With a population of 1.2 billion and a 1.3 percent growth rate, India’s already $3 billion medical device market is set for growth based upon demographics alone. But before orthopaedic device manufacturers and suppliers choose a path to enter or expand in the Indian market, they need to consider the regulatory environment, economic conditions and competitive landscape.
Hangsterfer’s Laboratories has sold through global distribution for more than 50 years. BONEZONE spoke with Skip Wolford, Sales Manager at Hangsterfer’s, about the challenges and opportunities presented by India’s medical device industry.
BONEZONE: What originally attracted Hangsterfer’s to the Indian market?
Skip Wolford: There’s no question that the Indian marketplace is vibrant, with a talented pool of individuals for engineering and manufacturing. It is a very aggressive marketplace, with many companies planning to expand there or already in place with operations. It’s natural progression for a global business to seek a presence in that marketplace.
BONEZONE: In your experience, what unique challenges are faced by companies that do business in India’s orthopaedic market?
Wolford: As with any developing country, there is no shortage of local supply outlets. You’re dealing with currency issues, geopolitical issues, regulatory issues, things of this nature, as well as in-country supply.
BONEZONE: Do you expect new challenges to arise?
Wolford: I think that the political structure internally, within the government itself, presents one of the greater challenges. There are tremendous inflation and monetary issues. That affects how people do business and it also has a great effect on the psyche of the customer base in India. When the country doesn’t have enough rain or when storms hit, everybody talks about it and everybody reacts to it.
BONEZONE: What are the unique advantages or opportunities in the India market?
Wolford: There is a growing base of surgeons who produce their own products, as well as ongoing operations from global members that are manufacturing products in India and seeking world-class solutions to go along with the infrastructure that they have invested in the country.
BONEZONE: Are you seeing a lot of competition in India? Do you expect that to change?
Wolford: We have in-country competition, but very few at our level. There’s always going to be low-end competition, but specifically for the high-end medical device market, the requirements and restrictions for the types of fluids that are used will dramatically reduce the amount of competitors. Factoring in REACH compliance and the new GHS regulations as well as special cleanliness requirements limits the group further. Companies that sell products in India and wish to participate within Europe or the U.S. are going to have to meet those regulations.
BONEZONE: What advice do you have for OEMs and suppliers thinking of entering or expanding their presence in India?
Wolford: India is a land of vast opportunities. It requires a vast amount of homework, infrastructure and infinite amounts of patience.
For more on India, including current and proposed regulatory changes, click here.