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

PROJECT 3- DESIGN AND DEVELOPMENT OF DISPOSABLE SYRINGE(MEDICAL TECHNOLOGY)

DISPOSABLE SYRINGE

• Disposable syringes are becoming ever more common within the medical industry. This is due in no short part to both the want to streamline the workload and to prevent the spread of blood-borne illnesses.
• They’re also relatively cheap and easy to mass-produce allowing for a higher level of accessibility.
• Generally speaking, syringes are instruments used to either insert or draw solutions from a larger body. Typically operated via a piston-pump system, they are the primary method by which a doctor or nurse would administer medication to their patients.
• Historically, syringes would be cleaned and reused. However, within more modern times the disposable syringe has risen in popularity over the traditional reusable syringe.
• The primary difference being that a disposable syringe is intended for one-time use and is then disposed of, typically into a contamination unit.

Types of Disposable Syringes

While simple in concept, syringes have multiple variants and parts that are interchangeable depending on the intended use of the syringe. Generally speaking, these are factors that may vary dependent on the syringe being used.

• Size
• Tip
• With / Without Needles
• Needle Length
• 2-part Disposable Syringe
• 3-part Disposable Syringe

TASK 1

MARKET ANALYSIS

1-Existing and potential customers, addressable market size

• The global disposable syringes market was estimated at USD 6.73 billion in 2021 and is predicted to reach USD 11.02 billion by 2030, expanding growth at a CAGR of 5.6% over the forecast period 2022 to 2030.

• As a substitute for the glass hypodermic needles, disposable plastic syringes have been launched. These are used in all the healthcare services across the globe to provide medicines to uncountable patients following this breakthrough.

• Syringes are accessible in bulks and are among other items, can be used to administer medications via intravenous, intramuscular or intradermal routes. Disposal of them can have impact on the environment which is a major concern.

• This is ill-suited to demand for supportable growth, but healthcare organization is growing worldwide in response to the growing demand for decent medical care and the rise in chronic diseases, drug administration is becoming increasingly prevalent. In any healthcare environment, it is a actual simple operation, and disposable syringes are an integral part.

• Dealings like the latest COVID-19 epidemic make investing in the future more profitable for the market for disposable syringes. The growth of the global demand for disposable syringes is motivated by an increase in the incidence of needle stick injuries, increased healthcare spending worldwide, supportive government policies, and a rise in chronic conditions and infectious diseases.

• However, costly disposable syringes for protection and access to various distribution modes inhibit the growth of the market. On the other hand, in developed countries, the rise in untapped capacity generates new prospects in the coming years.

2-Top Players contending in the Market:

• The market is highly fragmented and is characterized by high competition with the presence of major global players. These companies particularly focus on enhancing product quality by adopting advanced and innovative techniques to enhance their market presence and expand their geographical reach.The key players are concentrating on research and development is anticipated to lead the disposable syringes market.
• Key companies like Baxter International and Fresenius Kabi AG are aiming towards profitable development by accepting strategies like mergers and acquisitions, weighty investments in the industrial facilities that is expected to fuel the worldwide market growth in near future. This tendency is likely to continue and will enhance growth of the aiming industry in forecast time frame. Also, stringent government regulations regarding usage of secure and engineered devices in medical sector will flourish target market growth over the forecast time frame.

Foremost players challenging in global disposable syringes market are:

• Fresenius Kabi AG
• Flextronics International Vita Needle Company
• Braun Medical, Inc.
• Baxter International, Inc.
• Terumo Corporation
• Novo Nordisk
• Henke-Sass, Wolf
• Retractable Technologies, Inc.
• UltiMed, Inc.
• Covidien
• Becton, Dickinson and Company.

3-History of the product

Syringe is one of the most widely used instruments in medical institutions, and it is an item that nurses must come into contact with every day. It is necessary for us to have some understanding of its historical knowledge.

The word syringe comes from the Greek word “syninx”, which means “tube, barrel”. As early as the 15th century, the Italian Cartinel proposed the principle of the syringe. In 1657, Englishmen Boyle and Wren, based on Catinel’s hypothesis, used a feather tube as a puncture needle and a dog’s bladder as a liquid container, and squeezed the dog’s bladder. into the human body. But because it is very inconvenient to use, it has not been widely used.

In 1809, the French physiologist Francois Magendie pierced the patient’s body with strychnine-coated wood chips through the skin, but unfortunately, his patient died.

In 1844, Irish doctor Francis Reid invented a hollow needle-21, which has a very important significance in the history of the invention of the syringe.

In order to relieve the pain of a neuralgia patient, Scotsman Alexander Wood invented hypodermic injection therapy by injecting morphine through a syringe near the nerve involved in the pain. Since then, the patient no longer has to endure the pain caused by cutting the skin.
The invention of subcutaneous injection facilitates another route of administration in addition to oral administration. Because it can act quickly and directly enter tissues without passing through the intestinal tract, it reduces the damage of digestive enzymes to the drug, so it is highly favored by doctors. favor.
Soon, intelligent human beings discovered the microbe and its relationship to human disease, so there was a lot of focus on the use of sterile items when injecting.

Therefore, people began to sterilize the syringe by boiling it or soaking it in ethanol. Needles become dull after multiple applications, so there is a practice of periodically grinding the needle on a whetstone.

In 1869, the Frenchman wulingLu developed Ferguson’s improved syringe, and the syringe entered the stage of history with a new look, and the all-glass syringe he made made sterilization easier.

Later in the clinical application process, people gradually changed the shape of the syringe, which made it more convenient and firm to take the syringe, and made it possible to operate with one hand. In order to prevent medical workers from infecting diseases in the process of injecting multiple patients with one needle, Arthur e smith invented a single-use syringe from 1949 to 1950 and obtained a number of US patents.

In 1955, plastic was used in the design of syringes and the world’s first disposable plastic syringes came out. Since then, plastic syringes have become very popular, and new, safer, more wear-resistant and cheaper products have appeared in the field of human health. Syringes have played a very important role in promoting human health.

4-State-of-the-art products

Depending on their intended use, syringes can come in a wide variety of different shapes and sizes. Syringes made to penetrate bone are not as thin and brittle as those used simply to provide insulin to the blood stream. Despite the variation in size however, the general idea behind the device remains more or less uniform.

While simple in concept, syringes have multiple variants and parts that are interchangeable depending on the intended use of the syringe. Generally speaking, these are factors that may vary dependent on the syringe being used.

• Size
• Tip
• With / Without Needles
• Needle Length
• 2-part Disposable Syringe
• 3-part Disposable Syringe

5-Market Trends/Key Takeaways

• The current COVID-19 pandemic has, in general, stressed on the use of single-use plastics and disposable syringes in the healthcare sector.
• New and single-use products are more hygienic and aid in preventing infectious diseases.
• However, widespread use of plastics and disposable products also increases biowaste. Such scenario has given rise to a major debate over the use of disposables in the healthcare sector.
• High prevalence of needlestick injuries in emerging economies is expected to aid in growth of the global disposable syringes market.
• For instance, according to an Environmental Health and Preventive Medicine study published in August 2019, the prevalence of needlestick injuries among the Ethiopian healthcare workers was 28.8% and 43.6% for the 12 months and lifetime, respectively.

TASK 2

PRODUCT PLANNING AND CONCEPT GENERATION

1-Customer needs study

• Customers are increasingly emphasizing purchasing advanced products to improve their lifestyle and health.
• Customers are always worried about the poor hygiene of syringes in the hospital as they spread wide range of diseases from one person to another.So, customers are always looking for a hygiene way of injecting medicine into the body.
• For customers injecting medicines regularly, always require syringes in large quantity. So, they prefer syringes which are affordable and have quality.
• Customers need to inject different dosage of medicine as prescribed by the doctor, so they prefer having syringes with proper label and in different range of quantities.
• Consumer Trends Change Over Time. It’s no surprise that with the changing environment comes a change in consumer trends and consumer shopping patterns. Many customers enjoy the ease of shopping and purchasing what they need online and have it shipped straight to their front door. This trend is made even easier with mobile phones allowing customers to browse while on their phones on the syringe production line.
• As manufacturers, it’s important to listen to customers and stay ahead of the trends, so that time and resources are not wasted manufacturing products which are no longer in demand.
• Customers now require the same level of service from producers as they do from retailers. One of the best ways to address this need is by directing more energy towards communication technology. Utilize technology to help improve communication between employees, as well as customer service, because remaining connected is a basic necessity.
• This is especially true as we see the consequences of globalization, which opens up more business opportunities and demands a greater level of communication. At this stage, manufacturers can no longer rely simply on telephones to stay connected but should try to incorporate instant messaging and video conferencing to enhance communication.

2-Value proposition of the product

• Value proposition-"Your health is in our hands and your peace of mind starts here"

A Value proposition comes from the heart of the product or service you’re selling. And that, without exception, gives way to a more emotive proposition. At the end of the day, people buy from people. And people are not cold, fact-driven, decision-making machines. Actually, our emotions tend to come into play first, then we use the facts to post rationalise our judgments. A purely fact-based play might make sense rationally, but it’s unlikely to help build those emotional connections.

3-Mission statement

Product Description:- A convenient and affordable disposable syringe with wide variety of syringe sizes that are ideal for different applications.

Benefits Statement:- A safe, hygiene, comfortable and affordable disposable syringe.

Business Objectives:- Keeping the health of the customers at the top of our priority list, we aim to provide a healthy and hygiene way of injecting medicine into your body.

Core Market :-U.S; Canada; UK; Germany; France; Italy, Spain;Japan; China; India; Australia; South Korea; Brazil;Mexico; Colombia; Argentina; South Africa; Saudi Arabia;UAE

Stakeholders:-Defines customers, shareholders, in-vestors, employees, suppliers, government agencies, research institutes and communities that directly and indirectly affect its business operations as its stakeholders.

3-Product platform plan for current and future products

4-Product roadmap

5-Resource allocation and concept generation

Staffing requirements:

• Generally we require mechanical and industrial engineers.
• No. of staffs depends on the volume of production.

Budget requirements:

• To develop a disposable syringe, requires lot many parts like Raw materials, Specialty chemicals, needles, Technology components and cost of these parts depends on the company that we buy from.
• the cost of the staff, depends on the volume of production, high production means requires many staff members.
• It also includes fixed cost like land, machines etc.

The concept generation was based on the major benefits of disposable syringes which include being the most cost-effective type of syringe, non-toxic and disposed of safely, ease of handling with minimal instruction, training or explanation before use (although syringe should only be used by medical professionals) and durable construction.

TASK 3

PRELIMINARY DESIGN AND DEVELOPMENT PHASE

(A)-Systems-based product design and planning

1-Feasibility study summary

As a substitute for the glass hypodermic needles, disposable plastic syringes have been launched. These are used in all the healthcare services across the globe to provide medicines to uncountable patients following this breakthrough. Syringes are accessible in bulks and are among other items, can be used to administer medications via intravenous, intramuscular or intradermal routes. Disposal of them can have impact on the environment which is a major concern. This is ill-suited to demand for supportable growth, but healthcare organization is growing worldwide in response to the growing demand for decent medical care and the rise in chronic diseases, drug administration is becoming increasingly prevalent. In any healthcare environment, it is a actual simple operation, and disposable syringes are an integral part. Dealings like the latest COVID-19 epidemic make investing in the future more profitable for the market for disposable syringes. The growth of the global demand for disposable syringes is motivated by an increase in the incidence of needle stick injuries, increased healthcare spending worldwide, supportive government policies, and a rise in chronic conditions and infectious diseases. However, costly disposable syringes for protection and access to various distribution modes inhibit the growth of the market. On the other hand, in developed countries, the rise in untapped capacity generates new prospects in the coming years.

Crucial factors accountable for market growth are:

• Increasing number of patients at risk of developing stroke
• Increasing patient awareness
• Increased health care expenditure
• Large pool of geriatric population

COVID-19 Impact on Global Disposable Syringes Market

The implications on the overall market, including both the demand side and supply side viewpoints, of the Covid-19 pandemic will be played out and analyzed. All nations around the globe have conducted life saving immunization programs for different diseases and viral infections, increasing the market for disposable syringes. In addition, the WHO has proposed the use of disposable and auto-disable syringes to obtain blood samples from 19 patients with Covid, which in turn helps prevent transmission through healthcare facilities.

Future of Global Disposable Syringes Market

Key companies like Baxter International and Fresenius Kabi AG are aiming towards profitable development by accepting strategies like mergers and acquisitions, weighty investments in the industrial facilities that is expected to fuel the worldwide market growth in near future. This tendency is likely to continue and will enhance growth of the aiming industry in forecast time frame. Also, stringent government regulations regarding usage of secure and engineered devices in medical sector will flourish target market growth over the forecast time frame.

2-Concept of Operation (ConOps) document

• Identify the required mission(s) in functional terms.
• Define the risks to accomplishing the functional outcomes.
• Describe capabilities required by the customer or its’ stakeholders/partners to accomplish the mission.
• Describe the capabilities independently of whether or not the customer currently possesses them.
• Do not specify capabilities in terms of assets, equipment, or other means that might satisfy the need; i.e., state the capability (need), not the solution (equipment).

• Measures of Effectiveness - Operational measures of success that are closely related to the achievements of the mission or operational objectives evaluated in the operational environment, under a specific set of conditions.
• Measures of Performance ‒ characterize physical or functional attributes relating to the system operation, measured or estimated under specific conditions.
• Key Performance Parameters ‒ capabilities and characteristics so significant that failure to meet them can be cause for reevaluation, reassessing, or termination of the program

Without the ConOps, we're laying the groundwork for project trouble and these root causes ...

3-Requirements for the product

Some of the basic machines and equipment needed to make disposable syringes are the following:

• Injection Moulding Machine
• Sterilization Plant
• Scrap Grinding Machine
• Air Compressor
• Bilster Packing Machine
• Water Pump
• Chilling Plant
• Different types of Moulds
• Vacuum Dust Cleaner
• Rubber-tip Washing Machine.
• Foil stamping or screen printing equipment.
• Lab Equipment
• Weighing Devices
• Granulator
• Packing Materials

4-Work Breakdown Structure (WBS)

5-Product verification and validation plan

Solidworks- Syringe 3D model, Rendering sketch and 2D drawing- PDF ATTACHED

TASK 5

(A)FAILURE MODE AND EFFECT ANALYSIS(FMEA)

1-

2-

(B)- FAULT TREE ANALYSIS(FTA)

TASK 6