Novascan marginscan™ preclinical trial prototype Development
NovaScan is developing technologies that improve the detection and stratification of cancer, including initial detection, during procedures, and for post-procedural pathology. Their goal is to improve patient outcomes, increase physician economics, and reduce the cost of care. NovaScan’s first product, MarginScan™ Skin, offers dermatologists the ability to screen patient tissue samples quickly and accurately.
NovaScan considered various medical device development companies to assist with the design development effort before retaining Design Integrity in Chicago to collaborate on exploratory development work on the MarginScan™ device.
Early stage prototypes of key subsystems were prototyped and tested, and the work culminated with the design and fabrication of two preclinical test prototypes that allowed NovaScan to run multiple successful trials with prototype MarginScan™ devices.
Challenge
NovaScan had been performing early stage research and development work on the underlying technology, impedence, in an effort to accurately and reliably detect the presence of cancer cells in human tissue. Impedance has long history in the field of cancer detection, with decidedly mixed results.
Impedance calculations are mathematically complex with real and imaginary components, and values vary with the presence of cancer but they vary with mass and other variables, as well. Prior academic research and initial NovaScan MarginScan™ prototypes displayed promising results, but technical challenges prevented the team, initially, from reaching target performance levels.
Technology Development
During preliminary research efforts, NovaScan team members identified a key parameter, the Cole relaxation frequency (a derived electrical bioimpedance signature), which varies by several orders of magnitude for cancerous and non-cancerous tissue. The Cole relaxation frequency does not vary with mass, and there is virtually no overlap between cancerous and benign tissue.
NovaScan recently combined Cole frequency assessments with machine learning on other elements of spectral impedance to further improve accuracy on their system. The result is a broadly applicable, extremely accurate platform solution for cancer detection that is low in cost and not constrained by equipment size.
Proof-of-Concept Prototype
In parallel with the core impedance technology development, the physical device required extensive ideation, R&D, prototyping, and testing to arrive upon the target performance requirements. The talented NovaScan team led the effort with a handful of consultants, and their development work, including some outside-the-box thinking, resulted in a simple yet truly innovative and elegant design solution one of the key technical challenges.
Design Integrity was asked to develop a proof-of-concept prototype of the new system layout. The device was designed with SolidWorks 3D CAD software with a CNC machined aluminum frame. The electronic, mechanical, and electro-mechanical components were mounted to the base plate and frame.
The proof-of-concept prototype worked flawlessly. It was lauded by the NovaScan for its simplicity, performance and durability. On the proof-of-concept prototype, no side panels were added to enclose the device, which left the internals open for easy access and adjustment.
Preclinical Test Prototypes
Following the successful testing of the proof-of-concept benchtop prototype, NovaScan asked Design Integrity to develop the second generation prototype MarginScan™ device, which was intended for preclinical testing. The goals were to reduce the weight, develop an initial design concept for the housing, shrink the overall size, and implement measures to prevent or limit liquid ingress.
Two preclinical trial prototypes were fabricated, assembled, calibrated and tested at Design Integrity’s facility in Chicago. The prototypes were delivered to NovaScan for review and assessment prior to preclinical testing.
Successful Preclinical Testing
The two preclinical test prototypes of the MarginScan™ device performed well during multiple test iterations. The project was a huge success, and NovaScan is now making further progress with their technology and the development of devices for multiple applications across their target markets.
Advancements to Technology
During NovaScan’s research, development and testing efforts, the team at NovaScan discovered that NovaScan’s core technology shows promise in its ability to predict the likelihood of the aggressiveness and predisposition for metastasis. In this context, it acts as a point of care genetic test that can be applied broadly.
Ongoing Development at NovaScan
At its core, NovaScan’s Cole relaxation frequency measurement technology is a platform that can be used to instantaneously detect a wide variety of cancerous conditions (ex vivo and in vivo) without expensive capital equipment. The core technology has a number of advantages over alternative technologies, including size, sensitivity, specificity, speed, and cost.
Last year, NovaScan announced the launch of a collaboration with PHC Corporation, formerly the biomedical division of Panasonic Healthcare, to explore the feasibility of the MarginScan™ device to help enable real-time margin detection of non-melanoma skin cancers (NMSC), which are the most common cancers in the world. One of the proposed uses of MarginScanTM is the support of Mohs surgery procedures for skin cancer treatment, among other ex vivo and in vivo applications.
PHC CORPORATION (FORMERLY THE BIOMEDICAL DIVISION OF PANASONIC HEALTHCARE)
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