1 Table of contents 2 Abstract 3 Research and Development of medical devices

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1 Table of contents

2 Abstract

3 Research and Development of medical devices

3.1 Design for Minimally Invasive Surgery

3.2 Methodologies for design and development of innovative devices

3.3 Design of medical components

3.3.1 Microtubes 3.3.2 Materials

3.3.3 Design for manufacturability 3.3.4 Assembly Techniques

3.3.5 Component Outsourcing 3.3.6 Sterilization Methods

3.4 Regulation

3.4.1 Certification aspects: definitions and classification

3.5 Quality system

3.6 Risk Management

3.6.1 The methodology of ISO 14971

4 Muneretto Beam Navigation device

4.1 Analysis of the medical background

4.1.1 Clinical evaluation in patients with AF

4.2 Surgical treatments for atrial fibrillation

4.2.1 The Maze Procedure

4.2.2 Circumferential pulmonary vein ablation (CPVA) 4.2.3 Radiofrequency ablation endoscopic procedures 4.2.4 Left atrial appendage (LAA) excision

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4.2.5 Robotically Assisted AF surgery

4.3 Technological state of the art

4.3.1 Magnetically guided systems 4.3.2 Robots for atrial fibrillation

4.4 Analysis and search of materials

4.4.1 Permanent magnets

4.4.2 The B-H Curve

4.5 Design History

4.5.1 Muneretto approach

4.5.2 Analysis of potential configurations 4.5.3 Finite Element Analysis

4.5.4 Model validation 4.5.5 Main FEA results

4.6 Prototypes and Tests

5 Video drain

5.1 Analysis of the medical background: Anatomy and Complications of

abdominal surgical wounds

5.1.1 Anatomical district

5.1.2 Ethiology and Pathophysiology

5.2 Market Analysis

5.3 State of the art: Commercial systems

5.3.1 Abdominal drainage tubes

5.3.2 Endoscopic covers

5.3.3 Trocar for extraperitoneal dissection (Balloon dissectors)

5.3.4 Balloon systems for diagnosis and intervention without insufflation 5.3.5 Abdominal ultrasound

5.3.6 Diagnostic Laparotomy

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5.3.8 Analisys of competitors features

5.4 Patent Search

5.5 Design of the device

5.5.1 Analysis of potential configuration and Computer assisted design 5.5.2 Analysis of materials

5.5.3 Final configuration and prototype 5.5.4 Accessories

5.6 Tests

5.6.1 Mechanical tests 5.6.2 Animal trials

5.7 Risk Managment

5.7.1 VideoDrain intended use 5.7.2 Classification

5.7.3 Functional Analysis

6 Floseal GI (Gastro Intestinal) catheter

6.1 Analysis of the medical background: bleedings in upper and lower

gastrointestinal tract

6.1.1 GI Endoscopy

6.1.2 Ethiology and Pathophysiology

6.2 Market Analysis

6.3 State of the art: Commercial systems and therapies

6.3.1 Endoscopic injection needles

6.3.2 Thermo coagulation 6.3.3 Mechanical Devices 6.3.4 Combined Therapy 6.3.5 Hemostyptic sprays

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6.4 Intellectual property

6.4.1 Accessory device: Floseal Matrix

6.5 Design History

6.5.1 Initial Specification 6.5.2 Underlined problems 6.5.3 Connections

6.5.4 Analysis of materials

6.5.5 Final configuration and prototype 6.5.6 Manufacturing process

6.6 Test sessions

6.6.1 In vitro tests 6.6.2 Ex-vivo tests 6.6.3 Control tests

6.7 Risk Management

6.7.1 Risk assessment

6.7.2 Risk evaluation and control 6.7.3 Sterilisation method

6.7.4 Instruction for Use – IFU 6.7.5 Packaging

7 Conclusions

8 List of publications

Annex I

Classification of Medical devices

Annex II

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Annex III

Flow Chart – Risk Management Activities in Design and Development

Grids for Risk and Measures Assessment

Risk Assessment Criteria Measures Assessment Criteria

1 Table of contents 2 Abstract 3 Research and Development of medical devices