Keystone Solutions Group
A Partner-Advisor Approach to Product Development

The drivers of competitive advantage are always evolving. When it comes to product development in the medical device market, maximizing chances for success in getting an idea to market for improving patients’ lives can be a daunting task. “Medical device companies are often very effective at attaining new ideas and creating intellectual property, and they frequently have the sales channel developed and in place. However, they often require support to develop the product, get it approved by the FDA, and ready for manufacturing, packaging, sterilization, etc,” begins Jim Medsker, President of Keystone Solutions Group. A seasoned expert in product development and operational expertise in the manufacturing industry, Medsker is well-positioned to speak about the key levers of a successful manufacturing program. Drawing on his in-depth understanding of product development and program management issues, Medsker and his dynamic team at Keystone Solutions Group are turning product ideas into success stories.

With more than two decades of a successful track record in the industry, the company serves as an efficient turnkey product development and contract manufacturing resource for meeting its clients’ sourcing, assembly, kitting, and packaging needs. Established on a holistic model, the company does the entire heavy lifting and offers a gamut of services from the conception of a product idea through production and distribution. One of Keystone’s key differentiators is its partner-advisor approach when developing and manufacturing a solution for each client, ensuring an efficient launch and long-term success for their programs. “Our number one priority is creating a path to success for our clients. With this in mind, we first put our partner, advisor, and counselor hat on when exploring their initiative and throughout the relationship. We truly become a part of their team, many times not only serving as a collaborative service provider, but also as a board member, advisor, and/or investor.” Medsker adds.

Our number one priority is creating a path to success for our clients

Keystone specializes in managing the entire supply chain, assisting with sterilization validation and management, warehousing, and distribution. Supporting the strong startup scene in the industry, the company also offers complete development services—from design, analysis, and testing to design history file documentation, and overall program management. Ensuring the success of great novel medical devices, Keystone keeps pace with the technological advances in material science, like 3D-printing and other automation technologies, incorporating innovation in packaging equipment and assembly processes.

A certified ISO 13485:2016 company, Keystone is comprised of two distinct entities, namely Keystone Product Development and Keystone Manufacturing. Keystone Product Development manages all the key aspects of transforming a product idea into a well-documented, well-tested state including ideation, concept development, prototyping, testing, and analysis so that it can move into the manufacturing phase. Additionally, Keystone can also assist clients with their regulatory filings and intellectual property strategies. Keystone Manufacturing then picks up the ball from there and feeds the finalized design into a manufacturing environment, so that the product is produced, sterilized, packaged, and ready for distribution.

Medsker credits the success of Keystone to its seasoned and well-trained team, advanced equipment and infrastructure, and its capability to meet the clients’ needs at virtually any level of production volume. In one instance, Keystone was approached by a startup client to assist in the FDA approval and launch of a medical device that is a permanent implant within the body. Keystone collaborated with its seasoned regulatory team and broke through the regulatory hurdles to market it as a Class II 510 (k) approved product. Thanks to Keystone’s assistance in developing all the processes, equipment, and fixturing, the product developed by the client has been instrumental in improving patient outcomes for more than six years now.

Moving ahead, Keystone looks forward to expanding its impact in the markets served.