Innovating within Constraints: What Med Device Designers and Manufacturers in Developed Markets Can Learn from Emerging Markets

In innovation, medical device by Cressida MurrayLeave a Comment

This is an excerpt from an interview Generis Group did with Palani Palaniappan, EVP, Innovation & Development at Terumo BCT in advance of the 2017 American Medical Device Summit, where Palani spoke on “The Democratization of Healthcare Technologies”. Read the full interview here. “Often when we create products for the developed world, we think about value for money: creating value to charge a high premium. In the developing world, we should not be thinking about high premiums. We need to think about value for many: it is a high volume business where prices and profit margins are low. We need to be thrifty in product development and innovate within these constraints. Constraints feed creativity. In developing markets we are challenged to ensure we create an affordable product. But developed markets also face price constraints—more and more so. Western markets are becoming saturated. Affordability and accessibility of healthcare is a challenge worldwide in every market. We’ve heard this many times now—it’s become the common sentiment of the populist way of thinking: “Healthcare is too expensive. Drug prices are being controlled. Device prices are being controlled.” And it’s true! Against the backdrop of people living longer and population growth, it is not sustainable to continue serving developed markets with high-premium products. In India and several other emerging economies, there is extreme price control on medical devices, those classified as “essential medical devices.” For instance, the cost of a stent has been forced …

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Global Regulatory Intelligence: Evaluating the Developments to the EU MDR

In compliance, medical device, regulations by Cressida MurrayLeave a Comment

Is your company prepared for the new EU MDR? Michael Santalucia, Vice President of Global Regulatory Affairs for Terumo BCT, is responsible for managing the global regulatory affairs function regarding the development and execution of product submission strategies for the company’s medical devices, regulatory compliance requirements, and industry advocacy. As medical device companies face large regulatory challenges to comply with the new European Union Medical Device Regulation (EU MDR), we sat down with Michael Santalucia to learn how Regulatory Affairs organizations are evolving along with global regulations, what Terumo BCT has been doing to comply with EU MDR, and how members of the medical device industry can stay informed. “The EU MDR is arguably the most important legislation to affect our industry in the last two decades. Because of the impact this will have for any firm with CE marked devices, it is essential to have someone in the organization that can provide the company with advice and guidance to the requirements that have been established and those that are yet to evolve.”

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eBook: Design Thinking with Terumo BCT

In commercialization, Design Thinking, manufacturing, medical device, medtech, operational excellence, product development by GenerisLeave a Comment

Generis Group is honored to have Palani Palaniappan, EVP, Innovation and Development at Terumo BCT join the speaker faculty at the upcoming American Medical Device Summit 2016. With the summit right around the corner, we took the opportunity to sit down with Dr. Palaniappan to gather his insights and discuss the importance of ‘Design Thinking’ in the journey from concept to commercialization. Check out the eBook!  

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