Industry Spotlight: Martin Burns, Chief Executive Officer, BBI

Q: Please describe your background, training and experience.

A: I have more than15 years of experience as a management consultant in the United States and Europe at Deloitte Consulting and PricewaterhouseCoopers. I’ve led corporate strategy, innovation, operations, quality/regulatory, mergers/acquisitions, and global expansion assignments for medical device and life sciences companies.

My management consulting experience has conditioned me to think creatively about solutions to health care challenges. I’ve spoken with many clinicians and have listened closely as they describe the problems encountered in pressure ulcer diagnosis. And I’ve come to recognize that pressure ulcer prevention is a complex issue that involves synthesizing information from many disciplines and moving confidently toward a solution based on improved detection. Martin_Burns

Q: What differentiates BBI from other companies in the wound prevention/wound management field?

A: BBI, LLC, is unique in its focus on developing advanced sensor-based devices for monitoring and detecting diseases earlier and with greater diagnostic certainty than currently accepted methods.

The company’s first product is the SEM Scanner, a hand-held, noninvasive device that can detect early-stage pressure ulcers as much as 10 days earlier than visual observation.

The SEM Scanner is the first and only device providing accurate, actionable diagnostic information to alert health care practitioners in real time when a pressure ulcer begins to develop under the skin. It’s like having a wound care nurse in your pocket.

Q: Please provide an overview of the SEM Scanner for pressure ulcer prevention.

A: Approximately 80% of pressure ulcers can be prevented. Unfortunately, the United States still sees 2.5 million cases a year, which means patients, particularly those with dark skin tones, are suffering unnecessarily.

The key to preventing pressure ulcers is detecting them before the skin begins to break down with interventions to reverse the damage. The current method of diagnosing pressure ulcers is visual observation of the skin, but once the condition is visible the damage to the skin has already begun.

Until now, health care professionals have not had the tools to empower them to intervene early with targeted care. The SEM Scanner makes the invisible visible by revealing inflammation beneath the skin. The device measures sub-epidermal moisture—a biophysical marker associated with localized edema in the initial inflammatory phase of pressure ulcer formation. Customers using the SEM Scanner as part of BBI’s proprietary Pressure Ulcer Reduction Program (PURP) have seen drastic reductions in the incidence of avoidable hospital-acquired pressure ulcers.  

With early detection, clinicians can initiate treatment before chronic damage develops. This improvement in the treatment paradigm is transformational to pressure ulcer reversal and prevention.

Q: What are some of BBI’s biggest accomplishments thus far?

A: BBI won CE mark approval for the SEM Scanner in 2014. Health care professionals are realizing that no other technology in the marketplace can match the SEM Scanner in terms of accuracy or time-to-detection. As a result, uptake of the device is growing rapidly in the United Kingdom and Ireland, where it is now available as part of a limited launch.

For BBI, our biggest accomplishment is the impact we are having on patients. In the United Kingdom – which has stringent policies about pressure ulcer prevention – the incidence of pressure ulcers has decreased to zero in every hospital ward using the SEM Scanner. This translates into a cost savings of £10,000 to £50,000 per month. How many companies can say fewer patients are afflicted with pressure ulcers or dying from pressure ulcer-related complications because of their product?

In recognition of these accomplishments, Frost & Sullivan named BBI as the winner of its 2015 European New Product Innovation Award for Pressure Ulcer Diagnostics.

Q: Please describe other wound prevention applications in development for BBI’s technology.

A: BBI is developing P02M, a blood perfusion and oxygen delivery-monitoring device that utilizes multispectral imaging. P02M is designed to work as either a hand-held device or a wearable sensor, and it is the first technology designed to monitor tissue oxygenation at a specific location in real time. The device initially is being tested for the continual monitoring of tissue and vascular viability in the feet of diabetics. Diabetes can cause peripheral artery disease and peripheral neuropathy, putting patients at risk for foot ulcers.  

Q: What do you like most about working at BBI?
What’s most gratifying is that our technology has made a real difference for health care professionals. When pressure ulcer rates dropped to zero in hospital wards using the SEM Scanner, other hospitals took notice, and the momentum for the device has grown ever since. The bottom line is fewer people are getting pressure ulcers thanks to our technology, and that’s especially motivating.

Q: What is the biggest challenge you’ve faced working in wound prevention/wound management?
A: New approaches to detection and diagnosis are often met with skepticism, and this was initially the case with the SEM Scanner. But we’ve overcome the naysayers with solid evidence that the device is effective and that hospitals using it have achieved significant savings in pressure ulcer treatment costs.

Q: What is BBI’s next anticipated milestone?
A:  In the United States, BBI is working with the U.S. Food & Drug Administration to make the SEM Scanner available in 2016. The path to approval includes a multisite pivotal trial in up to 500 subjects that is expected to begin in early 2016.