14. Prosthetic Devices

Introduction

Implanted prosthetic devices are used for functional, cosmetic, or therapeutic purposes in medical treatments. These devices include a wide range of implants, such as breast implants, catheters, and joint replacements like hips and knees. The demand for hip and knee replacements is growing rapidly, with over 102,000 knee replacements and 91,000 hip replacements performed annually in the UK alone. This demand is projected to increase significantly, with estimates predicting an increase of 174% for hip replacements and 673% for knee replacements by 2050. Despite the success of these procedures, they come with considerable risks, including prosthetic joint infections (PJIs), which contribute to high failure rates, complications, and extended recovery periods. PJIs can lead to reduced quality of life for patients, an increased burden on healthcare services, and significant economic costs.

Task

Your team is tasked with designing an innovative method or procedure to protect patients from infections following total hip or knee replacements. The solution should focus on minimising infection risks and reducing the long-term burden on healthcare services like the NHS. Your solution should also account for the sustainability and biocompatibility of materials used, ensuring minimal adverse effects on patients. Start by researching the types of implants currently in use, evaluating materials for cost, availability, and effectiveness. The solution should be affordable, reduce infection and rejection rates, and offer long-term benefits to both patients and healthcare systems.

Considerations

1. Technology
Biocompatibility is a crucial factor when designing prosthetic implants, as the materials used must not cause harm or adverse reactions in patients. Explore current research and databases that provide information on biocompatible materials and consider how innovative technologies like antimicrobial coatings or surface modifications could further reduce infection risks.

Questions to consider:

• What biocompatible materials are currently used in prosthetic implants, and how effective are they in preventing infections?

• Are there new or emerging materials or technologies (e.g., antimicrobial coatings) that could improve implant safety and longevity?

• How can your design improve existing implant materials to ensure minimal infection risks while maintaining functionality?

2. Infrastructure
Prosthetic implants must be integrated into the current healthcare infrastructure for seamless implantation and post-operative care. Consider how your proposed solution can be implemented using existing medical technologies and systems. Additionally, evaluate how the solution fits into the existing supply chain, manufacturing processes, and healthcare facilities.

Questions to consider:

• How will your solution integrate with current surgical practices and post-operative care procedures?

• What infrastructure, in terms of hospital resources and equipment, will be required for your solution to be effectively implemented?

• Are there logistical considerations in manufacturing and delivering the implants to healthcare facilities?

3. Market Factors
As the demand for hip and knee replacements grows, the market for prosthetic devices continues to expand. Your solution must be economically viable, both for healthcare providers and patients. Consider how the cost of your design compares to current alternatives and whether it can be scaled to meet the growing global demand.

Questions to consider:

• What are the cost implications of your solution compared to current prosthetic devices, and how will it impact healthcare budgets?

• How will your design reduce costs related to post-operative infections and long-term care?

• Is your solution scalable to meet increasing global demand for prosthetic implants?

4. Safety, Security, and Risks
Safety is paramount in the design of prosthetic devices, particularly when dealing with infection risks. Assess the risks associated with surgical implantation, post-operative complications, and long-term durability of the implant. Consider how your design can minimise these risks while enhancing patient outcomes.

Questions to consider:

• What are the most common infections associated with prosthetic devices, and how can your design reduce the risk of these infections?

• What safety protocols should be implemented during surgery and post-operative care to ensure the success of your solution?

• How will your solution address long-term risks such as implant failure, infection recurrence, or complications?

5. Project Management Approach
Designing and developing a new prosthetic device or procedure requires a structured project management approach. Consider how your team will manage research, development, testing, and eventual deployment of the solution. Outline a timeline for key milestones and allocate resources efficiently.

Questions to consider:

• What project management methodology will you adopt to ensure timely completion of the design, testing, and deployment phases?

• What are the key milestones in the development of your solution, and how will progress be measured?

• How will you allocate resources, including budget and personnel, to ensure successful project execution?

6. Costing and Feasibility
Cost is a critical factor in healthcare, particularly when considering the affordability of new medical devices. Your solution should offer an improvement over existing technologies without significantly increasing costs. Evaluate the cost-effectiveness of your design, including manufacturing, implementation, and long-term care costs.

Questions to consider:

• What are the estimated costs of developing, manufacturing, and distributing your prosthetic device or procedure?

• How does the cost of your solution compare to current prosthetics in terms of both short-term and long-term affordability?

• Is your solution financially sustainable for healthcare providers and patients, and what is the expected return on investment?

7. Sustainability, Ethics, Equality, Diversity, and Inclusion
Sustainability is an important consideration in medical device design. Your solution should minimise environmental impact while maintaining long-term viability. In addition, consider the ethical implications of the design and its accessibility to diverse patient populations. Ensure that your solution promotes equality and is available to all patients, regardless of socioeconomic status or geographic location.

Questions to consider:

• How will your solution minimise environmental impact in terms of materials, manufacturing, and waste?

• What ethical considerations should be taken into account when designing prosthetic devices, especially regarding patient safety and long-term outcomes?

• How will your solution ensure accessibility and inclusivity for all patients, including those from underserved or marginalised communities?

Further Information

1. The National Joint Registry Editorial Board, “15th Annual Report 2018,” Natl. Jt. Regist. England, Wales, North. Irel. Isle Man, vol. 15, 2017. Available:  https://www.hqip.org.uk/wp-content/uploads/2018/11/NJR-15th-Annual-Report-2018.pdf [Accessed October 9, 2024].

2. B. D. Springer, S. Cahue, C. D. Etkin, D. G. Lewallen, and B. J. McGrory, “Infection burden in total hip and knee arthroplasties: an international registry-based perspective,” Arthroplast. Today, vol. 3, no. 2, pp. 137–140, Jun. 2017.Available: https://pubmed.ncbi.nlm.nih.gov/28695187/. [Accessed October 9, 2024].

3. E. Lenguerrand et al., “Risk factors associated with revision for prosthetic joint infection following knee replacement: an observational cohort study from England and Wales,” Lancet Infect. Dis., vol. 19, no. 6, pp. 589–600, Jun. 2019. Available:  https://www.sciencedirect.com/science/article/pii/S1473309918307552?via%3Dihub, [Accessed October 9, 2024].

4. A. J. Tande and R. Patel, “Prosthetic joint infection,” Clin. Microbiol. Rev., vol. 27, no. 2, pp. 302–345, 2014. Available: https://pubmed.ncbi.nlm.nih.gov/24696437/. [Accessed October 9, 2024].

5. Karim, Mohammad Rezaul, et al. "Nanotechnology and Prosthetic Devices: Integrating Biomedicine and Materials Science for Enhanced Performance and Adaptability." Journal of Disability Research 3.3 (2024): 20240019. Available: https://www.scienceopen.com/hosted-document?doi=10.57197/JDR-2024-0019  [Accessed October 9, 2024].