Why Quality Control Important in the Biomedical Industry?
The Indian medical devices market is estimated to be worth USD 11 billion and is expected to grow to USD 50 billion by 2030, with a projected 10-12% global market share over the next 25 years. As the industry embarks on this ambitious growth trajectory, quality control will remain a critical factor.
The biomedical industry is at the forefront of healthcare innovation, developing essential products and technologies that play a critical role in diagnosing, treating, and managing diseases. Quality control is a crucial component of this industry, ensuring that biomedical products meet the highest standards for safety, efficacy, and reliability.
Recently, mojo4industry hosted a Digital Dialogue titled “Why Quality Control Important in the Biomedical Industry,” where industry experts shared their insights on the significance of quality control in this field. The discussion featured perspectives from:
– Rajiv Nath, Managing Director, Hindustan Syringes & Medical Devices Ltd. & Forum Coordinator, Association of Indian Medical Device Industry (AIMED)
– Sunil Khurana, CEO & MD, BPL Medical Technologies Pvt Ltd.
– Dr. Rajiv Chhibber, Vice President External Affairs (Corporate Affairs, Outreach & CSR), Sahajanand Medical Technologies
– Federico Poli, Biomedical Group Industry Manager, Marposs
– Raman Upmanyu, Industry Manager for Biomedical, Marposs India
The Importance of Quality Control in the Biomedical Industry
Dr. Rajiv Chhibber emphasized the crucial role of quality control in the biomedical industry, illustrating how these processes are integrated throughout the entire manufacturing cycle. He explained that quality control is not confined to the final product inspection but starts much earlier, with the selection of raw materials, and continues through every stage of production. “Quality control is not just about checking the final product; it begins with the raw materials and continues through every stage of production. This comprehensive approach ensures that every component—whether it’s a coronary stent, an orthopedic screw, or a dialysis machine—meets rigorous standards of safety and efficacy,” he noted.
Chhibber elaborated on how each phase of production, from the initial sourcing of raw materials to the final packaging, undergoes meticulous scrutiny. For instance, in the manufacturing of orthopedic screws, quality control involves precision measurements of external diameters and profile angles, ensuring these components meet strict standards for accuracy and reliability. Similarly, in the production of coronary stents, rigorous testing is conducted to ensure optimal diameter measurements and performance under various conditions.
He also highlighted the role of continuous improvement within the quality control process. He said, “At Sahajanand Medical Technologies (SMT), for example, the quality evaluators follow a structured approach that includes planning, execution, checking, and acting. This method ensures that each product undergoes several rounds of evaluations to meet quality objectives. Feedback loops involving clients, healthcare professionals, and internal evaluations contribute to refining the processes further, guaranteeing that the end product—whether a life-saving device or a diagnostic tool—delivers the highest possible standard of performance and safety.”
The Current Status of Quality Control in India
Rajiv Nath discussed the status of quality control in India’s biomedical industry, emphasizing India’s vision to become a top manufacturing hub for medical devices. He highlighted that the recent adoption of a national medical device policy has further solidified this vision, paving the way for India to compete on the global stage. Nath elaborated that quality control, conformity assessment, and quality assurance are critical components that underpin the reputation of any brand, especially in a sector where the consistency of product quality can make or break a company.
He explained that achieving high-quality standards is not merely about meeting regulatory requirements but requires a cultural shift within organizations. Nath emphasized, “Achieving quality requires a mindset shift, where the CEO’s milestones for quality become more stringent than the regulatory demands.” This approach ensures that products such as surgical instruments, diagnostic equipment, and life-support devices meet the highest standards of safety and efficacy. By prioritizing quality over cost-cutting measures, Indian manufacturers can not only enhance their competitiveness but also establish themselves as reliable suppliers in the global market.
Quality Assurance Over Quality Control
Sunil Khurana from BPL Medical Technologies shared his insights on the critical shift from mere quality control to a more holistic approach to quality assurance, emphasizing how this evolution is reshaping the healthcare industry. He elaborated on the necessity of integrating quality assurance at every stage of production, from the initial design phase to the final delivery of the product. According to Khurana, this comprehensive approach ensures not only compliance with regulatory standards but also significantly enhances patient safety and the overall reliability of medical devices.
Khurana highlighted the importance of this shift by referencing BPL’s product lineup, which includes advanced medical imaging solutions, patient monitoring systems, and life support devices. He explained that quality assurance in these products goes beyond basic functionality checks; it involves rigorous testing and validation processes that account for real-world conditions and potential risks. “Quality assurance is not just about meeting standards; it’s about exceeding them to ensure patient safety and customer satisfaction,” Khurana asserted. He further added that this proactive approach to quality not only mitigates risks associated with medical equipment failure but also brings long-term cost efficiencies by reducing the need for frequent repairs or replacements, thereby enhancing the overall value proposition for healthcare providers.
Impact of Measurements and Testing Solutions
Federico Poli and Raman Upmanyu from Marposs shed light on how their state-of-the-art measurement and testing solutions are pivotal in elevating the quality of biomedical devices. These devices, which include intricate and high-stakes products like stents, prosthetics, and surgical instruments, must adhere to stringent global standards. Upmanyu passionately articulated the gravity of their work by stating, “Quality means life. One life lost is far too many.” He emphasized that Marposs’ solutions, which encompass precision measurement systems, non-destructive testing technologies, and advanced inspection tools, play a crucial role in ensuring that these life-saving devices are not just reliable but also capable of meeting the highest standards of safety and performance. Their commitment to safeguarding lives through meticulous quality control underscores the importance of accuracy and innovation in the biomedical field.
Concluding Remarks
When the panelists were asked about the importance of quality control in the biomedical industry, their responses underscored its critical role from various perspectives.
Rajiv Nath highlighted that “If I’m aiming my company to be a global top three player and I want my brand to be the top three globally, it starts from quality competitiveness.” He stressed that achieving such goals requires a relentless focus on quality.
Dr. Chibber echoed this view, stating, “Quality is paramount…quality control and assurances are needed to be beyond standards. We need to look at it from a company perspective, a reputation perspective, and a nation perspective.” He emphasized that quality control should exceed mere compliance and consider broader implications.
Sunil Khurana added, “This will put less of a burden on our nation, both in the short-term and long-term. India’s reputation is very key, and we need to be very cognizant of it. Patient safety and growth beyond India. These are the top of mind, which will be met with only quality mindset.” He noted that high standards in quality control are crucial for patient safety and enhancing India’s international standing.
Raman Upmanyu remarked, “For me, again, I will say quality means one life lost is far too many. So why quality control is important? Just to save individual life by checking your equipment with the most accurate and highly reliable instruments, which Marposs can provide you.” He emphasized that the primary aim of quality control is to safeguard lives through precise and dependable equipment.
Conclusion
Quality control in the biomedical industry is not just a regulatory requirement; it is a vital aspect of ensuring patient safety, product efficacy, and industry credibility. As the Indian biomedical industry continues to grow, maintaining rigorous quality control standards will be key to its success on the global stage.
