アイコンは製薬、バイオテクノロジー、医療機器産業を対象とした開発受託業務を提供するグローバル CRO です。当社は開発戦略策定のサポートから第 IIV 相臨床試験に至るまで、臨床開発を支える各プログラムの戦略的開発、マネージメント、データ解析を専門としています。

細分化が進む製薬業界において、 アイコン は国や地域単位、またグローバル規模の臨床試験や開発プロジェクトを実施できる規模と専門性を備えた数少ないグローバル CRO1 つです。

アイコンは、スタンドアロンのサービスでも、またフルサービスでも開発業務を提供できる柔軟性を備えています。


ICON Forms Partnership with Mereo BioPharma for Clinical Development

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ICON Views

It’s no secret that the stakes are higher than ever in the device industry. Clients know they must embrace change and often ask us how to go about it.

We sat down with Vicki to learn more about
ICON’s new Medical Device & Diagnostics Research Group and her advice to help medical device and diagnostic manufacturers stay competitive in today’s market.

Q: Name some of the biggest challenges manufacturers face today.
We’re seeing an increased output of novel, innovative high-risk devices to diagnose or solve complex medical issues. This is undoubtedly great for patients, but as a result regulators demand more evidence of safety and effectiveness and payers want additional evidence to demonstrate value. Investors, of course, are careful not to write a check unless they see that companies have de-risking strategies in their clinical trial design and market access strategies. It’s a perfect storm right now.

ICON created the Medical Device & Diagnostics Research Group to provide device manufacturers with tailored resources to support their development and commercialisation challenges at any stage of the life cycle, from feasibility through post-market.

Q: You and your team wrote an article in MD+DI about strategies to stay competitive this year. Can you talk about those strategies?

Manufacturers can stay competitive by designing their clinical studies to collect the most compelling evidence. There are three specific strategies to focus on: 1) adaptive designs, when appropriate, to right size a trial, shorten white-space, and to analyse interim data to allow for course correction; 2) an error-based risk-based monitoring approach that not only deploys mitigation resources based on a site’s record of errors, but goes further to determine the root cause of these errors and implement mitigation strategies to both fix and prevent them; and 3) collecting health economics data to support the device value proposition and doing so early in the design process. When combined, these strategies introduce tremendous efficiency into a trial and significantly improve development decision-making.

Q: How can manufacturers thrive in the dry investment climate?
Those three approaches to stay competitive outlined above will attract investors, who are alert to these strategies. Since it’s no longer feasible to compete on price alone, companies must demonstrate true value in their offerings. One way to compete is by offering a wider range of products, thus many large device companies are constantly on the lookout for acquisition and merger opportunities. You’d think this climate would make it easier to get funds, but with everyone pressed for time and money it takes real differentiation of a development and commercialisation strategy to get noticed.

Q: What’s the best strategy for market access and gaining market share?

As mentioned previously, you cannot compete on price alone anymore. The device life cycle is short, so manufacturers must convincingly demonstrate as early as possible that their device is better than what’s already on the market. One does not want a product to stagnate after entering the market. The key is to start thinking about commercial launch well in advance of getting there. The most successful manufacturers establish a “clinical-commercial link” by using their pre-approval studies to collect the evidence that the market demands.

The same strategy does not work across the globe. Working with an experienced CRO like ICON that not only understands how to present a device for approval, but also how to streamline a global product launch can decrease the evidence burden on all device manufacturers regardless of their size.

Q: When should manufacturers start thinking about clinical trial and post-market studies?
It’s never too early and, in fact, the best-case scenario is to start thinking about regulatory and reimbursement strategy during the design stage. From the regulatory perspective, that means asking what evidence is needed for submission and what can wait until post-market. At the root of those questions, however, must be a thorough understanding of device class, equivalence, and the degree of uncertainty regulators will accept. A recent FDA draft guidance states pre- and post-market data requirements will vary depending on the agency’s risk-benefit analysis of the device. From the reimbursement perspective, the design stage is the perfect time to conduct competitive analysis and create your device’s value proposition. You can then design the clinical study to collect the evidence that will increase chances of reimbursement and profit.

Q: What indications are growing the fastest?

Cardiovascular, orthopedics, and IVDs. These are also some of the more complex indications from the development perspective because the devices are typically high-risk and novel. ICON specialises in these indications, both in terms of therapeutic and operational expertise.

Q: How can ICON’s new group help manufacturers seeking answers to these and other development and commercialisation questions?
Get in touch with us today. The Medical Device and Diagnostics Research Group is available to answer questions, solve problems, and develop winning strategies from the prototype phase through to ensuring the level of market penetration required to recoup investment and improve health outcomes.

More Information:
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