Over the past three decades, improved diagnostic and MedTech innovations have significantly improved both life expectancy and quality of life. The world’s leading medical device and diagnostics product development firms have been at the helm of this innovation trail, and Ximedica is leading the way.
As a full-service ISO 13485-certified and FDA-registered company, Ximedica leads the industry in some of the most groundbreaking medical product development. Ximedica’s product solutions improve the lives of patients, caregivers, and clinicians every day. For the last thirty years, Ximedica has provided a unique growth platform that enables its clients to successfully design, develop, and manufacture advanced medical technology products.
Ximedica has its headquarters in Providence, R.I., and offices in Hong Kong, Minneapolis, San Francisco, and Silicon Valley. In November 2014, SV LifeSciences, a Boston-based private equity firm, acquired a majority stake in Ximedica, which was a crucial step in enabling and facilitating the medical company’s growth strategy.
Creating Medical Products that Matter
The medical device industry is evolving with new research in medical science and digital technologies to deliver value and meet clinical needs. For the clients, it is not only important that the industry understands its needs, but also responds with the expert knowledge and intuitive solutions. For example, recent research in neuroscience shows that video games are essentially replacing drug therapies in a variety of diseases. This innovation does not only hold potential for improving therapy but potentially can be a substitute to major difficulties faced by patients such as ADHD.
Because of the complexity and precision required to develop healthcare products, as well as the associated risks, Ximedica focuses exclusively on medical devices. Ximedica’s team provides a comprehensive service platform to deliver solutions for MedTech, drug delivery, diagnostics, and patient care.
Ximedica’s designers, engineers, and project leaders are fueled by ingenuity and creativity. They understand that the design and development process isn’t always linear, and that no two projects are the same. By drawing on years of experience and a passion for creative solutions to complex challenges, they enhance usability and improve outcomes.
Backed by a reliable proprietary development process, Ximedica adapts to each unique situation to deliver an efficient, risk-mitigated path to commercialization. Whether a client is in concept development with early stage intellectual property or fully mature on the market seeking product improvements or manufacturing partnerships, Ximedica can help at every stage.
Today, the incredible proliferation of new medical technologies makes Ximedica’s work more important than ever. The explosion of digital health, including AI, IoT, machine learning, mobile apps, Cloud-based solutions, and big data are causing MedTech clients to need more and more support on developing clear data strategies. Additionally, the collision of consumer and healthcare needs as patients become more empowered complements Ximedica’s strong background in both consumer and medical design.
The company has also managed to place itself not only to major MedTech companies but also to startups develop meaningful, safe, effective, and affordable products in a rapidly expanding landscape. At any given time, Ximedica is involved in the development of between 40 and 50 new products, including new technologies in digital health, biomaterials, diagnostics, and traditional medical devices.
Ximedica’s Four Pillars of Inspiration
Creativity: Ximedica’s team of problem-solvers and innovators are constantly discovering new, creative ways to enhance usability while meeting the complex demands of the industry and creating market-leading value.
Collaboration: The Company believes that the best relationships are built on trust and collaboration. Each Ximedica facility is equipped with secure labs and office spaces built to foster effective synergy between Ximedica’s team and those of its clients.
Diligence: FDA-registered and ISO 13485-certified for both development and manufacturing, Ximedica is uniquely positioned to ensure smooth passage through regulatory hurdles at every stage of the development lifecycle, skillfully reconciling FDA guidelines with clients’ individual goals and preferences in mind.
Human-Centric Design: The Company recognizes that all medical technology serves one unified purpose – to help human beings – and has made human-centric design the bedrock of its development process.
35 Years of Excellence
Randy Barko is the President and CEO of Ximedica. Prior to his appointment as Chief Executive Officer in 2012, Randy served as a longstanding executive advisor to the organization.
Randy has over 35 years of experience leading medical device and healthcare organizations to global and financial growth. He currently serves on the Boards of several privately-owned companies and is also involved with several private equity and venture capital groups.
Prior to these roles, Randy gained leadership and business development skills serving as Vice President of Corporate Development at Flextronics (NASDAQ: FLEX), and as Nypro Inc.’s Corporate Vice President, Marketing & Business Development and member of its Board of Directors. During his 25 years with Nypro, he led the business teams that generated steady growth in annual sales from $40 million to $1 billion.
Randy is an eminent industry figure and his perceptive insights have been a prime driving factor behind Ximedica’s remarkable success.
A League of Their Own
Ximedica has several elements that contribute unique value to clients. First, Ximedica’s manufacturing facilities offer a unique ability to support small pilot production for clients as they grow. Ximedica’s teams of experienced professionals ensure diligence in even the smallest volumes of prototypes and low-volume launch quantities. They also facilitate the hand-off from a development project to commercial manufacturing on a large scale. The company can serve as an effective partner at all stages of the development process, from a concept on the back of a napkin to commercialization and anywhere in-between.
With their founders from Rhode Island School of Design, Ximedica’s grounding capabilities are their expertise in – and emphasis on -human factors. Its senior staff’s longstanding emphasis on human-centric design is a major factor in its current domination of the market.
Another powerful aspect of Ximedica’s operations is its extensive worldwide network of offices. Global healthcare companies prefer working with local partners that can assist them with identifying the needs of regional customers. In addition, they expect these partners to recognize global trends and provide up-to-date solutions.
With its branches at key locations on the East Coast, West Coast, Midwest, and in Asia, Ximedica helps its clients identify regional trends and build region-oriented products.
Clients also emphasize the importance of the range of Ximedica’s registrations and certifications. Many product development firms try to strike the balance between regulatory specifications, usability design, and commercial viability, an approach which can adversely affect a project. However, Ximedica is known for its ability to successfully reconcile all three.
A Trend Setter and Reformer
A passion for human-centric design was the inspiration behind the founding of Ximedica in 1985 as Item Group, a general industrial design firm. After two decades of growth as a design and manufacturing firm, it became clear that medical devices were becoming a key part of the healthcare landscape. It was recognition of this fact that led to the focus on medical product design and rebranding as Ximedica in 2007.
Explaining the inspiration behind the company’s inception, Co-founder & Chief Innovation Officer of Emeritus, Aidan Petrie says, “We chose to devote our resources exclusively to expertise in the medical field because we felt we could have a meaningful influence on the entire healthcare ecosystem.” Since its establishment, Ximedica has focused on human-centric innovation and kept abreast of industrial trends to better serve its customers.
One of the most important trends in healthcare today is the combination of consumer (wellness) products and traditional MedTech. As patients are better educated, their relationship with the healthcare system begins to look more like relationships in the consumer world. Ximedica’s roots in consumer design and core expertise in human-centric design catapult them into a leadership position in this new, empowered world.
Digital health is also rapidly changing the healthcare landscape. Connected health devices and solutions are able to deliver more targeted patient care, allowing for better clinical and financial results. As medical technology shifts toward the consumer, Ximedica has drawn on its deep consumer product design roots to deliver connected devices that offer higher value by creating unprecedented levels of performance.
These connected devices challenge this balance in new ways – cyber-security issues enter the equation as do consumer protection regulations. While the benefits may be vast, connected devices live across multiple lines of standards and regulations, including the FDA and HIPPA. Ximedica is uniquely qualified to create these interconnected health ecosystems.
Expanding Range and Reach
With its recent acquisitions, Ximedica has broadened its portfolio to include digital products and diagnostics, and now is in full growth mode.
The company has spent the last 5 years expanding rapidly, with new offices in the Boston/Providence area, Minneapolis, San Francisco, Silicon Valley, and Hong Kong. Ximedica is looking to continue building impeccable products and strengthen its market presence in both the U.S. and abroad. Ximedica’s investments in its ability to manufacture Class III devices now enable it to support clients from concept to completion. Talking about the future, Randy says, “We’ll be focusing on expanding, particularly on our digital health platform and our diagnostics capabilities, as both of these core areas are key to the future of global health.”
Ximedica has a proven track record of developing effective and innovative products for the healthcare sector. The company intends to continue on the path to more human-centric innovations that improve the lives of everyone they touch.