26 Aug 2014
Joseph Schmitt of St Jude Medical believes entering new sectors is easier than ever, but planning is still the key.
Optical coherence tomography (OCT) is a good example, rapidly finding a path to market in ophthalmology thanks to its combination of features and a favorable match with clinical culture in that sector. But finding ways to commercialize it in other areas has proven a challenge.
Joseph Schmitt has first-hand experience of the issues involved, as CTO of LightLab Imaging before its acquisition by St. Jude Medical in 2010.
LightLab, originally co-founded by OCT pioneer Jim Fujimoto, applied OCT to the challenging task of catheter-based imaging inside cardiovascular systems as an aid to diagnosis and surgical treatment. Schmitt will discuss the hurdles involved and the particular story of LightLab Imaging at next month's Strategies in Biophotonics conference in Boston.
"In fields outside of ophthalmology, OCT has indeed struggled to find lucrative medical markets," commented Schmitt to Optics.org. "Although the origins of the difficulties are application-specific, there are several fundamental impediments that have become apparent to me over the years."
One is the healthcare environment in the US, where evidence of patient outcome benefits are insisted upon as justification for any increase in equipment costs or complexity. Here OCT has historically faced a problem, its benefits often considered either not compelling enough to bring about an overhaul of clinical practice, or requiring expensive large-patient trials to demonstrate - trials that may be risky or expensive for companies to fund.
"An example of this would be OCT-guided biopsies for cancer detection in several organ systems," said Schmitt. "The observed improvement has not thus far been compelling enough to justify the additional costs and complexity. On the other hand, biopsy replacement, or at least the proven ability to identify dysplasia unequivocally without excising tissue, would have more compelling value."
A second issue is the inherent concerns of medical-device companies about technologies requiring large capital equipment expenditures, especially if they are not supported by high-volume sales of disposable accessories, and most particularly those diagnostic technologies that are not coupled tightly with a common therapeutic procedure. Cheap and disposable therapeutic devices enjoy a much stronger demand.
In addition, the technical limitations of OCT itself are factors in soft tissue imaging, particularly its shallow penetration depth and lack of intrinsic contrast. This can be a hindrance when modern pathologies are best understood at the cellular-level and organ-level scales.
"Monitoring symptomatic lesion growth often requires imaging of the entire volume of a relatively large vascularized lesion, at least several millimeters, while screening for manifestations of very early pathologies usually requires sub-cellular imaging," Schmitt noted.
In LightLab's case, some of the application-specific hurdles involved in intravenous OCT included the difficulties of imaging in blood, which necessitated innovations in delivery devices and electro-optics; and proving the clinical utility in current coronary interventions, while convincing cardiologists to consider the potential benefits of more advanced imaging techniques.
Lower barriers - in the right markets
Against these issues, the ease of initial entry for a developer into the biophotonics sector has definitely become easier across the board. Assembling sufficient resources to found a company, hire a small number of employees and build a device prototype has become more straightforward, not least due to stimulus measures made available.
"Lower IP barriers, less equipment development risk, and wider availability of OCT experts have improved the situation," Schmitt said. "Also, the success stories of ophthalmic and intravascular OCT have given investors a bit more confidence to risk capital than in the past."
However, the inability of companies to connect the technology with a specific unmet clinical need has landed many companies in the no-man's land between the niche research market and the mainstream markets of clinical medicine. There is also the issue of what Schmitt diplomatically refers to as naive entrepreneurs and investors in the biophotonics field.>
"Most applications of OCT are suited to small research markets where they can make the most worthwhile contributions, rather than to high-profit-margin commercial applications," he commented.
The complex financial systems surrounding health care development all but ensure that some sectors are likely to continue posing a more stressful path than others, especially those applying diagnostic devices to procedures that receive low payments under the US Diagnosis Related Groups (DRG) system.
"In the new health care era, diagnostic equipment is unlikely to earn a special reimbursement; instead, costs must be absorbed into the DRG payment," Schmitt said. "If the cost of a diagnostic device consumes more than about 10 percent of the total DRG payment, it is unlikely to be used routinely. Therefore, expensive and complicated cardiovascular, spinal, and oncology procedures are likely to be the best candidates for application of expensive diagnostic devices."
Resist bells and whistles
LightLab's path eventually led to the acquisition by St. Jude Medical, where Schmitt is now Vice President, Advanced Technology.
The company's work on OCT in cardiovascular systems includes the Ilumien Optis platform, combining OCT with a measurement of artery obstruction via a parameter called fractional flow reserve. Ilumien Optis is designed to assist surgeons during coronary interventions and the placement of stents, and received FDA clearance for use in the US in October 2013.
From Schmitt's current perspective at St Jude, the lessons worth learning for biophotonics developers include:
"Concentrate on understanding the fundamental clinical needs. Resist the temptation to add bells and whistles that solve problems that are not sufficiently important to justify the use of expensive and complicated technologies. And try to find the simplest and most elegant approach to providing or guiding therapy in a way that improves effectiveness or lowers cost. Disposable therapeutic devices that integrate sensors or imaging devices are an emerging opportunity."
About the Author
Tim Hayes is a contributor to Optics.org