Project 1 - Design and Development of Crutch ( Medical Technology)
Task 1
Canes And Crutches Market size was valued at USD 873.29 Million in 2020 and is projected to reach USD 1.15 Billion by 2028, growing at a CAGR of 3.59% from 2021 to 2028. The rise in the geriatric population, musculoskeletal disorders, and the growing prevalence of osteoporosis, ankylosing spondylitis, and arthritis is expected to fuel the growth of the Global Canes And Crutches Market. In addition, a surge in the proportion of admissions to rehabilitation centers due to rising instances of substance abuse and alcohol addiction is likely to accelerate the use of canes and crutches, as patients tend to lose their balance during these programs. The Global Canes And Crutches Market report provides a holistic evaluation of the market. The report offers a comprehensive analysis of key segments, trends, drivers, restraints, competitive landscape, and factors that are playing a substantial role in the market. Medical crutches are used by individuals who cannot use their legs to support their weight due to some form of disability. There are various types of crutches such as forearm, leg, underarm, platform, and others which help transfer weight from the lower part of the body to the upper part. These are used normally in cases of arthritis, fracture, walking impairment, developmental disabilities, balancing problems obesity among others. The crutches provide more self-confidence and self-dependence to persons facing difficulties in moving.
The high prevalence of osteoporosis & arthritis and the rise in awareness & adoption of crutches are expected to drive market growth during the forecast period. In addition, factors like technological advancements in medical crutches, an increasing number of initiatives & funding by international organizations and governments, and an increase in the number of post-surgery rehabilitation programs are expected to boost the market growth. Moreover, the rise in the geriatric population and the increase in the number of hip, knee and joint replacement surgeries are the other factors that drive the growth of the market. The COVID-19 pandemic initially negatively impacted the demand for the product. The supply chain was highly disrupted due to the pandemic. The pandemic impacted the overall shipping and logistics of crutches and personal care products globally which has also resulted in the high cost of container shipping. The rising cost of supply chain and logistics has had an adverse effect on the company’s finances and liquidity. However, the market is again steadily increasing in every region post-COVID-19 pandemic as the need and demand for crutches increases.
Based on the product, underarm crutch is anticipated to account for the highest market share due to the increase in the number of surgeries combined with the rise in prevalence of the long-term disability disorders are the major factors that boost the growth of the market. In addition, the rise in the geriatric population, surge in cases of accidents, and increase in demand for underarm crutches across the globe are the other factors that drive the growth of the market. The North America region is expected to witness the largest market share and growth over the forecast period. The factors such as the advanced healthcare infrastructure, the presence of favorable government policies, and the highly aging population are some factors contributing to its large share. According to CDC, nearly 61 million adults in the U.S. live with a disability. In addition, acquisitions, investments, and product launch strategies adopted by players are expected to drive market growth.
The industry is marked by the presence of numerous small and large industry players. The medical crutches market is highly competitive in the regions such as North America and Europe. Key global industry players include Sunrise Medical, Nova Medical Products, Millennial Medical, Chinesport, IWALKFree, Cardinal Health, Home Medical Products, New York Millennium Pharmaceutical, AMG Medical, Breg, Inc, and Valley Tool Die, Inc.
Task 2
Crutches are medical devices designed to aid in ambulation, by transferring body weight from the legs to the torso and arms. They are mainly used to assist individuals with lower extremity injuries and/or neurological impairment. This activity describes the types of crutches, their indications, and contraindications and highlights the role of the interprofessional team in proper evaluation and training of patients needing ambulatory devices. Axilla crutches are the most common type. Their ease of use makes them an excellent option for most individuals. They are best for short-term use. The design is intended to transfer most of the user’s body weight to the arms and torso. Axilla crutches are not ideal for individuals with wrist problems, weak upper body strength, or impairment of coordination. Most health care facilities discharge patients with axilla crutches for immediate use. Forearm crutches are better for long-term use. The weight of the user is transferred mainly to their entire upper arms. The user needs good upper body strength to use these crutches properly. Individuals with long-term disabilities looking to be more active or participate in sports may choose forearm crutches as an option. Platform crutches are the least common of the three. The weight of the patient is transferred mainly to the user’s forearms. The platform allows the user more stability than the axilla and forearm crutches, but the platform crutch has less maneuverability. They are intended for long-term use. Individuals with long-term disabilities from severe neurological impairment of their lower extremities with decreased stability may choose platform crutches as an option.
Patients can receive training for different gait patterns depending on their current injury and coordination level.
One crutch gait: This pattern utilizes only one crutch. Crutch positioning is on the side of the uninjured lower extremity. The crutch and the injured leg are advanced forward. Then the uninjured leg proceeds while the crutch supports the user's weight.
Two-point gait: The left crutch and right leg move forward followed by the right crutch and left leg.
Three-point gait: This is the most used technique. The left and right crutch along with the injured leg are both advanced while the uninjured leg supports the body weight. Next, the uninjured leg is advanced.
Four-point gait: This technique provides the most support. The left crutch is advanced followed by the right leg, right crutch and at last the left leg.
Swing-to gait: The left and right crutch are advanced. Then the left and right legs are advanced.
The user’s strength and coordination should undergo evaluation before issuing them a set of crutches. The use of the wrong crutches can lead to injury. Most injuries are a direct result of falling. Crutch palsy is observable in axilla crutch users who rest their weight on the shoulder rest. The pressure on the brachial plexus can result in palsy to the radial and ulnar nerves. Extra padding on the shoulder rest can aid in preventing crutch palsy. Education should be provided to patients to discourage supporting body weight on the shoulder rest. With treatment, this can be a repairable injury.
Task 3
The design of a new and feasible tool that allows us to control and improve the accuracy of loads exerted on crutches during aided gait is necessary, so as to unburden the lower limbs. Crutches need to be redesigned to be more user-friendly; this means that our product design specifications are based on the needs of clients. The design requirements should refer to the policies of world health organization (WHO). The WHO lists the examples of policies on medical devices in their words as;
• Regulations of medical devices minimize risk to the population,
• Safe use and availability of medical devices improve health service delivery,
• Affordability of medical devices increases health service coverage,
• Telemedicine enhances patient centered care,
• Health technology assessment provides basis for priority setting and informed decision-making,
• Needs assessment helps in the rational allocation of resources,
• Research and innovations respond to the needs of a particular health system and population.
On the other hand, sprained ankles and leg injuries are the most frequent health issues around the world. The use of crutches assists the walking with one leg to be mobile. Besides, according to the report of 2013, the number of walker users is 1.8 million people and the number of crutch users is 566,000 per day in US.
The objective of this specification is to help organizations in procuring good quality crutches that are durable and which assist the individuals with mobility impairments in walking and standing.
Mechanical Interface: The crutch is a mechanical device in itself without having any electrical connection to move around. The usage of the device is not a big hassle.
Human-machine Interface: Just before using the crutch, if it self assemble, assemble it. They put your arm in the slot and get up with the strength of the arms. Then move one crutch ahead at one time not more thna that or you might fall flat on face.
Task 4
Roadmap:
| Q1 2021 | Q2 2021 | Q3 2021 | Q4 2021 | Q1 2022 | Q2 2022 | |
| Handle | Normal Grip | Customized | ||||
| Hand Grip | Plastic | Rubber Grip | Silicon Grip | |||
| Shaft | Integral | Modular | ||||
| Foot Grip | Traditional | Foot Grip | Suction Foot | |||
Mission Statement:
Delivering products and solutions to improve the lives of people every day. We offer expertise and high standards of professionalism normally associated with national durable medical equipment companies, while retaining the vital aspects of personal contact and close attention that characterize us and set us apart from the competition.
Staffing Requirements:
Department would need the design workers to be working on the design as well as the mechanical engineers to work on the mechanics of the crutch. 100% of the staff would be needed in 50% for the Q2 release and 50% for Q4 release. This way if a new project comes up the engineers working on Q4 release can work on the new and urgent project.
Product Schedule:
First phase of crutches will be released in Q2, thus the design and manufacturing should be completed atleast 15 days before the launch date. Initially about 10% of the decided pieces will be made to release in the market. Depending upon the response by the public, production of the crutches will go underway. For the design and manufacturing of the suction cup crutch, it should be completed by second month of the third quarter. Once the design is made, it needs to be approved by the design department. Once it gets the verification, a prototype will be made and the product needs to be validated. Once the validation is done for the prototype, validation for the manufacturer needs to be done.
Task 5
| Simplicity | The design of the crutch is different from the original design, thus bringing in a sense of familarity. Adding an arm lock to slide the arm. |
| Immediate Intuition | The intution of a crutch are two rods with a wooden piece stuck between them. |
| Approachable Innovation | The foot rubber be changed to a foot design and the handle have some silicon in it so that the person using it does not get tired. |
| Aesthetics | The crutch should not look like a handcuff. |
| Egronomics | It should be comfortable to use and easy to move in. |
Design drawing of crutch is attached below.
References
https://www.ncbi.nlm.nih.gov/books/NBK539724/
https://www.mdpi.com/1424-8220/16/6/925
https://ebrary.net/191200/engineering/conceptual_design_composite_crutches
https://www.mdpi.com/2076-3417/9/23/5032
https://northwoodinc.com/wp-content/uploads/2020/01/Canes-and-Crutches.pdf
https://www.mountsinai.org/health-library/discharge-instructions/using-crutches