Medical devices hold a pivotal role within the healthcare industry. Renowned American athlete and actress Aimee Mullins, who faced the amputation of both her legs due to a medical condition, once wisely noted, "At some juncture in every individual's life, the need for a medical device becomes apparent – whether it's eyeglasses, contact lenses, or, as we age, interventions like hip replacements, knee replacements, or pacemakers. The generation relying on these life-enhancing devices is all around us."
The roots of medicine extend back to ancient times, including the Stone Age, when herbal remedies were prevalent. However, a transformative milestone in the history of medicine occurred with the birth of Hippocrates in 460 BCE. His pioneering contributions, grounded in objective observation and deductive reasoning, have left an indelible mark on the field.
Hippocrates' enduring influence is evident in the modern practice of medicine, where physicians take the Hippocratic oath and uphold the foundational principle of "nil nocere" – to do no harm.
Early instances of surgical instruments date back to the era of Sushrata, which transpired during the last centuries of BCE (although there's no consensus among historians regarding the exact timeline). The invention of the magnifying glass by Roger Bacon in 1250 AD further advanced surgical techniques. The contemporary production of medical devices took shape during the post-Industrial Revolution period.
As technology continued to progress, medical devices evolved in tandem to address the evolving healthcare needs of society.
The medical device industry makes a varied number of products ranging from surgical gloves and artificial joints to imaging equipment. It plays a pivotal role in driving technological advancements that amplify our capacity to diagnose and treat various medical conditions.
The industry comprises a small number of large, diversified companies and a large number of smaller companies involved in research and development for specific therapeutic areas.
Among the multifaceted facets of healthcare, the realm of orthopedics specifically addresses conditions related to the musculoskeletal system. The term "orthopedics" traces its origins to the French word "Orthopédie," which, in turn, has roots in the ancient Greek words ὀρθός orthos (meaning "correct" or "straight") and παιδίον paidion (signifying "child").
However, the history of dealing with problems of musculoskeletal and the developments in Orthopaedics goes back to the middle ages. When war time experiences helped bring major advancements in the domain.
During the period of the First World War, a few individuals like Hugh Owen Thomas and his nephew, Robert Jones, made major contributions to expand the domain into the general treatment of musculoskeletal problems.
The strong desire to make a difference and improvement in people's lives and the opportunities laden by the liberalization process motivated Ashok Luthra to incept Auxein Medical.
They want to improve people's lives through their orthopedic implants that exceed the highest expectations of their customers in terms of Quality and Safety.
Ashok began manufacturing products in a small one-room engineering equipment manufacturing unit with virtually no experience in entrepreneurship.
The quality and finesse of the products made his surgeon friend urge him to enter the specialized and niche domain of Orthopaedic Implants. This persuasion resulted in the start of Delhi's first-ever production unit specialized in manufacturing Austin Moore Prosthesis in 1996 under the appellation "Crown Plastic."
Soon it established itself as a brand and found a following in the National Capital Region's top clinics, nursing homes, and hospitals.
Following three years of substantial progress within clinics and hospitals in the domestic market, specifically the National Capital Region (NCR), the company initiated significant enhancements. In 1999, it welcomed Ashok Luthra's two elder sons, Deepak and Gaurav Luthra, into the fold. This strategic move harnessed their individual proficiencies in business management and technology, igniting a trajectory of consistent company growth. Concurrently, the team expanded in size, and the company established a state-of-the-art facility where a diverse range of orthopaedic implants for trauma cases was manufactured to cater to the burgeoning domestic market.
In 2008, the enterprise witnessed another wave of fresh energy when the youngest son Rahul Luthra returned after completing higher studies in Australia and New Zealand.
He embarked on his journey with the family enterprise, fueled by a vision to embark on a global trajectory. Alongside his proficient team of young collaborators and creative minds specializing in medical expertise and marketing, he is spearheading an era marked by modernization and the company's expansion onto the international stage.
This was the birth of Auxein Medical in its current avatar. An indigenous enterprise with world-class systems, a global footprint, and a futuristic vision.
Auxein Medical became a leading manufacturer & exporter of a broad range of Orthopaedic Implants and medical Equipment available in 70+ countries while associating with 100+ partners.
Auxein Medical earned the esteemed ISO 13485:2016 certification, validating its capacity to manufacture a diverse array of over 1000 high-quality, research-driven, and cost-effective generic orthopedic implants. These products have garnered trust from healthcare professionals and patients across different regions.
Currently, the firm's dedicated team of experts is placing special emphasis on the commitment made to their clients and winning the trust of their prospective new clients.
Auxein Medical has diligently aligned its facilities with essential regulatory requirements, demonstrating a commitment to upholding the most rigorous standards across various aspects, including quality control, design and development, prototyping, packaging, and sterilization. The company has secured all crucial and prerequisite certifications in this pursuit of excellence.
The firm has received various certifications: –
ISO 13485 for International Standard for Medical Devices.
USFDA 510k from the US Food and Drug Administration Approved.
CE, Compliance with European Guidelines (For Implants, Surgical Instruments & External Fixator).
WHO GMP Certificate.
Export House Certificate.
Drug Licence (Indian version of FDA).
Indian medical device industry is growing steadfastly with a CAGR of 15.8%. It is more than the global MD industry, according to a market research report by Invest India.
The company's leadership has adopted a multifaceted approach to keep pace with the industry's rapid growth and maintain a leadership position. These measures encompass the integration of advanced and innovative devices, rigorous compliance with both national and international regulatory standards, offering competitively priced products accompanied by superior service, employing world-class manufacturing technology, prioritizing device safety and performance, and providing expert surgeon-led user training.
The manufacturing process of these precision products involves sourcing raw materials from top-quality providers ensuring international safety and hygiene assessments. The firm routinely collaborates with R&D teams from IIT labs and CSIR to improve product design.
In a firm's prototype production process, product parts undergo numerous functionality tests before they are deemed fit for mass production. The firm employs CAD/CAM/CAE programs to provide the most effective solutions to their clients.
The organization's production processes are designed to offer their partners the maximum flexibility to incorporate their special requirements in keeping with international quality control parameters.
The firm's colour anodizing process takes into account environmental conditions, voltage values, waiting time, redactor sensitivity, solution rate, and operator experience to give their products a lasting finish.
Designed to ISO 14644-1 norms, under category Class 10000, Auxein Medical's clean rooms offer possibilities for adapting to special requirements.
The firm's facilities are well-equipped to carry out every stage of sterile and non-sterile packaging operations with maximum speed and minimum error.
The firm witnessed Grand Success in the corporate events at SCHOT 2018 Chile, MEDICA 2018 Düsseldorf / Germany, FEMECOT 2018 Merida, Mexico, and FIME 2018 – Orlando, Florida, United States.
The Indian medical device industry exhibits several distinct categories, including diagnostic imaging, consumables, IV diagnostics, patient aids, orthopaedics and prosthetics, dental products, and various other verticals. Within this diverse landscape, Auxein Medical specializes in the active manufacturing and export of orthopaedic and prosthetic segments, defining its core mission and focus.
The company witnessed an exemplary growth rate of 25% in recent years. It became one of the leading organizations in the medical device supply category. Due to the adoption of a unique approach to ensure quality, some of the in-house designed and developed product range.
Auxein Medical achieved a significant milestone by pioneering the creation of India's inaugural Metal 3D Printed Patient-Specific Implant, specifically for the Maxillofacial region. This groundbreaking achievement was realized in collaboration with PGI Chandigarh. Subsequently, Auxein Medical continued its innovative journey by crafting several more patient-specific implants, catering to esteemed clients both within India and abroad.
Auxein Medical was founded under the auspices of Ashok Luthra. According to Ashok, every individual in their enterprise is driven by the motivation to heal people. As an Indian organization, it is a moment of pride to showcase Auxein Medical's capability to deliver excellence every time.
Deepak Luthra, a commerce graduate from the University of Delhi, is currently the Managing Director of Auxein Medical. The firm is consolidating its learning across the ranks to make its systems more efficient and foolproof.
Auxein Medical has embraced global best practices while also pioneering methods that account for India's distinctive social context, placing a paramount focus on maintaining impeccable standards of quality and hygiene.
The company has made substantial investments in training its workforce, ensuring they remain well-informed about the most recent industry standards and best practices. This commitment to ongoing education also extends to the ideation process, where meticulous attention to detail is a non-negotiable principle. Every product undergoes a rigorous quality check to meet their stringent satisfaction criteria before it is released from their facilities.
Gaurav Luthra apprenticed on the factory shop floor for four years. In order to understand the fundamentals of production under the guidance of an old-school guru. Gaurav is very passionate about technology and machinery, with an ardent belief in the power of modern science.
He is an accomplished leader with a track record in the development of medical products, proficient in program and product management, and adept in research and engineering. His areas of expertise encompass product development, program management, orthopaedics, orthopaedic implants, project management, software engineering, and hardware engineering. At present, he serves as the Technical Director within the organization.
Rahul Luthra heads the International Sales department. He is a graduate of Business Studies from Massey University. He hopes to progress toward proprietary innovations. It involves working closely with medical professionals for breakthroughs in intuitive, cost-effective, and more personalized care.
Rahul has profound knowledge of export sales matters and experience in building up export organizations and businesses. He is responsible for top key account customers and internal/ external sales teams. His specialities are Business Development, Customer Acquisition, Negotiation, Product Marketing, Branding, Consulting and sales.
In developed nations, the healthcare industry is a major part of the country's economy. The global expenditure on healthcare is expected to reach $ 9.5 trillion.
According to a report by IBEF (India Brand Equity Foundation), the Indian healthcare Industry is projected to reach $ 372 bn by 2022. Recently, the government of India launched the world's largest government-funded healthcare system, Ayushman Bharat, last year in September.
Globally, government spending accounts for 55% of the total expenditure on health, and private spending accounts for the remaining 45%. In South Asia, the scenario is different. The private players hold the majority share of the healthcare market.
The global medical device markets are expected to reach $409.5 billion by 2023 and are forecasted to grow at a CAGR of 4.5% from 2018 to 2023. The current market size of the Indian medical device industry is $5.2 billion and is expected to reach $50 billion by 2025 at a CAGR of 15.8%. Also at the CAGR of 4.1% for the Global medical devices industry.
Within the realm of orthopedic prosthetics and patient aids, these two verticals stand out as the most rapidly expanding segments. As per a market research report released by Invest India, they are anticipated to exhibit impressive compound annual growth rates (CAGR) of 9.6% and 8.8%, respectively.
In the Greek language, Auxein means 'to grow,' and they are growing with an emphasis on product quality and close relationships with every partner.
Over the past years, Auxein Medical witnessed a rapid expansion in its customer base. They are attracted by the distinguishable quality and value advantage delivered by its generic orthopedic implants.
They got many opportunities to provide OEM services to leading names in the industry. Upon a strong foundation of proven customer satisfaction, Auxein Medical is covering 70+ countries and aims to connect with more customers globally. Along, with building a world of exciting possibilities in R&D, Innovation, Customization, and education.
Medical Device Industry is enormous and is accelerating with rapid force. It is playing a key role in making India healthier and stronger. The experienced management's advice for future leaders before entering into the medical device industry is to consider the following points: –
▪ A proper understanding of market requirements
▪ Proper Product Knowledge
▪ Knowledge about government rules and regulations
▪ Knowledge of manufacturing and testing processes of medical devices is required
▪ Quality Management and Material Management