OSTEOCHEX

Osteoporosis is a common metabolic disease categorized by decreased bone mass and increased liability to fractures. It is one of the silent alarming diseases worldwide that may be a considerable cause for morbidity and disability, also for mortality in aged patients thereby increases economic burden on the health care systems. The bone mineral density test gives a picture of our bone health. DXA is the commonly used method to diagnose osteoporosis. It has limitations such as: lack of standardization in bone and soft tissue measurements, large inconsistencies in measurements obtained on instruments from the manufacturers of DXA machines, high machine cost, need of expert personnel’s to perform the scan. Furthermore, for a given manufacturer, results vary by the model of the instrument, the mode of operation or the version of the software used to analyze the data. A male normative database is used for T-score calculation that makes diagnosis of osteoporosis controversial.DXA is not suitable for the bone density measurement in pediatrics. DXA scan images are only for the confirmation of correct positioning of the patient and correct placement of the regions of interest (ROI). This project can propose to develop a portable, low cost X-ray device for the measurement of BMD, T-score, and Zscore from the X-ray images to detect the osteoporosis condition accurately similar to a DEXA machine.

Osteoporosis is one of the pandemic diseases that affect people aged above 50. Osteoporosis is diagnosed by performing bone mineral density test. There are various methods to evaluate the bone mineral density. The gold standard method is the DEXA (Dual Energy X-ray Absorptiometry) scan. But it has certain limitations such as high machine cost, high scan cost, inconsistencies in databases among various manufacturers; expert personnel needed to perform the scan and it is not widely available in developing countries like India. Furthermore, for a given manufacturer, results may vary by the model of the instrument, the mode of operation or the version of the software used to analyze the data. Thus, our work is to develop an automatic handheld device that uses to evaluate the bone mineral density and classify fracture risk in human bones by providing a decision support system based on digitized X-ray images at low cost.

The main objectives of this proposal are as follows:

To develop a simple, low cost, accurate, handheld device to measure bone mineral density(BMD) for the early diagnosis of Osteoporosis.

To develop a software phase which involves, applying image processing algorithms for preprocessing and segmentation of region of interest, followed by the calculation of BMD.

To design a hardware which involves design of proposed device with a processor where the software is interfaced and the results will be displayed on a LCD display.

The solution of a low-cost portable bone mineral density (BMD) device for osteoporosis detection serves a wide demographic, particularly those in underserved communities, elderly individuals, and individuals at risk of osteoporosis due to factors like aging, hormonal changes, or certain medications. This device democratizes access to early detection and monitoring of osteoporosis, empowering individuals to take proactive steps in managing their bone health. By providing a portable and affordable option, it enables healthcare providers to conduct screenings in various settings, from community health centers to remote areas, facilitating early intervention and reducing the burden of late-stage osteoporosis complications. Ultimately, this solution promises to enhance the quality of life for those susceptible to osteoporosis by enabling timely diagnosis and tailored treatment plans, thus minimizing the risk of fractures and associated health complications.

Our team comprising experts in biomedical engineering, software development, and healthcare delivery, ensuring that we have the necessary skill sets to address the technical complexities of device development and also experience in designing and prototyping medical devices, conducting clinical research, and navigating regulatory pathways, providing valuable insights and guidance throughout the project lifecycle. By harnessing our collective expertise, passion, and resources, we are well-positioned to deliver a solution that has the potential to make a meaningful impact on global bone health

We have already conducted initial research and development to conceptualize the low-cost portable BMD (Bone Mineral Density) device for osteoporosis detection. At this stage, we are ready to transition from conceptualization to tangible product development by building functional prototypes. Prototyping allows us to validate our design concepts, test key functionalities, and identify areas for improvement before moving into full-scale production. By focusing on prototyping, we can refine the device's design, optimize its performance, and ensure that it meets the needs and expectations of end-users, healthcare providers, and other stakeholders.

Early detection allows for timely intervention and management to prevent further bone loss, reduce the risk of fractures, and improve overall bone health. By identifying individuals with osteoporosis or those at risk, healthcare professionals can implement appropriate treatment strategies such as medication, lifestyle modifications, and dietary changes to help maintain bone density and reduce the risk of fractures. Early detection and intervention can significantly improve the quality of life for individuals affected by osteoporosis and reduce healthcare costs associated with fractures and complications. In order to overcome technological, legal, and commercial obstacles while expanding, we look for Solve help. Having access to capital, knowledge, and collaborations will help us refine our solution and make sure it is successfully implemented, which will improve the health outcomes for mothers and children in the long run.

Innovativeness of the Proposed Solution:

1. Computer based system in health care environment for diagnosis of bone fracture risk at early stage will prove to be very effective.
2. We expect that our proposed system will provide accurate classification and segmentation of osteoporosis region in X-ray images using benchmark image processing algorithms. This supports the physician to provide appropriate treatment based on segmented region of interest.
3. If we achieve the above outcomes, we submit this simple image analysis system for bone abnormality detection to the medical hospitals and scanning centers through our medical experts and also submit this image analysis system to the hospitals in rural areas as our proposed simple image analysis system for bone abnormality detection is affordable to rural people who are not economically well. This can be done through our medical experts.
4. As this system is economically affordable to all, definitely it will be commercially viable to make profit.

Our impact goals for the low-cost portable BMD device for osteoporosis detection are multifaceted. Our aim for Osteochex is to improve access to osteoporosis screening, particularly in underserved communities where traditional BMD testing may not be readily available due to cost or infrastructure limitations. We strive to enhance early detection rates, thereby reducing the incidence of fractures and associated morbidity and mortality. Additionally, we aim to empower individuals to take proactive steps towards bone health management through accessible and convenient screening tools. To measure our progress towards these goals, we employ both quantitative and qualitative metrics. Quantitatively, we track the number of devices deployed, screenings conducted, and subsequent interventions initiated based on screening results. Qualitatively, we gather feedback from healthcare providers and patients to assess the device's usability, impact on clinical decision-making, and overall satisfaction. By continuously evaluating these metrics, we ensure that our solution effectively addresses the unmet needs in osteoporosis detection and management.

The present invention shall disclose a simple and cost effective X-ray BMD meter for the measurement of Bone Mineral Density in turn detects the Osteoporosis condition.

Hardware Implementation of X-ray Device:

• The proposed system consists of Analog X-ray system in a compact, simple design.
• High-quality exposures are retrieved with a single charge.
• Motors and oversized casters are used for various movements.
• Microprocessor based system is used for simplicity of design.
• Compact manual Collimator

Software Implementation:

The proposed method involves the use of appropriate filter for pre-processing the X-ray images. The second process involves the segmentation process which uses Deep Convolutional Neural Networks. Segmentation algorithm extracts the bone parts accurately from the X-ray images. BMD is the measure of calcium content in the bone. If the calcium content in our bone is low then the bone is said to be osteoporosis based on the values of BMD and T-Score.

According to World Health Organization statistics,

i.    If the T-Score is -1and above, the bone is said to be normal.

ii.   If the T-Score is between -1&-2.5, the bone is said to be osteopenia.

iii.  If the T-Score is -2.5 and below, the bone is said to be osteoporosis. 

Model of the proposed device for measuring BMD and T-score:

A linear regression equation is defined for the estimation of BMD as:

                      Estimated BMD = 0.0035 *X + 0.032

where X is the Mean ± SD of the filtered or segmented Image.

T score is calculated by the standard formula. The T-Score definition used here is the standard definition used for the estimation of T-Score.

Where Estimated BMD is the calculated BMD,   Reference BMD  is the standard BMD based on the age factor and SD is the standard deviation of the Image. 

6 Full-time Workers,

4 Part-time Workers

2 years

We ensure diversity in our team composition, actively seeking individuals with varied backgrounds, experiences, and perspectives to foster innovation and creativity. we conduct thorough research to understand the diverse needs and challenges of the populations we aim to serve, including marginalized communities and those with limited access to healthcare resources. This informs the design process, ensuring that the device is user-friendly, culturally sensitive, and accessible to individuals of all backgrounds and abilities. we are committed to ensuring equitable access to the device by exploring affordability options, such as subsidized pricing models or partnerships with healthcare providers and insurers to facilitate reimbursement. Overall, our approach prioritizes inclusivity, accessibility, and equity to ensure that the low-cost portable BMD device effectively addresses the needs of diverse populations, contributing to improved health outcomes and reduced disparities in osteoporosis detection and management.

• Product Sales: We generate revenue by selling the BMD device to healthcare facilities, clinics, and individual practitioners.
• Subscription Services: We offer subscription-based services that provide ongoing support, maintenance, and updates for the device.
• Licensing Agreements: We establish licensing agreements with healthcare institutions, research organizations, and other relevant stakeholders to use our technology in clinical trials, research studies, and other applications. These agreements generate revenue through licensing fees and royalties.           

Our plan for financial sustainability involves to offer the device at a competitive price point, leveraging economies of scale and efficient manufacturing processes to keep production costs low. We also plan to explore partnerships with healthcare providers and government agencies to secure reimbursement for screenings conducted with our device. We aim to offer subscription-based models for ongoing support and updates, as well as licensing agreements for use in clinical settings.