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Archive for the ‘MEMS’ Category


Cancer Genomics: Multiomic Analysis of Single Cells and Tumor Heterogeneity

Curator: Stephen J. Williams, PhD

 

scTrio-seq identifies colon cancer lineages

Single-cell multiomics sequencing and analyses of human colorectal cancer. Shuhui Bian et al. Science  30 Nov 2018:Vol. 362, Issue 6418, pp. 1060-1063

To better design treatments for cancer, it is important to understand the heterogeneity in tumors and how this contributes to metastasis. To examine this process, Bian et al. used a single-cell triple omics sequencing (scTrio-seq) technique to examine the mutations, transcriptome, and methylome within colorectal cancer tumors and metastases from 10 individual patients. The analysis provided insights into tumor evolution, linked DNA methylation to genetic lineages, and showed that DNA methylation levels are consistent within lineages but can differ substantially among clones.

Science, this issue p. 1060

Abstract

Although genomic instability, epigenetic abnormality, and gene expression dysregulation are hallmarks of colorectal cancer, these features have not been simultaneously analyzed at single-cell resolution. Using optimized single-cell multiomics sequencing together with multiregional sampling of the primary tumor and lymphatic and distant metastases, we developed insights beyond intratumoral heterogeneity. Genome-wide DNA methylation levels were relatively consistent within a single genetic sublineage. The genome-wide DNA demethylation patterns of cancer cells were consistent in all 10 patients whose DNA we sequenced. The cancer cells’ DNA demethylation degrees clearly correlated with the densities of the heterochromatin-associated histone modification H3K9me3 of normal tissue and those of repetitive element long interspersed nuclear element 1. Our work demonstrates the feasibility of reconstructing genetic lineages and tracing their epigenomic and transcriptomic dynamics with single-cell multiomics sequencing.

Fig. 1 Reconstruction of genetic lineages with scTrio-seq2.

Global SCNA patterns (250-kb resolution) of CRC01. Each row represents an individual cell. The subclonal SCNAs used for identifying genetic sublineages were marked and indexed; for details, see fig. S6B. On the top of the heatmap, the amplification or deletion frequency of each genomic bin (250 kb) of the non-hypermutated CRC samples from the TCGA Project and patient CRC01’s cancer cells are shown.

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Fig. 1 Reconstruction of genetic lineages with scTrio-seq2.

Global SCNA patterns (250-kb resolution) of CRC01. Each row represents an individual cell. The subclonal SCNAs used for identifying genetic sublineages were marked and indexed; for details, see fig. S6B. On the top of the heatmap, the amplification or deletion frequency of each genomic bin (250 kb) of the non-hypermutated CRC samples

 

 

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Use of 3D Bioprinting for Development of Toxicity Prediction Models

Curator: Stephen J. Williams, PhD

SOT FDA Colloquium on 3D Bioprinted Tissue Models: Tuesday, April 9, 2019

The Society of Toxicology (SOT) and the U.S. Food and Drug Administration (FDA) will hold a workshop on “Alternative Methods for Predictive Safety Testing: 3D Bioprinted Tissue Models” on Tuesday, April 9, at the FDA Center for Food Safety and Applied Nutrition in College Park, Maryland. This workshop is the latest in the series, “SOT FDA Colloquia on Emerging Toxicological Science: Challenges in Food and Ingredient Safety.”

Human 3D bioprinted tissues represent a valuable in vitro approach for chemical, personal care product, cosmetic, and preclinical toxicity/safety testing. Bioprinting of skin, liver, and kidney is already appearing in toxicity testing applications for chemical exposures and disease modeling. The use of 3D bioprinted tissues and organs may provide future alternative approaches for testing that may more closely resemble and simulate intact human tissues to more accurately predict human responses to chemical and drug exposures.

A synopsis of the schedule and related works from the speakers is given below:

 

8:40 AM–9:20 AM Overview and Challenges of Bioprinting
Sharon Presnell, Amnion Foundation, Winston-Salem, NC
9:20 AM–10:00 AM Putting 3D Bioprinting to the Use of Tissue Model Fabrication
Y. Shrike Zhang, Brigham and Women’s Hospital, Harvard Medical School and Harvard-MIT Division of Health Sciences and Technology, Boston, MA
10:00 AM–10:20 AM Break
10:20 AM–11:00 AM Uses of Bioprinted Liver Tissue in Drug Development
Jean-Louis Klein, GlaxoSmithKline, Collegeville, PA
11:00 AM–11:40 AM Biofabrication of 3D Tissue Models for Disease Modeling and Chemical Screening
Marc Ferrer, National Center for Advancing Translational Sciences, NIH, Rockville, MD

Sharon Presnell, Ph.D. President, Amnion Foundation

Dr. Sharon Presnell was most recently the Chief Scientific Officer at Organovo, Inc., and the President of their wholly-owned subsidiary, Samsara Sciences. She received a Ph.D. in Cell & Molecular Pathology from the Medical College of Virginia and completed her undergraduate degree in biology at NC State. In addition to her most recent roles, Presnell has served as the director of cell biology R&D at Becton Dickinson’s corporate research center in RTP, and as the SVP of R&D at Tengion. Her roles have always involved the commercial and clinical translation of basic research and early development in the cell biology space. She serves on the board of the Coulter Foundation at the University of Virginia and is a member of the College of Life Sciences Foundation Board at NC State. In January 2019, Dr. Presnell will begin a new role as President of the Amnion Foundation, a non-profit organization in Winston-Salem.

A few of her relevant publications:

Bioprinted liver provides early insight into the role of Kupffer cells in TGF-β1 and methotrexate-induced fibrogenesis

Integrating Kupffer cells into a 3D bioprinted model of human liver recapitulates fibrotic responses of certain toxicants in a time and context dependent manner.  This work establishes that the presence of Kupffer cells or macrophages are important mediators in fibrotic responses to certain hepatotoxins and both should be incorporated into bioprinted human liver models for toxicology testing.

Bioprinted 3D Primary Liver Tissues Allow Assessment of Organ-Level Response to Clinical Drug Induced Toxicity In Vitro

Abstract: Modeling clinically relevant tissue responses using cell models poses a significant challenge for drug development, in particular for drug induced liver injury (DILI). This is mainly because existing liver models lack longevity and tissue-level complexity which limits their utility in predictive toxicology. In this study, we established and characterized novel bioprinted human liver tissue mimetics comprised of patient-derived hepatocytes and non-parenchymal cells in a defined architecture. Scaffold-free assembly of different cell types in an in vivo-relevant architecture allowed for histologic analysis that revealed distinct intercellular hepatocyte junctions, CD31+ endothelial networks, and desmin positive, smooth muscle actin negative quiescent stellates. Unlike what was seen in 2D hepatocyte cultures, the tissues maintained levels of ATP, Albumin as well as expression and drug-induced enzyme activity of Cytochrome P450s over 4 weeks in culture. To assess the ability of the 3D liver cultures to model tissue-level DILI, dose responses of Trovafloxacin, a drug whose hepatotoxic potential could not be assessed by standard pre-clinical models, were compared to the structurally related non-toxic drug Levofloxacin. Trovafloxacin induced significant, dose-dependent toxicity at clinically relevant doses (≤ 4uM). Interestingly, Trovafloxacin toxicity was observed without lipopolysaccharide stimulation and in the absence of resident macrophages in contrast to earlier reports. Together, these results demonstrate that 3D bioprinted liver tissues can both effectively model DILI and distinguish between highly related compounds with differential profile. Thus, the combination of patient-derived primary cells with bioprinting technology here for the first time demonstrates superior performance in terms of mimicking human drug response in a known target organ at the tissue level.

A great interview with Dr. Presnell and the 3D Models 2017 Symposium is located here:

Please click here for Web based and PDF version of interview

Some highlights of the interview include

  • Exciting advances in field showing we can model complex tissue-level disease-state phenotypes that develop in response to chronic long term injury or exposure
  • Sees the field developing a means to converge both the biology and physiology of tissues, namely modeling the connectivity between tissues such as fluid flow
  • Future work will need to be dedicated to develop comprehensive analytics for 3D tissue analysis. As she states “we are very conditioned to get information in a simple way from biochemical readouts in two dimension, monocellular systems”  however how we address the complexity of various cellular responses in a 3D multicellular environment will be pertinent.
  • Additional challenges include the scalability of such systems and making such system accessible in a larger way
  1. Shrike Zhang, Brigham and Women’s Hospital, Harvard Medical School and Harvard-MIT Division of Health Sciences and Technology

Dr. Zhang currently holds an Assistant Professor position at Harvard Medical School and is an Associate Bioengineer at Brigham and Women’s Hospital. His research interests include organ-on-a-chip, 3D bioprinting, biomaterials, regenerative engineering, biomedical imaging, biosensing, nanomedicine, and developmental biology. His scientific contributions have been recognized by >40 international, national, and regional awards. He has been invited to deliver >70 lectures worldwide, and has served as reviewer for >400 manuscripts for >30 journals. He is serving as Editor-in-Chief for Microphysiological Systems, and Associate Editor for Bio-Design and Manufacturing. He is also on Editorial Board of BioprintingHeliyonBMC Materials, and Essays in Biochemistry, and on Advisory Panel of Nanotechnology.

Some relevant references from Dr. Zhang

Multi-tissue interactions in an integrated three-tissue organ-on-a-chip platform.

Skardal A, Murphy SV, Devarasetty M, Mead I, Kang HW, Seol YJ, Shrike Zhang Y, Shin SR, Zhao L, Aleman J, Hall AR, Shupe TD, Kleensang A, Dokmeci MR, Jin Lee S, Jackson JD, Yoo JJ, Hartung T, Khademhosseini A, Soker S, Bishop CE, Atala A.

Sci Rep. 2017 Aug 18;7(1):8837. doi: 10.1038/s41598-017-08879-x.

 

Reconstruction of Large-scale Defects with a Novel Hybrid Scaffold Made from Poly(L-lactic acid)/Nanohydroxyapatite/Alendronate-loaded Chitosan Microsphere: in vitro and in vivo Studies.

Wu H, Lei P, Liu G, Shrike Zhang Y, Yang J, Zhang L, Xie J, Niu W, Liu H, Ruan J, Hu Y, Zhang C.

Sci Rep. 2017 Mar 23;7(1):359. doi: 10.1038/s41598-017-00506-z.

 

 

A liver-on-a-chip platform with bioprinted hepatic spheroids.

Bhise NS, Manoharan V, Massa S, Tamayol A, Ghaderi M, Miscuglio M, Lang Q, Shrike Zhang Y, Shin SR, Calzone G, Annabi N, Shupe TD, Bishop CE, Atala A, Dokmeci MR, Khademhosseini A.

Biofabrication. 2016 Jan 12;8(1):014101. doi: 10.1088/1758-5090/8/1/014101.

 

Marc Ferrer, National Center for Advancing Translational Sciences, NIH

Marc Ferrer is a team leader in the NCATS Chemical Genomics Center, which was part of the National Human Genome Research Institute when Ferrer began working there in 2010. He has extensive experience in drug discovery, both in the pharmaceutical industry and academic research. Before joining NIH, he was director of assay development and screening at Merck Research Laboratories. For 10 years at Merck, Ferrer led the development of assays for high-throughput screening of small molecules and small interfering RNA (siRNA) to support programs for lead and target identification across all disease areas.

At NCATS, Ferrer leads the implementation of probe development programs, discovery of drug combinations and development of innovative assay paradigms for more effective drug discovery. He advises collaborators on strategies for discovering small molecule therapeutics, including assays for screening and lead identification and optimization. Ferrer has experience implementing high-throughput screens for a broad range of disease areas with a wide array of assay technologies. He has led and managed highly productive teams by setting clear research strategies and goals and by establishing effective collaborations between scientists from diverse disciplines within industry, academia and technology providers.

Ferrer has a Ph.D. in biological chemistry from the University of Minnesota, Twin Cities, and completed postdoctoral training at Harvard University’s Department of Molecular and Cellular Biology. He received a B.Sc. degree in organic chemistry from the University of Barcelona in Spain.

 

Some relevant references for Dr. Ferrer

Fully 3D Bioprinted Skin Equivalent Constructs with Validated Morphology and Barrier Function.

Derr K, Zou J, Luo K, Song MJ, Sittampalam GS, Zhou C, Michael S, Ferrer M, Derr P.

Tissue Eng Part C Methods. 2019 Apr 22. doi: 10.1089/ten.TEC.2018.0318. [Epub ahead of print]

 

Determination of the Elasticity Modulus of 3D-Printed Octet-Truss Structures for Use in Porous Prosthesis Implants.

Bagheri A, Buj-Corral I, Ferrer M, Pastor MM, Roure F.

Materials (Basel). 2018 Nov 29;11(12). pii: E2420. doi: 10.3390/ma11122420.

 

Mutation Profiles in Glioblastoma 3D Oncospheres Modulate Drug Efficacy.

Wilson KM, Mathews-Griner LA, Williamson T, Guha R, Chen L, Shinn P, McKnight C, Michael S, Klumpp-Thomas C, Binder ZA, Ferrer M, Gallia GL, Thomas CJ, Riggins GJ.

SLAS Technol. 2019 Feb;24(1):28-40. doi: 10.1177/2472630318803749. Epub 2018 Oct 5.

 

A high-throughput imaging and nuclear segmentation analysis protocol for cleared 3D culture models.

Boutin ME, Voss TC, Titus SA, Cruz-Gutierrez K, Michael S, Ferrer M.

Sci Rep. 2018 Jul 24;8(1):11135. doi: 10.1038/s41598-018-29169-0.

A High-Throughput Screening Model of the Tumor Microenvironment for Ovarian Cancer Cell Growth.

Lal-Nag M, McGee L, Guha R, Lengyel E, Kenny HA, Ferrer M.

SLAS Discov. 2017 Jun;22(5):494-506. doi: 10.1177/2472555216687082. Epub 2017 Jan 31.

 

Exploring Drug Dosing Regimens In Vitro Using Real-Time 3D Spheroid Tumor Growth Assays.

Lal-Nag M, McGee L, Titus SA, Brimacombe K, Michael S, Sittampalam G, Ferrer M.

SLAS Discov. 2017 Jun;22(5):537-546. doi: 10.1177/2472555217698818. Epub 2017 Mar 15.

 

RNAi High-Throughput Screening of Single- and Multi-Cell-Type Tumor Spheroids: A Comprehensive Analysis in Two and Three Dimensions.

Fu J, Fernandez D, Ferrer M, Titus SA, Buehler E, Lal-Nag MA.

SLAS Discov. 2017 Jun;22(5):525-536. doi: 10.1177/2472555217696796. Epub 2017 Mar 9.

 

Other Articles on 3D Bioprinting on this Open Access Journal include:

Global Technology Conferences on 3D BioPrinting 2015 – 2016

3D Medical BioPrinting Technology Reporting by Irina Robu, PhD – a forthcoming Article in “Medical 3D BioPrinting – The Revolution in Medicine, Technologies for Patient-centered Medicine: From R&D in Biologics to New Medical Devices”

Bio-Inks and 3D BioPrinting

New Scaffold-Free 3D Bioprinting Method Available to Researchers

Gene Editing for Gene Therapies with 3D BioPrinting

 

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What could replace animal testing – ‘Human-on-a-chip’ from Lawrence Livermore National Laboratory

The iCHIP research, Moya said, could have implications for creating new drugs to fight cancer, vaccines or evaluating the efficacy of countermeasures against biowarfare agents.

Lab scientist Heather Enright is leading research into the peripheral nervous system (PNS), which connects the brain to the limbs and organs. The PNS device has arrays of microelectrodes embedded on glass, where primary human dorsal root ganglion (DRG) neurons are seeded. Chemical stimuli such as capsaicin (to study pain response) then flow through a microfluidic cap to stimulate the cells on the platform.

The microelectrodes record electrical signals from the cells, allowing researchers to determine how the cells are responding to the stimuli non-invasively. Microscopic images can be acquired at the same time to monitor changes in intracellular ion concentrations, such as calcium. This platform is the first to demonstrate that long-term culture and chemical interrogation of primary human DRG neurons on microelectrode arrays is possible, presenting researchers with an advantage over current techniques.

Read full article at the SOURCE

 

http://universityofcalifornia.edu/news/human-chip-could-replace-animal-testing

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Medical MEMS, BioMEMS and Sensor Applications

Curator and Reporter: Aviva Lev-Ari, PhD, RN

 

Contents for Chapter 11

Medical MEMS, BioMEMS and Sensors Applications

Curators: Justin D. Pearlman, MD, PhD, FACC, LPBI Group, Danut Dragoi, PhD, LPBI Group and William H. Zurn, Alpha IP

FOR

Series E: Patient-centered Medicine

Volume 4:  Medical 3D BioPrinting – The Revolution in Medicine

Editors: Larry H Bernstein, MD FCAP and Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/biomed-e-books/series-e-titles-in-the-strategic-plan-for-2014-1015/volume-four-medical-3d-bioprinting-the-revolution-in-medicine/

Work-in-Progress

ContactLens

Image Source

http://www.memsjournal.com/2010/05/medical-applications-herald-third-wave-of-mems.html

Image is courtesy of Google Images

 

WirelessPressure

Image Source

Stanford Engineering Team Invents Pressure Sensor That Uses Radio Waves | CytoFluidix

Image is courtesy of Google Images

 

Introduction by Dr. Pearlman

 

Chapter 1: Blood Glucose Sensors

1.1       MINIATURIZED GLUCOSE SENSOR – Google

  • Tiny wireless chip and miniaturized glucose sensor
  • Embedded between two layers of soft contact lens material
  • Accurate glucose monitoring for diabetics
  • Using bodily fluids, i.e. tears
  • Prototypes can generate one reading per second
  • Experimenting with LEDs
  • Early warning for the wearer

 

Chapter 2: Blood Chemistry Tests – up to 100 Samples

2.1       NON-INVASIVE BLOOD MONITOR- UCSD

  • Digital tattoo monitors blood below the skin
  • Tattoos are needle-less
    • Sensor-laden transdermal patch
  • Painless for the user Tiny sensors “ink”
  • Can read blood levels of:
    • Sodium, glucose, kidney function
  • Prototypes contain probes
  • Wireless, battery-powered chip
  • Continually test up to a hundred different samples

 

2.3       CELLPHONE-BASED RAPID-DIAGNOSTIC-TEST (RDT) READER – UCLA

  • Lateral flow immuno-chromatographic assays
  • Sense the presence of a target analyte in a sample
  • Device connects to the camera on a cell phone
  • Weighs only 65 grams

 

2.4       IMPLANTABLE BLOOD ANALYZER CHIP – EPFL

  • Implantable device for instantaneous blood analysis
  • Wireless data transmission to a doctor
  • Applications include monitoring general health
  • Tailor drug delivery to a patient’s unique needs
  • Includes five sensors and a radio transmitter
  • Powered via inductive coupling from a battery patch
  • Worn outside the body

 

Chapter 3: Motion Sensors for Head-Impact

3.1       HEAD-IMPACT MONITORING PATCH – STMicro & X2Biosystems

  • Wearable electronic contains MEMS motion sensors
  • Microcontroller, low-power radio transmitter, and power management circuitry
  • Cloud-based system combines athlete concussion history
  • Pre-season neurocognitive function, balance, and coordinate-performance data
  • Creates a baseline for comparison after a suspected injury event

 

Chapter 4: Drug Delivery & Drug Compliance Monitoring Systems

4.1       Smart Pill delivers Therapeutic Agent Load to target – ELECTRONIC PILL – Phillips

  • Electronic pill to treat gastrointestinal cancer
  • An ingestible pill is swallowed by the patient, finds its way to the tumor, dispenses the drugs and passes harmlessly from the body
  • Smart pill contains reservoir for drug supply, fluid pump for drug delivery, pH sensor (for navigation), thermometer, microprocessor, communication

 

4.2       Drug Compliance Monitoring Systems

4.2.1    INGESTIBLE BIOMEDICAL SENSOR – Proteus Digital Health

  • Biomedical sensor that monitors medication adherence
  • Embedded into a pill, the sensor is activated by stomach fluid
  • Transmits a signal through the body to a skin patch
  • Indicates whether a patient has ingested material

 

4.2.2    MICROPUMP DEVICES – Purdue University

  • Device based on skin contact actuation for drug delivery
  • Actuation mechanism only requires body heat
  • Induced actuation can result to a gradient of 100 Pa/oC
  • Sufficient to drive liquid drug through micro-needle arrays
  • Prototypes exhibit low fabrication costs, employment of biocompatible materials and battery-less operation Suitable for single- or multiple-use transdermal drug dispensers

 

4.2.3    IMPLANTABLE MEMS DRUG DELIVERY SYSTEM – MIT

  • Device can deliver a vasoconstrictor agent
  • On demand to injured soldiers to prevent hemorrhagic shock
  • Other applications include medical implants
  • For cancer detection and monitoring
  • Implant can provide physicians and patients
  • Real-time information on the efficacy of treatment

 

Chapter 5: Remove Monitoring of Food-related Diseases

5.1       LASER-DRIVEN, HANDHELD SPECTROMETER

  • For analyzing food scanned
  • Information to a cloud-based application
  • Examines the results Data is accumulated from many users
  • Used to develop warning algorithms
  • For Allergies, Bacteria

 

Chapter 6: Skin Protection and Photo-Sensitivity Management

6.1       WEARABLE-UVEXPOSURESENSOR – Gizmag

  • Wristband for monitoring UV exposure
  • Allows user to maximize vitamin D production
  • Reducing the risk of sun
  • Over-exposure and skin cancer
  • LED indicators light up as UV exposure accumulates
  • Flashes once the safe UV limit has been reached

 

6.2       WEARABLE SKIN SENSOR KTH – Chemistry 2011

  • Bio-patch for measuring and collecting vital information through the skin
  • Inexpensive, versatile and comfortable to wear
  • User Data being gathered depends on where it is placed on the body

 

Chapter 7: Ophthalmic Applications

7.1       INTRAOCULAR PRESSURE SENSOR – Sensimed & ST Microelectronics

  • Smart contact lens called Triggerfish
  • Contact lens can measure, monitor, and control
  • Intra-ocular pressure levels for patients
  • Catch early cases of glaucoma
  • MEMS strain gage pressure sensor
  • Mounted on a flexible substrate MEMS

 

7.2       MICRO-MIRRORS ENABLING HANDHELD OPHTHALMIC – OCT News

  • Swept source OCT model for retinal 3D imaging
  • Replaces bulky galvanometer scanners in a handheld OCT probe for primary care physicians
  • Ultrahigh-speed two-axis optical beam steering gimbal-less MEMS mirrors
  • MEMS Actuator with a 2.4 mm bonded mirror and an angular reach of +6°
  • Low power consumption of <100mW including the MEMS actuator driver Retinal 3D Imaging

 

Chapter 8: Hearing Assist Technologies

8.1       MEMS TECHNOLOGY FOR HEARING RESTORATION – University of Utah

  • Eliminates electronics outside the ear
  • Associated with reliability issues and social stigma
  • Accelerometer-based microphone
  • Successfully tested in cadaver ear canals
  • Prototype measures 2.5 x 6.2mm, weighs 25mg

 

Chapter 9: Lab-on-a-Chip

9.1       ORGAN-ON-A-CHIP – Johns Hopkins University

  • Silicon substrate for living human cells
  • Controlled environment
  • Emulate how cells function inside a living human body
  • Replace controversial and costly animal testing
  • Lab-on-a-chip: a cost effective end to animal testing

 

Chapter 10: Intra-Cranial Studies: Pressure Measurement, Monitoring and Adaptation

10.1:   CEREBRAL PRESSURE SENSOR – Fraunhofer Institute

  • Sensor to monitor cerebral pressure that can lead to dementia
  • Pressure changes in the brain can be measured and transmitted
  • Reading device outside the patient’s body
  • Operating at very low power, the sensor module
  • Powered wirelessly by the reading device

 

10.2    WIRELESS, IMPLANTABLE BRAIN SENSOR – National Institute of Biomedical Imaging and Bioengineering

  • Fully implantable within the brain
  • Allow natural studies of brain activity
  • Cord-free control of advanced prosthetics

Wireless charging Prototypes transmitted brain activity data

 

Chapter 11: Cardiac and Cardiovascular Monitoring System

11.1    IMPLANTABLE MICRO DEVICE FOR MONITORING AND TREATING ANEURISMS – Electronic Design

  • RF-addressed wireless pressure sensor are powered by inductive coupling
  • Do not need batteries MEMS pressure sensor
  • Wireless antenna are inserted near the heart
  • With a catheter, Blood-pressure readings
  • Are sent to a wireless scanner for monitoring Pressure changes
  • Deflect the transducer’s diaphragm
  • Change the LC circuit’s resonant

 

11.2    CUSTOM- FITTED, IMPLANTABLE DEVICE FOR TREATMENT AND PREDICTION OF CARDIAC DISORDERS – Washington University

  • Working prototypes were developed on inexpensive 3D printers
  • The 3D elastic membrane is made of a soft, flexible, silicon material
  • Precisely shaped to match the outer layer of the heart

 

Chapter 12: microfluidic chips

12.1    MICROFLUIDIC MEMS FOR DIABETES TREATMENT – Micronews

  • Watertight pump mounted on a disposable skin patch
  • Provides continuous insulin infusion
  • Controlled by a dedicated smart phone device
  • Incorporating a BGM (blood- glucose meter)

 

12.2    ACOUSTIC RECEIVER ANTENNA/SENSOR PDMS MEMBRANE – Purdue

POLY-DI-METHYL-SILOXANE (PDMS)

Polydimethylsiloxane called PDMS or dimethicone is a polymer widely used for the fabrication and prototyping of microfluidic chips.

It is a mineral-organic polymer (a structure containing carbon and silicon) of the siloxane family (word derived from silicon, oxygen and alkane). Apart from microfluidics, it is used as a food additive (E900), in shampoos, and as an anti-foaming agent in beverages or in lubricating oils.

For the fabrication of microfluidic devices, PDMS (liquid) mixed with a cross-linking agent is poured into a microstructured mold and heated to obtain a elastomeric replica of the mold (PDMS cross-linked).

 

Why Use PDMS for Microfluidic Device Fabrication?

 

PDMS was chosen to fabricate microfluidic chips primarily for those reasons:

Human alveolar epithelial and pulmonary microvascular endothelial cells cultured in a PDMS chip to mimick lung functions

  • It is transparent at optical frequencies (240 nM – 1100 nM), which facilitates the observation of contents in micro-channels visually or through a microscope.
  • It has a low autofluorescence [2]
  • It is considered as bio-compatible (with some restrictions).

The PDMS bonds tightly to glass or another PDMS layer with asimple plasma treatment. This allows the production of multilayers PDMS devices and enables to take advantage of technological possibilities offered by glass substrates, such as the use of metal deposition, oxide deposition or surface functionalisation.

PDMS, during cross-linking, can be coated with a controlled thickness on a substrate using a simple spincoat. This allows the fabrication of multilayer devices and the integration of micro valves.

It is deformable, which allows the integration of microfluidic valves using the deformation of PDMS micro-channels, the easy connection of leak-proof fluidic connections and its use to detect very low forces like biomechanics interactions from cells.

SOURCE

http://www.elveflow.com/microfluidic-tutorials/microfluidic-reviews-and-tutorials/the-poly-di-methyl-siloxane-pdms-and-microfluidics/

 

  • Ferrite RF radiation Acoustic wave Rectifier
  • Buried in PDMS Implantable miniature pressure sensor
  • Powered by an acoustically actuated cantilever
  • No battery required
  • Acoustic waves in the 200-500 hertz range
  • Cause cantilever to vibrate
  • Scavenging energy to power pressure sensor

 

Chapter 13: Peropheral Neuropathy Management

13.1    WIRELESS SHOE INSERT – Mobile Health News

  • WIRELESS SHOE INSERT – Mobile Health News
  • Help diabetics manage peripheral nerve damage
  • Insole collects data of where wearers
  • Putting pressure on their feet
  • Transmits wirelessly to a wristwatch-type display
  • Prevent amputations that often stem from diabetic foot ulcers

 

Chapter 14: Endoscopic Diagnostics Tools

14.1    ENDOSCOPE USING MEMS SCANNING MIRROR

  • For gastrointestinal and urological imaging
  • Alternative to biopsies in cancer detection
  • A laser beam pointed at the mirror is precisely deflected
  • Steered by the scanning mirror to reach a target

 

Chapter 15: MEMS guided Surgical Tools

15.1    MICROMACHINED SURGICAL TOOLS; SILICON MEMS TWEEZERS – ElectrolQ Used for minimally invasive surgical (MIS)

  • Procedures where diagnosis, monitoring, or treatment of diseases are performed
  • Performing with very small incisions MEMS
  • Based microsurgical tools is a key enabling technology for angioplasty, catheterization, endoscopy, laparoscopy, and neurosurgery

 

Summary by Dr. Pearlman

  • Multiple projects by Academia & Industry
  • Multiple MEMS devices for measuring body activities.
  • Many patch type devices attached to the skin
  • Devices attached to the eye
  • Smaller is better, lower footprint, lower power

 

 

 

 

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BioMEMS based Optical Sensors

Author of Presentation: Danut Dragoi, PhD

Optical sensors are so well developed that many applications can benefit from them. Important applications in medical field that utilizes embedded optical sensors are using the BioMEMS. In this presentation we focus on BioMEMS based optical sensors in ophthalmology, eyes artificial retina, LASIK, micro endoscope, plasmonic devices with single molecules detection utilizing SERS-Surface Enhance Raman Scattering in which photon interaction (scattering) with bio-cells is a major effect of the detection. It will be shown how cancer detection works (utilizing kapa/lambda ratio).

The presentation will focus also on eye vision correction, vision for the blind, and virtual reality for entertainment.

Slide 4 shows the results of the interaction of photons with living cells. Examples are given to illustrate the physical effects of the interaction. The abbreviations used in the text are: abs for absorption, H for Hydrogen, e for electron, m* for excited mass of the living cell, ElemPart for elementary particles.

Slide4

Photon as an elementary particle, can be found in lasers, the best source of artificial light today. As we can remark on Slide 5 , the intensity of the lasers of very high power in peta watts range, one peta watts is 10 raised to the power of 15 watts, is expected to play a major role in the future of medicine.

 

Slide5

 

Slide 6 shows the world’s most powerful laser fired at Japanese Lab of Osaka University.

Slide6

On Slide 6 the laser beam is so intense, 2PW, so that the scattering from the air molecules can be seen on very large distances.

Slide 7 shows schematically our natural sensor, the eye, that works on visualizing objects like a tree exposed to natural light of Sun, in which light reflects / scatters in all directions, the lens of the eye focuses some rays on retina that give a signal to the brain through the optical nerve.

 

 

Slide7

 

Slide 8 gives the location of visual spectrum in the general electromagnetic spectrum, in which color green is in the middle of visible spectrum. The nature selected the maximum of sensitivity of our eyes to be green color that coincides with the color of chlorophyll, the green pigment, present in all green plants.

Slide8

Slide 9 shows the branch of eye care called Ophthalmology, in which correction of vision is done utilizing eye glasses or LASIK, an eye special surgery on cornea of the eye.

Slide9

 

Slide 10 shows three options of eye correction of vision, normal vision gasses, contact lenses, and LASIK..Slide10

 

Slide 11 explains LASIK procedure, which is laser assisted in situ keratomileusis. In the three picture is shown the process of precise cut of the top of cornea, tissue removal using an eximer laser, whose wavelength is so short that does not penetrate the ocular lens, and the last step of flipping back the cut from cornea in the first stage. In many countries milions of people opted for this procedure.

Slide11

 

Slide 12 is an attempt to explain the etymology of keratomileusis in the word LASIK.Slide12

 

Slide 13 suggests what beyond LASIK procedure, in which the concept for blindness is given as a solution utilizing implantable photo-detector arrays.

Slide13

Slide 14 compares natural optical sensors with artificial optical sensor based on Si microelectronic technology.

Slide14

 

Slide 15 shows a bio-optical sensor made by Anitoa, a company in Palo Alto CA. What is special about this photo-detector is its high sensitivity pushed toward one photon detection.

Slide15

Slide 16 shows an endoscope with one fiber optic and two electrical lines, which is recognized as an Optical Coherent Topography device.

Slide16The optical fiber guides a laser beam towards the end of the fiber where a GRIN lens, which is a gradient index lens, focuses the beam on a mirror that rock around an axis in order to scan the beam on the object, then the reflected beam goes back on mirror through the GRIN lens and the fiber again where an image is produced.

 

Slide 17 shows a MEMS endoscope made by  Santec, where we recognise all elements described in previous slide.

 

Slide17

Slide 18 compares sensors sensitive to visible spectrum made in nature, fruit flies eye, and those sensors made in the lab utilizing the model of fly eye. Because the resolution of the recreated eye fly is poor we expect that technology to not be used. The actual Si microelectronics is much better in producing high performance photo detectors.

Slide19

Slide 19 shows a ‘smart’ contact lens to monitors the pressure inside the eye that can produce glaucoma and possibly lose the sight.

Slide20

Slide 21 shows schematically  a prosthetic retina for people who have the photoreceptors retina destroyed, either by disease or by an accidental  exposure to a laser beam.

Slide21

Slide 22 shows an implantable BioMEMS subretinal Alpha IMS for blind people.

Slide22

Slide 23 shows the number of pixels in natural vision for different types of eyes, starting with low pixels for insect and ending with very high pixels for predatory birds. The horizontal axis describes the number of images . The red lines represent the memory storage of pixels for different vision systems.

Slide23

Slide 24 shows the implantable retina micro-array from Sandia National Lab.

Slide24

Slide 25 an artificial retina from Lawrence Livermore Lab.

Slide25

Slide 26 describe other advanced optical devices based on SERS (Surface Enhanced Raman Scattering) for single molecule detection such as cancer cells, toxic molecules, poison molecule and other.

Slide26

Slide 27 gives the definition of plasmon and Raman spectroscopy which is s the measurement of the wavelength and intensity of in-elastically scattered light from molecules. The Raman scattered light occurs at wavelengths that are shifted from the incident light by the energies of molecular vibrations.

Slide27

Slide 28 is for how SERS works.

Slide28

Slide 29 explains  the principle of SERS for detection of single molecules.

Slide29

Slide 30 shows the principle of SERS enhancement of the spectrum  using Ag nano particles.

Slide30

Slide 31 examples of molecules detected by SERS,

Slide31

Slide 32 shows a mini-device plasmonic biosensor for leukemia detection.

Slide32

Slide 33 shows how the optical plasmonic device is tuned to detect cancer cells by measuring IgG-kappa and IgG-lambda ratio.

Slide33

 

Slide 34 shows how the ratio IgG-kappa and IgG-lambda is determined in clinical diagnostic utilizing SERS wave guides.

Slide34

Slide 35 shows a MEMS device as a mini-spectrometers in visible range of the electromagnetic spectrum.

Slide35

Slide 36 shows how the mini-spectrometers works.

Slide36

Slide 37 shows  a mini-spectrometer at work utilizing a laptop, an absorption cuvette and optical fibers for input into spectrometer and electrical connections between a laptop and spectrometer.

Slide37

Slide 38 shows a mini MEMS USB spectrometer based WiFi.

Slide38

Slide 39 shows MEMS USB spectrometer connected to an iPhone.

Slide39

Slide 40 shows an integrated color sensors for blood glucose meters.

Slide40

Slide 41 shows an optical device for measuring Oxygen saturation of blood.

Slide41

Slide 42 shows how the oxymeter works.

Slide42

Slide 43 shows the glaucoma can destroy the optical nerve producing total blindness.

Slide43

Slide 44 gives the definition of glaucoma.

Slide44

Slide 45 shows the micro-systemic approach for glaucoma.

Slide45

Slide 46 shows bio MEMS coil for glaucoma. The graph on the slide show a calibration curve, resonant frequency of the coil versus pressure in a water testing device, where the pressure of water is well known and the frequency measured precisely with a pressure instrument.

Slide47

Slide 48 shows the definition of cataract which is a leading eye problem for the older.

Slide48

Slide 49 shows a BioMEMS artificial lens.

Slide49

Slide 49 shows how artificial lens is working.

Slide50

Slide 51 shows a sub-retinal BioMEMS principle of working.

Slide51

Slide 52 shows a higher complex BioMEMS artificial retina system.

Slide52

Slide 53 shows a BioMEMS artificial retina system by Professor Wilfried Mokwa of RWTH Aachen University.

Slide53

Slide 54 shows  a BioMEMS and epiretinal stimulation from Retina Implant AG.

Slide54

Slide 55 shows a Bionic Microchip at the back of the eye with 1500 pixels.

Slide55

Slide 56 shows a bionic microchip installed on the back of the eye.Slide56

Slide 57 shows a schematic of retinal bionic implant, 3×3 mm with a light processing cells, which is the latest generation of a light sensitive chip.

Slide57

Slide 58 shows  a contact lens for Virtual Reality applications. Notice in this application the eye is healthy and normal functioning.

Slide58

Slide 59 shows a description of  contact lenses for Virtual Reality applications.

Slide59

Slide 60 and 61 show the conclusions.

Slide60

Slide61

This is the end of the presentation. Thank you!

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Applications in Medicine of Piezoelectric Mini Cantilever Beam

Curator: Danut Dragoi, PhD

Piezoelectric materials are now finding applications in a wide variety of environmental conditions and medicine. Such materials are capable of converting mechanical energy into electrical energy. Indeed, when subjected to mechanical stress become electrically charged at their surface and vice versa. In their paper titled “Analytical Modeling of a Piezoelectric Bimorph Beam”, the researchers from Mechanical Engineering Department, Faculty of Technology Sciences, University Constantine 1, Algeria and Departement de Mécanique Appliquée, ENSMM, France, see the link in here, focused on a simple analytical model based on Euler–Bernoulli beam theory with the following assumptions:

  • (a) the piezoelectric layer thickness in comparison to the length of the beam is very thin and
  • (b) the electrical field between the upper surface and lower surface of the piezoelectric layer is uniform.

They have applied this model to study its static responses and predict the ambient deformations into usable electrical energy from a cantilever piezoelectric beam.

The piezoelectricity of well known materials, such as Pb[ZrxTi1-x]O3 (0≤x≤1) is due to the asymmetry of central atom that creates a local electrical dipole whose amplitude is direct proportional to the displacement of Ti/Zr+4 ions from the center of the crystallographic unit cell. These materials do not possess any piezoelectric properties owing to the random orientations of the ferroelectric domains in the ceramics before poling. During poling, which is an electric field applied on the ferroelectric ceramic sample during the fabrication to force the domains to be oriented or preferred oriented in the direction of polling of the electric field. After poling, the electric field is removed and a remnant polarization and remnant strain are maintained in the sample, so a preferred orientation of the domains exist and the sample exhibits piezoelectricity. We can imagine that a single crystal will have 100% orientation in the direction we like to be, but the processing cost may be prohibited in this way.

The work presented in the paper concerns the problems of characteristic phenomena of piezoelectricity. The attention is focused on the different deformations effect by voltage generation of the piezoelectric beam. The relation between the voltage imposed and the curvature is analytically derived which is used to explain the effect of voltage generation as a function of the curvature of the beam. Figure 4 from the paper,  shows the deflection family of curves as a function of asymmetry of the four electrodes on the mini piezo beam, where a and b on Figure 4 are the position of the gap between electrodes on two parallel faces of the beam relative to the middle section plan that runs parallel to the longest side of the beam.

Deflection_Piezo_beam

The dimensions of the piezo cantilever beam are 10 mm x 1 mm x 0.200 mm. We notice the higher asymmetry (high values for a and b parameters) the better, as the slope on lines on Figure 4 are coupled with the beam deflection, the parameter of interest. We remark the case when a=b=0, no asymmetry, the deflection is zero as expected. Also we notice that the device has two piezo materials glued together. The need for two piezo materials is due to the fact that we have four asymmetric electrodes that produce four asymmetric polarizations that induce the necessary curvature of the beam and ultimately the deflection. In order to reduce the mechanical influence of the electrodes on deflections, the electrodes were made extremely thin, about 0.5 microns thickness. The electrodes were glued to the piezoelectric cantilever beam using epoxy. Analytical data showed that the proposed model simulations are in good agreement with the FE results. A detailed analysis of piezoelectric cantilever bi-morph is made on a dissertation thesis, see link in here.

Pushing for deflection parameter higher on piezoelectric devices is now related not only with energy harvesting in industry, but also with medical devices like BioMEMS where short life batteries for powering the electronic microcircuits have a major inconvenient of recharging once they are depleted of energy, and also they have to be replaced after a not so high number of charging cycles.The usage of human body movement is a viable approach for using piezoelectric cantilever beam to power implantable medical devices as well as other microbot and BioMEMS devices. The predictive models presented are very promising and show the trend towards a highly efficient device that will replace the actual batteries in many applications.

SOURCES

American Journal of Mechanical Engineering, 2016, Vol. 4, No. 1, 7-10, Available online at http://pubs.sciepub.com/ajme/4/1/2 © Science and Education Publishing

http://pubs.sciepub.com/ajme/4/1/2/

ANALYTICAL MODELING AND DESIGN OPTIMIZATION OF PIEZOELECTRIC BIMORPH ENERGY HARVESTER by LONG ZHANG

A DISSERTATION

http://acumen.lib.ua.edu/content/u0015/0000001/0000457/u0015_0000001_0000457.pdf

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Human Factor Engineering: New Regulations Impact Drug Delivery, Device Design And Human Interaction

Curator: Stephen J. Williams, Ph.D.

Institute of Medicine report brought medical errors to the forefront of healthcare and the American public (Kohn, Corrigan, & Donaldson, 1999) and  estimated that between

44,000 and 98,000 Americans die each year as a result of medical errors

An obstetric nurse connects a bag of pain medication intended for an epidural catheter to the mother’s intravenous (IV) line, resulting in a fatal cardiac arrest. Newborns in a neonatal intensive care unit are given full-dose heparin instead of low-dose flushes, leading to threedeaths from intracranial bleeding. An elderly man experiences cardiac arrest while hospitalized, but when the code blue team arrives, they are unable to administer a potentially life-saving shock because the defibrillator pads and the defibrillator itself cannot be physically connected.

Human factors engineering is the discipline that attempts to identify and address these issues. It is the discipline that takes into account human strengths and limitations in the design of interactive systems that involve people, tools and technology, and work environments to ensure safety, effectiveness, and ease of use.

 

FDA says drug delivery devices need human factors validation testing

Several drug delivery devices are on a draft list of med tech that will be subject to a final guidance calling for the application of human factors and usability engineering to medical devices. The guidance calls called for validation testing of devices, to be collected through interviews, observation, knowledge testing, and in some cases, usability testing of a device under actual conditions of use. The drug delivery devices on the list include anesthesia machines, autoinjectors, dialysis systems, infusion pumps (including implanted ones), hemodialysis systems, insulin pumps and negative pressure wound therapy devices intended for home use. Studieshave consistently shown that patients struggle to properly use drug delivery devices such as autoinjectors, which are becoming increasingly prevalent due to the rise of self-administered injectable biologics. The trend toward home healthcare is another driver of usability issues on the patient side, while professionals sometimes struggle with unclear interfaces or instructions for use.

 

Humanfactors engineering, also called ergonomics, or human engineering, science dealing with the application of information on physical and psychological characteristics to the design of devices and systems for human use. ( for more detail see source@ Britannica.com)

The term human-factors engineering is used to designate equally a body of knowledge, a process, and a profession. As a body of knowledge, human-factors engineering is a collection of data and principles about human characteristics, capabilities, and limitations in relation to machines, jobs, and environments. As a process, it refers to the design of machines, machine systems, work methods, and environments to take into account the safety, comfort, and productiveness of human users and operators. As a profession, human-factors engineering includes a range of scientists and engineers from several disciplines that are concerned with individuals and small groups at work.

The terms human-factors engineering and human engineering are used interchangeably on the North American continent. In Europe, Japan, and most of the rest of the world the prevalent term is ergonomics, a word made up of the Greek words, ergon, meaning “work,” and nomos, meaning “law.” Despite minor differences in emphasis, the terms human-factors engineering and ergonomics may be considered synonymous. Human factors and human engineering were used in the 1920s and ’30s to refer to problems of human relations in industry, an older connotation that has gradually dropped out of use. Some small specialized groups prefer such labels as bioastronautics, biodynamics, bioengineering, and manned-systems technology; these represent special emphases whose differences are much smaller than the similarities in their aims and goals.

The data and principles of human-factors engineering are concerned with human performance, behaviour, and training in man-machine systems; the design and development of man-machine systems; and systems-related biological or medical research. Because of its broad scope, human-factors engineering draws upon parts of such social or physiological sciences as anatomy, anthropometry, applied physiology, environmental medicine, psychology, sociology, and toxicology, as well as parts of engineering, industrial design, and operations research.

source@ Britannica.com

The human-factors approach to design

Two general premises characterize the approach of the human-factors engineer in practical design work. The first is that the engineer must solve the problems of integrating humans into machine systems by rigorous scientific methods and not rely on logic, intuition, or common sense. In the past the typical engineer tended either to ignore the complex and unpredictable nature of human behaviour or to deal with it summarily with educated guesses. Human-factors engineers have tried to show that with appropriate techniques it is possible to identify man-machine mismatches and that it is usually possible to find workable solutions to these mismatches through the use of methods developed in the behavioral sciences.

The second important premise of the human-factors approach is that, typically, design decisions cannot be made without a great deal of trial and error. There are only a few thousand human-factors engineers out of the thousands of thousands of engineers in the world who are designing novel machines, machine systems, and environments much faster than behavioral scientists can accumulate data on how humans will respond to them. More problems, therefore, are created than there are ready answers for them, and the human-factors specialist is almost invariably forced to resort to trying things out with various degrees of rigour to find solutions. Thus, while human-factors engineering aims at substituting scientific method for guesswork, its specific techniques are usually empirical rather than theoretical.

HFgeneralpic

 

 

 

 

 

 

 

 

 

 

 

The Man-Machine Model: Human-factors engineers regard humans as an element in systems

The simple man-machine model provides a convenient way for organizing some of the major concerns of human engineering: the selection and design of machine displays and controls; the layout and design of workplaces; design for maintainability; and the work environment.

Components of the Man-Machine Model

  1. human operator first has to sense what is referred to as a machine display, a signal that tells him something about the condition or the functioning of the machine
  2. Having sensed the display, the operator interprets it, perhaps performs some computation, and reaches a decision. In so doing, the worker may use a number of human abilities, Psychologists commonly refer to these activities as higher mental functions; human-factors engineers generally refer to them as information processing.
  3. Having reached a decision, the human operator normally takes some action. This action is usually exercised on some kind of a control—a pushbutton, lever, crank, pedal, switch, or handle.
  4. action upon one or more of these controls exerts an influence on the machine and on its output, which in turn changes the display, so that the cycle is continuously repeated

 

Driving an automobile is a familiar example of a simple man-machine system. In driving, the operator receives inputs from outside the vehicle (sounds and visual cues from traffic, obstructions, and signals) and from displays inside the vehicle (such as the speedometer, fuel indicator, and temperature gauge). The driver continually evaluates this information, decides on courses of action, and translates those decisions into actions upon the vehicle’s controls—principally the accelerator, steering wheel, and brake. Finally, the driver is influenced by such environmental factors as noise, fumes, and temperature.

 

hfactorconsideroutcomes

How BD Uses Human Factors to Design Drug-Delivery Systems

Posted in Design Services by Jamie Hartford on August 30, 2013

 Human factors testing has been vital to the success of the company’s BD Physioject Disposable Autoinjector.

Improving the administration and compliance of drug delivery is a common lifecycle strategy employed to enhance short- and long-term product adoption in the biotechnology and pharmaceutical industries. With increased competition in the industry and heightened regulatory requirements for end-user safety, significant advances in product improvements have been achieved in the injectable market, for both healthcare professionals and patients. Injection devices that facilitate preparation, ease administration, and ensure safety are increasingly prevalent in the marketplace.

Traditionally, human factors engineering addresses individualized aspects of development for each self-injection device, including the following:

  • Task analysis and design.
  • Device evaluation and usability.
  • Patient acceptance, compliance, and concurrence.
  • Anticipated training and education requirements.
  • System resilience and failure.

To achieve this, human factors scientists and engineers study the disease, patient, and desired outcome across multiple domains, including cognitive and organizational psychology, industrial and systems engineering, human performance, and economic theory—including formative usability testing that starts with the exploratory stage of the device and continues through all stages of conceptual design. Validation testing performed with real users is conducted as the final stage of the process.

To design the BD Physioject Disposable Autoinjector System , BD conducted multiple human factors studies and clinical studies to assess all aspects of performance safety, efficiency, patient acceptance, and ease of use, including pain perception compared with prefilled syringes.5 The studies provided essential insights regarding the overall user-product interface and highlighted that patients had a strong and positive response to both the product design and the user experience.

As a result of human factors testing, the BD Physioject Disposable Autoinjector System provides multiple features designed to aide in patient safety and ease of use, allowing the patient to control the start of the injection once the autoinjector is placed on the skin and the cap is removed. Specific design features included in the BD Physioject Disposable Autoinjector System include the following:

  • Ergonomic design that is easy to handle and use, especially in patients with limited dexterity.
  • A 360° view of the drug and injection process, allowing the patient to confirm full dose delivery.
  • A simple, one-touch injection button for activation.
  • A hidden needle before and during injection to reduce needle-stick anxiety.
  • A protected needle before and after injection to reduce the risk of needle stick injury.

 

YouTube VIDEO: Integrating Human Factors Engineering (HFE) into Drug Delivery

 

Notes:

 

 

The following is a slideshare presentation on Parental Drug Delivery Issues in the Future

 The Dangers of Medical Devices

The FDA receives on average 100,000 medical device incident reports per year, and more than a third involve user error.

In an FDA recall study, 44% of medical device recalls are due to design problems, and user error is often linked to the poor design of a product.

Drug developers need to take safe drug dosage into consideration, and this consideration requires the application of thorough processes for Risk Management and Human Factors Engineering (HFE).

Although unintended, medical devices can sometimes harm patients or the people administering the healthcare. The potential harm arises from two main sources:

  1. failure of the device and
  2. actions of the user or user-related errors. A number of factors can lead to these user-induced errors, including medical devices are often used under stressful conditions and users may think differently than the device designer.

Human Factors: Identifying the Root Causes of Use Errors

Instead of blaming test participants for use errors, look more carefully at your device’s design.

Great posting on reasons typical design flaws creep up in medical devices and where a company should integrate fixes in product design.
Posted in Design Services by Jamie Hartford on July 8, 2013

 

 

YouTube VIDEO: Integrating Human Factors Engineering into Medical Devices

 

 

Notes:

 

 Regulatory Considerations

  • Unlike other medication dosage forms, combination products require user interaction
  •  Combination products are unique in that their safety profile and product efficacy depends on user interaction
Human Factors Review: FDA Outlines Highest Priority Devices

Posted 02 February 2016By Zachary Brennan on http://www.raps.org/Regulatory-Focus/News/2016/02/02/24233/Human-Factors-Review-FDA-Outlines-Highest-Priority-Devices/ 

The US Food and Drug Administration (FDA) on Tuesday released new draft guidance to inform medical device manufacturers which device types should have human factors data included in premarket submissions, as well final guidance from 2011 on applying human factors and usability engineering to medical devices.

FDA said it believes these device types have “clear potential for serious harm resulting from use error and that review of human factors data in premarket submissions will help FDA evaluate the safety and effectiveness and substantial equivalence of these devices.”

Manufacturers should provide FDA with a report that summarizes the human factors or usability engineering processes they have followed, including any preliminary analyses and evaluations and human factors validation testing, results and conclusions, FDA says.

The list was based on knowledge obtained through Medical Device Reporting (MDRs) and recall data, and includes:

  • Ablation generators (associated with ablation systems, e.g., LPB, OAD, OAE, OCM, OCL)
  • Anesthesia machines (e.g., BSZ)
  • Artificial pancreas systems (e.g., OZO, OZP, OZQ)
  • Auto injectors (when CDRH is lead Center; e.g., KZE, KZH, NSC )
  • Automated external defibrillators
  • Duodenoscopes (on the reprocessing; e.g., FDT) with elevator channels
  • Gastroenterology-urology endoscopic ultrasound systems (on the reprocessing; e.g., ODG) with elevator channels
  • Hemodialysis and peritoneal dialysis systems (e.g., FKP, FKT, FKX, KDI, KPF ODX, ONW)
  • Implanted infusion pumps (e.g., LKK, MDY)
  • Infusion pumps (e.g., FRN, LZH, MEA, MRZ )
  • Insulin delivery systems (e.g., LZG, OPP)
  • Negative-pressure wound therapy (e.g., OKO, OMP) intended for home use
  • Robotic catheter manipulation systems (e.g., DXX)
  • Robotic surgery devices (e.g., NAY)
  • Ventilators (e.g., CBK, NOU, ONZ)
  • Ventricular assist devices (e.g., DSQ, PCK)

Final Guidance

In addition to the draft list, FDA finalized guidance from 2011 on applying human factors and usability engineering to medical devices.

The agency said it received over 600 comments on the draft guidance, which deals mostly with design and user interface, “which were generally supportive of the draft guidance document, but requested clarification in a number of areas. The most frequent types of comments requested revisions to the language or structure of the document, or clarification on risk mitigation and human factors testing methods, user populations for testing, training of test participants, determining the appropriate sample size in human factors testing, reporting of testing results in premarket submissions, and collecting human factors data as part of a clinical study.”

In response to these comments, FDA said it revised the guidance, which supersedes guidance from 2000 entitled “Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management,” to clarify “the points identified and restructured the information for better readability and comprehension.”

Details

The goal of the guidance, according to FDA, is to ensure that the device user interface has been designed such that use errors that occur during use of the device that could cause harm or degrade medical treatment are either eliminated or reduced to the extent possible.

FDA said the most effective strategies to employ during device design to reduce or eliminate use-related hazards involve modifications to the device user interface, which should be logical and intuitive.

In its conclusion, FDA also outlined the ways that device manufacturers were able to save money through the use of human factors engineering (HFE) and usability engineering (UE).

– See more at: http://www.raps.org/Regulatory-Focus/News/2016/02/02/24233/Human-Factors-Review-FDA-Outlines-Highest-Priority-Devices/#sthash.cDTr9INl.dpuf

 

Please see an FDA PowerPoint on Human Factors Regulatory Issues for Combination Drug/Device Products here: MFStory_RAPS 2011 – HF of ComboProds_v4

 

 

 

 

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