Postgraduate DiplomaHealth, Biomechanics, Wearables & Operational Safety Applications open

Postgraduate Diploma in Clinical Acceptance and Change Management

Online 800-hour Postgraduate Diploma in Clinical Acceptance and Change Management. 8 modules covering IEC 62366-1 (usability of medical devices), Regulation (EU) 2017/745 (medical devices) and NVivo. 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

Explain the models of healthcare technology adoption and their barriers.

02

Identify and prioritise the stakeholders of a clinical implementation.

03

Analyse clinical workflows to detect the impact of a new technology.

04

Apply usability engineering and human factors methods in clinical environments.

05

Design change management strategies adapted to healthcare professionals.

06

Evaluate implementation outcomes using clinical and organisational indicators.

07

Integrate regulatory and governance requirements into the implementation plan.

Profile

Who it's for

  • Healthcare technology implementation manager who wants to specialise in Clinical Acceptance and Change Management.
  • Human factors specialist who wants to specialise in Clinical Acceptance and Change Management.
  • Digital health transformation consultant who wants to specialise in Clinical Acceptance and Change Management.
  • Hospital innovation manager who wants to specialise in Clinical Acceptance and Change Management.
  • Health technology assessment analyst who wants to specialise in Clinical Acceptance and Change Management.
  • Clinical engineer who wants to specialise in Clinical Acceptance and Change Management.
  • Graduates in engineering or sciences seeking to enter hospitals.
Standards & tools

What you'll work with

  • IEC 62366-1 (usability of medical devices)
  • Regulation (EU) 2017/745 (medical devices)
  • ISO 14971 (risk management of medical devices)
  • ISO 9241-210 (human-centred design)
  • ISO 13485 (quality management systems)
  • Regulation (EU) 2021/2282 (health technology assessment)
Syllabus

8 modules · 800 h

  1. 1.1Acceptance theories: TAM and UTAUT
  2. 1.2Rogers' diffusion of innovations
  3. 1.3NASSS framework of non-adoption and abandonment
  4. 1.4Clinical, organisational and technical barriers
  5. 1.5Professional culture and resistance to change
  6. 1.6Clinical evidence as a driver of adoption
  7. 1.7Failed implementation experiences
  8. 1.8Success factors in hospitals
  9. 1.9Measuring adoption
  10. 1.10Case study: NASSS analysis of a telemonitoring platform
  1. 2.1Map of actors: clinicians, managers, patients and IT
  2. 2.2Power-interest matrix
  3. 2.3Clinical leaders and champions
  4. 2.4Nursing versus medical needs
  5. 2.5Role of IT departments
  6. 2.6Patient associations
  7. 2.7Suppliers and insurers
  8. 2.8Conflicts of interest
  9. 2.9Interviews and focus groups
  10. 2.10Workshop: stakeholder map of a wearables project
  1. 3.1Observation of clinical processes
  2. 3.2Process mapping with BPMN
  3. 3.3Identification of workloads
  4. 3.4Integration with the electronic health record
  5. 3.5Alert and alarm fatigue
  6. 3.6Task time and time studies
  7. 3.7Redesigning the workflow with the new technology
  8. 3.8Simulation of clinical scenarios
  9. 3.9Process indicators
  10. 3.10Practice: BPMN redesign of an alarm circuit
  1. 4.1IEC 62366-1 in medical devices
  2. 4.2Task analysis and use errors
  3. 4.3Formative and summative evaluation
  4. 4.4Testing with clinical users
  5. 4.5SUS and NASA-TLX scales
  6. 4.6Alert and visualisation design
  7. 4.7Training and learning curve
  8. 4.8Usability for older patients
  9. 4.9Usability engineering report
  10. 4.10Laboratory: usability test with clinical scenarios
  1. 5.1Kotter's model in healthcare organisations
  2. 5.2ADKAR model
  3. 5.3Communication plan
  4. 5.4Role-based training
  5. 5.5Pilots and progressive scaling
  6. 5.6Managing resistance
  7. 5.7Incentives and recognition
  8. 5.8Post-implementation support
  9. 5.9Sustainability of change
  10. 5.10Practice: ADKAR plan for an intermediate care unit
  1. 6.1Design of implementation studies
  2. 6.2RE-AIM framework
  3. 6.3Clinical outcome indicators
  4. 6.4Patient experience and PROMs
  5. 6.5Economic evaluation and cost-effectiveness
  6. 6.6Health technology assessment
  7. 6.7NICE Evidence Standards Framework for digital technologies
  8. 6.8Publication of results
  9. 6.9Iterative improvement based on data
  10. 6.10Case study: RE-AIM evaluation of a telemonitoring programme
  1. 7.1Hospital innovation committees
  2. 7.2Public procurement of innovation
  3. 7.3MDR requirements for implementation
  4. 7.4Data protection and the DPO
  5. 7.5Clinical and technological liability
  6. 7.6Supplier agreements and SLAs
  7. 7.7Hospital cybersecurity
  8. 7.8Clinical ethics and consent
  9. 7.9Financial sustainability
  10. 7.10Case study: dossier for an innovation committee
  1. 8.1Definition of the technology and context
  2. 8.2Stakeholder analysis
  3. 8.3Clinical workflow analysis
  4. 8.4Usability plan
  5. 8.5Change management plan
  6. 8.6Evaluation design
  7. 8.7Governance and risks
  8. 8.8Scaling plan
  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 intake, which makes 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 NVivo, Microsoft Project, Bizagi Modeler, Qualtrics, Miro, in free, academic or evaluation versions. Assays are studied using real procedures from usability studies in simulated clinical environments, hospital implementation pilots and clinical workflow mapping. Assessment is continuous by module, plus the final integrative project.

Accredited laboratories(EN ISO/IEC 17025) with rotor test bench, EMC/Lightning pre-compliance, HIL/SIL, vibration/acoustics.
Evidence-focused final project:safety case, test plan, compliance dossier and operational limits.
Industry mentoring:lecturers with experience in training, , eVTOL/UAM and flight test.
Flexible format(hybrid/online), international cohorts and support from SEIUM Career Services.
Ethics and safety:safety-by-design approach, cyber-OT, 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.

Definition of the technology and context

Explain the models of healthcare technology adoption and their barriers.

Stakeholder analysis

Identify and prioritise the stakeholders of a clinical implementation.

Clinical workflow analysis

Analyse clinical workflows to detect the impact of a new technology.

Usability plan

Apply usability engineering and human factors methods in clinical environments.

Change management plan

Design change management strategies adapted to healthcare professionals.

Career opportunities

Where this takes you

Healthcare technology implementation managerHuman factors specialistDigital health transformation consultantHospital innovation managerHealth technology assessment analystClinical engineer
Admissions & scholarships

Requirements

  • Prior technical training or professional experience in the sector. No university degree is required.
  • Internet connection and a computer capable of running the programme's software.
  • Sufficient level of Spanish to follow technical regulatory texts.

Ready to start?

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

FAQ

Frequently asked questions

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

You will work with NVivo, Microsoft Project, Bizagi Modeler, Qualtrics, Miro. Free, academic or evaluation versions are used, and the tutor indicates the free alternative where one exists.

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

Yes. Modules passed in a course or postgraduate diploma in the same area are credited towards the higher programme. Check the credit recognition policy when you enrol.

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