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Postgraduate DiplomaHealth, Biomechanics, Wearables & Operational Safety Applications open

Postgraduate Diploma in Gamified Clinical Protocols and Adherence

Online Postgraduate Diploma of 800 h in Gamified Clinical Protocols and Adherence. 8 modules covering Regulation (EU) 2017/745 (MDR), IEC 62304 (medical device software lifecycle) and Unity. Assigned tutor and open enrolment.

Duration800 h
ModeOnline
LanguageEnglish
Start datesSet by the faculty
AwardSEIUM Institute diploma
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Learning outcomes

What you will be able to do

01

Analyse the determinants of therapeutic adherence.

02

Apply behaviour change models to the design of interventions.

03

Use game mechanics with a psychological basis.

04

Design clinical protocols that integrate gamified elements.

05

Select technology platforms for the intervention.

06

Determine the product's regulatory and evidence requirements.

07

Evaluate the adherence and clinical outcomes of the intervention.

Profile

Who it's for

  • Digital therapeutics designer who wants to specialise in Gamified Clinical Protocols and Adherence.
  • Therapeutic adherence researcher who wants to specialise in Gamified Clinical Protocols and Adherence.
  • Serious games designer who wants to specialise in Gamified Clinical Protocols and Adherence.
  • Digital health product manager who wants to specialise in Gamified Clinical Protocols and Adherence.
  • Behavioural science specialist who wants to specialise in Gamified Clinical Protocols and Adherence.
  • Digital clinical studies coordinator who wants to specialise in Gamified Clinical Protocols and Adherence.
  • Graduates in engineering or sciences seeking to enter digital health.
Standards & tools

What you'll work with

  • Regulation (EU) 2017/745 (MDR)
  • IEC 62304 (medical device software lifecycle)
  • IEC 62366-1 (usability engineering)
  • ISO 82304-1 (health software safety)
  • ISO 14155 (clinical investigation of medical devices)
  • Regulation (EU) 2016/679 (GDPR)
Syllabus

8 modules · 800 h

  1. 1.1Definitions: adherence, compliance and persistence
  2. 1.2Scale of the problem and associated costs
  3. 1.3Non-adherence factors according to the WHO
  4. 1.4Measurement: self-report, pill counts and dispensing records
  5. 1.5Morisky scales and the Haynes-Sackett questionnaire
  6. 1.6Electronic monitoring with smart packaging
  7. 1.7Proportion of days covered and possession ratio
  8. 1.8Adherence to exercise and rehabilitation
  9. 1.9Adherence in chronic diseases
  10. 1.10Case study: adherence analysis in hypertensive patients
  1. 2.1COM-B model and the behaviour change wheel
  2. 2.2BCT taxonomy of behaviour change techniques
  3. 2.3Self-determination theory
  4. 2.4Fogg Model: motivation, ability and prompt
  5. 2.5Habit formation and contextual cues
  6. 2.6Cognitive biases and behavioural economics
  7. 2.7Reinforcement, rewards and reinforcement schedules
  8. 2.8Self-efficacy and goal setting
  9. 2.9Motivational interviewing as a complement
  10. 2.10Workshop: COM-B mapping of an adherence problem
  1. 3.1Mechanics, dynamics and aesthetics: the MDA framework
  2. 3.2Bartle and Marczewski player types
  3. 3.3Points, badges and leaderboards: uses and risks
  4. 3.4Narrative and progression in health experiences
  5. 3.5Flow and the balance between challenge and skill
  6. 3.6Serious games versus gamification
  7. 3.7Intrinsic motivation and the overjustification effect
  8. 3.8Social challenges and peer comparison
  9. 3.9Ethical design versus dark patterns
  10. 3.10Practice: paper prototype of an adherence mechanic
  1. 4.1Translating clinical guidelines into game objectives
  2. 4.2Personalisation by profile and severity
  3. 4.3Gamification in diabetes and glycaemic control
  4. 4.4Gamification in motor rehabilitation
  5. 4.5Exergames and active video games
  6. 4.6Gamification in mental health and digital therapeutics
  7. 4.7Programmes for paediatric populations
  8. 4.8Clinical safety and the limits of gamification
  9. 4.9Integration with the consultation and the professional
  10. 4.10Case study: gamified knee physiotherapy protocol
  1. 5.1Health mobile applications and their architecture
  2. 5.2Wearables for measuring activity and adherence
  3. 5.3Connected packaging and devices
  4. 5.4Adaptive notifications and reminders
  5. 5.5Just-in-time adaptive interventions
  6. 5.6Integration with clinical records using FHIR
  7. 5.7Usage and engagement analytics
  8. 5.8Accessibility and inclusive design
  9. 5.9Data protection and consent
  10. 5.10Laboratory: designing adaptive notification rules
  1. 6.1Software as a medical device under the MDR
  2. 6.2Digital therapeutics and the German DiGA model
  3. 6.3NICE evidence guidance for digital technologies
  4. 6.4Randomised trials of digital interventions
  5. 6.5MRT micro-randomised trial designs
  6. 6.6CONSORT-EHEALTH guidelines
  7. 6.7Usability evaluation according to IEC 62366
  8. 6.8Risk management according to ISO 14971
  9. 6.9Reimbursement and business models
  10. 6.10Practice: MDR classification of a gamified app
  1. 7.1Adherence variables and clinical outcomes
  2. 7.2Digital engagement and attrition curves
  3. 7.3Survival analysis of use
  4. 7.4Mixed-effects models for repeated data
  5. 7.5Cost-effectiveness analysis
  6. 7.6Qualitative evaluation of the experience
  7. 7.7Equity in use and the digital divide
  8. 7.8Scaling up and sustained implementation
  9. 7.9RE-AIM framework for evaluating implementation
  10. 7.10Case study: attrition analysis of a rehabilitation app
  1. 8.1Selection of the pathology and the adherence problem
  2. 8.2Behavioural diagnosis with COM-B
  3. 8.3Design of mechanics and progression
  4. 8.4Integration with the clinical protocol
  5. 8.5Technology and data specification
  6. 8.6Risk and regulatory analysis
  7. 8.7Efficacy evaluation plan
  8. 8.8Usability testing with users
  9. 8.9Report and presentation
  10. 8.10Final review with the tutor
Methodology, software & labs

How you'll learn

100 % online training on the SEIUM campus, with downloadable material, recorded classes and an assigned technical tutor. No fixed timetable: students progress at their own pace within the enrolment period, making it possible to combine the programme with work.

Each module combines theory, guided reading of the original standard and applied exercises. The working software is Unity, Figma, Firebase, REDCap, R, in free, academic or evaluation versions. Trials are studied through real procedures of gamified prototypes tested with patients, adherence studies with electronic records, and summative usability tests. Assessment is continuous by module plus the final integrating project.

Accredited laboratories(EN ISO/IEC 17025) with rotor test rig, EMC/Lightning pre-compliance, HIL/SIL, vibration/acoustics.
Evidence-focused Master's Thesis:safety case, test plan, compliance dossier and operational limits.
Industry-led mentoring:lecturers with experience in training, , eVTOL/UAM and flight test.
Flexible delivery(hybrid/online), international cohorts and support from SEIUM Career Services.
Ethics and safety:a safety-by-design approach, OT cyber, DIH and compliance as core pillars.
Capstone project

Build it end to end

Your final project follows the real engineering workflow, step by step, reviewed by your tutor.

Selection of the pathology and the adherence problem

Analyse the determinants of therapeutic adherence.

Behavioural diagnosis with COM-B

Apply behaviour change models to the design of interventions.

Design of mechanics and progression

Use game mechanics with a psychological basis.

Integration with the clinical protocol

Design clinical protocols that integrate gamified elements.

Technology and data specification

Select technology platforms for the intervention.

Career opportunities

Where this takes you

Digital therapeutics designerTherapeutic adherence researcherSerious games designerDigital health product managerBehavioural science specialistDigital clinical studies coordinator
Admissions & scholarships

Requirements

  • Prior technical training or professional experience in the sector. A university degree is not required.
  • Internet connection and a computer capable of running the programme's software.
  • Sufficient command of Spanish to follow technical regulatory reading.

Ready to start?

Send your application today. Our admissions team replies within 72 hours with your study plan and funding options.

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FAQ

Frequently asked questions

The programme consists of 800 hours in total, spread over 6 to 8 months. That is between 10 and 15 hours per week on average, compatible with full-time work.

The programme uses Unity, Figma, Firebase, REDCap, R. Free, academic or evaluation versions are used, and the tutor indicates the free alternative where one exists.

SEIUM's own diploma upon passing the continuous assessment and the integrating project. This is in-house training, not an official Ministry qualification.

Yes. Modules passed in a course or Postgraduate Diploma in the same area are recognised towards the higher programme. Check the recognition policy when you enrol.

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