Medical device development is a complicated process already, whether creating a less complex device or a sophisticated, Class III implantable. When fabricating a device for neurovascular applications, the difficulty level multiplies even more. Treating this area of the body comes with a long list of factors that must be identified and considered. Failure to do so will, at best, delay a product launch; at worst, it could cost lives.
With this in mind, it’s critical to address these challenges as early in the process as possible. A better solution, however, may be to enlist the assistance of a company that’s already been down this road. Instantly gaining the extensive expertise of a company that’s developed a large number of neurovascular technologies could very well be the key to success for a project.
To help further explain how best to overcome the obstacles that could come into play with a product for the neurovascular space or why it may make more sense to partner, Edward Arguello, director of R&D and product development at Integer, responded to several questions in the following Q&A. He speaks to the topics of capabilities to seek in a partner, testing, early involvement, IP protection, and more.
Sean Fenske: Can you detail Integer's specialized capabilities in developing and manufacturing neurovascular devices, including the specific medical conditions these devices are designed to address?
Edward Arguello: Absolutely. Our approach is heavily influenced by specific disease states and clinical needs. Take, for instance, the demands of treating conditions like ischemic and hemorrhagic strokes. These situations often require devices like aspiration catheters, which are quite different from other types of catheters. At Integer, we focus on the critical features that make these catheters effective. They need to be extremely thin and flexible yet robust enough to navigate to a clot, reach an obstruction, and withstand the necessary vacuum to keep the lumen clear. This precision engineering enables physicians to effectively remove clots, which is a delicate and precise procedure.
Catheters designed for other applications, such as delivering high chronic outward force devices or navigating specialized anatomical paths, require a different set of capabilities. For these types of devices, we emphasize the durability and integrity of the catheter. This involves using reinforced, continuous layers with smooth transitions to prevent any potential points of failure. Additionally, we ensure precise and consistent lamination across the catheter's length. This level of detail is critical for the successful delivery of not just mechanical devices but also lytics and chemotherapeutic agents. We aim to provide a reliable tool that meets the complex demands of various medical interventions.
Fenske: Why is early involvement from Integer critical in the neurovascular device development process? What advantages does this bring to the project's outcome?
Arguello: Engaging a contract manufacturer early in the development process is highly beneficial. It allows us to integrate fundamental design principles such as scalability and repeatability right from the start. This proactive approach helps mitigate potential challenges during the crucial stages of verification and validation.
Furthermore, choosing the right partner from the start is pivotal. Obtaining feedback on manufacturability is essential when considering various design options and directions. Another aspect that sets Integer apart is our strong commitment to vertical integration. This approach minimizes supply chain delays, which are particularly critical during the development phase, and enhances our ability to help streamline the entire production process. This opens a broader range of possibilities, freeing our customers from supply chain constraints and allowing their design capabilities to truly shine.
Fenske: Considering the critical nature of neurovascular applications, could you explain the rigorous testing protocols Integer employs through various stages of device development?
Arguello: Integer's commitment to safety and efficacy, especially regarding our stringent quality control and testing processes, is an essential value we bring as a contract manufacturer.
At Integer, we provide comprehensive support at various stages of product development. Our development sites offer a range of services including simulated use, characterization, and testing—all aligned with international standards and tailored to specific development needs. This capability is essential for speed to market, as it allows us to deliver expected outcomes and support iterative processes efficiently. Instead of sending components, devices, or sub-assemblies across the country for evaluation, we maintain a shorter feedback loop. This approach significantly enhances our ability to refine and optimize designs more swiftly and effectively.
Additionally, Integer's various sites enforce robust internal quality controls capable of handling a wide array of devices, from Class I to Class III (e.g., permanent implantables). Our quality system is particularly flexible, designed to adapt and meet the evolving needs of our customers. This adaptability extends to practices such as the Production Part Approval Process (PPAP) and component qualification, ensuring we meet any specific customer requirements and comply with market standards. This comprehensive and flexible approach underscores our commitment to delivering the highest levels of safety and efficacy.
Fenske: How does Integer ensure the protection of intellectual property while leveraging its extensive expertise across multiple customer projects in neurovascular development?
Arguello: Integer’s commitment to respecting our customers’ proprietary information is unwavering. We have a longstanding history of managing multiple projects and customers simultaneously while ensuring strict confidentiality and project isolation. Despite our extensive collaborations with numerous companies in similar market segments, our customers can rest assured their intellectual property (IP) is securely protected.
Reflecting on my own experience about 16 years ago, when I was a customer of Integer, I had no concerns regarding IP security due to the clear separation and isolation maintained between projects. Integer's core competency lies in our manufacturing expertise. This expertise is not only about producing high-quality products but also about applying robust internal protocols that protect each customer’s interests. This approach is universally beneficial as it can be adapted and leveraged across various projects.
Moreover, Integer is flexible enough to meet diverse contract requirements, which are rigorously upheld by maintaining strict separations across different projects. This system ensures every customer’s proprietary needs are met, and their concerns are addressed at a fundamental level.
Fenske: Can you describe the typical engagement model between Integer and its customers in the development and manufacturing of neurovascular devices? How does this partnership vary across different projects?
Arguello: In exploring the dynamic relationship models, it's clear one of Integer's key differentiators, particularly within the neurovascular space, is not only our flexibility but also the breadth of services we offer. Our comprehensive range of value-added services allows us to handle different types of projects. This capability is crucial because it enables us to address different phases and scales of customer needs effectively.
At Integer, we have a solid history of providing OEM products and services, but what sets us apart is our ability to tailor these solutions to meet specific patient and customer requirements. We work closely with our customers to ensure their needs are fully met, acting as a true partner rather than just a supplier.
Moreover, Integer can function as an independent developer with regular checkpoints, ensuring we align with our customers' predefined needs and timelines from the outset. This approach isn't limited to OEM devices but serves as a starting point for customized development projects.
Finally, we engage in hands-on co-development relationships, characterized by ongoing interaction and iterative review with the customer. This process includes continuous engagement and requires customer approval at critical stages, ensuring all development aligns with their expectations and requirements.
Our ability to adapt to the customer’s level of complexity and review requirements underpins the flexibility of our engagement models. This adaptability is integral to our strategy, allowing us to meet diverse customer needs effectively.
Fenske: What are the key, value-added services Integer provides in the neurovascular space that distinguish it from other service providers?
Arguello: Transitioning from a customer to a team member at Integer, I have developed a deep appreciation for the rich history of the company and the extensive expertise across its various sites. This appreciation extends not only to neurovascular devices but also to a broad range of medical devices.
One aspect that has particularly impressed me is our approach to internal independent technology development, which is closely aligned with emerging industry trends. We're not merely reactive to the demands of the market; instead, we proactively understand and address the clinical problems that require solutions. This approach helps to ensure we are always ahead in innovation, incorporating the latest advancements and understanding into our projects.
Moreover, the vast experience across Integer’s sites and the deep levels of expertise we possess contribute significantly to our efficiency. Our virtual tubing model is a perfect example of this, as it significantly cuts down on development time by leveraging existing knowledge and capabilities from various projects, both in neurovascular fields and beyond.
Lastly, our clinical awareness and understanding of design intent are critical. It often feels like we're speaking the same language, which is incredibly valuable. This synergy helps eliminate potential misunderstandings and intermediaries, ensuring our projects are streamlined and fast-tracked, thus accelerating the time to market. This internal coherence and shared understanding across teams are what set Integer apart in the industry.
Fenske: Reflecting on our discussion or your experience, what key piece of advice would you give to leaders at medical device OEMs and startups entering the neurovascular market?
Arguello: For OEMs and startups venturing into the neurovascular space, my advice centers around choosing a partner who not only meets your current needs but also expands your capabilities and awareness. It's critical to engage with someone who can anticipate and respond to challenges you may not yet foresee. This approach should be a decisive factor in whether you opt to develop internally or partner externally. Essentially, you want a partner that amplifies to your efforts, helping you achieve faster and more effective market entry.
At Integer, we embody this forward-thinking perspective, with thought leaders who guide current solutions and shape future industry trends. As a newer member of the team, I’ve witnessed first-hand the balance Integer maintains between localized innovation and our broad-scale knowledge and global manufacturing capabilities. This is evident across various specialties, not just in neurovascular but also in cardiovascular and peripheral vascular sectors.
We have multiple neurovascular centers of excellence, such as our Pembroke Pines, Fla., and Galway, Ireland, sites, which focus on the development and manufacturing of neurovascular devices, as well as our manufacturing center in Trenton, Ga., as a few examples. These sites collaborate extensively to ensure we match our customers with the best development partners while leveraging our diverse capabilities.
Moreover, Integer is adept at managing specialized components, sub-assemblies, and single-use applications, tapping into a wide spectrum of medical device expertise. This holistic approach ensures we are equipped to support our customers comprehensively, reinforcing their market positions or assisting them in entering new markets with confidence.
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