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This presentation will help to understand what is the pill, its new product development cycle, its use , procedure,advantages and disadvantages.
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Presented by- Shakil S.Siddiqui
Rizvi Institute of Management studies & Research.Mumbai.
PILLCAMA pill with a view
PILLCAMA product by GIVEN IMAGING
Approved by European Medicines Agency
Capsule Endoscopy
3 typesPillcam ESOPillcam SBPillcam colon
New product development of the Pillcam
IDEA GENERATIO
N
PRODUCT SELECTION
PRELIMINARY
PRODUCT DESIGN
FINAL PRODUCT DESIGN
PROTOTYPING THE DESIGN
TESTING OF PROTOTYPE
6 S T E P S
1.IDEA GENERATIONNormal traditional endoscopy
Problems with normal endoscopy
Sore throatGreater recovery timeRequires sedationPainfulTime consumingaccidental puncture fever
Imagine a vitamin size pill sized camera that could travel through our body taking pictures, helping to
diagnose a problem
2.Product selection
Endoscopy with -Clear imagesSimple and safeNo need of inducing sedationDetect evidence of disease that traditional
endoscopy cannotNo painSmall recovery time
3.Preliminary product design
Basic components for required for designing a product were
Lens Illuminating LEDImage sensorBatteryTransmitter
Preliminary product design
PARTS OF THE PRODUCT
1.Optical dome2.Lens holder3.Lens4.Illuminating LED”s5.CMOS image sensor6.Battery7.ASIC transmitter8.Antennae
1.Optical dome
Have Light receiving windowMade up of non conductor materialPromote easy orientationPrevent infiltration of digestive fluids inside the
capsuleEasy propelling
2.Lens holder
Helps to accommodate the lensHelps the lens to fix properlyAvoids dislocation of lens
3.Lens
Integral componentLocation – behind light receiving windowLight through window falls on the lens
4.Illuminating LED”s
Six white light emitting diode (LED) ensure proper lighting for taking pictures.
5.CMOS image sensor
140° field of viewDetects object as small as 0.1 mmPreciseDetect a polyp which is not possible in traditional
endoscopy
6.Battery
2 batteryButton shapedMade up of silver oxideDisposable Harmless8 hrs. working
7.ASIC transmitter
Application specific integrated circuitLocation – behind the batteries2 transmitting electrodes are presentElectrodes are electrically isolated
8.Antennae
Receives data from ASIC transmitterSend to data recorder
4.PROTOTYPING THE DESIGN
PROBLEMS WITH THE PROTOTYPE AND THEIR SOLUTIONS
Patients with narrow gastrointestinal structures are not good candidates for this procedure due to risk of obstructionSolution -Use of nanotechnology pill size has been reduced like normal vitamin capsule
Impossible to control camera behavior in colon (rotation of pill can be possible)Solution-Use of bi-directional telemetry camera
5.TESTING OF PROTOTYPEClinical trialsSampling method : Non-probability sampling
Ages eligible for study: 18 Years to 70 Years
Genders Eligible for Study: Both
Tested on both healthy volunteers as well as on ill patients
ill patients includes-
mechanically ventilated and sedated
mild-to-moderate brain injury patients
admitted to an intensive care unit (ICU)
Patients having GERD (gastro esophageal reflux disease)
Cancer patients
RESULTS
large studies with consistent clinical data continue to support the use of Pillcam capsule endoscopy as a first-line diagnostic tool for patients who suffer from unresolved G.I.T symptoms
It is completely safe
6.FINAL PRODUCT DESIGN
Pillcam SB take 50,000 images in 8 hr. i.e., 2 image/sec
Pillcam Eso.Take 2,600 images in 20 min i.e., 14 images/sec
SENSOR ARRAY BELT
This sensor array belt has to worn around patients waist over clothing
it has data recorder in it which has battery which receives pictures from the antennae of the Pillcam and record it which is later displayed on the monitor
PROCEDURE
Fasting for 10-12 hoursNo iron pills for 5 daysSwallow the capsule with few sips of waterCapsule moves by peristalsis movementPatient can leave the centerAfter 7-8 hours the patient must returnCollect images from data recorder and examine it
ADVANTAGES OF PILLCAMPainless No side effectsAccurate pictures(view of 150 degree)High quality imagesEasy procedureHigh sensitivity and specificityNo sedation is requiredMore efficient than X-ray ,CT-Scan and normal
endoscopy
LIMITATIONSVery expensive Gastrointestinal obstruction prevent the free flow of
PillcamPregnant woman and patients with pacemaker face
difficulties Not a replacement for colonoscopyNot reusableBatteries may not last long
THANK YOU