In this era of intense global competition and slow market growth in the U.S. and Europe, getting your product out to market first might be the difference between financial success and being an also-ran.

There are key strategies that must be followed to ensure a nimble product development cycle especially when coming out with a disruptive technology, says Chirag Tilara, director of coronary quality with Medtronic's cardiovascular group. Tilara will be speaking about how to build speed to market in and compliance into the medical device design process at BIOMEDevice San Jose, Dec. 3. He took some time to discuss the correct approach with MD+DI.

Build a Scalable Process
A scalable process is key to quickly developing a product and getting into market, Tilara says.

"If you have a disruptive technology and you want to get out into the market as fast as possible, you still need to ensure that you are using a process that’s scalable and not going through the traditional product development cycle, the typical iteration of a therapy that is well known in the marketplace," he says.

To create the scalable process, having the right team and management buy-in is very important.

"Because you are planning on moving fast, you need to have representation from the most important functions - R&D, design and quality assurance, clinical, sales and marketing - from whom you need immediate feedback on and dedicated resources," he explains. "So the question is have you set about an environment where the teams are aware of the importance of the project, where the teams are able to navigate the process in a fast way, and more importantly the management is aware of the way you are scaling up and down."

Having a strong financial value proposition for why the product should be developed is also key to getting that management buy-in, Tilara says.

Choose Design Features Wisely
Sometimes engineers get too carried away in adding exciting, new features designed to blow away the physician-customer. Tilara advises being more selective.

"When you start out, you have grandiose visions of what that product is going to look like and so you should make sure you have certain exciting features, but you should focus on the primary features and not too many bells and whistles that consume more time and take longer to get out," he says. "There may be features that differentiate you in the long term but also may be slowing you down when you are dealing with disruptive technologies."

And when dealing with therapies already established in the marketplace, Tilara advises bringing an even more critical evaluation of features to make sure that the final product is truly differentiated in the marketplace.

Get Outside Help When Needed
Hiring contract manufacturing or contract lab services and outsourcing some functions may be a better way to approach speed to market instead of hiring the complementary skill sets in house.

"When you are working on a product you know that is short enough from a development cycle, you may not want to spend hiring and laying off people," he says. "I think that’s important because you might spend three months hiring the skill set that you need and in a year and a half you might have to let them go."

This is especially useful for smaller companies that may not have the breadth of resources and skills that a large medtech player has.

"Leveraging or hiring complementary skills and not getting too confident about what you can do with your own resources and your own skills," is important, Tilara says.
However, when developing a product for overseas locations - especially China - it will be wise to keep things close to the vest.

"If I am going to develop a product in China for the Chinese market, for a company the size and scale of Medtronic, we are not going to outsource our development cycle, given the risk that we may carry their with more competitors," Tilara says alluding to the potential for theft of intellectual property that many have been stung by.

But aside from the threat of IP theft, it's also possible that medtech players operating in new markets may not be aware of the skills available in the market, and in that case it's wiser to create a scalable process for that region, he says.

Partner With Regulatory Agencies
Tilara believes that partnering with regulatory bodies earlier in the development cycle is another key component of speed to market.

"It's important to partner upfront with regulatory agencies when it comes to either designing of clinical trials, or [discussing] technical challenges...or if you are operating in an emerging market like India or China or wherever you may be, where the regulations are evolving and you don't want to find that two years down the road you developed a product that is now not compliant to the upcoming regulations," he says. "So you need to partner more or maybe have the right consultants in your team."

[Photo Credit: iStockphoto.com user 3dts] 

-- By Arundhati Parmar, Senior Editor, MD+DI
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