MAXIS Medical
Innovating Medical Device Development

Medical device entrepreneurs are arguably among the toughest innovators—a typical start-up must endure a multi-year process full of obstacles to success. Creating a new technology that significantly helps patients is not for the faint of heart—from product design to regulatory approvals and commercial reality, the process is pockmarked with pitfalls. It is a journey that Kathleen A. Marshall, President and Founder of MAXIS Medical knows well—she has nurtured several medical device start-ups to fruition and now spends her time building a company whose sole purpose is to foster the development of emerging medical technologies. To quote Kathleen Marshall, “Many early-stage medical device companies struggle to determine the most efficient strategies for developing their device. The process can be overwhelming with critical decisions—ranging from engineering testing, animal models, quality systems, and targeted geographies for regulatory submissions and market acceptance. Establishing priorities and determining trade-offs is a must for a successful start-up.”



Start-up companies are often surprised by the labyrinth of design choices, regulatory strategies, and financial realities they must traverse to achieve the commercialization of their products. The average cost of bringing a medical device to market in the USA alone amounted to 31 million dollars through a 510(k) and 94 million dollars through a PMA (Mass Device, September 2019). Approximately one-fifth of the 510(k) costs were on pre-clinical testing, proof of concept, prototypes, and clinical units, with the remaining 80 percent dependent on regulatory and clinical data activities such as First-In-Human, Safety/ Feasibility, Performance, and Pivotal studies (Starfish Medical Whitepaper, July 2020).

In Europe, the new, more stringent Medical Device Regulation (MDR) is being implemented, often requiring longer development times and more extensive clinical evidence. In the USA, multiple communication channels with the FDA, such as Pre-Submissions, Early Feasibility (EFS), and Breakthrough status are newer options along the way to 510k clearance or PMA approval. All of these have led to greater complexity in designing the most efficient and effective pathway to success. Even for serial entrepreneurs, clearly there is a need for expertise to swiftly assess when and where to leverage and streamline solutions.

For those who can successfully navigate the process, the reward is substantial and benefits all stakeholders of the healthcare system. Over the last two decades, medical device developments have continued to increase rapidly, leading to improved outcomes, less invasive procedures, and better quality of life with shorter hospital stays and recovery times. According to recent data, the size of the global medical device industry is nearing 500 billion dollars, with the USA comprising a little over one third of this market. In Europe, the medical device industry is projected to reach more than 60 billion dollars by 2025, up from close to 50 billion in 2020. In China, the market has almost tripled since 2015 to approximately 70 billion dollars in 2020, and India and Israel, among others, have also grown rapidly.

More than three-quarters of early start-ups have fewer than 50 employees, which highlights the volume of companies trying to introduce new devices. Hence, making efficient strategic choices at each step of the development continuum is critical to managing a limited start-up budget while enabling the survival of new concepts and medical devices.

An Iterative and Interactive Process

This is where MAXIS Medical, a medical device development company, brings innovative ways to fast-track development and orchestrate clinical strategies seamlessly for successful market entry. It is comprised of 30 employees and has operational offices in San Jose, California and Frankfurt, Germany to span the globe and support medical device entrepreneurs and device start-ups.

Our methodology is focused on engineering a market for important emerging technologies. Just as we apply a rigorous process to the technical development of new medical devices, we also implement disciplined and integrated approaches to regulatory strategies and clinical trials

A new device therapy often creates disruption, requiring changes in behavior. The MAXIS methodology, honed over two decades of experience, benefits emerging medical technology companies by providing a team that can be in sourced at all levels of the company—and who also understand the challenges and the necessity of upsetting the status quo. Interactions are as frequent and intense as if the team were directly employed. All options are thoroughly brainstormed and challenged until a consensus is achieved.

An Undying Passion for the Start-up Culture

Kathleen Marshall established MAXIS in 2003 to bring the preclinical expertise, strategic regulatory submissions, and clinical study execution that came from her own experience in start-ups. Joined by several successful medical device experts, the MAXIS group is now an exceptional team with comprehensive, multidisciplinary backgrounds, including engineers, physicians, other medical professionals, and business strategists, all of whom have lived through the process of bringing successful medical innovations to market.

“Our methodology is focused on engineering a market for important emerging technologies. Just as we apply a rigorous process to the technical development of new medical devices, we also implement disciplined and integrated approaches to regulatory strategies and clinical trials,” says Kathleen Marshall.

The most prominent characteristic that differentiates the MAXIS methodology is the ability to synergize the unique demands of each customer. Often, medical device start-ups collaborate with multiple providers to develop their pathway, rendering the process siloed and isolated. But each step along the way needs to be coordinated to create a targeted solution, customized and unique to each situation. The MAXIS team strives to simplify, streamline, and connect the activities of the medical device lifecycle. This holistic methodology is based on a deep understanding of the requirements for emerging technologies and is concentrated on multi-disciplinary perspectives to provide wrap-around support and services. MAXIS creates and integrates preclinical engineering services, strategic regulatory submissions, and precise clinical trial implementation to emerging medical technology companies. With careful adherence to appropriate guidelines and requirements, MAXIS covers the entire spectrum of start-up needs.