Project 3 - Design and Development of Disposable Syringe (Medical Technology)

Task 1

The global disposable syringes market size was valued at USD 13.45 billion in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 6.12% from 2022 to 2030. The growth is attributed to the growing prevalence of chronic disorders, increasing adoption of safety syringes, and a growing number of surgeries globally. For instance, according to Mölnlycke Health Care AB in 2021, 70 million surgical procedures are performed every year in Europe. Since the introduction of disposable syringes, patients no longer have to rely solely on the doctor's sterilization protocols for their safety, as they are discarded after one use. As a result, there is no risk of cross contamination. Advantages of disposable syringes include their low cost and environmental friendliness. These factors are positively impacting sales growth. Manufacturers are focused on efficient sterilizing procedures to avoid infections among healthcare practitioners and patients in the wake of the rapidly spreading COVID-19 pandemic. As a result, companies operating in the market are focusing on improving operational performance in order to increase their global credibility. According to the World Health Organization (WHO), there will be a 2.0 billion needle deficiency by 2022. This is due to increased demand, supply-chain disruptions, and ‘syringe nationalism' that "may pose substantial hurdles in 2022. As a result, most countries throughout the world have begun to reduce security regulations and resume certain elective treatments, indicating that the market will continue to develop during the projection period. 

The safety syringes led the market and accounted for a revenue share of 64.03% in 2021. However, conventional disposable syringes have been in use from a long time, safety syringes are more preferred nowadays due to their benefits. Safety syringes also eliminate the risk of patient-to-patient transmission of infections due to which safety syringes are likely to retain its position throughout the forecast period. The safety syringes are majorly used for administering medications by utilizing specialized and standard techniques. Every year, over 33,800 HIV infections, 315,000 hepatitis C transmissions, and 1.7 million hepatitis B infections are caused by hazardous injecting practices around the world. Unsafe practices such as multiple use of a syringe & needle without taking precautionary measures as guided by the healthcare professionals lead to needle stick injuries. In addition, conventional disposable syringes provide protection to the recipient, but do not assure the safety of patients. Such factors are anticipated to boost the segment growth. The conventional syringes are the second leading segment and accounted for market reveue share of 35.97% in 2021. Conventional syringes are mostly made of plastic with visible graduation and are intended for single use. Some of the advantages of disposable conventional syringes are that they eliminate the risk of infections from blood-borne pathogens, such as HIV, Ebola virus, and Hepatitis B & C. The governments in emerging countries are undertaking initiatives to increase the use of conventional disposable syringes & needles with an aim to reduce the transmission of diseases in patients; thereby, propelling the segment growth over the forecast period. 

Asia Pacific dominated the market and accounted for market revenue share of 31.06% in 2021. Various government measures to reassure the use of single-use medical supplies to prevent infections, as well as the presence of prominent market participants in the region, are expected to help to the region's growth. Furthermore, increase in aging population and prevalence of chronic diseases in the region coupled with high awareness regarding the safety of disposable products are likely to increase the demand for disposable syringes in this region. The syringes are used to administer immunizations for a variety of diseases, including yellow fever, measles, and hepatitis B. The production capacity of 0.5ml syringes AD has already been doubled from 500 million to 800 million per year, with the goal of reaching 1 billion by June 2021 which is expected to spur the market growth. The market is likely to grow at a 6.83% rate. According to U.N. children’s agency in 2021, the shortage might affect up to 2.2 billion auto-disposable syringes that spontaneously lock to prevent re-use. The looming shortfall comes as the delivery of COVID-19 vaccine doses to Africa picks up after months of delay. Due to such shortfall the demand for disposable syringe will continue to grow. Moreover, the market is being driven by increased healthcare spending and adoption of modern healthcare facilities. The South African government, for example, budgeted 13.5% of overall government spending on healthcare program, according to UNICEF Health Budget South Africa 2017/2018. Such occurrences are projected to provide new and significant players in the MEA market with growth prospects.

Companies operating in the market are stepping up their efforts to get their products approved so that manufacturers can start mass production. One of the main areas of concern for manufacturers is the avoidance of unintentional needle stick injuries in healthcare settings. As the injection preparation is completed inside an enclosed system, innovative innovations in prefilled syringe products safeguard nurses and pharmacists from exposure to dangerous substances. Key players in the market are beefing up their R&D capabilities in order to deploy safe and simple medical practices, which is expected to enhance market growth in the near future. Some prominent players in the disposable syringes market include

• MEDTRONIC (Covidien)

• Nipro Corporation

• Fresenius Kabi AG    

• Baxter International, Inc.

• B. Braun Melsungen AG

• BD

• Terumo Corporation

• Novo Nordisk

• UltiMed, Inc.

• Henke-Sass, Wolf

• Retractable Technologies

• Flextronics International Vita Needle Company 

Task 2

The customer needs include

• Quality of the material used
• How freely does the plunger work in the syringe
• Are needles safe to be inject
• Are there any after effects after being injected

Mission Statement: Disposable syringes with great innovation in the field of medical equipment.

Roadmap for disposable syringe

	Q1 2021	Q2 2021	Q3 2021	Q4 2021	Q1 2022	Q2 2022
Syringe Body	Polypropylene body			New material co-engineered with AI
Plunger Rubber	Old Traditional Rubber			New type of rubber that is not actually rubber
Plunger	Old Design			New Egronomic Design
Manufacturing	Vendors			In-house

Task 3

Different material is going to be used rather than the traditonal one to get a good grip and flexible. 

To manufacture plastic syringes, the machinery required will be injection moulding machines, set of multi cavity moulds and sterilization chamber. Polypropylene granules are fed into an injection-moulding machine, where they are plasticized and then injected into a Multi cavity mould. The mould is held under pressure
and material is cooled, the product is then ejected.
PP syringes are made of:
(a) Barrel
(b) Plunger
(c) Gasket
(d) Protector
(e) Hub

Barrel and Plunger are made of PP by injection moulding whereas Gasket is made separately. Syringes produced are packed and then sterilized using Gamma Radiation or Ethylene oxide.

Task 4

The SOLIDWORKS diagram is attached below.

Task 5

FMEA of syringe is attached below.

Fault tree is attached below. 

Task 6

Disposable syringe is a basic responding siphon comprising of a plunger that fits firmly inside a round and hollow cylinder called a barrel. For syringe manufacturing plunger can be directly pulled and pushed along within the cylinder, enabling the syringe to take in and oust fluid or gas through a release hole. The open part of the bargain might be fitted with a hypodermic needle, a spout or tubing to coordinate the stream into and out of the barrel. 

Machineries used for disposable syringes are

• Sterilization Plant
• Blister Packaging machinen
• Automatic packaging machine
• Scrap Guiding machine
• Zigma injection molding machine
• Weighing scale
• Water Pump
• Air Compressor
• Chilling Plant
• Testing Equipment
• Electrical Fittings & Socket
• Set of molds for barrels
• Set of molds for syringes body 16 cavities for barrel & 16 cavity for plungers.

There are generally two types of raw materials, required to manufacture syringes. The first thing is polypropylene and the other is the needle. 

Task 7

The DSM table of disposable syringe is attached below.

Task 8

S. No.	Patent Code	Name	Link
1.	US5085638A	Single use disposable syringe	https://patents.google.com/patent/US5085638A/en
2.	US2478844A	Disposable syringe	https://patents.google.com/patent/US2478844A/en
3.	US2771879	Disposable syringe	https://patents.google.com/patent/US2771879
4.	US2497562	Disposable syringe	https://patents.google.com/patent/US2497562
5.	213035	Single shot disposable syringe	https://www.allindianpatents.com/patents/213035-single-shot-disposable-syringe-and-needle

Task 9

The disposable syringe meet the requirements and updated trends in market for product generation. The product is easier to use compared to traditional syringes.

References

https://www.grandviewresearch.com/industry-analysis/disposable-syringes-market

https://www.alliedmarketresearch.com/india-disposable-syringes-market-A14049

https://www.slideshare.net/zia_ak/disposable-syringe-production-process

https://www.entrepreneurindia.co/project-and-profile-details/Disposable%20Plastic%20Syringes

https://www.justice.gov/archive/jmd/irm/lifecycle/appendixc9.htm

https://www.advancingnortheast.in/wp-content/uploads/2021/09/Disposable-needles-for-syringes.pdf