At Opharmic, Innovation for Impact is our core value. We are committed to developing novel ultrasound‑mediated solutions that can make a meaningful impact across therapeutic areas — many of which are highly regulated. Our mission is to create disruptive technologies that transform established processes, products, and industries, ultimately changing the way businesses and end users operate.
Building Market‑Ready Solutions with Quality and Compliance
Bringing breakthrough technologies to market requires more than scientific ingenuity. It demands a rigorous approach to quality, safety, and compliance. That’s why our development activities are carefully planned within an ISO 13485‑compliant quality system framework. To succeed, we must not only align internally but also communicate effectively with our value chain partners — including manufacturers, service providers, regulators, certification bodies, and research organizations. Each speaks a different “industrial language,” and a robust, systematic product development toolkit is essential to bridge these worlds.
Learning from Best Practices Across Industries
Developing a comprehensive product development toolkit is a long‑term journey requiring multidisciplinary expertise. To accelerate this process, we studied best practices from diverse fields — including Technology Readiness Levels (TRLs), consumer electronics cycles, medical device development, drug development, and Good Manufacturing Practice (GMP). Inspired by the automotive industry’s success, we adopted Advanced Product Quality Planning (APQP) as the backbone of our development process. APQP provides a common language that connects upstream clients and downstream suppliers, ensuring alignment across the entire value chain.
What is APQP?
APQP has been a cornerstone of the automotive industry since the 1980s, embedded in the IATF 16949 standard. It is a proven methodology designed to ensure the development and production of high‑quality products that meet customer requirements and expectations.
APQP integrates a range of quality tools — such as Failure Mode and Effects Analysis (FMEA), risk assessments, control plans, production trials, and validation processes — to bring new products successfully to market while driving continuous improvement throughout the product lifecycle. By identifying and resolving potential failures early, APQP helps reduce the cost of poor quality and enhances customer satisfaction.
The Five Phases of APQP
- Planning and Defining Program: Define product requirements and establish the project plan.
- Product Design and Development Verification: Design the product and develop prototypes.
- Process Design and Development Verification: Develop the production process and assess risks.
- Product and Process Validation: Test both product and process to ensure compliance with customer needs.
- Production, Feedback, Assessment, and Corrective Actions: Launch the product, gather feedback, and implement improvements.
Each phase includes specific elements to ensure APQP is implemented effectively and consistently.
Looking Ahead
At Opharmic, adopting APQP marks the first step in building a comprehensive product development toolkit that supports our mission of innovation with quality excellence. In our next articles, we will explore the benefits of APQP and share how we introduced this concept to a diverse team with different professional backgrounds.