Mark Coates, VP, Business Development“The world of medical devices is undergoing a tectonic shift,” says Mark Coates, Vice President of Business Development at CITO medical. “Innovations like wireless tech, miniaturization, targeted therapies, and robotic surgery, as well as consumer self-diagnostics are opening up opportunities for enterprises of all sizes.”
The Santa Cruz, California-based medical product development and manufacturing company collaborates with organizations ranging from entrepreneurial startups to the NIH and Fortune 100 companies.
With 20 years of experience and a full array of engineering capabilities, CITO offers solutions for complex mechanical and electrical designs. The company’s quality management systems and ISO 1345 certification ensure medical traceability of all components.
“Medical innovators are not always aware of the challenges they face on the path to FDA clearance,” explains Coates. “We’re able to help them navigate the regulatory process.”
During the COVID-19 pandemic, CITO worked with multiple companies involved with consumer test solutions.
“This was the ultimate test of our ability to turn product designs around quickly,” says Coates. “We met the challenge of working with multiple agencies through the regulatory and product development cycle.” In fact, CITO became a strategic supplier to the National Institute of Health.
CITO often delivers a product concept within days instead of the typical industry lead time of weeks—or even months.
Once the solution is achieved, CITO has the capacity to manufacture products onsite, providing a full end-to-end solution for clients.
Importantly, CITO’s clients retain their intellectual property as well as their full quality management documentation. This ensures that clients’ IP does not end up in the hands of competitors, as is common in the industry.
Another core competency of CITO is budget and timeline transparency.
“Too many companies underestimate the time and budget required to bring a medical device to market,” says Coates. “CITO takes the time during the brainstorming and proposal process to truly understand all the steps required to successfully develop a new product.”
CITO also has the advantage of operating its own manufacturing facility, to ensure the manufacturability of clients’ products.
Importantly, CITO’s clients retain their intellectual property as well as their full quality management documentation. This ensures that clients’ IP does not end up in the hands of competitors, as is common in the industry
Contrast this with a scenario in which manufacturers must adjust or alter designs to improve yields and TAKT times. Notes Coates, “This adds costs and creates delays.”
To ensure the transferability of designs to high volume manufacturers, CITO collaborates with the client and with selected manufacturers in the early phases of product development. This lessens the “learning curve” of the high volume manufacturer.
“The primary reason that I enjoy working at CITO is that we’re honest with our clients. Our culture helps create relationships of trust and partnership that last for years.”
