Project 2 - Design and Development of Pulse Oximeter (Medical Technology)

Task 1

Pulse oximeter is a device that is used to record the heartbeat of a person. This device reads the pulse of a human being via the blood flow in the blood vessels. Due to the recent events such as Covid-19 the market cap of pulse oximeter reached to 2.66 bilion USD in 2021. The market is expected to reach 3.02 billion USD by 2029. The highest sellers for pulse oximeter in India are Hesley, Dr. Trust etc. The state-of-art pulse oximeters in market is Hesley Pulse Oximeter Fingertip. These oximeters have 66% of the users rating it five stars and it has features like Plethysmograph anbd Perfusion Index.

key market players in the world :

major players in thid market are Metronic plc (ireland) , masimo corpration ( US ) , Nonin medical ( US), Nihon Kohden corpration (japan), GE healthcare (US).

induatrial trends :

The recent trends being in the market are oximeters which are reliable, accurate and fast. Such oximeters are on the rise for sale in the market.

Task 2

	Customer Statement	Need Statement
1	Body is fragile.	Oximeter needs a good build.
2	Too tight to open.	The opening mechanism needs to be loosened a bit.
3	Screen is too small.	Screeen size should be increased or an alternative needs to be provided.
4	Top is fragile and button is impossible to press.	The function button needs to be made of better quality.
5	Battery needs frequent replacement.	Battery should be an option only when the patient is in mobile state.

	Mission Statement
Product Description	Oximeter with customize options and fixed options with redesigned wearable design.
Benefits Statement	No more wearbale problems. No battery issues. Robust body.
Buisness Objectives	Competitve pricing over the existing oximeters in the market. Recieve 5-star ratings in safety. Launch product by the fourth quarter this year.
Core Market	The patients who use oximeters for longer time intervals and have problems seeign on screen or have children who live far but want to keep a check on their parents.
Stakeholders	Manufacturing and supply chain partners. Retailers and stores Existing and new customers

Roadmap of oximeters

	Q1 2022	Q2 2022	Q3 2022	Q4 2022	Q1 2023	Q2 2023
Battery	Old Battery Type			New power type with charger and battery
Screen	LCD Screen		OLED Screen		Screen shifted to mobile via app
Button	Push Button			Touch Sensor
Body	Plastic Body			Plastic Body and Carbon Fiber

Resource Requirement: The device needs carbon fiber for the body to be made and a coder to make the ap exclusive to the device and a design engineer to fit all of the components inside the device and make it minimal.

Task 3

work breakdown structure

The architecture selection for the pulse oximeter would be a integral architecture. Now why would I select an integral architectural system. Well right now we have more of a modular structure for the oximeters, like if it gets damaged the company can easily change the part and since it is modular it will be having somewhat parts that can be swapped. But if it is integral then the whole of the oximeter is one system, i.e. all of the parts of the system need to depend on each other and the integral one will have significantly less breakdowns since everything will be one part thus rejection and delay will not be an issue for the oximeter.

3D rendring image

2D engineering drawing

Task 4

Component/Process	Failure Mode	Failure Effect	SEV	Potential Cause	OCC	Existing Detection Method	DET	RPN
Battery	Less backup or not turning on	The machine does not turn on or just doesn't take any reading.	2	Used Batteries Batteries falling because of lost battery compartment lid	9	Changing the batteries to see if that is the cause and also checking if the oximeter has a back lid first.	1	18
Lose Arms	Falls off patient	The machine does not stay on that patient's finger and slips the any chance it gets.	6	Banged on a machine while shifting patient or maybe fell off due to staff carelessness Spring got loose due to use overtime	7	Check if there are any visible cracks or if the machine is getting easier to put on.	3	126
No Input	SPO2 not detected	The machine does not show any reading and the screen is showing error.	4	Internal wiring got snapped Faulty equipment at the time fo purchase LED got busted	3	Check if the LEd is blinking or not and check at the time of recieving.	1	12
Screen	Low visibility	Cannot see the reading clearly as you could before.	2	The display lost its contrast Got banged at a wall or on the wall while shifting the patient	5	You can detect it normally by looking at the screen.	1	10
Button	Cannot switch between modes	Either does not work or just siimply gives no output.	2	The rubber gets soft and loses tension The button gets moisture in it and stops working	2	It can be confirmed by pressing the button several times.	1	4
PCB Short Circuiting	Machine not responding	Machine does not even boot up.	4	Any type liquid be it water opr blood goes inside the casing due to open cover of batteries can cause the reaction	1	It can confirmed by changing the batteries and pressing the buttton several times. If these things do not work open the lid to see the traces.	2	8
Coding Error	Less accuracy everytime	Boots up but will not give reading or just give a wrong reading.	3	The product came defective from the company	1	By comparing with other oximeters.	5	15

Component/Process	Recommended Actions	Responsibility	Target Date	Action Taken	SEV	OCC	DET	NEW RPN
Battery	Make sure the battery lid does not fall off and batteries are changed at any sign of weakness.	Owner	Immediately	Batteries are changed	1	9	1	9
Lose Arms	Make sure the oximeters are handled with care and have some spare oximeters.	Owner	In a few days	Taught staff and took traioning sessions.	2	7.	3	42
No Input	Have a spare oximeter.	Owner	In a week	Checked the product when it arrives	1	3	1	3
Screen	Order some sparen oximeters in time.	Owner	In a week	Kept some oximeters in stock and checked all oximeters before leaving the shift.	1	5	1	5
Button	Make sure you have spares and button is used with care.	Owner	In a few days	Make sure the buttons are taken care for.	1	2	1	2
PCB Short Circuiting	Make sure th elid covers are in place.	Owner	Immediately	Lid covers are sealed with tape so they dpo not fall off and any oximeter with crack was taped up.	1	1	2	2
Coding Error	Keep some spares just in case.	Company	Immediately	As soon as a faulty one is encountered contact the supplier.	2	1	5	10

fault tree analysing

Task 5

So the main area where the DFMA will be maing the most impact is planning of assembly of the device. Also how to make the device use the least amount of energy and material to be produced. So the assembly of the oximeter neess to be planned inorder for it to be not able to be revrse engineered and leave the leasta mount of waste material. I would make use of AI for getting the assembly line in order. If i wish to use human assembly line along with the machines, then I have to evaluate first which person can do what the best. Since the machines will be doing the most part the human being should be able to monitorn the machine while it goes on with the work. Also too long of a process will certainly take a lot opf energy as well as time and will not be either cost efficient or time efficient. So I will have just a few of the process line. With the AI analysis on the assemblyline I can reduce the amount of steps it will take to make a device and I cut the process short. This wil lead to lesser energy usage. A viewe on the themals of the machiones will also help me save on energy. Also some of the materials can be 3D printed to save time. Now when carbon fiber will be used for 3D printedd so the cost regarding getting the material processed beforehand will be cut off. Also the double cost for shipping will be removed. So if generation of one oximeter if it was going to cost 1000 at first will not go down to 800 including shipping charges. Also getting the materials made in the home company itself is benefitial for the company. Now getting the material 3D printed and made in the company itself is quite environment friendly. It saves up on the detyeoration that would have happened in getting the material made soemwhere else and then gfetting it shipped twice and throwing away excess material. Now since the material that will be used is carbon fiber, thye material stronger than stell but polluter of environment. So what would we do. We will ask the users to like return the piece that has been destroyed. Now if it is repairable, we will repair it, but if it is not repairable we will recycle it. For giving back to the comapny the user will be given off on the next billing of the oximeter. This way any working oximeters will be restored and sold to small buisnesses at a discounted price and the customers get a discount.This will reduce the amount of waste in the landfills. now we just cannot just go and launch the product in the market right? So for launching we need to get the permission from the higher ups. Now how to get that? Prototyping. Once the design is approved by the design team, some people are shortlisted for making the prototype, but since the company is targetting to make everything in their premises, the prototypes will be made by the manufacturing team. The made prototypes will be tested and data collected from the public and doctors if they will be intrigued with the design and go on with it. Once the protoype with the best reviews is obtained the production will begin. All of the parts will be printed in the company itself, so the design will be made modular and robust. A chain of human will be used to assemble the product after its made. Now the PCB will be made by the electronics department of the company and design will be overseen by the design team. The large scale, heavy duty 3D printer wil be used to make the base. The PCB will be made complex that will make it hard to revrse engineer. Since the machine will be of integral architecture it will not take much time to be made. The oximeter will be 3D printed since 3D printing is the fastest way till date to make a part or a whole pieve of a car. That's why we will get the oximeter 3D printed. For maing it harder to be revrse engineered, the PCB needs to be made complicated and the oximetr nearly impossible to be opened by a hand. Such things will protectt he devcie from being revrse engineered. Now regardignt the software, the best computer engineers will be asked to make the code without outside help so that the code is unique and only 2 applications can be actiovated onmce after beign downloaded. Such measures can be taken to prevent revrse engineeing.