Operon Biotech and Healthcare: Crafting a Healthier Tomorrow in India

Operon Biotech & HealthCare
Operon Biotech & HealthCare

The landscape of healthcare is ever-evolving, with innovation and patient-centric solutions as keystones. Operon Biotech and Healthcare has established itself as an institution of relentless commitment in this dynamic domain. Situated in the vibrant setting of Bangalore, Karnataka, this professionally managed biomedical powerhouse is rewriting the healthcare narrative in India.

Led by the visionary Afser Shariff, a leading figure in the field of IVD – Medical Devices, Operon Biotech and Healthcare has emerged as a formidable force in the Indian healthcare landscape. With a global outlook, the company forges strong collaborations with some of the finest brands worldwide, working in unison with its customers to deliver comprehensive end-to-end solutions.

Afser is not just the Founder and CEO of Operon Biotech and Healthcare but also the co-founder of Dfine Bioinnovations Pvt Ltd, an aspiring MedTech startup. While Operon Biotech and Healthcare with its 14 years of market standing has introduced several stellar products in Indian Medical Device Industry and continues to support the diagnostic Labs with important testing tools sourced across the globe that would empower them with latest in technology and help them deliver quality reports fairly and quickly without much burn on their pocket. While Dfine Bioinnovations Pvt Ltd is an aspiring MedTech startup focused on indigenous design, development and manufacturing of medical devices that would effectively address the pain-points of rural labs with customized solutions.

Specializing in the field of Hemostasis (Coagulation), Operon Biotech and Healthcare proudly identifies itself as “Composite Coagulation Experts,” constantly striving to add business value to this critical domain.

Operon biotech’s strength lies in its exclusive product range, reputable customer base and its commitment to the customers to ensuring accurate results every time. Empowered by a dedicated team, profound industry knowledge, and a strong customer network, the company is steadily expanding its footprint across the vast expanse of the country, solidifying its presence through a network of distributor partners and satisfied customers alike.

In an exclusive interview with Mr Afser, we dive into the captivating journey that led to the creation of one of India’s most trusted healthcare solution providers.

Join us as we uncover the vision, dedication, and innovation driving Operon Biotech and Healthcare towards a brighter, healthier future for all.

The Founding Story

Established in August 2008, Operon Biotech embarked on a mission to provide stable and sustainable tools for clinical laboratories. Its impressive product portfolio, spanning lab diagnostics and point-of-care testing (POCT) in coagulation, reflects a commitment to diverse and comprehensive solutions.

“Be it a simple single channel system for a clinical lab or a self-testing device for INR monitoring to an affordable entry-level automation to mid-sized automation, we have it all,” proudly asserts Mr Afser.

Specializing in in-vitro diagnostic tools for clinical laboratories, healthcare, and point-of-care testing, Operon Biotech and Healthcare’s strength lies in its robust product line, a respected customer base, and a relentless commitment to unparalleled customer support.

Dfine Bioinnovations Pvt Ltd (DBI), an ISO 13485-2016 and ZED-certified, CDSCO-registered MedTech Startup based in Bangalore, India, is an integral part of this healthcare narrative. Incubated at the prestigious FSID (An incubation arm of IISC – Bangalore), Dfine Bio-Innovations, with a founding team of 4 members boasting a cumulative industry experience of over 50 years, aims to indigenously develop cost-effective and sustainable medical devices indigenously, maintaining high standards in design and delivery. DBI is a proud winner of “EMERGING SMB” by the Lenovo IT4SMB Awards 2023, Bangalore Edition and the All India MediCALL innovation award (finalist) held at Chennai 2023. DBI is supported by Honeywell and Nidhi Prayas funding.

With a strong product range, an exceptional team, enviable market standing, domain expertise, and a commitment to continuous innovation, Operon Biotech and Healthcare has evolved into a strong regional player, making its mark in Karnataka. The company is resolute in replicating its regional success across India and aims to extend its footprint beyond the borders of Karnataka.

From Twist of Fate to Entrepreneurship

Mr Afser’s entry into the IVD medical device industry was an unexpected turn of events, a beautiful stroke of serendipity. In the year 1998, he found himself in the field of IVD not by choice but by a twist of fate while filling out a credit card application form for the director of Rashmi Diagnostics Pvt Ltd, a happening IVD company at the time.

Although the stint at Rashmi Diagnostics was brief, lasting no more than a year, Mr Afser’s trajectory continued as he assumed the role of Marketing Manager at Rapid Diagnostics Pvt Ltd. Here, he passionately continued his focus on Haemostasis (Coagulation) products, contributing significantly to market penetration and business consolidation across India.

Rapid Diagnostics represented Sigma Diagnostics for its Coagulation range in reagents and Amelung Gmbh for its instrument range. In an interesting turn, Sigma Diagnostics later acquired Amelung Gmbh, and the chain of acquisitions eventually led to Trinity Biotech Plc, an Irish company acquiring Sigma-Amelung brands. This sequence concluded with a full circle, as Trinity Biotech Plc, in turn, was acquired by the company, Diagnostica Stago, where Mr Afser had started his professional journey.

He embarked on a new chapter after gaining profound product knowledge and understanding specific customer needs. Following a successful 9+ years at Rapid Diagnostics, armed with a determination to create something unique, Mr Afser laid the foundation for Operon Biotech and Healthcare in August 2008. Thus, a journey that began with a stroke of serendipity and a credit card application form came full circle with establishing his own venture.

Principles for Professional Excellence

For Mr Afser, whether in the capacity of an employee or as an entrepreneur, his core beliefs and values have remained consistent. These principles serve as the guiding light through different roles, encapsulating a philosophy that resonates with his professional journey. Here are the enduring values that define Mr Afser:

  1. Don’t stop learning: The pursuit of knowledge is a constant, irrespective of roles or positions.
  2. Take Risks: Embracing challenges and taking calculated risks is fundamental to growth and innovation.
  3. “Try” before saying NO and do it any which way: A proactive approach to problem-solving, where attempts precede negations, is a key mindset.
  4. Build Trust by staying True to self and others around you: Trust is nurtured through authenticity and integrity, both within oneself and in relationships with others.
  5. Be honest in talks, commitment, and offers: Transparency and honesty form the foundation of meaningful interactions and business dealings.
  6. Be patient, persevere, and stay put in the process: Long-term success requires patience, perseverance, and commitment to the journey.
  7. It’s one life, take care of yourself and live to the Potential: A holistic approach to life, emphasizing self-care and unlocking one’s full potential.

His mantra is clear: Start small but start now. This outlook reflects the urgency to seize opportunities and capitalize on the significant growth that India is poised to experience in the present and the future.

Cutting-Edge Coagulation Solutions

In the field of coagulation, Operon Biotech possesses a suite of revolutionary services and products, redefining hemostasis with unparalleled precision and efficiency. Here’s a glimpse into Operon’s groundbreaking offerings:

  1. FibriTimerTM ZETA-1

A FIRST Hemostasis System to be developed by any INDIAN COMPANY. Yes, FibriTimerTM is a MADE-IN-INDIA medical device built by DBI. It is the first Indian company to indigenously develop a Multipurpose Hemostasis Device. The Zeta -1 is exquisitely designed, lightweight crafted by professionals for professionals and proudly boasts of a 3.5-inch touch capacitive screen, easy menu options, a single use disposable cuvette to carry out array of coagulation assays, an optional automated pipette for accurate clot activation and an inbuilt printer helping the user with a hardcopy printout. FibriTimer ZETA -1 is born unconventional to bust the stereotypes.

  1. Operon XL 1000i: State-of-the-Art Automation

A fully automated blood coagulation analyzer with a compact benchtop design, capable of effortlessly performing routine PT, PTT, Fib, and TT, accommodating special investigations with ease.

  1. Operon XL 1000e: Efficiency in Mid-Size Laboratories
  • A benchtop system tailored for mid-size laboratories handling 50-100 samples per day.
  • Features a throughput of 120T/hour, 35 sample positions, 20 reagent positions, and unique advantages such as dual technology support, bi-directional LIS, barcode reading, inbuilt QC records, and chromogenic testing capabilities.
  • Within 4 years of launch it touched close to 100 users in Karnataka itself making it the biggest player in this segment.
  1. XL 3690 Floor Model: High Throughput Automation
  • A 10-channel automated system with an integrated PC, designed for high-throughput coagulation labs processing 150 samples per day and above.
  • Boasts a throughput of 600T/hour, 60 sample positions, and reagent positions, with unique features like pre-heated probe continuous sample loading, dual probe technology, integrated barcode, and bidirectional LIS support.
  1. QuikCoag by BioMedica Diagnostics: Comprehensive Coagulation Solutions
  • Operon Biotech represents the FDA 510(k) cleared, CE marked, and/or Health Canada registered QuikCoag brand in India.
  • BioMedica Diagnostics develops and manufactures a comprehensive line of reagents, kits, calibrators, and controls for routine and specialty coagulation.
  1. qLabs®: Handheld Point-of-Care Precision
  • A handheld Point-of-Care device by Operon Biotech, offering rapid testing for PT-INR and APTT using fingerstick blood.
  • Enables real-time, lab-quality results within minutes, either at Point of Care or in the comfort of home.
  • Cleared and certified for global markets by CE, TUV, and LUMC authorities, revolutionizing coagulation testing compared to conventional laboratory methods.

Navigating the Dynamics of India’s IVD Market

The Indian In-Vitro Diagnostics (IVD) market stands robust at a staggering 80,000 Crores (9600 million USD), with Hemostasis carving its niche at 500 Crores (60 Million USD) and showcasing a commendable 10-14% Compound Annual Growth Rate (CAGR).

Within this landscape, coagulation emerges as a key pillar, poised to be continually lead in the IVD market. The commonly requested tests, including Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen (FIB), Thrombin Time (TT), and D-Dimer, underscore the pivotal role of coagulation testing. Tertiary care hospitals and referral labs are driving this demand, seeking greater automation and integration, particularly for esoteric coagulation tests like D-Dimer, Thrombotic Panel, and APLA testing.

Coagulation tests serve critical purposes such as:

– Diagnosing Bleeding Disorders: Including inhibitor screening.

– Monitoring Anticoagulant Therapies: Assessing the effectiveness of ongoing treatments.

– Identifying Thrombo-embolic Diseases: Such as APCR (Factor V mutation) or elevated Homocysteine levels.

– Pre-Surgery Screening: Essential for patients with potential bleeding disorders.

– Screening and Monitoring Hemophilia Patients: Ensuring proactive healthcare for this patient demographic.

– Monitoring Liver Functions: Especially Vit-K dependent factors.

– Understanding Coagulopathies: Such as Disseminated Intravascular Coagulation (DIC), Liver Disease, etc.

Challenges Faced by Indian MedTech Startups in the Global Arena

Venturing on the journey of a MedTech startup in India, a landscape brimming with innovation, promises, and aspirations comes with its set of challenges. Among these, a key hurdle standing prominently is the acute lack of exposure to funds. This challenge, common among startups, often becomes the decisive factor, dictating the pace of growth and even leading to the downfall of many promising ventures.

In the backdrop of India’s historical reliance on imports, another significant challenge surfaces – the absence of certification and accreditation bodies equivalent to CE/FDA standards. This absence acts as a red flag, requiring strategic navigation for startups to establish credibility and meet global benchmarks.

Market acceptance of “Made in India” products adds yet another layer to the challenges. Overcoming preconceived notions and establishing trust in the quality and innovation of indigenous products becomes a continual uphill battle.

Further complicating the journey is the fierce competition posed by foreign companies. The global stage, while ripe with opportunities, also exposes startups to intense competition, requiring them to showcase unique value propositions to gain a foothold.

The tendering system in India, often perceived as unfriendly to startups, adds to the complexities. Negotiating this landscape demands resilience and strategic acumen to navigate bureaucratic processes.

Innovation Amidst Challenges

India is emerging as a promising market, attracting homegrown startups to carve a niche in the unfolding opportunities. It’s a period of sustained endurance through the turbulent and evolving times – a test where the “survival of the fittest” theory finds a perfect fit.

The Indian government actively engages with representatives like AIMED, adopting a favourable environment for growth. Mr Asfer firmly believes that this juncture offers the ideal moment for young, ambitious entrepreneurs to pioneer the new age of next-generation medical devices.

The team at Dfine Bioinnovations Pvt Ltd exemplifies this spirit, actively innovating and navigating the challenges to not only withstand the tides of time but to continuously evolve and stay relevant. The “Do It In-house” approach adopted during the development of FibriTimer reflects a commitment to quality and innovation, steering away from off-the-shelf solutions. From an engineering perspective, this approach presents a daunting task, involving numerous iterations to realize the envisioned product.

Careful planning, thorough selection of components, down to the smallest details like capacitors or adapters, without compromising on quality, have resulted in a product that stands at least 30% more cost-effective than imported models. This, Mr Asfer asserts, is the power of self-belief – the power of the right individuals coming together to achieve what may seem impossible.

DBI Invites You!

We are proud to participate in MEDICAL FAIR INDIA: India’s no. 1 exhibition and conference for healthcare, which acts as a platform where connections are made and business relationships are nurtured.

Please visit this exciting event held at Bombay Exhibition Center, Mumbai during 13-15 March 2023. Do mark our stall G65 (CliniLab India) and visit our stall to know our products, offerings and solutions for clinical labs across India.
BIG participation from over 20 countries, MEDICAL FAIR INDIA provides an opportunity and awareness on the trends in Medical Device and IVD industry.
Find diverse solutions to your diverse healthcare needs and
Explore how the latest digital technologies and new approaches shaping healthcare.

Hoping to meet you in person at our stall!

Team DBI

#medicafair #pathologist #meddevice Association of Indian Medical Device Industry (AIMED) CPDMED TBI IISc Medical Fair India Startup India Startup Karnataka YourStory Media #ivd

Visit our website, www.operonbiotech.com and www.dfinebio.in, for the latest updates and product offerings.

We are open to exchange ideas and business possibilities via email at ceo@dfinebio.in

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