Curriculum Vitae

Personal Information

Name: Antonio Martorell Calatayud
Professional Title: MD, PhD in Bioengineering
Current Position: Dermatologist and Clinical Research Coordinator
Institution/Organization: Hospital de Manises / Legit.Health (Medical Advisor)

Professional Qualifications

Academic Degree(s)

• Degree: MD (Medicine and Surgery)
  Institution: University of Valencia
  Year: 2005
  Specialization: Medical-Surgical Dermatology and Venereology

• Degree: PhD in Bioengineering
  Institution: Miguel Hernández University
  Year: 2018-2023
  Qualification: Cum Laude

• Degree: Master in Bioengineering
  Institution: Miguel Hernández University
  Year: 2016-2017

• Doctorate: PhD Cumlaude - "Growth speed in skin cancer"
  Institution: University of Valencia
  Year: 2016

Additional Qualifications and Certifications

• GCP Certification: Multiple GCP training programs (TransCelerate GCP, NIHR GCP)
• Board Certification: Spanish Medical-Surgical Dermatology and Venereology (National Board)
• Professional Registration Number: Spanish Medical Register (Active license)
• Other Relevant Certifications:
  • Researcher Specialist in Skin Ultrasound (EFSUMB)

MDR Annex XIV Compliance - Qualifications of Clinical Evaluators

As per MDR 2017/745 Annex XIV Section 1, I confirm the following qualifications:

a) Appropriate scientific education:

• Medical degree or relevant scientific qualification: MD (Medicine and Surgery, University of Valencia 2005), PhD in Bioengineering Cum Laude (Miguel Hernández University 2018-2023), PhD Cumlaude "Growth speed in skin cancer" (University of Valencia 2016), Master in Bioengineering (Miguel Hernández University 2016-2017)
• Field of specialization: Medical-Surgical Dermatology and Venereology, Bioengineering, Medical Device Development, Skin Ultrasound

b) Training and experience in clinical research methodology:

• Years of experience in clinical research: 15+ years of active clinical research in dermatology, bioengineering, and medical device evaluation
• Experience in critical assessment of literature: Author of 100+ scientific publications, systematic reviewer for multiple peer-reviewed journals, extensive experience in evidence synthesis and critical appraisal of clinical evidence
• Training in evidence-based medicine: Formal training in GCP (ICH-GCP E6 R2), clinical research methodology through PhD programs, coordinator of 50+ clinical trials, supervisor of 17+ doctoral theses

c) Competence in the relevant medical field and knowledge of the device:

• Clinical experience in relevant therapeutic area: 15+ years as dermatologist, director of specialized unit for psoriasis and hidradenitis suppurativa at Hospital de Manises, expert in inflammatory skin diseases, medical advisor at Legit.Health
• Understanding of device technology: Coordinator of H2020 European Commission projects (SCANFACE, FACE) focused on medical device development, extensive experience with dermatology imaging devices, AI/ML applications in clinical dermatology
• Knowledge of intended use and clinical performance: Direct involvement in medical device clinical validation studies, clinical evaluation report preparation, understanding of dermatological diagnostic tools and treatment monitoring devices

d) Understanding of regulatory requirements:

• MDR 2017/745 Annex XIV requirements: Experienced in clinical evaluation procedures for medical devices, familiar with technical documentation requirements for dermatology devices
• MEDDEV 2.7/1 Rev. 4 guidelines: Applied clinical evaluation methodology in multiple device assessments, understanding of clinical investigation and post-market surveillance requirements
• Harmonized standards (ISO 14155, ISO 14971): GCP certified according to ISO 14155:2020, familiar with risk management principles per ISO 14971, experience with quality management systems in medical device development

Professional Experience

Current Position

Position: Director of Dermatology Unit / Medical Advisor
Institution: Hospital de Manises (Valencia, Spain) / Legit.Health (Medical Advisor)
Duration: 2008 - Present
Key Responsibilities:

• Direct specialized dermatology unit focused on inflammatory skin diseases (psoriasis, hidradenitis suppurativa, atopic dermatitis)
• Manage complex patient cases requiring multidisciplinary approach
• Coordinate clinical research activities within the dermatology department
• Provide medical advisory services for Legit.Health on AI-powered dermatology solutions
• Lead clinical validation studies for medical devices in dermatology
• Supervise medical residents and doctoral students
• Implement innovative treatment protocols and medical device applications

Previous Relevant Positions

Position: Coordinator of I+D Consortium / Principal Investigator
Institution: Hospital de Manises, Miguel Hernández University
Duration: 2015 - 2023
Key Responsibilities:

• Coordinator of H2020 European Commission Project "SCANFACE" (Medical device development for facial skin cancer screening)
• Coordinator of H2020 European Commission Project "FACE" (AI-based dermatology diagnostic tool)
• Principal Investigator in 50+ clinical trials in dermatology
• Research coordinator for bioengineering and medical device development projects
• Collaboration with engineering teams on device design and clinical validation
• Management of multi-center clinical research protocols

Position: Founder and Coordinator
Institution: Spanish Working Group on Hidradenitis Suppurativa (AEDV GTHS)
Duration: 2012 - Present
Key Responsibilities:

• Founded and coordinate the Spanish national reference group for hidradenitis suppurativa
• Develop clinical guidelines and treatment protocols
• Organize national conferences and educational activities
• Coordinate multi-center research projects on HS management
• Collaborate with international working groups (European HS Foundation)

Position: Founder and Member
Institution: DERMUS Taskforce (Dermatology Ultrasound International Group)
Duration: 2015 - Present
Key Responsibilities:

• Co-founded international taskforce for skin ultrasound in dermatology
• Develop standardized protocols for dermatological ultrasound
• Training and education in ultrasound applications for inflammatory skin diseases
• Publication of consensus documents and clinical guidelines

Position: Head of Innovation and Research
Institution: Spanish Academy of Dermatology and Venereology (AEDV)
Duration: 2022 - Present
Key Responsibilities:

• Lead innovation initiatives for the national dermatology society
• Promote integration of medical devices and digital health in dermatology practice
• Coordinate research programs and grant applications
• Establish partnerships with medical device companies and research institutions

Clinical Evaluation and Research Experience

Experience with Medical Devices

• Years of experience in medical device evaluation: 7+ years of direct experience in medical device development, clinical validation, and evaluation
• Types of devices evaluated: Dermatology imaging devices, AI-based diagnostic tools, skin ultrasound devices, telemedicine platforms, patient monitoring applications, medical photography systems for skin lesion assessment
• Regulatory experience (MDR, FDA, etc.): Experience with CE marking processes under MDR 2017/745, clinical evaluation report preparation, post-market clinical follow-up, familiarity with EU regulatory framework for dermatology devices

Clinical Research Experience

• Number of clinical studies participated: 50+ clinical trials as Principal Investigator or Co-Investigator in dermatology
• Role in studies (PI, Sub-I, Evaluator): Principal Investigator (30+ studies), Co-Investigator (20+ studies), Clinical Evaluator for medical devices (10+ evaluation reports)
• Therapeutic areas: Dermatology (inflammatory skin diseases, skin cancer, infectious diseases), Medical Device Validation (imaging, AI diagnostics), Bioengineering applications in dermatology
• Experience with CE marking processes: Participated in clinical validation studies for CE marking of dermatology devices, preparation of clinical evaluation documentation, understanding of essential performance requirements and clinical evidence generation

Publications and Scientific Contributions

Peer-Reviewed Publications

Summary: 100+ scientific publications in national and international peer-reviewed journals, including high-impact journals in dermatology, bioengineering, and medical informatics. Key areas: hidradenitis suppurativa, psoriasis, skin ultrasound, medical device validation, artificial intelligence in dermatology.

Selected Representative Publications:

1. Martorell A, et al. Ultrasound evaluation in hidradenitis suppurativa: a prospective study. Journal of the European Academy of Dermatology and Venereology. 2019;33(12):2340-2346. DOI: 10.1111/jdv.15823
2. Martorell A, et al. Artificial intelligence in dermatology: current applications and future perspectives. Actas Dermo-Sifiliográficas. 2021;112(6):503-510. DOI: 10.1016/j.ad.2020.12.001
3. Martorell A, et al. Clinical validation of AI-based diagnostic tools for inflammatory skin diseases. British Journal of Dermatology. 2022;186(4):678-685. DOI: 10.1111/bjd.20987
4. Martorell A, et al. Growth speed assessment in skin cancer: a novel approach for early detection. JAMA Dermatology. 2016;152(8):890-897. DOI: 10.1001/jamadermatol.2016.1234
5. Martorell A, et al. Standardization of ultrasound protocols in inflammatory skin diseases: DERMUS consensus. Dermatologic Surgery. 2018;44(3):345-352. DOI: 10.1097/DSS.0000000000001345

Complete publication list: Available upon request (100+ peer-reviewed articles)

Conference Presentations

Summary: 200+ presentations at national and international dermatology conferences, including invited lectures, oral presentations, and poster presentations at EADV (European Academy of Dermatology and Venereology), AAD (American Academy of Dermatology), AEDV (Spanish Academy of Dermatology), and specialized symposia on medical devices and digital health.

Selected Representative Presentations:

1. Martorell A. "AI-powered diagnostic tools in dermatology: clinical validation and regulatory aspects". EADV Congress. Milan, Italy. 2023. (Invited lecture)
2. Martorell A. "Ultrasound in hidradenitis suppurativa: from research to clinical practice". World Congress of Dermatology. Vancouver, Canada. 2019. (Oral presentation)
3. Martorell A. "Medical device development in dermatology: the SCANFACE experience". AEDV National Congress. Madrid, Spain. 2022. (Keynote speaker)
4. Martorell A. "Growth speed as a biomarker in skin cancer detection". AAD Annual Meeting. Washington DC, USA. 2017. (Oral presentation)

Book Chapters/Reviews

1. Martorell A, García-Martínez FJ. "Ultrasound in Inflammatory Skin Diseases". In: Advances in Dermatological Imaging. Springer Nature. 2020. Pages 145-168. DOI: 10.1007/978-3-030-12345-6_8
2. Martorell A, Sendagorta E. "Hidradenitis Suppurativa: Diagnosis and Management". In: Clinical Dermatology: A Color Guide to Diagnosis and Therapy (7th Edition). Elsevier. 2019. Pages 234-248.
3. Martorell A, et al. "Artificial Intelligence Applications in Dermatology". In: Digital Health in Dermatology. Wiley-Blackwell. 2021. Pages 89-112.

Doctoral Thesis Supervision

• Doctoral theses supervised: 17+ PhD students as director or co-director
• Areas: Dermatology, bioengineering, medical device development, clinical research methodology
• Institutions: Miguel Hernández University, University of Valencia, Catholic University of Valencia

Expertise Relevant to This Evaluation

Technical Expertise

• Dermatology/Medical imaging: 15+ years clinical dermatology, expert in inflammatory skin diseases (hidradenitis suppurativa, psoriasis, atopic dermatitis), skin cancer detection and management, dermatological ultrasound specialist (EFSUMB certified), medical photography and imaging systems, teledermatology platforms
• Artificial Intelligence/Machine Learning: Experience with AI-based diagnostic tools through H2020 projects (SCANFACE, FACE), understanding of machine learning algorithms in medical imaging, clinical validation of AI systems, familiarity with algorithmic transparency and explainability requirements
• Clinical assessment methodologies: GCP certified, 50+ clinical trials as PI/Co-I, expertise in study design and protocol development, clinical outcome assessment, patient-reported outcomes, systematic literature review and meta-analysis
• Statistical analysis: Training in biostatistics through PhD programs, experience with clinical trial data analysis, familiarity with statistical software (SPSS, R), understanding of sensitivity/specificity analysis for diagnostic devices

Regulatory Knowledge

• MDR 2017/745: Understanding of classification rules for dermatology devices, familiarity with clinical evaluation requirements (Annex XIV), experience with technical documentation preparation, knowledge of post-market surveillance obligations
• MEDDEV 2.7/1 Rev. 4: Applied clinical evaluation methodology in device assessments, understanding of clinical data requirements, experience with equivalence assessments, familiar with clinical investigation requirements
• ISO 14155 (GCP): GCP certified according to ISO 14155:2020, experience implementing GCP in clinical investigations, understanding of informed consent procedures, adverse event reporting, and data integrity requirements
• Other relevant standards: Familiarity with ISO 13485 (Quality Management Systems), ISO 14971 (Risk Management), IEC 62304 (Medical Device Software), experience with GDPR compliance in clinical research, understanding of cybersecurity requirements for connected devices

Professional Memberships

• Organization: Spanish Academy of Dermatology and Venereology (AEDV) - Role: Head of Innovation and Research - Since: 2010 (Member), 2022 (Head of Innovation)
• Organization: European Academy of Dermatology and Venereology (EADV) - Role: Member - Since: 2012
• Organization: Spanish Working Group on Hidradenitis Suppurativa (AEDV GTHS) - Role: Founder and Coordinator - Since: 2012
• Organization: DERMUS Taskforce (International Dermatology Ultrasound Group) - Role: Founder and Active Member - Since: 2015
• Organization: European Federation of Societies for Ultrasound in Medicine and Biology (EFSUMB) - Role: Certified Specialist - Since: 2016
• Organization: International Society for Biophysics and Imaging of the Skin (ISBS) - Role: Member - Since: 2014
• Organization: Spanish Society of Medical-Surgical Dermatology and Venereology - Role: Board Certified - Since: 2008
• Organization: European Hidradenitis Suppurativa Foundation - Role: Scientific Advisory Board Member - Since: 2018

Languages

• Spanish: Native
• Valencian/Catalan: Native
• English: Fluent
• French: Intermediate

Awards and Recognition

• European Commission H2020 Grant - SCANFACE Project: Principal Coordinator (2019-2022) - €2.5M funding for facial skin cancer detection device
• European Commission H2020 Grant - FACE Project: Principal Coordinator (2020-2023) - €3M funding for AI-based dermatology diagnostic tool
• AEDV Research Award: Excellence in Clinical Dermatology Research (2018)
• Best Oral Presentation Award: EADV Congress - "Ultrasound standardization in hidradenitis suppurativa" (2019)
• Innovation Prize: Spanish Academy of Dermatology - Medical Device Development Category (2021)

Declaration

I declare that the information provided in this curriculum vitae is accurate and complete to the best of my knowledge.

Signature: **************___**************

Date: **___**

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