How Superior & Agile Product Engineering Triggered Establishment of a Medical Devices GCC by Gadgeon

Biotechnology companies often face challenges in building high-quality next-gen medical devices. While feature development contributes significantly to these challenges, compliance is a new ball game. 

Companies with inadequate compliance know-how and proficiency often face rejections from the Food and Drug Administration (FDA). This can result in massive rework, high legal fines, and a weakened business reputation. 

Learn how medical device companies can ensure precision and compliance with product engineering support by global capability centers (GCCs) and quickly bring innovative products to market. 

Medical Device Compliance Challenges

Medical device manufacturers collaborate with various stakeholders throughout the development lifecycle to bring high-quality devices to market. Responsibilities include extensive research, prototyping, quality testing, safety and compliance monitoring, and more. 

Standard procedures must also be adopted for high-risk medical devices. This includes obtaining scientific advice on the clinical development strategy and proposals for clinical investigation. In addition, the U.S. FDA requires medical device companies to comply with appropriate quality and safety practices. 

Firms must ensure proper maintenance, repair, and servicing to maintain the safe, effective, and reliable performance of devices used in the health care system. If companies cannot adhere to regulations listed by the FDA, it can lead to patient risks and costly recalls. For instance, medical device company Sentec recently recalled its VDR4 Phasitron breathing circuits due to a malfunction that could reduce pressure and volume flow. 

Maintaining medical device quality and compliance is challenging for various reasons: 

• Limited internal engineering resources can lead to poor safety feature development. 
• Inadequate verification and validation (V&V) can result in a sup-par user experience and restricted product scalability or security.  
• Lack of expertise in medical device engineering and limited knowledge of the regulatory environment can cause FDA non-compliance.

The Role of Product Engineering Expertise in Medical Device Compliance 

Product engineering support offered by GCCs can help turn business and regulatory needs into practical solutions. The proper support can help control costs, improve product quality, and ensure necessary compliance with evolving requirements. 

Here are the key benefits product engineering expertise from an established GCC brings to the compliance table: 

• Compliance Management: Product engineering support delivered by new-age GCCs can help medical device companies streamline software design and development. This can ensure safety, reliability, and compliance with standards such as ISO 13485 and IEC 62304. Teams can maintain security by securely storing sensitive medical data and establishing secure communication protocols. 
• Continuous Verification and Validation: Product engineering support can also enable robust verification and validation of medical devices. GCC teams can conduct various testing, such as functional and performance testing, design and system verification, and code validation. They can carry out necessary verification against the FDA's Quality System Regulation (QSR) and ensure compliance with relevant security requirements. 
• Traceability and Documentation: A skilled GCCcan enable traceability through adequate documentation. From design to code testing, the team can document and verify details for regulatory approval. It can also support the submission processes to the FDA, CE marking, and other certification authorities.

A Case Study 

A clinical-stage biotechnology company developing DNA-based medicines had developed a drug delivery system alongside its DNA-based medicine. However, after submitting the device for FDA approval, multiple observations led to a rejection of its Biologics License Application (BLA). 

To resubmit successfully, the client had to address all identified shortcomings and conduct full V&V. It also needed engineering support for its complex electro-mechanical Class-3 medical device. With a lean internal team, it sought an experienced technology partner to support device engineering, verification, and validation.

Gadgeon’s deployed a team of skilled experts across engineering, testing, and automation, ensuring a structured and efficient approach to device validation:

• Test protocol development & execution enabled compliance with regulatory standards.
• Third-party compliance testing ensures seamless temperature cycling and high-altitude testing.
• Specialized testing tools and board testing jigs ensure practical functional evaluation of disassembled systems.

Quality product engineering support helped the client address FDA concerns, refine its medical device, and ensure successful regulatory approval by setting up a fully operational V&V facility and a 35-member engineering team in just two months. 

Through deep engineering expertise, innovative testing solutions, and an unwavering commitment to compliance, the client could accelerate product development, achieve consistent, high-quality results, and optimize costs—positioning itself for long-term success in the highly regulated medical device industry.

Carving the Future of Medical Device Innovation 

As medical devices get increasingly complex, product engineering expertise offered by established global capability centers can help in timely and high-quality development. Gadgeon offers a range of engineering, testing, and automation services, ensuring a structured and efficient approach to medical device development, validation, and approval. We can set up a fully-functional GCC and align our processes with necessary quality and regulatory requirements, ensuring full compliance with ISO 13485 medical device standards and US FDA 21 CFR Part 820 regulations.

Explore our medical device development services today to get started!