Simon Aliwell, Director of the Sensors and Instrumentation Knowledge Transfer Network, National Physical Laboratory, in the UK, has a piece in the latest issue of MDT magazine. His outfit is a network of excellence supported by the UK Technology Strategy Board to develop innovation in sensing. Check out their web site here.

In his story Aliwell suggests that regulatory hurdles represent the greatest market barrier for developers of new sensor technology.

Technologies for use in the medical arena must undergo a thorough and
well defined testing and approval process before they can be adopted.
This is the case even when technologies have proven their effectiveness
in other fields and applications. Although this is to patients'
benefit, it does delay the return on investment for companies and makes
the path to commercial success longer. This, in combination with the
significant upfront investment required to develop, manufacture and
trial new devices, may mean failure for many small companies as they
wait months or even years for returns.

Certainly starting a new medical device company represents a major investment. And certain sensor technologies, like the Oncoprobe chemotherapy sensor that Aliwell mentions must be tested for each clinical application (i.e., or type of cancer in the case of Oncoprobe) – a heavy regulatory burden. A bigger burden I think is creating the “whole product solution” for senors.

In a perfect world, the value of a novel sensor technology is recognized and eagerly licensed and incorporated into medical device vendor's products. In the imperfect world of health care, almost all sensor vendors must create and sell their own product to create the market demand that drives existing vendors to incorporate new sensor technology. There are few Fields of Dreams (build it and they will come…) in health care.

This line between OEM supplier and medical device vendor is a thin one, and must be approached carefully. One one side, your sensor-based product must be compelling enough to win end-user sales and fuel market demand. On the other you need a rapid time to market at a cost you can underwrite. So what might a “whole product solution” include?

In addition to productizing your novel sensor technology, a company has to package it so it can be used in its intended clinical setting. The relative maturity of other medical devices at the point of care – patient monitors, infusion pumps – create expectations among clinicians for certain capabilities. These expectations include:

  • Some degree of wireless operation – an increasing number of devices are battery powered and wireless connectivity is de riguer for portable medical devices, battery powered or otherwise.
  • EMR integration – any hospital with paperless charting will insist on the ability to electronically move sensor data into the patient's electronic record.
  • Monitoring – sensors provide a monitoring function – alone, in conjunction with other sensors, or as feedback to therapy. Monitoring requires surveillance (data display), alarms, and retrospective event review.
  • Point of care workflow – all these capabilities must be implemented in a system design that supports the care delivery process – where caregivers circulate between the bedside, central station and elsewhere. The system must enhance caregiver productivity and patient safety, rather than the opposite.

These expectations define the system that supports the practical use of your sensor in a real world customer environment. Along with these system features, there is a whole range of business requirements to properly sell, manufacture, install, service and support the whole product solution.

Conventional product development strategies for these system features entail developing most all of the features from scratch, a very time consuming and expensive approach. While we are still a ways from being able to license these features from a medical systems OEM vendor, there are innovative new development strategies that can greatly minimize time to market and R&D costs.

Rome wasn't built in a day, and a new medical device system will not be full featured at first release. In fact, you'll need some system capabilities to support sensor development, like data acquisition and analysis. Part in parcel with your development strategy is the product roadmap. The roadmap lays out the progression of system features over time, and must align with your sensor product development plan and your market entry strategy.

Most novel sensor technology requires that clinicians adopt a new use model different from that used with conventional sensors. Getting anyone in health care to change the way they do things is a challenge, and this has an impact on market entry strategies. Because market entry strategies drives both system requirements and product roadmap, the whole process is rather iterative, with each variable impacting the others until a balance is achieved.

So there you have it, an overview of productization issues for novel sensor in health care.

Pictured right is some Nexense sensor silicon.