Biomedical device innovation methodology: applications in biophotonics

Abstract

Abstract. The process of medical device innovation involves an iterative method that focuses on designing innovative, device-oriented solutions that address unmet clinical needs. This process has been applied to the field of biophotonics with many notable successes. Device innovation begins with identifying an unmet clinical need and evaluating this need through a variety of lenses, including currently existing solutions for the need, stakeholders who are interested in the need, and the market that will support an innovative solution. Only once the clinical need is understood in detail can the invention process begin. The ideation phase often involves multiple levels of brainstorming and prototyping with the aim of addressing technical and clinical questions early and in a cost-efficient manner. Once potential solutions are found, they are tested against a number of known translational factors, including intellectual property, regulatory, and reimbursement landscapes. Only when the solution matches the clinical need, the next phase of building a "to market" strategy should begin. Most aspects of the innovation process can be conducted relatively quickly and without significant capital expense. This white paper focuses on key points of the medical device innovation method and how the field of biophotonics has been applied within this framework to generate clinical and commercial success.

Challenges and opportunities in clinical translation of biomedical optical spectroscopy and imaging

“…Finally, innovation in any field, including OSI, is ultimately dependent on scientific and technological creativity, a spontaneous activity. However, translating this into clinical practice is a more managed process and this paper, as well as other recent publications [1][2][3] have attempted to layout some of the structure for this.…”

“…In considering the barriers to a new clinical technology being widely adopted, it is worth listing the multiple factors involved, some of which are common to consumer products while others are distinctly different and involve a much more diverse set of stakeholders, namely inventors, academic institutions and medical centers, investors, physicians, patients, health-care providers, and governments that need to be engaged at different stages. 2 The barriers include: scientific and technical, clinical, socio-economic, geographic, cultural and educational, as can be illustrated by a recent and striking example. Cervical cancer is a significant health-care problem worldwide but in particular, in the words of the World Health Organization, it is "an avoidable cause of death in sub-Saharan Africa," where the incidence is five times higher than in the USA and the death rate is nine times higher.…”

“…For example, a radiofrequency device 51 has already received FDA approval and is commercialized, which becomes a likely predicate device against which any new OSI device will be evaluated: note, this does not necessarily mean that a head-to-head clinical trial is required, but rather that the clinical performance of the OSI system (e.g., sensitivity and specificity for detecting positive margins) needs to be at least equivalent in terms of the intended use. Developing a clear regulatory strategy early in the translation process can help minimize the costs of obtaining governmental approval, as has been discussed by Beswick et al 2 • The technology is too "clunky," i.e., has poor ergonomics for use in the intended clinical environment, or has a poor user interface (e.g., complex, confusing, or delayed display of the data), or requires too much technical support in the clinic.…”

“…1 There is increasing recognition of the need to debate the opportunities and challenges in bringing biomedical technologies, including light-based approaches, from the concept stage through preclinical studies, clinical trials, commercialization, and into routine clinical adoption. [1][2][3] The focus of this paper is to consider the particular challenges and potential solutions for the translation of OSI into the clinic, either ex vivo (biofluids including blood, urine and saliva; tissue biopsies; cells) or in vivo (non-or minimally invasive probing in live patients). It will become clear that most biotechnologies face similar challenges in clinical translation, so that much of this discussion is equally applicable to nonoptical approaches.…”

“…It will become clear that most biotechnologies face similar challenges in clinical translation, so that much of this discussion is equally applicable to nonoptical approaches. 2 However, wherever possible we will use examples drawn from OSI to illustrate the issues and will also indicate throughout what challenges and opportunities are specific to these optical technologies.…”