This is a steerable catheter handle platform that can be customized to meet a specific customer’s needs. People can call over to the stand to learn more about the platform and see a physical demonstration of the platform. This technology complements our complex catheter offerings. A customer can incorporate the WaySteer steerable handle platform into their catheter design. This is our latest offering to try and accelerate our interventional catheter customers development projects.
We are also emphasizing our EPIC Centers. These are a really great way of beginning your project and getting the DFM knowledge of a vertically integrated OEM with over 40 years’ experience into your design from the start.
Fenske: What’s the most common challenge customers inquire about and how do you address it?
Dr. Lynn: Customers are often looking to ensure the manufacturing costs of their device are affordable. This is a critical question but it needs to be asked early enough in the process to allow it to be answered meaningfully. Often customers have locked into a design concept and are well into prototyping before this conversation starts.
We think the real challenge is because people don’t think about the design from a manufacturing perspective enough in the early design phases. Clearly each device design is fundamentally driven by the need to meet a key clinical user need or address a poorly met clinical need. That is the consensus approach, which makes logical sense, and aligns with the patient first philosophy that rightly dominates the industry.
Early stage design, however, is best seen as the one area of complete and total opportunity in medical device development. Each decision taken at that point will resonate through the device development process. At this stage, you really need to look at manufacturability, particularly through DFM (Design for Manufacturing). DFM at concept stage is a philosophy that Teleflex Medical OEM believes in deeply. We and our customers have seen the benefits it brings. Once concept development is complete, often unintended constraints have been put in place that can require very tight tolerances, complex inspection strategies, and difficult to validate processes. If the concept has been developed collaboratively with a development and manufacturing partner with the capability to provide strong DFM input, your cost of manufacture can be significantly reduced. This is a well-studied area and David Anderson’s book Design for Manufacturability should resonate with anyone familiar with the challenges of ensuring new product development is done in a manner that can be efficiently manufactured while simultaneously meeting the clinical need.
Also, design reliability improves as you are generally leveraging proven, well understood and characterized technology platforms for much of the device development. This is a technique Toyota have used for years in automotive design. They rightly get plaudits for their approach to manufacturing. Arguably, however, their approach to design and the reuse of proven technology in non-differentiated aspects of the new design/model is the bedrock that Toyota’s well-earned reputation for reliability is built on. James Morgan and Jeffrey Liker wrote a great book (Toyota Product Development System) on it. Arguably, these principles are just as applicable in medical device development.
Fenske: If you could give one piece of advice to companies seeking a manufacturing partner before they make a decision, what would it be?
Dr. Lynn: Look for vertical integration. Often, those companies that are vertically integrated understand manufacturing very deeply and, with current supply chain challenges, are likely to be better placed to be responsive. Also, look for companies with a history in the space. It’s a complicated space and you need to be sure your manufacturing partner has the depth and the experience to deal with the unanticipated changes and challenges that are part of every medical device development. In the interventional catheter space in particular, you need to see scale because many companies can partner in development, but it’s the transfer to robust high volume and efficient scaled up manufacturing where problems that relate to poor process design, poor validation strategy, and poor manufacturing understanding are generally seen.
You need to be sure the company you are dealing with has the skills to address all stages of a collaborative product development project. Teleflex Medical OEM has been in this space since 1979 so clearly, we are one of the original development and manufacturing partners. Over the 43 years, we have seen dramatic changes in technologies and design requirements and the rigor applied to the design and development process. Despite that, the constant has been the need for collaboration, trust, and two-way communication about what is practical and possible in terms of reliable manufacturing. In the long run, as a customer, you are better having a development and manufacturing partner that’s willing and capable of having that type of conversation with you. No point leaving the manufacturing discussion to the end. The product design and how it’s toleranced is, in our experience, the biggest input factor into final manufacturing unit cost.
Fenske: What are the forces driving medical device manufacturers to seek your technology/services over doing it in-house?
Dr. Lynn: Medical therapies and the associated devices are becoming more complex and sophisticated. This is particularly the case in the interventional space. There are numerous new technologies and combinations of technologies being commercialized. This is driving the demands on catheter-based delivery systems in terms of materials, technologies, and the manufacturing systems to ensure quality. Many companies are looking to focus on their critical differentiating technology and refining and improving that.
To maintain the level of focus on being a market leader and being able to progress quickly, they outsource what are seen as non-core activities to competent development and manufacturing partners. This makes a lot of sense strategically. They are taking advantage of the knowledge, competence, and economic scale of established development and manufacturing partners to de-risk and speed up their device commercialization process.
Fenske: In what ways is your company able to aid in getting a product (project) to market faster?
Dr. Lynn: Our EPIC Medtec Centers are our answer to that question. You have a great idea for a medical device. You know what the device needs to do. But maybe your R&D resources are involved with other projects; or you may need insight or an unbiased opinion of a device’s design for manufacturability. Working together at one of our EPIC (Engineering, Prototyping, Innovation, Collaboration) Medtec Centers, we can identify challenges and find answers, while controlling concept development and production costs.
We start by learning everything we can about your device concept and its application. Then launch into our proprietary, multi-stage IDEA (Innovation, Development, Engineering Accelerator) Medtec Process that incorporates your requirements early in the concept stage and maintains focus on DFM. This IDEA process leans heavily on established and proven Design Thinking techniques and aligns well with the principles of needs driven innovation as outlined in the Stanford Biodesign process. To complement that in the later stages of our IDEA process, we use our DFM knowledge to ensure the design concept has been optimized in terms of manufacturability.
Ready to go into production? We can handle that too. With a global network of state-of-the-art industry facilities, we provide extensive, vertically-integrated, manufacturing capabilities. We have EPIC Centers in our Limerick, Ireland; Maple Grove (MN); and Mansfield (MA) sites. These locations are co-located with production sites that specialize in the technologies the EPIC is focused on. This means our DFM knowledge is constantly revised and updated.
In medical device development, there is a synergy that comes from bringing an expert understanding of the user need (customer’s input) and collaboratively developing the optimal design concept with an OEM partner that has deep manufacturing experience as well as development capability. This approach helps de-risk projects and allows the final device to hit unit cost targets. Also, it allows a customer to work from concept to commercialization with one single partner that’s deeply experienced in both development and manufacturing.
From a Teleflex Medical OEM perspective, we have worked very hard over the last seven years to put in place a seamless process that allows our customers to get to market faster, and when they get there, to have the confidence their product has been designed with volume manufacturing in mind.
Teleflex Medical OEM is located at Medica/Compamed in Hall 8A, Booth/Stand L27.
Sean Fenske: What technology or service are you emphasizing at Medica/CompaMed this year?
Dr. Sean Lynn: At Teleflex Medical OEM, we understand the need to progress through the early stages of the device development process quickly but still take advantage of the opportunity for learning and developing a deep understanding of how best to meet the device’s key user needs. We have observed that the customers who develop very successful products tend to spend these early stages prototyping numerous different concepts and ideas to learn and iterate their design quickly. Much of our efforts at developing technology and services over the last seven years are around making it easier for our customer to progress their device designs in a faster time frame. We have strengthened our development groups and development capacity at our various sites. As a vertically integrated company, we buy very few outside components. This allows us to be very responsive.
At Medica/Compamed, we are emphasizing the WaySteer quick-turn steerable handle platform. This is a steerable catheter handle platform that can be customized to meet a specific customer’s needs. People can call over to the stand to learn more about the platform and see a physical demonstration of the platform. This technology complements our complex catheter offerings. A customer can incorporate the WaySteer steerable handle platform into their catheter design. This is our latest offering to try and accelerate our interventional catheter customers development projects.
We are also emphasizing our EPIC Centers. These are a really great way of beginning your project and getting the DFM knowledge of a vertically integrated OEM with over 40 years’ experience into your design from the start.
Fenske: What’s the most common challenge customers inquire about and how do you address it?
Dr. Lynn: Customers are often looking to ensure the manufacturing costs of their device are affordable. This is a critical question but it needs to be asked early enough in the process to allow it to be answered meaningfully. Often customers have locked into a design concept and are well into prototyping before this conversation starts.
We think the real challenge is because people don’t think about the design from a manufacturing perspective enough in the early design phases. Clearly each device design is fundamentally driven by the need to meet a key clinical user need or address a poorly met clinical need. That is the consensus approach, which makes logical sense, and aligns with the patient first philosophy that rightly dominates the industry.
Early stage design, however, is best seen as the one area of complete and total opportunity in medical device development. Each decision taken at that point will resonate through the device development process. At this stage, you really need to look at manufacturability, particularly through DFM (Design for Manufacturing). DFM at concept stage is a philosophy that Teleflex Medical OEM believes in deeply. We and our customers have seen the benefits it brings. Once concept development is complete, often unintended constraints have been put in place that can require very tight tolerances, complex inspection strategies, and difficult to validate processes. If the concept has been developed collaboratively with a development and manufacturing partner with the capability to provide strong DFM input, your cost of manufacture can be significantly reduced. This is a well-studied area and David Anderson’s book Design for Manufacturability should resonate with anyone familiar with the challenges of ensuring new product development is done in a manner that can be efficiently manufactured while simultaneously meeting the clinical need.
Also, design reliability improves as you are generally leveraging proven, well understood and characterized technology platforms for much of the device development. This is a technique Toyota have used for years in automotive design. They rightly get plaudits for their approach to manufacturing. Arguably, however, their approach to design and the reuse of proven technology in non-differentiated aspects of the new design/model is the bedrock that Toyota’s well-earned reputation for reliability is built on. James Morgan and Jeffrey Liker wrote a great book (Toyota Product Development System) on it. Arguably, these principles are just as applicable in medical device development.
Fenske: If you could give one piece of advice to companies seeking a manufacturing partner before they make a decision, what would it be?
Dr. Lynn: Look for vertical integration. Often, those companies that are vertically integrated understand manufacturing very deeply and, with current supply chain challenges, are likely to be better placed to be responsive. Also, look for companies with a history in the space. It’s a complicated space and you need to be sure your manufacturing partner has the depth and the experience to deal with the unanticipated changes and challenges that are part of every medical device development. In the interventional catheter space in particular, you need to see scale because many companies can partner in development, but it’s the transfer to robust high volume and efficient scaled up manufacturing where problems that relate to poor process design, poor validation strategy, and poor manufacturing understanding are generally seen.
You need to be sure the company you are dealing with has the skills to address all stages of a collaborative product development project. Teleflex Medical OEM has been in this space since 1979 so clearly, we are one of the original development and manufacturing partners. Over the 43 years, we have seen dramatic changes in technologies and design requirements and the rigor applied to the design and development process. Despite that, the constant has been the need for collaboration, trust, and two-way communication about what is practical and possible in terms of reliable manufacturing. In the long run, as a customer, you are better having a development and manufacturing partner that’s willing and capable of having that type of conversation with you. No point leaving the manufacturing discussion to the end. The product design and how it’s toleranced is, in our experience, the biggest input factor into final manufacturing unit cost.
Fenske: What are the forces driving medical device manufacturers to seek your technology/services over doing it in-house?
Dr. Lynn: Medical therapies and the associated devices are becoming more complex and sophisticated. This is particularly the case in the interventional space. There are numerous new technologies and combinations of technologies being commercialized. This is driving the demands on catheter-based delivery systems in terms of materials, technologies, and the manufacturing systems to ensure quality. Many companies are looking to focus on their critical differentiating technology and refining and improving that.
To maintain the level of focus on being a market leader and being able to progress quickly, they outsource what are seen as non-core activities to competent development and manufacturing partners. This makes a lot of sense strategically. They are taking advantage of the knowledge, competence, and economic scale of established development and manufacturing partners to de-risk and speed up their device commercialization process.
Fenske: In what ways is your company able to aid in getting a product (project) to market faster?
Dr. Lynn: Our EPIC Medtec Centers are our answer to that question. You have a great idea for a medical device. You know what the device needs to do. But maybe your R&D resources are involved with other projects; or you may need insight or an unbiased opinion of a device’s design for manufacturability. Working together at one of our EPIC (Engineering, Prototyping, Innovation, Collaboration) Medtec Centers, we can identify challenges and find answers, while controlling concept development and production costs.
We start by learning everything we can about your device concept and its application. Then launch into our proprietary, multi-stage IDEA (Innovation, Development, Engineering Accelerator) Medtec Process that incorporates your requirements early in the concept stage and maintains focus on DFM. This IDEA process leans heavily on established and proven Design Thinking techniques and aligns well with the principles of needs driven innovation as outlined in the Stanford Biodesign process. To complement that in the later stages of our IDEA process, we use our DFM knowledge to ensure the design concept has been optimized in terms of manufacturability.
Ready to go into production? We can handle that too. With a global network of state-of-the-art industry facilities, we provide extensive, vertically-integrated, manufacturing capabilities. We have EPIC Centers in our Limerick, Ireland; Maple Grove (MN); and Mansfield (MA) sites. These locations are co-located with production sites that specialize in the technologies the EPIC is focused on. This means our DFM knowledge is constantly revised and updated.
In medical device development, there is a synergy that comes from bringing an expert understanding of the user need (customer’s input) and collaboratively developing the optimal design concept with an OEM partner that has deep manufacturing experience as well as development capability. This approach helps de-risk projects and allows the final device to hit unit cost targets. Also, it allows a customer to work from concept to commercialization with one single partner that’s deeply experienced in both development and manufacturing.
From a Teleflex Medical OEM perspective, we have worked very hard over the last seven years to put in place a seamless process that allows our customers to get to market faster, and when they get there, to have the confidence their product has been designed with volume manufacturing in mind.
Teleflex Medical OEM is located at Medica/Compamed in Hall 8A, Booth/Stand L27.
