Technology Due Diligence

Technology Due Diligence holds particular significance in healthcare-related due diligence processes.

This involves assessing critical elements such as the technology itself—whether the efficacy of pharmaceuticals or medical products, underlying production processes, licensing, intellectual property (IP), and patents. The primary objective is to evaluate sustainability. Even when a company’s financial data appears robust and management demonstrates competence, significant risks may lie within its technological foundation.

During a Technology Due Diligence, various key elements are typically assessed, including:

Preclinical and clinical data and studies
Production processes or combined product and system evaluations
Technology, including electronics, mechanics, and/or software
Regulatory approvals (such as CE, FDA)
Intellectual Property and patents
Quality and risk management systems
Packaging standards
Production scalability and manufacturing feasibility
And more

These insights are invaluable, assisting acquirers in assessing the target company's value, informing contract negotiations, and anticipating integration requirements post-transaction.

ConAlliance’s transaction experts offer a fully integrated Technology Due Diligence solution. A dedicated project manager leads the process, coordinating the work of various experts and ensuring seamless communication throughout.

Reach out to learn more about our approach.

ConAlliance: Specialized Commercial Due Diligence for Healthcare Sector

ConAlliance is a leader in conducting comprehensive Commercial Due Diligence for companies within the healthcare sector, with a particular focus on medical devices.

Technology Due Diligence: Key Areas of Focus

Risk Identification: Assessment of technology-related risks within the company.
Production Process Validation: Evaluation according to DIN EN ISO 13485 or through combined product and system inspections.
Scalability of Production: Assessment of product scalability for mass production.
Regulatory Approvals: Verification of existing approvals (CE, FDA) and assessment of the regulatory pathway if approvals are pending.
Quality Management Systems: Analysis of implemented quality management systems and their effectiveness.
International Standards Compliance: Verification of technology, electronics, mechanics, and software against international standards (e.g., EN 60601 in the EU, 21 CFR 820 QSR for U.S.-sold medical device software).
Product Safety and Environment Controls: Inspection of work environment controls to ensure product safety.
Risk Management During Development: Focus on risk management activities integrated into product development.
Traceability and Inspection for Implantable Devices: Assurance of inspection requirements and traceability for implantable devices.
Documentation and Validation for Sterile Devices: Assessment of documentation and process validation standards specific to sterile medical devices.

These critical assessments span across various healthcare segments, including pharmaceuticals, pharmacology, phytomedicine, microbiology, biotechnology, genetic engineering, stem cells, physiology, pharmacogenomics, proteomics, medical technology, medical devices, and instruments.

The Role of Due Diligence in Transactions

Due diligence is essential in any corporate transaction, often conducted under significant time constraints and with substantial personnel requirements. ConAlliance identifies the strengths and weaknesses of the transaction partner, anticipates potential obstacles, and evaluates both risks and opportunities.

Due Diligence Services Offered

Market Viability Confirmation
Drug Approval Processes
Medical Device Development and Certification
Certification Support
Due Diligence Opinions
Combination Products (Drug-Device) Compliance
Technical Documentation Review
Biological Safety Assessments
Medical Device Requirements and Biocompatibility
Biological Safety Reports
Risk Analysis for Medical Devices
Technical Aspects of Medical Technology Due Diligence
Biological and Clinical Safety Assessments
Global Harmonization Task Force (GHTF) Compliance
Summary Technical Documentation (STED) for Notified Bodies

Quality and Risk Management Evaluation

Our comprehensive Quality and Risk Management evaluations encompass:

Compliance with international standards for technology, electronics, mechanics, and software.
Adherence to local market regulatory requirements.
Rigorous risk management during product development.
Inspection and traceability for implantable devices.
Process documentation and validation for sterile devices.
Environmental controls to ensure product safety.

Notable Project References

ConAlliance’s expertise spans numerous high-profile due diligence projects, including:

Commercial Due Diligence in Endoscopy
Market Due Diligence in Medical Technology
Market Due Diligence for Private Equity on an Ultrasound Device Manufacturer
Due Diligence for Wound Care Companies
Market Due Diligence for Medical Devices
Commercial Due Diligence for In-Vitro Diagnostics
Implantable Devices Due Diligence
Commercial Due Diligence for Care Facilities
Market Due Diligence in Imaging Technology (MRI, CT, X-Ray, Ultrasound)
Due Diligence for Sterilization and Autoclave
Laser Surgery Due Diligence
Commercial Due Diligence for Intensive Care, Anesthesia, and Respiratory Devices

Our integrated approach allows ConAlliance to offer a seamless Technology Due Diligence experience, with a dedicated project lead managing all aspects of communication and expert coordination.

Advisory Services
Technology Due Diligence

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Prof. Dr. Dr. Ulrich Hemel

Günter Carl Hober

Dipl.-Kfm. Martin Franz

Quickcontact

Prof. Dr. Dr. Ulrich Hemel

Günter Carl Hober

Dipl.-Kfm. Martin Franz

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