BAAT Medical Articles

31 Articles

1 2
Titanium 3D-printed spinal cages for PLIF, ALIF and TLIF procedures
Articles •

Entrepreneur seeing a business opportunity

Situation Two entrepreneurs with extensive experience in the spinal device industry recognized a business opportunity. They wanted to offer ...

Read More

Support Mid-size OEM with Development
Articles •

Support Mid-size OEM with Development

Situation A leading European mid-sized orthopedic company wanted to accelerate the launch of a new double mobility acetabular cup. ...

Read More

Articles •

Address a clinical problem of hip fractures

Situation A trauma surgeon noticed a high failure rate when treating intracapsular hip fractures with the standard Dynamic Hip ...

Read More

Articles •

Clinical evaluation report for CE mark

Situation A leading European mid-sized orthopedic OEM faced significant time pressure and limited internal resources while developing Clinical Evaluation ...

Read More

Local Gain without Corporate Strain
Articles •

Complete portfolio for a multinational

Situation A multinational orthopedic company wanted to add a specific plate size to its product portfolio. Although the project ...

Read More

Compliant Transition for Global Operations
Articles •

Compliant Transition for Global Operations

Situation A global provider of at-home aesthetic and beauty devices, operated with its Legal Manufacturer address in Israel while ...

Read More

Design and verification of a concept_Printing the imPossible FEA
Articles •

Design and verification of a concept

Situation A European startup set out to develop a fully 3D-printed spinal cage with an expandable design. The concept ...

Read More

Erik van de Garde en Matthijs van Dam over 3D-geprinte patiëntspecifieke instrumenten
Articles •

3D-geprinte instrumenten in de orthopedische chirurgie: deskundige inzichten van Matthijs van Dam

In het iconische Hotel de Wereld in Wageningen sprak Erik van de Garde, CEO van 3D Medical Models, met ...

Read More

Erik van de Garde interviewing Matthijs van Dam about 3D-printed patient-specific instruments
Articles •

3D-Printed Instruments in Orthopedic Surgery: Expert Insights from Matthijs van Dam

At the iconic Hotel de Wereld in Wageningen, Erik van de Garde, CEO of 3D Medical Models, spoke with ...

Read More

surgical instrument tray design with instruments arranged for sterile workflow
Articles •

The Hidden Complexity Behind Designing Surgical Trays (And Why It Catches Startups Off Guard)

A practical guide to designing, validating, and launching surgical instrument trays and why getting it right early saves you ...

Read More

Your compliant 3D printed surgical guide with BAAT Medical and 3DMM
Articles •

Regulatory Compliance for 3D Printed Tools

A new regulatory approved route for custom made 3D printed products The rise of 3D printing in healthcare has ...

Read More

Quality Assurance with BAAT Medical
Articles •

The Costs of a QMS for Medical Devices

Since the introduction of the Medical Device Regulation (MDR) in Europe, quality management systems (QMS) and regulatory compliance have ...

Read More

Post Market Surveillance with BAAT Medical
Articles •

Navigating Post-Market Surveillance for Medical Devices in the EU

The European Union’s medical device regulations have changed significantly with the introduction of the Medical Device Regulation (MDR) and ...

Read More

Mechanical performance validated with BAAT Medical
Articles •

Medical Device mechanical testing & sample size determination – Part one

Medical Device Mechanical Evaluation: Why Sample Size Matters When developing a medical device, pre-clinical testing is critical to quantify ...

Read More

Product development with BAAT Medical
Articles •

Dynamic MedTech Product Development: Navigating decisions

Navigating MedTech Product Development: Why Flexibility Matters Assuming that simply following a development process step by step will lead ...

Read More

Your Clinical Trial with BAAT Medical
Articles •

Clinical Investigation; Roles & Responsibilities

MDR Clinical Investigation: Roles and Responsibilities Medical devices in the European Union (EU) must meet strict safety and performance ...

Read More

Obtain FDA clearance with BAAT Medical
Articles •

FDA 510(k) Pathway and Opportunities Introduction

The US is becoming a priority market for medical device development more than ever before. Many new medical projects ...

Read More

Biologic Safety validated with BAAT Medical
Articles •

Biocompatibility Testing for Medical Devices

Biocompatibility Testing: Beyond Material Choice Many believe that using titanium, stainless steel, or PEEK guarantees biocompatibility. This assumption is ...

Read More

1 2