Know and understand medical applications including printing of prosthetics, tissue engineering, artificial blood vessels, customised medicines

6 ICT Applications – Medical Applications

Learning Objective

Know and understand the medical applications of information and communication technology (ICT), including:

• Printing of prosthetic devices
• Tissue engineering
• Artificial blood vessels
• Customised (personalised) medicines
• How expert systems and recognition technologies support these applications

Mapping to Cambridge IGCSE 0417 Syllabus (Section 6)

Key Concepts (Essential for IGCSE)

• File formats: .stl, .obj, .3mf (3‑D models); .dcm (DICOM imaging); .csv, .json (data records).
• Systems life‑cycle stages: Specification → Design → Development & Testing → Implementation → Evaluation.
• Data‑protection legislation: GDPR (EU) and HIPAA (USA).
• Regulatory marks: CE (EU) and FDA Premarket Approval (USA).

Extension (Further Reading)

• ISO 10993 (biocompatibility), ISO 13485 (medical‑device quality management).
• Advanced printing technologies: SLS, SLA, bioprinting, electro‑spinning.
• Pharmacogenomics databases (e.g., PharmGKB) and file format .vcf (variant call).

1. Printing of Prosthetic Devices

Overview

3‑D printing (additive manufacturing) turns a digital model into a physical prosthetic limb or orthotic device by depositing material layer‑by‑layer. It enables rapid, low‑cost, patient‑specific production.

Systems Life‑Cycle

1. Specification: Capture patient anatomy with 3‑D scanning or MRI; define functional requirements (load, range of motion).
2. Design: Build a CAD model; export as .stl or .obj.
3. Development & Testing: Choose a biocompatible material (e.g., medical‑grade nylon, titanium alloy); run virtual simulations for strength and fit.
4. Implementation: Print using FDM, SLA or SLS; perform post‑processing (cleaning, curing, surface finishing).
5. Evaluation: Fit to patient, record feedback, and revise the design for future iterations.

Physical Safety & Regulatory Compliance

• Materials must meet ISO 10993 biocompatibility standards.
• Manufacturers require CE marking (EU) or FDA clearance (USA).
• Risk analysis must address mechanical failure, skin irritation and sterilisation.

E‑Safety & Data Protection

• Patient scans stored as encrypted .dcm (DICOM) files; access limited to authorised staff (GDPR/HIPAA).
• Design files and version history kept in a secure repository (e.g., Git with access control).
• Intellectual‑property of the digital model belongs to the patient or health service unless otherwise agreed.

File Management & Formats

• Design models: .stl, .obj, .3mf
• Imaging data: .dcm (DICOM)
• Project documentation: PDF specifications, CSV/JSON bill‑of‑materials, version‑control logs.

Advantages & Limitations

Evaluation Checklist

• Fit accuracy (≤ 1 mm tolerance)
• Mechanical strength vs. required load
• Patient comfort & skin compatibility
• Compliance with CE/FDA regulations
• Cost per unit compared with traditional prosthesis

2. Tissue Engineering

Overview

Combines living cells, biodegradable scaffolds, and ICT‑driven design to grow functional tissue for repair or replacement.

Systems Life‑Cycle

1. Specification: Identify target tissue; obtain patient‑specific MRI/CT data; select stem‑cell source.
2. Design: Model scaffold geometry in CAD using imaging data; export as .stl.
3. Development & Testing: Bioprint scaffold; seed with harvested cells; monitor viability in a bioreactor.
4. Implementation: Sterile surgical implantation of the cultured tissue.
5. Evaluation: Post‑operative imaging and sensor data to assess integration and function.

Physical Safety & Ethical Considerations

• Compliance with the Human Tissue Act (UK) or equivalent legislation.
• Informed consent required for cell harvesting.
• Bioreactor operation follows ISO 13485 quality‑management standards.

E‑Safety & Data Protection

• Cell‑line and genetic data stored encrypted (.json or .csv) with role‑based access.
• Imaging data kept in encrypted DICOM format.
• Audit trails must record who accessed patient data and when.

File Management & Formats

• Scaffold models: .stl, .obj
• Medical imaging: .dcm (DICOM)
• Cell‑culture data: CSV growth curves, JSON metadata
• Regulatory documentation: PDF, XML for ethics‑committee submissions

Benefits vs. Challenges

Evaluation Checklist

• Structural integrity (tensile/compressive strength)
• Cell viability > 90 % after 7 days
• Biodegradation rate aligned with tissue regeneration
• Regulatory status (CE marking, FDA IDE)
• Cost per cm³ of engineered tissue

3. Artificial Blood Vessels

Overview

Manufactured using ICT‑guided processes (3‑D printing, electro‑spinning) to replace or bypass diseased arteries and veins.

Systems Life‑Cycle

1. Specification: Determine required diameter, wall thickness, and compliance from patient imaging.
2. Design: Create CAD model; calculate compliance C = (ΔD/D) / ΔP; export as .stl or .step.
3. Development & Testing: Produce prototype via electro‑spinning or 3‑D printing; test burst pressure, fatigue, and compliance.
4. Implementation: Sterilise and surgically implant the vessel.
5. Evaluation: Post‑operative imaging and haemodynamic monitoring to verify patency and mechanical performance.

Physical Safety & Regulatory Compliance

• Materials must satisfy ISO 10993 biocompatibility and ISO 13485 manufacturing standards.
• Regulatory pathway: CE marking (EU) or FDA Premarket Approval (USA) with a full risk‑analysis dossier.
• Testing criteria: burst pressure > 2 × physiological pressure; compliance within 5 % of native vessel.

E‑Safety & Data Protection

• Patient imaging stored encrypted (.dcm); access controlled under GDPR/HIPAA.
• Design files and test data kept in a secure, version‑controlled repository.

File Management & Formats

• Design files: .stl, .step
• Imaging: .dcm (DICOM)
• Test data: CSV pressure‑diameter curves, PDF certification reports

Advantages & Limitations

• Advantages

  • Off‑the‑shelf availability reduces surgical waiting time.
  • Custom geometry matches patient anatomy.
  • Potential for drug‑eluting coatings to prevent restenosis.

• Limitations

  • Long‑term biocompatibility still under investigation.
  • Risk of thrombosis if surface properties are sub‑optimal.
  • Regulatory approval can be lengthy and region‑specific.

Evaluation Checklist

• Compliance match (≤ 5 % deviation from native vessel)
• Burst pressure > 2 × physiological pressure
• Surface roughness suitable for endothelialisation
• Sterility Assurance Level (SAL) of 10⁻⁶
• Regulatory clearance status (CE/FDA)

4. Customised (Personalised) Medicines

Overview

ICT enables medicines tailored to an individual’s genetic profile, disease state, and lifestyle, improving efficacy and reducing adverse effects.

Systems Life‑Cycle

1. Specification: Sequence patient genome; identify pharmacogenomic markers using databases such as PharmGKB.
2. Design: Choose active pharmaceutical ingredient (API) and dosage; model tablet geometry and release profile in CAD; export as .stl.
3. Development & Testing: 3‑D print the dosage form with precise API distribution; perform in‑line spectroscopy for quality control.
4. Implementation: Attach a digital prescription record (QR code) linked to the patient’s EHR; dispense to patient.
5. Evaluation: Monitor therapeutic outcome via EHR analytics; adjust formulation if required.

Physical Safety & Manufacturing Standards

• Production follows GMP (Good Manufacturing Practice) and ISO 13485 for medical devices.
• Batch records, validation reports and release certificates must be retained for traceability.

E‑Safety & Data Protection

• Genomic data stored encrypted (AES‑256) in .vcf or encrypted JSON files.
• Access limited to authorised clinicians; audit logs required (GDPR/HIPAA).
• Informed consent is mandatory for use of genetic information in drug design.

File Management & Formats

• Genomic data: .vcf, encrypted .json
• Prescription & dosage design: .stl, .xml (regulatory submission)
• Quality‑control data: CSV spectroscopy results, PDF batch records

Conventional vs. Customised Medicine

Evaluation Checklist

• Genetic‑marker match to selected API
• Printed dose accuracy (±5 %)
• Release profile meets therapeutic window
• Compliance with GMP, ISO 13485 and data‑protection regulations
• Patient adherence and clinical outcome data

5. Expert Systems in Medical ICT

What They Are

Computer programs that use knowledge bases and inference engines to support decision‑making. In medicine they assist with:

• Diagnosis (e.g., symptom‑based rule engines)
• Treatment planning (e.g., selecting prosthetic design parameters)
• Drug design (e.g., AI‑driven CADD – Computer‑Aided Drug Design)

Link to the Four Applications

• Prosthetics: Expert systems suggest optimal material and geometry based on load calculations.
• Tissue Engineering: Predict scaffold porosity needed for cell infiltration.
• Artificial Vessels: Calculate compliance and burst‑pressure requirements automatically.
• Personalised Medicines: Match pharmacogenomic markers to suitable APIs.

Safety & Ethical Points

• Expert‑system recommendations must be validated by qualified clinicians.
• Algorithms should be transparent; bias checks are required under GDPR.

6. Recognition Systems in Medical ICT

Relevant Technologies

• RFID / NFC tags: Embedded in implants or prosthetic components for tracking, inventory and post‑operative monitoring.
• Biometrics (fingerprint, iris, facial recognition): Secure access to electronic health records (EHR) and device control panels.
• OCR / OCR‑enabled scanners: Convert handwritten prescriptions into digital format for personalised‑medicine workflows.

Application Examples

• RFID‑tagged prosthetic limbs enable automatic check‑in at clinics and remote condition monitoring.
• Biometric authentication ensures only authorised clinicians can modify a patient’s 3‑D printed dosage instructions.
• OCR of legacy patient records speeds up the creation of genomic‑medicine profiles.

Safety & Data‑Protection

• Tag data must be encrypted; access logs required (GDPR/HIPAA).
• Biometric templates stored as hashed values, not raw images.

7. Satellite Systems (Optional Awareness)

Satellite communication underpins tele‑medicine services, especially in remote areas. It enables:

• Real‑time transmission of imaging data (e.g., CT scans) to specialist centres.
• Remote monitoring of implanted device performance (e.g., artificial vessel pressure sensors).
• Delivery of software updates to smart prosthetic components.

Safety Considerations

• Data transmitted via satellite must be encrypted end‑to‑end.
• Latency and bandwidth limits may affect real‑time monitoring; contingency plans are required.

Overall Summary

Information and Communication Technology is reshaping modern medicine by providing:

• Rapid, patient‑specific production of prosthetic devices through 3‑D printing.
• Engineered tissues that can replace damaged organs, supported by bioprinting and sophisticated data management.
• Artificial blood vessels with customised geometry and mechanical compliance.
• Personalised medicines that integrate genomic data, computer‑aided design, and on‑demand manufacturing.
• Expert systems that guide design and treatment decisions.
• Recognition technologies (RFID, biometrics, OCR) that enhance safety, traceability and workflow efficiency.
• Satellite‑based tele‑medicine that extends specialist care to remote locations.

Understanding these applications equips ICT students to appreciate how digital tools improve health outcomes, meet safety and regulatory requirements, and open career pathways in biomedical engineering, health informatics and pharmaceutical technology.