In the rapidly evolving landscape of healthcare, the demand for innovative, safe, and sustainable medical devices is reshaping India’s approach to medical manufacturing. In an exclusive interview, Vikram Patil, Director – New Business, Specialty Materials for India, Middle East & Africa, Envalior engages with Dr. Asawari Savant from Elets News Network (ENN) to discuss Envalior’s pioneering role in advancing material science for medical devices, offering essential perspectives on how Indian healthcare manufacturers can navigate these demands while prioritizing patient safety and environmental sustainability. Edited excerpts 

The medical device landscape is increasingly complex due to heightened patient expectations and regulatory pressures. Can you elaborate on how these factors are influencing the demand for innovative solutions in the industry?

The need for medical devices and equipment has skyrocketed, forecasted to grow at a CAGR of 5.68% from 2024-2029. This growth is driven by the increasing reliance of caregivers, medical facilities, and hospitals on these devices. Patients expect highly personalized and efficient treatments, which has led to a demand for devices with improved usability and reliability. This shift has also prompted heightened regulatory pressures, requiring manufacturers to integrate new technologies and advanced materials in the production process. Together, these factors are pushing the medical device industry to adapt to these trends accordingly. In Envalior’s CARE portfolio, designed exclusively for the medical segment, each material undergoes stringent tests to comply with current application needs and exceed industry standards. As the industry continues to evolve, we are continuously working to incorporate more advanced materials in our portfolio to align with all current and future requirements.

Envalior has developed a portfolio of advanced materials for medical devices. What unique properties do these materials possess, and how do they specifically enhance device performance, safety, and durability?

Many manufacturers may not realize that an improper choice of materials in the design of a medical device is a leading cause of device failure. At Envalior, we have developed a wide range of engineering materials designed and tested to meet the challenges medical device manufacturers face. Our engineered materials comply with the standards and specifications of the U.S. Food & Drug Administration (FDA), the International Organization for Standardization (ISO), the United States Pharmacopeia (USP), and other international organizations.

For example, Arnitel® Care is a high-performance polyester-based thermoplastic elastomer (TPC) used in manufacturing surgical gowns, ventilator tubing, catheters, and advanced wound care. Similarly, Arnite® Care (PBT & PET) offers a unique combination of low water absorption, wear properties, color stability, low extractables/leachables, and high dimensional stability, which are essential for the design and manufacturing of drug delivery devices. Additionally, we have Akulon® Care (Polyamide 6), Fortii® Care (PPA – Polyphthalamide), and Novamid® Care (PA6/PA66) for various applications in medical devices. Fortii® Care, in particular, can be used as an alternative to metal and PEEK in device components.

Could you share specific case studies that demonstrate how Envalior’s advanced materials have been successfully utilized in groundbreaking medical devices? What challenges did these projects address?

With an increasing demand for highly sophisticated medical equipment, device manufacturers are working rapidly to meet these demands. In this advanced environment, we require a next-generation, science-based approach to stay aligned with emerging trends in the medical industry. Envalior has focused heavily on developing advanced material solutions to meet the industry’s evolving needs. Our high-end material Arnitel® provides flexibility in design, allowing manufacturers to develop safer, patient-friendly, and simplified designs. Arnitel® Care has a broad hardness range, making it ideal for medical devices like catheters, wound care films, and surgical gown fabrics.

One groundbreaking application of Arnitel® has been in ventilator tubing manufacturing. Ventilator tubing is a critical component of a ventilator’s breathing circuit, providing oxygen to patients. However, it can be a breeding ground for bacteria, increasing the risk of ventilator-associated pneumonia (VAP) due to microdroplets accumulating in the water trap. Opening the water trap to clean or remove accumulated water increases the possibility of bacteria or virus ingress, raising the risk of infection. Arnitel® provides a high Moisture Vapor Transmission Rate (MVTR), allowing moisture to permeate directly through the tubing walls. This design helps ventilator breathing circuits by eliminating moisture traps, thereby reducing the risk of VAP and improving patient outcomes.

Regulatory compliance is a critical aspect of medical device manufacturing. How does Envalior ensure that its materials not only meet but exceed stringent regulatory requirements in the industry?

Regulatory compliance ensures patient safety, product effectiveness, and overall trust in the medical industry. Non-adherence to regulatory compliance can seriously impact patient health, treatment effectiveness, and trust in medical services. At Envalior, our fundamental goal is not only to meet but to exceed these stringent measures. Our CARE material portfolio follows rigorous protocols, such as manufacturing under Good Manufacturing Practices (GMP) and conducting related tests for compliance with standards like USP Class VI and cytotoxicity.

We ensure that our material solutions meet universal regulations such as FDA Food Contact, USP Class VI, and ISO 10993-5/10993-10 standards. At Envalior, we extensively test our materials during manufacturing to avoid any future non-compliance, enabling device manufacturers to surpass these regulations. For instance, Arnitel® VT offers a 100% bacterial and virus barrier combined with maximum comfort (breathability) for surgical gowns. Arnitel® VT is the only solution on the market that delivers this unique combination of maximum protection and comfort, and it is qualified for high-performance surgical gowns (EN13975) and AAMI Level 4 gowns.

As a sustainable materials innovator, how does Envalior integrate sustainability into its product development process, and what are some of the environmental benefits of using your advanced materials in medical devices?

The medical device industry plays a crucial role in improving patients’ lives but leaves significant waste during manufacturing, contributing to 4.4% of net global carbon emissions. With rising concerns over climate change and resource sustainability, the healthcare industry is imposing stricter measures to curb waste. Sustainability is essential, from material sourcing to disposal, to reduce the environmental impact of medical device manufacturing.

Envalior has been a leader in sustainability, not only through using renewable energy in our manufacturing plants but also by offering lower carbon footprint materials in our portfolio. We provide a range of sustainable product options to help reduce the environmental impact of device manufacturing, which is critical in today’s landscape.

Looking ahead, how do you envision advanced materials shaping the future of healthcare and medical device manufacturing? What trends do you foresee impacting the industry in the coming years?

Envalior anticipates several emerging trends will significantly impact the healthcare and medical device industry. The increasing demand for regulatory-compliant materials that meet global standards, sustainable manufacturing processes, heightened awareness of patient safety, and government initiatives in the medical device industry will drive the future.

With hospitals, investors, customers, and other stakeholders becoming more sustainability-conscious, the demand for eco-friendly solutions will only increase. This trend is pushing companies to set ambitious sustainability targets, making it essential for device manufacturers to leverage advanced materials for competitive advantage. At Envalior, our materials portfolio is produced through carbon-efficient, sustainable methods across the entire production chain. Beyond curbing carbon emissions and energy waste in manufacturing, we focus on expanding recycling-based and bio-based materials, specifically for the medical device and pharmaceutical industries.

Also Read: LinkOMed: Transforming Education, Collaboration, and Professional Growth in India’s Medical Community

For healthcare industry leaders looking to embrace innovation in medical device manufacturing, what key insights or best practices would you recommend for successfully integrating advanced materials into their product development strategies?

To become leaders in medical equipment manufacturing, companies must embrace innovation, prioritize patient-centric design, and promote biocompatibility. With regulatory bodies enforcing stricter standards, it’s essential to incorporate sustainable methodologies in production. Original equipment manufacturers (OEMs) often source high-carbon raw materials and services, increasing the overall carbon footprint in production.

We recommend a deep integration of biocompatible, recyclable materials in the supply chain to reduce this impact. While meeting sustainability standards is vital, companies should also prioritize patient-centric material production. Materials that offer design flexibility, improve patient outcomes, simplify manufacturing, and are provided by experienced material companies with strong application knowledge will serve as valuable development partners for device manufacturers. Lastly, 100% recyclable or bio-based materials that are lighter, safer, and more reliable will enable manufacturers to meet evolving industry standards.

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