Irwin & Associates
Enabling Success in the Medical Devices Industry

The medical device world has changed in the last two decades. New technologies have paved the way for updated manufacturing techniques and processes. Products are designed to be minimally invasive, wearable, a drug/device hybrid, and transmit considerable health data telemetry to a variety of smart devices. The medical device industry has evolved to meet new clinical demands and has transformed its models to keep up with new patient needs. Today, advanced technologies such as robotics are being leveraged across the entire production line—from assembly to inspection and packaging—to increase accuracy, efficiency, device margins, and throughput. With such innovations, the regulations have turned more stringent to ensure device safety, effectiveness, and performance. Besides the ever-changing regulatory environment, the last 20 years have also witnessed greater connectivity of information availability and sharing from product to physician and patient creating the need to focus on software and cyber security.

However, over this course of time, there has been one constant. Two decades into its inception, Irwin & Associates remains a consulting firm committed to the success of medical device professionals at all phases of the development to market lifecycle. Irwin & Associates was specifically established to assist clients faced with an upsurge in projects and tight deadlines. “We have been providing multifaceted consulting services, serving and supporting many of the top Bay Area medical device companies for over 20 years. Our highly experienced consultants and subject matter experts offer a wide variety of support throughout the product development lifecycle,” says Barbara Allen, Owner and President, Irwin & Associates.

Irwin & Associates specializes in diverse areas, such as project management, quality system creation, user documentation, quality engineering, verification & validation, risk management, design control, R&D to production transfers, process development, biocompatibility, and microbiology/sterilization validation and more.

Barbara’s experience at Irwin & Associates illustrates that the impact of technological advances and changing regulations in the medical devices industry has widened the skills gap. While high-end technologies have reshaped the terrain of product development, medical device professionals struggle to keep up with these industry shifts. Irwin & Associates’ strategy for addressing the skills gap is largely anchored in the engineering expertise along with thorough knowledge of regulations and the expert writing ability it brings to the table. Drawing on rich experience in the industry, Irwin & Associates’ adept team of project managers, quality system experts, manufacturing engineers, technical writers, design control experts, regulatory experts, and more, navigate client needs through diverse areas of product development.

“Because we have consultants with specific expertise, we are able to hit the ground running to fully understand the scope of the project and the key deliverables, and then start making progress toward meeting those deliverables right away,” adds Barbara.

Our highly experienced consultants and subject matter experts offer a wide variety of support throughout the product development lifecycle

Irwin & Associates is often approached by startups that have smaller teams and are looking for quick results. This is where the company plugs the gaps existing in the client organizations, delivering everything from technical support to innovative solutions, and attention to detail to help them move forward. For instance, if a startup is ready to build a quality system, the Irwin & Associates team leverages its expertise to help the clients create a quality system from scratch to meet their requirements, while adhering to regulations. Moreover, the team assists the company in setting up a document control system, a training program, a quality manual, and the appropriate procedures required to get them off the ground to conduct their initial studies and launch their products. For larger organizations, Irwin & Associates provides design control, process development, project management, regulatory, and technical writing to propel their projects forward.

To illustrate the prowess of Irwin & Associates, Barbara cites a customer success story, wherein the company engaged with a late-stage medical startup team, which was struggling with confusing, poorly written design control procedures in their quality system. The Irwin consultant worked closely with their engineering managers and quality team to rewrite and provide clear and concise SOPs, which were tailored to fit the particular needs of their product and organization. In less than two months, the client had a new set of procedures that supported their product development team.

In yet another impressive feat, the company worked closely with a well-established medical device company that had just acquired a startup company and needed to quickly incorporate the new products, documents and test methods into their system. The designated Irwin consultant conducted the project efficiently by updating the start-up documents and re-validating test methods, where needed, in a timely manner, in order to successfully meet the project goal.

Moving ahead, Irwin & Associates continues to adapt and expand in traditional and adjacent markets in the Bay Area and beyond. The company is foraying into new realms such as the autonomous car sector and consumer products. “The technology at play in the modern medical device and self-driving cars share many similarities in terms of the risk levels and human factors piece in that the importance of clearly defined specifications and a well-defined design control process is of extreme importance. For instance, a surgical robot and self-driving car are both highly complex systems interacting directly with a human in order to deliver optimal health and safety outcomes,” explains Barbara.

In days to come, the company plans to continue to provide excellence in consulting support by providing subject matter experts and highly knowledgeable and motivated consultants to constantly improve its services. “As new opportunities arise, we will eagerly take on these challenges with the end goal of propelling success with all of our valued clients,” concludes Barbara.