Interview with: Jyotsna Ghai, Ph.D.,

Global Head, VP Product Development,

Roche Tissue Diagnostics, Roche

"Winning cost strategies for medical devices takes a lot of forethought. It starts with innovation and robust design, while keeping an eye on costs throughout the product development and manufacturing process. The end product can only be cost-effective if the design is conducive to high reliability, manufacturability has wide market adoption addressing an unmet need and affects patient outcomes significantly," says Jyotsna Ghai, Global Head, VP Product Development, Roche Tissue Diagnostics.

"Creation of Medical Value and cost effectiveness depends on a deeper understanding of the structural stakeholders such as CMS/NHS/Government and private payers (reimbursement), national and local level policy, physician training, hospital and provider capacity and patient access. Any of these barriers can impede market adoption and thus cost effectiveness of a device, diagnostic or therapy."

Ghai was a speaker at the Marcus Evans Medical Device R&D Summit 2022.

How can medical device manufacturers focus more

on creating Medical Value? What message would

you like to share?

My message is very simple. Medical innovation, be it devices, diagnostics or pharma, should be democratized. It should serve humanity at large. Innovation should be such that it can serve all those who need it. Secondly, medical innovation should affect better outcomes and thus Medical Value. Innovation is critical but I feel that focusing on the benefit/Medical Value is very important.

Why is Medical Value and cost effectiveness important? Reimbursement dollars are limited, whether it is the CMS, NHS or private payers. If we do not link outcomes to meaningful innovation and gain appropriate reimbursement, it becomes difficult for innovation and innovative products to penetrate the broader market. At the end of the day, everyone is going to look at value. Companies need to do an even better job of understanding unmet needs and barriers to penetrate the market. Though the goal is clear, often novel product development precedes market development and the expectation is that somehow things will fall in place due to the innovative nature of products. It needs to happen concurrently with innovation and product development.

When costs keep rising, is cost reduction possible?

Cost depends on so many factors. It starts with design, reliability, and manufacturability. Other factors such as scale, distribution costs, and market penetration among many others have an immense bearing in cost determination. In each case, it's important to understand the underlying determinants of cost to effectively manage and mitigate rising cost. To elaborate further, it starts with a well thought through design that can be robust and manufactured at a lower cost. Factors such as supply chain, cost of materials, and complex manufacturing processes that can drive up the cost should be understood upfront and proactively considered. We need to look at the entire continuum of product development end-to-end, even before initiating the project, and fully understand assumptions behind the business/financial model in order to have better control on the desired outcome.

What gaps between R&D and manufacturing need to

be bridged? How?

Sometimes R&D teams create product designs that cannot necessarily be manufactured cost-effectively and reliably. They may have extremely high requirements for parts tolerance that are difficult to manufacture and, in turn, create a lot of waste. Unique supplier requirements also shift the design process, increasing cost, the dependence on a single supplier, and also adding risk and potentially higher downstream costs. Modular design across the portfolio helps with economies of scale and thus cost reduction. Close partnership and planning with suppliers also goes a long way in finding ways to effectively manage costs.

Find out more about the next Medical Device Summit