Matthew Perry

(HS)2 BioMEMS (Biological, Micro-electromechanical Engineered Systems) Ecosystem of SMART Systems, Devices & IOT Background: BioMEMS-Biomedical/Biological, Microelectromechanical Systems, otherwise known as biological micro-machines, is a vast and burgeoning area of biomedical engineering and biomedical device R&D and manufacturing. FedMatrix has thoroughly invested in this area with senior subject matter expertise and R&D infrastructure and is beginning to position and distinguish themselves as a true innovative leader by designing disruptive, integrated BioMEMS platforms, systems and devices that add value realization and transformation to any healthcare and life sciences organization. Figure 1-2:-Diagrams for Classification of BioMEMS Systems and Devices Introduction: FedMatrix initial entry into the BioMEMS market is through the design of their SOBER (SMART Opioid Biosensor Ecosystem for Rehabilitation) Methodology and platform. Biosensors are devices that consist of a biological recognition system, called the bioreceptor, and a transducer. The interaction of the analyte with the bioreceptor causes an effect that the transducer can convert into a measurement, such as an electrical signal. The most common bioreceptors used in biosensing are based on antibody–antigen interactions, nucleic acid interactions, enzymatic interactions, cellular interactions, and interactions using biomimetic materials. Common transducer techniques include mechanical detection, electrical detection, and optical detection (HS)2 Integrated (7) BioMEMS Solutions Ecosystem 1).Biosensor-IOT (Immunosensors/Nanobiosensors): The SOBER Solution consists of their SMARTMetaboLite Opioid IOT Ecosystem. This platform consists of 3 main components, 1).the SMARTMetaboLite Opioid Implantable Biosensor IOT, 2). the SMARTMetaboLite Opioid Ingestible Biosensor IOT and 3). the SMARTMetaboLite Opioid IOT Ecosystem, which together formulate an impenetrable system of SMART in vivo diagnostic tools, data analytics and visualization applications, interventions, alerts and maintenance solutions all in real-time so that the patient and provider both can focus on and commit to 100% medication/treatment adherence, trust that they have a secure fail-safe system that will result in 100% compliance to treatment programs/facilities. (HS)2 BioMEMS (Biological, Micro-electromechanical Engineered Systems) Ecosystem of SMART Systems, Devices & IOT Figure 3-4: (HS)2 Immunosensor Array for Opioid/Controlled Substances (HS)2 also has other BioMEMS systems, devices and tools in their upcoming R&D pipeline. The following are other classes of BioMEMS that are in high demand within the global healthcare and life sciences industry: The next-generation or 3rd generation of BioMEMS and Biosensors will incorporate SMART/Intelligent, Adaptive, converged, Integrated, Networked biomimetic, bioelectrical, biomagnetic, biophotonic, biooptical and biophysical micro-Devices and systems that are automated, enabled, governed, optimized and powered and by Biological, Evolutionary and Cognitive-AI/ML Data Science-Driven Semantic Computational Informatics/Data Systems, Technologies, Algorithms, Architectures, Data Models, Ontologies, Toolkits and Workflows. The example of this class of evolutionary systems is our design of the Homeostatic Immuno-Nanosensor (ImmunoNEMS). This biological microsystem ecosystem can be deployed either via an implant (subcutaneous microinjection system) or as an indigestible (HS)2 Ingestible Bioelectronic SMART capsule (Ingestible/Electroceuticals/Bioelectronic Medicine). The system utilized a confluence of bio-surveillance, detection, measuring, monitoring technologies designed for immunological homeostatic bioregulation. It’s powered by bio- photonic, electromagnetic, optical and energetic systems that are distributed and networked. The ImmunoNEMS are also called angio, cyto, hemo, immuno and neurogenicity. (HS)2 BioMEMS (Biological, Micro-electromechanical Engineered Systems) Ecosystem of SMART Systems, Devices & IOT 2). Microfluidic (Nanofluidic) Lab-on-Chip (LOC’s or BioChip’s): is a device that integrates one or several laboratory functions on a single integrated circuit (mm to cm) to achieve automation and high-throughput screening. LOCs may use microfluidics, the physics, manipulation and study of minute amounts of fluids. However, strictly regarded "lab-on-a-chip" indicates generally the scaling of single or multiple lab processes down to chip-format. The interdisciplinary nature of BioMEMS combines material sciences, clinical sciences, medicine, surgery, electrical engineering, mechanical engineering, optical engineering, chemical engineering, and biomedical engineering. Some of its major applications include genomics, proteomics, molecular diagnostics, point-of-care diagnostics, tissue engineering, single cell analysis and implantable micro-devices (HS)2 SMART Controlled Substances Lab-On-Chip). Figure 5-Microfuidic Real-time PCR BioMEMS System Diagram 3). Diagnostic BioMEMS: Genomic and Proteomic Microarrays are to make high-throughput genome analysis faster and cheaper, as well as identify activated genes and their sequences.There are many different types of biological entities used in microarrays, but in general the microarray consists of an ordered collection of microspots each containing a single defined molecular species that interacts with the analyte for simultaneous testing of thousands of parameters in a single experiment. Some applications of genomic and proteomic microarrays are neonatal screening, identifying disease risk, and predicting therapy efficacy for Personalized, P4 Medicine (which (HS)2 has built a proprietary P4Medicine platform that combines Diagnostic BioMEMS (Omics) with microfluidics, as well as, predictive analytics and collective medical intelligence and cognitive computing/neuromapping) 4). Point-of-Care Diagnostic BioMEMS: The ability to perform medical diagnosis at the bedside or at the point-of-care is important in health care, especially in developing countries where access to centralized hospitals is limited and prohibitively expensive. To this end, point-of-care diagnostic BioMEMS have been developed to take saliva, blood, or urine samples and in an integrated approach perform sample preconditioning, sample fractionation, signal amplification, analyte detection, data (HS)2 BioMEMS (Biological, Micro-electromechanical Engineered Systems) Ecosystem of SMART Systems, Devices & IOT analysis, and result display. In particular, blood is a very common biological sample and its contents are a very good Predictive indicator of good health/homeostasis. 5). BioMEMS for Stem Cell Nan-bioengineering: The goal of stem cell engineering is to be able to control the differentiation and self-renewal of pluripotency stem cells for cell therapy. Differentiation in stem cells is dependent on many factors, including soluble and biochemical factors, fluid shear stress, cell-ECM interactions, cell-cell interactions, as well as embryoid body formation and organization. BioMEMS have been used to research how to optimize the culture and growth conditions of stem cells by controlling these factors. Assaying stem cells and their differentiated progeny is done with microarrays for studying how transcription factors and miRNAs determine cell fate, how epigenetic modifications between stem cells and their daughter cells affect phenotypes, as well as measuring and sorting stem cells by their protein expression. 6). BioMEMS SMART Nanodrug Delivery Systems: Microneedles, formulation systems, and implantable systems are BioMEMS applicable to drug delivery. Microneedles of approximately 100µm can penetrate the skin barrier and deliver drugs to the underlying cells and interstitial fluid with reduced tissue damage, reduced pain, and no bleeding. Microneedles can also be integrated with microfluidics for automated drug loading or multiplexing. From the user standpoint, microneedles can be incorporated into a patch format for self-administration, and do not constitute a sharp waste biohazard (if the material is polymeric). Drug delivery by microneedles include coating the surface with therapeutic agents, loading drugs into porous or hollow microneedles for maximum drug loading. Microneedles for blood extraction, and gene delivery are also being developed. Figure 6-Microneedle Diagram for SMART, Targeted Drug Delivery (HS)2 BioMEMS (Biological, Micro-electromechanical Engineered Systems) Ecosystem of SMART Systems, Devices & IOT 7). BioMEMS for SMART Nanosurgical Devices: Bio-MEMS for surgical applications can improve existing functionality, add new capabilities for surgeons to develop new techniques and procedures, and improve surgical outcomes by lowering risk and providing real-time feedback during the operation.Micro-machined surgical tools such as tiny forceps, microneedle arrays and tissue debriders have been made possible by metal and ceramic layer-by-layer microfabrication techniques for minimally invasive surgery and robotic surgery. Incorporation of sensors onto surgical tools also allows tactile feedback for the surgeon, identification of tissue type via strain and density during cutting operations, and diagnostic catheterization to measure blood flows, pressures, temperatures, oxygen content, and chemical concentrations. Figure 7-Co2 SMART LASER Scalpel Surgical BioMEMS Diagram