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.
Postgraduate Diploma in Gamified Clinical Protocols and Adherence — studying from Malta
Malta's healthcare system relies on public hospitals alongside a growing private sector, creating demand for engineers in medical devices, clinical technology and facilities. The Medicines Authority and the Health Directorate set regulatory expectations that shape work on medical equipment. Biomechanics and wearable technology are emerging interests, particularly in rehabilitation, sports science and occupational safety. Professionals in this area often collaborate with clinicians, distributors and regulators to ensure devices meet national and European requirements.
Fees for Malta: €1,790 (Euro), with instalments and employer sponsorship available.
Relevant bodies in Malta
Typical roles
Questions from Malta
Is this programme recognised by a professional body in Malta for engineers working in health, biomechanics or wearables?
SEIUM Institute's qualifications are its own private qualifications. They are not official Maltese state degrees and are not accredited by any national body. In Malta, engineering titles are regulated through the Malta Council for Professions and the Chamber of Engineers, and medical devices fall under the Medicines Authority. Recognition of a private qualification is decided by employers or the relevant body, so check with them before enrolling.
Will employers in Malta value this training for roles in wearables or operational safety?
Employers in Malta's health technology, manufacturing and safety-related sectors decide for themselves how much weight to give a private online qualification. Many weigh practical experience and a final project heavily. SEIUM's programmes include a final project, but whether it helps your career in Malta depends on your employer's view. Speaking with prospective employers beforehand is the most reliable way to find out.
Can I study this alongside a full-time job in Malta, and is employer funding possible?
The programmes are 100% online and taught in English, so you can study from home without a student visa. Master's programmes are 1,900 hours, postgraduate diplomas 800 hours and specialist courses 300 hours, so plan your weekly time accordingly. Fees are payable in instalments, and employer sponsorship is possible. Each student gets an assigned technical tutor for support.
Take the controls.
Run a real engineering trade-off from this field. Move the sliders, watch the model react in real time and beat the challenge.
What you will be able to do
Analyse the determinants of therapeutic adherence.
Apply behaviour change models to the design of interventions.
Use game mechanics with a psychological basis.
Design clinical protocols that integrate gamified elements.
Select technology platforms for the intervention.
Determine the product's regulatory and evidence requirements.
Evaluate the adherence and clinical outcomes of the intervention.
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.
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)
8 modules · 800 h
1.1Definitions: adherence, compliance and persistence1.2Scale of the problem and associated costs1.3Non-adherence factors according to the WHO1.4Measurement: self-report, pill counts and dispensing records1.5Morisky scales and the Haynes-Sackett questionnaire1.6Electronic monitoring with smart packaging1.7Proportion of days covered and possession ratio1.8Adherence to exercise and rehabilitation1.9Adherence in chronic diseases1.10Case study: adherence analysis in hypertensive patients
2.1COM-B model and the behaviour change wheel2.2BCT taxonomy of behaviour change techniques2.3Self-determination theory2.4Fogg Model: motivation, ability and prompt2.5Habit formation and contextual cues2.6Cognitive biases and behavioural economics2.7Reinforcement, rewards and reinforcement schedules2.8Self-efficacy and goal setting2.9Motivational interviewing as a complement2.10Workshop: COM-B mapping of an adherence problem
3.1Mechanics, dynamics and aesthetics: the MDA framework3.2Bartle and Marczewski player types3.3Points, badges and leaderboards: uses and risks3.4Narrative and progression in health experiences3.5Flow and the balance between challenge and skill3.6Serious games versus gamification3.7Intrinsic motivation and the overjustification effect3.8Social challenges and peer comparison3.9Ethical design versus dark patterns3.10Practice: paper prototype of an adherence mechanic
4.1Translating clinical guidelines into game objectives4.2Personalisation by profile and severity4.3Gamification in diabetes and glycaemic control4.4Gamification in motor rehabilitation4.5Exergames and active video games4.6Gamification in mental health and digital therapeutics4.7Programmes for paediatric populations4.8Clinical safety and the limits of gamification4.9Integration with the consultation and the professional4.10Case study: gamified knee physiotherapy protocol
5.1Health mobile applications and their architecture5.2Wearables for measuring activity and adherence5.3Connected packaging and devices5.4Adaptive notifications and reminders5.5Just-in-time adaptive interventions5.6Integration with clinical records using FHIR5.7Usage and engagement analytics5.8Accessibility and inclusive design5.9Data protection and consent5.10Laboratory: designing adaptive notification rules
6.1Software as a medical device under the MDR6.2Digital therapeutics and the German DiGA model6.3NICE evidence guidance for digital technologies6.4Randomised trials of digital interventions6.5MRT micro-randomised trial designs6.6CONSORT-EHEALTH guidelines6.7Usability evaluation according to IEC 623666.8Risk management according to ISO 149716.9Reimbursement and business models6.10Practice: MDR classification of a gamified app
7.1Adherence variables and clinical outcomes7.2Digital engagement and attrition curves7.3Survival analysis of use7.4Mixed-effects models for repeated data7.5Cost-effectiveness analysis7.6Qualitative evaluation of the experience7.7Equity in use and the digital divide7.8Scaling up and sustained implementation7.9RE-AIM framework for evaluating implementation7.10Case study: attrition analysis of a rehabilitation app
8.1Selection of the pathology and the adherence problem8.2Behavioural diagnosis with COM-B8.3Design of mechanics and progression8.4Integration with the clinical protocol8.5Technology and data specification8.6Risk and regulatory analysis8.7Efficacy evaluation plan8.8Usability testing with users8.9Report and presentation8.10Final review with the tutor
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.
Build it end to end
Your final project follows the real engineering workflow, step by step, reviewed by your tutor.
Analyse the determinants of therapeutic adherence.
Apply behaviour change models to the design of interventions.
Use game mechanics with a psychological basis.
Design clinical protocols that integrate gamified elements.
Select technology platforms for the intervention.
Where this takes you
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.
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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