Production documentation

Device classification

Project description

This project focuses on designing an innovative shin brace aimed at assisting individuals suffering from shin fractures, shin splints, and associated pain. By integrating biomechanical principles, ergonomic design, and advanced materials, the brace will provide optimal support and targeted compression to alleviate discomfort while allowing for movement. The project will involve a comprehensive research phase to analyze existing solutions, followed by the development of customizable prototypes using CAD and 3D printing technology. Through biomechanical testing and user feedback, the project aims to refine the design, creating a functional product that enhances recovery outcomes and improves the quality of life for users engaged in physical activities.

Project context
Clinical needs

Shin braces (tibial braces) provide mechanical support, physical protection, and pain relief for several clinical conditions affecting the shin. The following are the major clinical applications of shin braces.

1. Treatment of Shin Splints
Shin splints are caused by over-using your lower leg muscles and bone tissue, usually from running or repetitive activities. The two main categories of shin splints are medial tibial stress syndrome and anterior tibial stress syndrome. Shin splints cause pain along the lower part of the shinbone often inside the edge of the shinbone. Shin braces are hand in reducing stress on the muscles and bones on the shin hence providing pain relief and preventing further injuries.

2. Treatment of Shin Stress fractures
Shin stress fractures are a result of cumulative strain on the bone without proper recovery time, this makes the bone weaken over time and forms tiny cracks. This is accompanied by localized pain while undertaking activities that involve the tibial bone. Shin braces stabilize the bone, reduce load, and allow proper healing by limiting movement of the tibial bone which could potentially worsen the shin fractures.

3. Treatment of Tibial fractures
Tibial fractures are open or covered breaks of the tibial bone caused by higher energy collisions, falls, and twisting motions. The fractures can also be caused by pre-existing medical conditions such as type 2 diabetes and osteoarthritis. In cases of partial or complete tibia fractures, shin braces help immobilize the leg, allowing the bone to heal properly by keeping it in alignment.

4. Post-operative treatment of compartment syndrome
This condition is where pressure within the muscles in the shin area builds to dangerous levels. This reduces blood flow to the shin tissues and prevents oxygen and nutrient nourishment. Whether acute or chronic compartment syndrome shin braces may be used post-surgery or during recovery to stabilize the muscles and alleviate symptoms

Existing solutions

Existing Solutions

Shin injuries, particularly shin splints and fractures, are prevalent among athletes and the physically active. These conditions also tend to result in unbearable aching and discomfort, in most instances compelling one to reduce the rate of physical activity for a considerable period. The literature review shall discuss the available solutions for the management of shin injuries, particularly focusing on the use of shin braces and splints, as well as other therapeutic interventions.

Shin splints: Current treatments
Medically, shin splints are referred to as medial tibial stress syndrome (MTSS), the inflammation of tendons and ligaments that connect the leg muscles to the inner portion of the shinbone. The major causes include overuse, poorly fitted shoes, and bad training methods. Traditional approaches to dealing with shin splints often comprise conservative measures, which usually incorporate the following:

Rest and Modification of Activity: This reduces physical activity to allow healing.
Ice Therapy: The application of ice reduces swelling and pain.
Compression: Wraps or sleeves can reduce swelling.
Physical Therapy: Exercising sore muscles and enhancing flexibility leads to strengthened muscles with targeted exercises.

In recent decades, another popular bracing intervention has been considered. Similarly, studies have indicated that a shin brace with support and compression reduces pain accompanying the onset of shin splints. A systematic review by Winkelmann et al. (2016) suggested that there may be a benefit in using a shin brace to aid patients with MTSS in an improved recovery rate.

Stress Fractures: Current treatments
Stress fractures result from the repetition of forces on the bone, which create small cracks in the bone. The area usually affected includes the tibia, especially in athletes who engage in high-impact sports. The currently existing solutions for stress fractures focus on:

Rest and Immobilization: Gives the bone time to heal.
Crutches and walking boots: These two help offload the weight on the affected limb.
Graded Return to Activity: After being healed, a well-programmed return to activity will avoid recurrence.

Other treatment options also include bracing. A study by McNamara et al. (2023) proved that rigid shin braces were useful in the management of tibial stress fractures, as they offer stability and reduce pain while healing.
Innovative Approaches
Besides traditional bracing, some new solutions are being developed in the sphere of sports medicine:

Customizable Braces: Personalised braces may be fabricated with the advancement of technology to adopt individual variability in anatomy.
Functional Bracing: Some designs incorporate into the design dynamic elements that allow for movement while still providing support.
Thermal Regulation Materials: Temperature-regulating materials can offer better wear comfort by releasing excess heat and absorbing coolness from the surroundings.

Various treatment options are currently used for shin trauma, from conservative treatments of shin splints and stress fractures to rest, ice therapy, physical therapy, and bracing. Shin braces have shown promise in alleviating pain and facilitating recovery for both conditions. As research continues to evolve, innovative approaches may further enhance the effectiveness of these interventions and improve the outcomes in individuals suffering from shin injuries.

Proposed solution and its innovative aspects

Conceptually, the design of the Shin Brace project will be made using PETG as the primary material in 3D printing. It is designed on SolidWorks CAD for accurate modeling, where iterative refinements can be made possible in response to user feedback.
PETG would be ideal for this application, as it boasts excellent mechanical properties like durability, flexibility, and impact resistance, which are the basic requirements for a wearable device intended to go through regular rigors associated with physical activities (PETG 2019). Hence, high ductility in tensile properties enables the device to absorb stress without breaking, a very critical factor, especially for those users who take part either in sports activities or in rehabilitation exercises. Additionally, good layer adhesion during printing ensures structural integrity in the 3D-printed product.
On the other hand, PETG is not without its disadvantages. It may be sensitive to UV exposure in time, which, if used outdoors, may affect its durability. Besides, it may require a fine surface finish after post-processing. All these minor disadvantages do not matter much considering the general characteristics of PETG while printing, in particular, flexibility and ability to work with the movement of the user without losing support.
This concludes that the use of PETG in the conceptual design of the shin brace presents a strong solution that comfortably balances durability and functionality, hence being optimal for recovering patients from shin injuries.

Intended users

Intended Users of our Shin Brace

Athletes are the most common candidates of shin braces. These cut across the entire spectrum of sportsmen whose profession require cyclical and intense loading of the tibia. Football players suffer lower extremity injuries quite often. They get shin splints as a result of the repetitive impact loading the tibia experiences when these players run, jump, land, and kick the ball. Many football player are diagnosed with tibial stress syndrome(Soccer, n.d.). Increased training intensity and duration especially when the season is just around the corner comes with increased shin splints.

Shin splints are also quite common among dancers. Most inflammations of the shin among dancers occurs during periods if intensified exercise, and when trying new, repetitive moves, especially when an upcoming performance is just around the corner(Shin Splint Solutions for Dancers, n.d.). The resulting increased activity overworks muscles, tendons and bone tissues causing shin splints. Thee dancers are potential users of shin braces to relieve the resulting pain.

Persons with general weakness in the tibia also need shin braces. Anatomical abnormalities resulting in unusual stresses in the tibia is also a common case that necessitates use of shin braces to treat resulting shin splints(Shin Splints, 2023). This help them alleviate pain as they train their legs to get stonier and accommodate more stress and cyclical loading.

ISO compliance

EN ISO 13485:2016
This standard specifies requirements for all entities involved in medical devices, in all stages of the product life cycle: from design to manufacture to installation to disposal. Ubora Platform is structured to be a guideline for design activities in compliance to this standard.
IEC 62366-1
This standard provides guidance on how to manage the human factors while designing a medical device (usability engineering).
ISO 60601
Mechanical properties testing standards for medical devices. Assess durability, elasticity, and load-bearing capacity relevant to orthopedic supports

Design and prototyping

User and evironment

Who is the intended user?
Self-user/patient
Is training required in addition to the expected skill level of the intended user?
No
Is any maintenance or calibration required by the user at the time of use?
No
Where will the technology be used?
Rural settings, outdoors, indoors, at home, primary level (health post, health center), secondary level (general hospital), tertiary level (specialist hospital)

Health technology specifications

Dimensions (mm3)
200 mm x 200 mm x 450 mm
Weight (kg)
0.5 kg
Does it require the use of consumables? For example, disposable batteries, disposable electrodes, etc.
No
Estimated life time
4 Years
Estimated shelf life
3 Years
Can it have a telemedicine or eHealth application?
No
Does it use any kind of software?
No
Is it portable?
Portable
Type of use
Reusable
Does the technology require maintenance?
No
Energy requirements
Mechanical energy (e.g. manually powered)
Facility requirements
Sterilization (description: In case of reuse between patients, sterilization is recommended. 3% - 5% hydrogen peroxide solution is recomended for PETG based materials.)

Design prototyping

Safety Assessment Considerations and Prototypes

For the modeling process in developing a shin brace to help people suffering from shin fractures, shin splints, and general pains in the shins, there is comprehensive prototyping and safety assessment to make sure that the final product is not only effective for users but also comfortable and safe to wear. The stages of prototyping and critical safety considerations we prepare for the entire duration of the project are what we will achieve.

Prototyping Process

Design and CAD Modeling
It includes the creation of very detailed three-dimensional models of the shin brace using SolidWorks CAD design software, thus allowing very accurate iteration of designs with consideration of anatomical data and principles of ergonomics.
Its special features will include adjustable straps for a customized fit, targeted compression zones to help take off the pain, and ventilation openings for enhanced breathability.

3D Printing Prototypes
The prototypes shall be fabricated from PETG, which was selected due to its durability, flexibility, and ease of printing. The properties of PETG are such that the wearable device is resistant to wear and tear but, at the same time, comfortable.
This will involve the printing of multiple iterations to test different design variations, allowing for rapid modifications in light of performance feedback.

User Testing
These prototypes will then get tried on recipients with shin injuries; this is a very important stage for qualitative data concerning comfort, fit, and functionality.
Evaluation involves getting the participants to wear the brace and conduct their usual activities in order to quantify how it might work in real life.

Iterative Refinement
User testing feedback will help in iterative refinements of the design. Some changes may involve the relocation of straps, the rearrangement of compression areas, or coming up with an overall look more aesthetically pleasing.
The aim is to come up with a final prototype that provides support in balance while comfort is placed abreast of ease of use.

Safety Assessment Considerations

This will have to involve a serious safety assessment to make the shin brace safe for its users. The following considerations shall form a guide for the process:

Biocompatibility Testing
Since the brace will be in direct contact with the skin, the performances of biocompatibility tests according to ISO 10993 will prominently be done, precisely skin irritation and sensitization tests to check that the used materials do not present any allergenic effect and do not determine adverse reactions at wear. Tests may involve in vitro tests and clinical testing using human subjects for the full realization of skin compatibility.

Mechanical Strength Testing
Sufficient mechanical strength of the brace concerning resistance to various kinds of forces that might occur in sports activities will be done. In this regard, tensile strength tests will be conducted to ascertain whether it can support stretching without tearing or deforming.
Other tests to be carried out will include those for impact resistance, which will determine the adequacy of protection the brace will accord in case of sudden forces or impacts, a feature quite relevant for persons who engage in sportive activities and other high-impact activities.

Fit and Functionality Assessment:
The proper fit would affect comfort and safety, and the wrong fitting of the brace may eventually lead to further injury or discomfort. Sizing trials will be performed with a heterogeneous group in order to capture the differences in the shapes and sizes of the legs. The functionality assessments will be employed to establish the extent to which the brace can support the tibia with full motion capability while running or jumping.

Regulatory Compliance
The final product needs to comply with regulatory standards relevant to medical devices, such as, but not limited to, ISO 13485. This generally involves detailed documentation through the design process, including design history files-DHF, device master records, and device history records. It also involves compliance with clear labeling and instructions to the user for guidance on proper utilization and maintenance.
Field Testing:
Field testing in naturalistic environments will be necessary to confirm the actual performance of the brace. Participants wear the brace in a range of activities continuously to garner durability, comfort, and effectiveness data. Field testing feedback will yield information on unforeseen issues in normal use.
The project will, therefore, make prototypes in a systematic manner that provides due consideration for these aspects of safety assessment in the design of an effective shin brace. This would merge into comprehensive prototyping with thorough safety assessments, which would ensure that the final product would meet the needs of both the users and the regulatory requirements for market entry. These are achieved through comprehensive methods or approaches that enhance product reliability, and users develop a level of trust in such products as an effective way to manage shin injuries.

Quality criteria and validation test

The design of a shin brace to help people who experience a shin fracture, splits, and aches should be based on rigorous quality criteria. These ensure that the device does not harm the user, that it is effective, and that it meets regulatory requirements. Key quality criteria to be implemented on the product lifecycle are highlighted below.

1. Quality Management System (QMS)

A robust QMS is important in ensuring that standards are maintained right from the design stage to manufacturing. Its key elements include:
Quality Manual: The quality policies, procedures, and responsibilities of all personnel participating in the development and production of the shin brace are described here. It acts as a basis through which guidelines on quality practices are laid down.
Control of Documents: Establish a procedure to control all documents related to design specifications, manufacturing processes, and quality assurance procedures. This shall also include procedures for document version control in order to ensure forces and organizations use only current documents.
Training Programs: Design the training programs for all personnel associated with the project. The training shall deal with norms regarding quality, safety measures, and specific roles while working within the QMS to ensure competency and compliance.

2. Design Control

Design control processes make sure that the product will meet user needs and regulatory requirements:
Design Inputs: The user requirements should be well identified, including comfort, support, flexibility, and durability. These inputs should be documented and reviewed in order to match up with the intended use.
Design Reviews: This involves the execution of periodic design reviews at every stage of the design. These should be cross-functional teams that may be required to assess design progress, identify potential problems, and verify adherence to quality standards.
Verification and Validation: The V&V mechanisms to establish that the design outcomes conform to the specified inputs should be provided. Verification can be in the form of testing prototypes mechanically, while validation can be about performance in a real scenario.

3. Risk Management

A comprehensive risk management strategy is crucial for identifying and mitigating potential hazards:
Perform Risk Analysis: Make a profound risk analysis according to the ISO 14971 standard. Recognize the associated risks that might be linked with the use of the device at work, including allergic reactions to materials or mechanical failure.
Controls: Risk control measures focusing on reducing highlighted risks are developed. For example, design modifications may be pursued to reduce pressure points by padding, or safety warnings in user instructions may be put into place.
Post-market surveillance: Establish a post-market surveillance system that would track the performance of the device upon placement on the market. Data gathering on adverse events or users' feedback has to be performed to monitor emerging risks that might need to be addressed.

4. Manufacturing Controls

Quality criteria at manufacture must be consistent and reliable. This is achieved through:
Good Manufacturing Practice: Implement the principles of GMP at the manufacturing stage to assist in sustaining the quality of the product. This will include facility cleanliness, proper calibration of equipment, and environmental control.
Material Inspection: Any material arriving in the factory should be inspected upon receipt. This would ensure that only quality material is used to begin the production process.
Process Validation: Validate manufacturing processes to confirm that they can routinely produce products that meet specifications. Documented manufacturing process procedures and conducted trial runs to establish baseline performance metrics.

5. Quality Control

Quality control processes are necessary to ensure that each lot of shin braces is within the set standard. Our shin bra
Acceptance Criteria: The function of product conformity is to clearly define acceptance criteria based on physical dimensions, material properties, and functional performance characteristics.

Quality Control: Apply full testing protocols ranging from mechanical strength tests, such as tensile tests, to biocompatibility tests, such as those of skin irritation, to functional performance assessments, such as range of motion.
Traceability: The manufacturing process should be done in a way that the proper material traceability relevant to the manufactured items is documented and that lots are linked to specific batches of finished products. This helps facilitate ease in case an issue arises concerning a particular batch.

6. Compliance with Regulations

Compliance with regulatory standards is critical for medical devices. Our shin brace designed as per the following regulations:
ISO 13485 Compliance: Ensure the alignment of all processes to the requirements of ISO 13485 with regard to medical devices. This is a standard that addresses the necessary framework that provides a quality management system for the manufacture of medical devices.
KEBS Regulations: The shin brace should comply with the KEBS regulations. Ensuring records shall be kept for all quality activities and also reporting any adverse events or product recalls.

7. Customer Quality Objectives

Understanding customer needs is critical in any product development. Our customer engagement processes involve the following:
User Feedback Mechanisms: Design mechanisms that will help gather user feedback during both the testing phase and post-market release. Some of the tools, like surveys and focus groups, can provide valuable insight into users' experience regarding comfort, usability, and effectiveness.
Performance Metrics Development: Establish performance metrics that are responsive to customer expectations concerning durability, weight, ease of use, and effectiveness at pain relief. This will enable subsequent improvements in the product.

References

Amazon.Com: Calf Compression Brace, 1 Pcs Adjustable Shin Splint Support, Calf Brace for Torn Calf Muscle & Shin Splint Pain Relief, Calf Sleeve for Men and Women, Black : Health & Household. https://www.amazon.com/Compression-Adjustable-Splint-Support-Muscle/dp/B0CFDYW4P5. Accessed 29 Nov. 2024.
Australia, Healthdirect. Shin Splints. 30 May 2024, https://www.healthdirect.gov.au/shin-splints.
Compartment Syndrome - OrthoInfo - AAOS. https://www.orthoinfo.org/en/diseases--conditions/compartment-syndrome/. Accessed 29 Nov. 2024.
McNamara, William, et al. “Treatment of Medial Tibial Stress Syndrome Using an Investigational Lower Leg Brace. A Pilot for a Randomised Controlled Trial.” BMJ Innovations, vol. 9, no. 4, Oct. 2023, pp. 257–63. DOI.org (Crossref), https://doi.org/10.1136/bmjinnov-2022-001054.
NV, Scilife. What Is Design History File (DHF)? Complete Definition | Scilife. https://www.scilife.io/glossary/design-history-file. Accessed 29 Nov. 2024.
“Shin Splint Solutions for Dancers.” Dance Buddy Shop, https://dancebuddyshop.com/blogs/exercise-recovery-selfcare-tips-dancers/shin-splint-solutions-for-dancers. Accessed 29 Nov. 2024.
“Shin Splints: Symptoms, Causes, Treatment, and Prevention.” Healthline, 22 June 2023, https://www.healthline.com/health/shin-splints.
“Soccer: Shin Splints | Orthopedic Blog.” OrthoCarolina, https://www.orthocarolina.com/media/shin-splints-in-soccer. Accessed 29 Nov. 2024.
Stress Fracture or Shin Splints? How to Tell the Difference - UChicago Medicine. https://www.uchicagomedicine.org/forefront/orthopaedics-articles/2020/june/stress-fracture-or-shin-splints. Accessed 29 Nov. 2024.
Ultimate Materials Guide - Tips for 3D Printing with PETG. https://www.simplify3d.com/resources/materials-guide/petg/. Accessed 29 Nov. 2024.
Winkelmann, Zachary K., et al. “Risk Factors for Medial Tibial Stress Syndrome in Active Individuals: An Evidence-Based Review.” Journal of Athletic Training, vol. 51, no. 12, Dec. 2016, pp. 1049–52. DOI.org (Crossref), https://doi.org/10.4085/1062-6050-51.12.13.
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Shin Brace