FRM 3 Traceability Matrix 04/05/2023

	A	B	C	D	E	F	G	H
1	Item #	User Needs, Intended Uses	Design Inputs (Technical Requirements)	Acceptance Criteria		Design Outputs	Design Verification (Outputs = Inputs)	Design Validation (User Needs Met)
2				Ideal/Goal	Limit
3
4		Microneedles (MNs)
5	1	Customer Requirements (e.g. Functional)						PMA, ISO, 510k standrads being met/not
6	1.1	MNs must not accidentally hurt the user	MNs must not be exposed before or after use	Painless procedure	Skin visibly red swollen	3D printed model showing needles being covered before use and resheathed after use	99.99% of MNs produced are successfully covered before and after use	Clinical trials result in an injury rate within industry requirements
7	1.2	Device is easily reusable	After each use, the used MN can be ejected and a new one can be attached in under 1 minute	MNs can be ejected and replaced within 1 minute	MNs can be ejected and replaced within 3 minutes	The device will have a snapping mechanism for new MN attachement, and a button for MN ejection after use	99.99% of MNs are successfully attatchable and ejectable	Clinical trials show that trained users can eject and attach a microneedle under 1 minute
8	2	Product Performance Requirements (e.g. Mechanical)
9	2.1	Minimally invasive	MNs will not puncture the skin beyond 1800 um	Skin appears normal/ redness disappear withing 5mins after application	Skin redness persists after 3-5hours	Upscaled CAD model and printing of MNs	100% of MNs are measured to be less than 1800 um	Animal and cadaver studies validate that needles do not puncture beyond 1800 um
10	2.2	MNs are secure against skin	Device holds MNs down against skin so the they are fully inserted	MN patch does not come off unless physically peeled off	MN patch comes off due to slight arm movement	Prototype of device with a mechanism for MN deployment that allows for MNs to be held in position until released	99.99% MNs adhere to skin upon application due to elastic nature of skin (closes in on MNs). perforation depth, and number (many MNs)	Animal and cadaver studies demonstrate secure MN to skin contact
11	2.3	MNs are able to draw blood after being inserted into skin	MN length/depth is between 1500- 1800 um, vacuum sealed for suction of at least 100 uL of blood	MNs draw >100uL blood	MNs draws between 80 -100uL blood minimum	Upscaled CAD model and printing of MNs	100% of MNs are between 1500-1800 um in length and vacuum pressure is able to draw at least 100 uL of blood in 99.99% of tests	Clinical trials demonstrate that MNs can draw an appropriate volume of blood
12	2.4	MNs withstand force of being inserted	No MNs break upon puncturing and removal from skin	MNs never break during blood drawing, storage, or transport	0.01% of MNs fail to pass the durablity test	MNs are made of stainless steel	99.99% of MNs do not experience anny breakage upon inserertion and removal from skin	Animal and cadaver studies validate MN durability
13	3	Biocompatability Requirements
14	3.1	MNs are sterile and hypoallergenic	MN material and packaging must be resistant to degradation and pathogens	MNs do not cause any reaction on patient skin	Skin redness persists after 3-5 hours	MNs will be made of stainless steel. They will arrive in uncompromised vaccuum-sealed packaging.	99.99% of MNs arrive in uncompromised packaging. 99.99% of pathogen tests are negative	Animal and clinical studies to verify biocompatability
15
16		Masager
17	1	Customer Requirements (e.g. Functional)
18	1.1	Device massages skin to increase blood flow	Device will vibrate at a frequency between 30-50 Hz	Device vibrates between 30-50Hz	Device vibratation is +/- 5 Hz	Prototype with motor that allows massager to move	Vibration testing shows that vibrations between 30-50 Hz can be consistently produced during the device's lifetime	Animal and clinical studies demonstrate increased blood flow after vibrations
19	1.2.	Device heats skin to increase blood flow	Device will contain a non-flammable heating pad that can produce adjustable temperatures between 40-50 degrees C	Device can be heated to between 40-50 degrees C	Device heating is +/- 5 degrees	Prototype with insulative fabric heating pad and 3D-printed CAD model of a heating system	Heating pad temperature is measured to be within 40-50 degrees C during the device's lifetime	Temperatures are clinically shown to dilate blood vessels without damaging the skin barrier or causing pain
20	1.3	Device can easily be secured to patient's arm or moved by the user	Device does not detatch from patient's arm when secured. Device does not detatch from user's hand when secured. Device can be secured within 30 seconds	Device can be secured within 30 seconds and remains in place	Device moves or detaches with considerable movement	Device will have a velcro strap that can be used to secure the device to the patients arm, or reversed so the device is secured to the user's hand for easy movement	Standard velcro strap tested for force tolerance and provides secure attachments and easy removal	Clinical studies verify that trained users can easily secure the device to their hand or the patient's arm
21	2	Product Performance Requirements (e.g. Mechanical)
22	2.1	Durability: Device can withstand rigors of daily use	Device can be used daily for 5 years without replacement	Device never compromised during its guaranteed lifetime	Device does not meet efficiency standard set during manufacture while in use	Sketches, CAD model and 3D printing of a sturdy device design	Accelerated life test is performed to simulate 5 years of use	Clinical studies verify that device can be used daily for 5 years
23	2.2	Portability: device must be compact and portable and lightweight to promote ease in transportation under different settings	Device must be 3lbs or less and smaller than 6in x 6in.	Device is under 3lbs and smaller than 6in x 6in	Device weighs 3.5 pounds, is smaler than 7in x 7in	Sketches, CAD model of device casing, 3D printed prototype	99.99% of devices will be measured and weighed and must fall within the specificaitons	Clinical studies verify that users are able to transport the device as needed
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25		Both
26	4	Regulatory Requirements
27	4.1	As a class II device, the product should be cleared through the 510(k) process	The device passes the 510(k) process	Device passes the 510(k) process	N/A	Description of the device's intended use and indication for use	Clearing through the 510(k) process	Device passes the 510(k) clearning process
28	4.2	Meet general FDA labeling requirements	The device meets FDA labeling requirements	Device meets FDA labeling requirements	N/A	Detailed Labelling specifications	Detailed Labelling specifications	Device meets FDA labeling requirements
29	4.3	Undergo mandatory performance standards	The device is tested and meets mandatory performance standards	The device is tested and meets mandatory performance standards	N/A	Performance specifications	Device is tested using standard procedures for a class II device	Device passes testing for a class II device
30	5	Interfaces with Other Systems
31	5.1	The microneedle and massager devices are able to be used together to improve blood drawing	The massager can be placed on the upper arm to increase blood flow while the microneedle draws blood from the lower arm	Devices can be used simultaneously or one after the other	Devices can be used one after the other	Detailed schematic including relevant dimensions and speciifcations	Devices do not physically interfere with each other during testing, and each device is shown to function properly while in the presence of the other	Clinical trials demonstrate successful blood drawing when devices are used together
32	6	Other
33	6.1	Detailed technical support of device is made available	Provide a comprehensive user manual and 24/7 technical assistance hotline for the device	All customer needs can be resolved by customer support resources	1% of support needs are not resolved	User Manual	User Manual and consumer support via calls and live chat on website	99% of customers report satisfaction with customer support
34	6.2	Efficient training for use must be provided to healthcare professionals	The training program should have a maximum duration of 2 hours for healthcare professionals with blood draw experience	All trainees are able to pass the training program	95% of trainees are able to pass the training program	2-hour training program for healthcare prfessionals	Curriculum is planned, practical and written tests are created to test essential knowledge	Trainees tested on their knowledge by practical demonstration and written quizzes are passed with 100% accuracy
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