Just having fire in the belly may not be enough for small and medium-size entrepreneurs. You also need to know how to access markets, and for that you need to know what regulators in those markets want.

So what do regulators want?

This million-dollar question haunting entrepreneurs is precisely what UL seeks to demystify for the 70-odd medical device makers it works with in India.

“At the end of the day what a regulator wants is to make sure devices sold in the different jurisdictions are safe,” says Suresh Sugavanam, Managing Director and Vice-President, UL (South Asia), explaining how they work with entrepreneurs of different hues, helping their products make the cut.

Small pockets, big dreams Small and medium entrepreneurs have good ideas and products, but the difficulty comes when they want to access global markets, he says. Different markets have different rules. For example, what the US Food and Drug Administration (FDA) is looking for may be different from what the Korean FDA requires and it’s important for people to know that. Even big pharmaceutical companies are struggling to keep pace with the requirements of regulators in developed markets. For instance, the requirements of the US FDA seem to have big drug-makers like Ranbaxy and Wockhardt in knots, as evident from the repeated raps they are getting from the US regulator on their manufacturing plants in India.

The question becomes even more critical for small and medium entrepreneurs, with small pockets, but big dreams.

Big groups do have an informed sense of what is required, backed by the infrastructure and resources to meet the regulatory requirements in different markets, says Sugavanam.

“That’s where the new entrepreneurs get left behind, and that’s where UL invests in, getting more people to be aware of what is required,” he adds.

It becomes tricky, as it is not just about getting it right one time, but to maintain the certification, as there are repeated audits, he points out.

As more Indian companies face the heat of global regulatory authorities, UL has started mock audits, he says, to help companies be more agile on regulatory requirements.

Globally, UL works across several industry segments, including high-tech, built-environment (from a fire standpoint), water-testing and financial security. And in life-sciences, it works with about 300 companies globally, supporting the safety features of their pharmaceutical and healthcare products.

Compliance relationship A compliance partner for the US FDA in co-developing content to train its inspectors, UL in India is part of committees of standard-setting organisations such as the Bureau of Indian Standards and the AERB (Atomic Energy Regulatory Board), says Sugavanam.

Explaining where UL gets into the picture with an entrepreneur, he says, it could span various stages, from process audits to getting a CE product certification that would allow the sale of the product in developed markets.

Medical device-makers sometimes run their systems audits at UL’s labs, in Bangalore, Gurgaon and Manesar. Bangalore-based medical devices start-up Forus is a company that UL worked with. An early-bird when it comes to frugal innovation in ophthalmology, its product 3nethra is an inexpensive, portable, pre-screening device.

By identifying five major eye ailments, 3nethra cuts the need for several expensive devices, and Forus has installed over 200 3nethras, with plans of many more, says Sugavanam. Last December, Forus received the ISO 13485 certification — a standard that ensures compliance of various aspects of a product lifecycle that affect safety and effectiveness of medical devices, including product design, manufacturing, installation, service and market surveillance of installed products.

And in its communication then, Shyam Vasudevarao, Forus President and Chief Technical Officer, said UL’s “early-engagement programme” had helped them grapple with not just getting the product ready for India but for various global markets. In the med-tech space, entrepreneurs have usually worked with the big boys, like a Philips or GE.

So they understand the markets and their requirement. Initially, it is about selling locally to known networks and hospitals. Then the desire grows to take the product national, and soon to other world markets, observes Sugavanam.

In fact, an UL product mindset study found Indian manufacturers more tuned to take their products to new shores, than their counterparts in China or Brazil.

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