3 Fundamental Risks to New Diagnostics

3 Fundamental Risks to New Diagnostics

Every new diagnostic and medical device faces three fundamental risks.
Achieving success in the in-vitro diagnostics (IVD) industry — and the time it takes to do so — depends on more than getting technology to work for you. Yes, managing to get consistent performance from your newly developed device or test is absolutely worth celebrating. You’ve eliminated a great deal of technical risk. Unfortunately, there are still others ahead.

These non-technical risks are often the greater cause of delay in achieving the widespread acceptance and use of a new device or test. Turning your prototype into something that can be marketed to help clinicians care for patients introduces a host of new questions. At MDC Associates, we help clients look ahead and draw up plans to minimize or even avoid these potential delays, better known as Product, Regulatory, and Commercial Risk.

Product Risk

Does your product deliver features unique enough to warrant routine clinical use?
Is your supply chain ready for real volume?

While it may seem easy to dismiss the simplicity and obvious nature of these questions, often even established IVD makers find themselves scrambling to address issues just like these.

Regulatory Risk

Is there a regulatory path that will allow for timely approval at a reasonable investment?
Is a smaller, less expensive approach to your clinical study likely to delay approval in the end?

Obtaining market access for your new diagnostic can be costly. Some of that cost comes from having to backtrack, collect more sample data, or perhaps even resubmit using a different regulatory strategy. The most sensible approach is to make sure your plan is guided by the experience of hundreds of market access wins.

Commercial Risk

Will the go-to-market strategy lead to high adoption at a price that supports a positive ROI?
What obstacles will you face when getting customers up and running after approval?

Once the regulatory party is over many IVD makers realize the real work is getting customers to use their diagnostic on a routine basis. Price, implementation, workflow, menu – these factors and more can quickly become a barrier to widespread adoption and use.

Can we help?

Have a new invention you’re preparing to offer to the market? Need help getting sites up and running for your clinical trial?

Contact us and tell us about your project. We’ll help you determine a sensible and commercially minded path to winning market access and achieving routine clinical use.