Maddy Moncla, Sales Engineer, Cortland Biomedical04.22.24
In the dynamic landscape of medical device development, partnerships with biomedical textile manufacturers play a critical role in driving innovation and advancing healthcare solutions. From orthopedics to cardiology, biomedical textiles enable the creation of cutting-edge medical devices that improve patient outcomes and enhance quality of life. However, to maximize potential, medical device OEMs must adopt a multifaceted approach that encompasses both traditional best practices and emerging considerations. This article explores key factors that contribute to productive engagement with biomedical textile partners, including sterilization methods, timelines, iterative prototyping, capabilities showcasing, equipment usage, and intelligent questioning. It also explores some of the lesser-regarded factors that can have a significant impact on a medical device’s path to regulatory approval and commercial launch that medical textile developers should be considering.
Partnerships are not just about achieving a shared goal; it is about embracing a shared vision and working together to overcome challenges and achieve success. Through shared efforts, OEMs and textile partners can devise original solutions, advance patient care, and redefine the future of healthcare.
Maddy Moncla is a sales engineer at Cortland Biomedical with a bachelor of science in textile engineering from North Carolina State University. She is a subject matter expert in medical textile product engineering and development.
1. Key Factors Innovation
Innovation serves as the cornerstone of progress in the healthcare industry. Yet, innovation may be hindered by business models that prioritize high-volume production over creativity and advancement. To bridge this gap, OEMs must seek partners who demonstrate agility, curiosity, and credibility, and are committed to pushing the boundaries of textile engineering. A synergistic environment that fosters ingenuity, infrastructure, and cross-disciplinary expertise can lead to the development of products that exceed expectations and redefine industry standards.2. Intelligent Questioning and Education
Effective collaboration is built on a foundation of mutual understanding and shared expertise. Textile partners should employ detailed questionnaires to gather insights into OEM requirements, preferences, and regulatory considerations. By asking intelligent questions and providing educational resources, textile partners empower OEMs to make informed decisions and navigate the complexities of textile engineering with confidence. Partnership thrives when both parties are committed to learning and growth, fostering a culture of innovation and problem-solving. By investing in education and knowledge sharing, OEMs and textile partners can drive transformative change and deliver solutions that exceed expectations.3. Showcasing Capabilities and Customization
Biomedical textile partners should leverage showcase sessions to highlight their diverse capabilities. These sessions provide OEMs with insights into the range of textile formations and manufacturing techniques available, inspiring creativity and exploration of novel solutions. By showcasing their expertise and willingness to customize solutions, textile partners empower OEMs to address unique challenges and meet specific design requirements. Collaboration flourishes when OEMs and textile partners embrace flexibility and originality, allowing for the development of tailored solutions that push the boundaries of medical device design.4. Timelines and Iterative Prototyping
Effective project management relies on clear communication of timelines and expectations. OEMs should establish realistic timelines for project milestones, which includes time for iterative prototyping throughout process development. Transparent communication with textile partners is essential to aligning expectations and addressing potential challenges or constraints that may impact timelines. In cases where deadlines are stringent, proactive problem-solving and adjustment of project milestones are imperative to maintaining project momentum. By fostering a culture of collaboration and flexibility, OEMs and textile partners can navigate timelines effectively and deliver high-quality products within the specified timeframe.5. Equipment Usage and Scalability
Engagement between OEMs and textile partners is strengthened when both parties prioritize scalability, adaptability, and continuous improvement. The selection of equipment plays a crucial role in the manufacturing process of biomedical textiles. Using commercial equipment not only for mass production but also for prototyping enables products to be immediately scalable once the design is approved. If less robust prototyping equipment is used for the development of the product, the project team must be prepared to take the necessary steps for proper scalability and transfer of the product.6. Sterilization Method Planning
Sterilization is a critical consideration in the development of medical devices, particularly those incorporating biomedical textiles. Sterilization methods such as gamma irradiation can profoundly impact the properties of textile materials, including strength, flexibility, and durability. To mitigate the risk of post-sterilization degradation or failure, OEMs must plan for sterilization methods that will be applied to their devices. Working closely with textile partners, materials can be selected that will withstand the rigors of sterilization while maintaining optimal performance characteristics. By considering sterilization requirements early in the design phase, OEMs ensure their devices meet regulatory standards and deliver reliable outcomes for patients.7. Essential Attributes
There are additional, often less-considered factors that can help identify a biomedical textile partner that stands apart from the pack in terms of its ability to innovate, adapt, and collaborate effectively.8. Cross-Disciplinary Teams
Textile engineering expertise alone may not suffice in creating optimal medical products. Agile cross-disciplinary teams that integrate engineers and specialists from various fields, including medical device development, offer a more comprehensive understanding of product requirements. By leveraging diverse skill sets and perspectives, these teams can anticipate real-world challenges and design solutions that meet the highest standards of performance and safety.9. Cleanrooms
Cleanroom environments play a critical role in maintaining the integrity and biocompatibility of medical textiles. While ISO Class 8 cleanrooms are common for fabric formation, Class 7 cleanrooms are increasingly essential for assembly, cleaning, and post-processing. These environments mitigate the risk of contamination and ensure product quality and safety. Attention to detail, including the selection of contact materials and implementation of cleaning protocols, is imperative to uphold the highest standards of quality assurance.10. Attention to Contact Surfaces
Every surface that comes into contact with medical textiles must meet stringent standards to prevent cross-contamination. From countertops to roll coverings, attention to detail is paramount in maintaining product integrity. High-performance medical-grade fibers require special consideration to ensure optimal performance and compatibility with surrounding materials. By prioritizing meticulous attention to contact surfaces, OEMs and textile partners can mitigate risks and uphold the highest standards of quality assurance.11. Investment in Water Quality
Water quality is a critical factor in textile manufacturing processes. Poor water quality can compromise the integrity of textile structures and, consequently, the safety and efficacy of medical devices. To address this concern, textile partners must implement fully integrated water purification systems to remove contaminants and manufacturing residues. Regular monitoring and testing protocols ensure water quality meets the stringent requirements of medical device manufacturing standards.12. Packaging Design
Packaging plays a pivotal role in preserving the sterility and integrity of implantable medical textiles. The selection of appropriate materials and packaging methods is essential to prevent contamination and ensure product efficacy. OEMs must join closely with textile partners to develop packaging solutions that meet regulatory requirements and maintain product quality throughout storage and transportation.13. Supply Chain Security
The reliability of the supply chain is fundamental to the success of medical device development. Textile developers rely on a network of suppliers to deliver high-quality materials essential to manufacturing processes. OEMs must prioritize supply chain security by vetting suppliers and establishing robust quality assurance protocols. A transparent and collaborative relationship with suppliers ensures continuity of supply and minimizes the risk of disruptions during the development lifecycle.Conclusion
In conclusion, productive engagement with biomedical textile partners requires a multifaceted approach that encompasses careful planning, clear communication, and a commitment to excellence. By embracing collaboration as a catalyst for transformation, OEMs and textile partners can pioneer new frontiers in medical device development and improve outcomes for patients worldwide.Partnerships are not just about achieving a shared goal; it is about embracing a shared vision and working together to overcome challenges and achieve success. Through shared efforts, OEMs and textile partners can devise original solutions, advance patient care, and redefine the future of healthcare.
Maddy Moncla is a sales engineer at Cortland Biomedical with a bachelor of science in textile engineering from North Carolina State University. She is a subject matter expert in medical textile product engineering and development.