September 26, 2012 -- “One of the biggest challenges today is the increasingly complex regulatory framework that is delaying time to market”, says Brent Hudson, Chief Executive Officer, Sagentia. “This means that more than ever you need to get the design right and have the right team in place from the start. Medical device R&D executives must also feel comfortable with a new set of success criteria.”
As CEO of a solution provider company at the upcoming marcus evans Medical Device R&D Summit Fall 2011, in Amelia Island, Florida, November 13-15, Hudson discusses competing against emerging market competitors, increasing regulations and the need to get products out faster.
What are the opportunities available to medical device R&D executives?
Brent Hudson: There are quite a few opportunities out there, particularly from a technology perspective. There is an increasing demand for cord-free, mobile-driven, lower energy devices. This gives R&D executives the chance to produce point-of-care devices which are smaller and more cost effective.
There is also the opportunity for more complex devices reliant on embedded software. This needs to be accompanied by rigorous control procedures around building and testing as FDA approval is required.
There are several others but I think the main point here is the innovative use of technology to serve more demanding requirements around cost, portability and usability. These are areas that Sagentia is well positioned to assist with given our 25 years of experience developing complex medical devices for clients.
What are the present challenges that medical device R&D executives are faced with?
Brent Hudson: The current regulatory framework is making design concepts more complex, therefore delaying time to market. This means that more than ever you need to get the design right and have the right team in place from the start. Medical device R&D executives must also feel comfortable with a new set of success criteria.
Equally, cost pressures in the Western markets are severe, while growth is low. To address this, medical device R&D executives need to understand new healthcare system constraints and come up with breakthrough concepts that address the core issues at a very low cost base.
Finally, the emerging markets are no longer optional markets; they are too big and too important. Western companies need to get in there now before local competitors out-innovate them. This requires an understanding of a completely different set of user needs and a frugal innovation approach to product development.
How is the convergence of home treatments changing medical devices?
Brent Hudson: The trend now is out of the hospital and into the home. Complex medical devices were historically used by fully trained physicians in a hospital and are now being used by Mr Smith aged 76 sitting in his home in Miami. This requires medical device companies to take a much more consumer and services based approach to development, sales and support.
What long-term strategies would you recommend?
Brent Hudson: Organizations must learn to balance the needs and opportunities of both developed and emerging markets. This needs to include in depth consideration about user requirements, materials costs, margins and brand. Long-term growth is really only obtainable if you succeed in markets such as Brazil, China and India. I think there is an opportunity for only a few players in the medical device sector to stake out massive long-term growth in these economies.
Another strategy is to continue investing in the understanding of regulatory pathways. This, as with user needs, will change from country to country.
Any final comments?
Brent Hudson: I think we are in the most exciting and challenging time for medical device development. The opportunities for companies who get things right the first time are immense.
Contact: Stacey Melvin, Journalist, marcus evans, Summits Division
Tel: + 357 22 849 400
About the Medical Device R&D Summit Fall 2011
This unique forum will take place at The Ritz-Carlton, Amelia Island, Florida, November 13-15, 2011. Offering much more than any conference, exhibition or trade show, this exclusive meeting will bring together esteemed industry thought leaders and solution providers to a highly focused and interactive networking event. The Summit includes presentations on lowering the costs of medical device R&D, issues in medical device compliance and introducing remote and home therapy treatments.
For more information please send an email to email@example.com or visit the event website
marcus evans group - manufacturing sector portal
Please note that the summit is a closed business event and the number of participants strictly limited.
Sagentia is a global technology and product development company, providing outsourced R&D consultancy services to the medical, industrial and consumer sectors.
We work with clients from front end needs analysis to transfer to manufacture, delivering innovation around new technologies and new generation products and services that provide commercial value and market advantage.
Further information can be found at: www.sagentia.com
About marcus evans Summits
marcus evans Summits are high level business forums for the world’s leading decision-makers to meet, learn and discuss strategies and solutions. Held at exclusive locations around the world, these events provide attendees with a unique opportunity to individually tailor their schedules of keynote presentations, think tanks, seminars and one-on-one business meetings. For more information, please visit www.marcusevans.com