“We are constantly strengthening our presence in India”

David Schwaas, Director,  Marketing & Distribution, Biopharma, Freudenberg Medical in an exclusive with BioVoice's Rahul Koul informed about the company's plans to introduce several new products in 2022 focused in the fluid handling space for biopharma

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Freudenberg Medical, a business unit of global technology group Freudenberg has announced its foray into India. The company designs and manufactures silicone tubing used in vaccine and drug processing. It also produces custom tubing for Oxygen Concentrators, Ventilators, Catheters, diagnostic test kits and other medical devices for customers worldwide. 
In this exclusive interaction with BioVoice, David Schwaas, Director, Marketing & Distribution, Biopharma, Freudenberg Medical shares details about the company’s business operations, product offerings, future plans and much more.

BV LogoPlease tell us in brief about Freudenberg Medical, its products and services, and operations globally? 
Freudenberg Medical designs, develops, and manufactures products for medical device and pharmaceutical companies from 11 locations worldwide.  We are a contract design and manufacturing firm and our manufacturing capabilities range from high precision molded components and medical/biopharma tubing to drug coatings, finished medical devices, catheter shafts and hypotubes for minimally invasive and catheter-based devices.  ISO 13485 certified quality systems and FDA registered sites are located throughout the Americas, Europe, and Asia.
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Why did you decide to make a foray into India? How do you view the business environment and potential opportunities?
Freudenberg Medical has been serving biopharma customers directly and with the help of a few distributors in India for the past few years, supplying standard and custom silicone tubing & fluid handling products from our dedicated manufacturing sites in Germany and the U.S. In 2020, Freudenberg medical added a support team in India to meet the growing sales and service needs of biopharma customers in the region. The company’s parent company, the Freudenberg Group, has done business in India since 1920. It also supplies products for medical device & Biopharma customers in India with custom tubing & molded components for certain Biopharma applications, oxygenators, ventilators, catheters, and other medical devices.
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What is your initial set of product offerings in India? Who are your key clients?
Currently Freudenberg Medical manufactures two brands of silicone tubing for the biopharma market- the PharmaFocus® Premium brand of silicone tubing which is extractables tested with a full validation package, perfect for demanding biopharmaceutical applications with standard, braid reinforced, and peristaltic pump tubing.  We also manufacture the HelixMark® brand of fluid handling products for medical device and pharmaceutical applications.  This product line is available off the shelf in a wide array of product types and sizes, including a choice of silicone raw materials from all the major manufacturers.
We are constantly strengthening our presence in India to achieve our growth objectives through a combination of distribution partners, OEMs, and end users of Biopharma Industry.
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How was the company’s revenue performance during FY 2020-21? 
The sales performance during 2020 and 2021 was very strong. We were able to stay open and ramp up production to meet the needs of our global client base. Sales of pharmaceutical tubing and the manufacture of in-vitro diagnostic devices for OEM customers increased significantly in 2020.
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How is the company promoting innovation in R&D? What is your Capex for various R&D initiatives?
Freudenberg spends considerable amount annually on R&D. Our global R&D team focuses on innovation in products and processing technologies in order to help our customers streamline efficiency and get their products to market faster.
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Overall market size for your products in the Indian medtech space? What will drive the future growth?
The medical device market in India is estimated at around US$ 7 Billion & projected to grow to US$ 50 Billion by 2026. Currently, India imports around 80% of its medical devices. The Government of India has taken several steps to ensure the growth of a vibrant ecosystem of medical devices manufacturing in India over the past 5 years. Authorities have recognized Medical Devices as a sunrise sector under Make in India campaign, 2014. The Medical Devices Rule of 2017 has adopted risk-based classification based on GHT guidelines: Classes A, B, C, D & Perpetual licenses for manufacturers. The Medical Devices Amendment Rules of 2020 brings all medical devices in India under regulation as drugs. A Productions Linked Incentives Scheme for Medical Devices, 2020 has been introduced. There has been increased funding for Medical Devices Parks in the country, 2020. Financing Common Infrastructure Facilities in 4 Medical Device Parks with financial implications of Rs. 400 crores.
These initiatives will further propel the growth of core manufacturing of medical devices in India. 
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How do you view the growth opportunities in pharma tubing solutions?  Any challenges?
With the explosive growth in global biologics production, which includes vaccines and cell and gene therapy, Freudenberg is able to support customers worldwide from two like for like manufacturing sites outfitted with the same top of the line manufacturing equipment, software, and quality systems.  The challenge in the global supply chain is about sustainability & security of supply of critical components & ingredients required to manufacture life-saving drugs & vaccines.
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What are your company’s immediate and future plans in India?
Freudenberg is planning to introduce several new products in 2022 focused in the fluid handling space for biopharma, these include extensions of our current PharmaFocus® product line plus a new product line.  Stay tuned or further announcements in upcoming months.