Boulder IQ: A One-Stop-Shop for Medical Device Development
Jim Kasic, President & CEO
Ideas can come from anywhere and at any time; often, the best product designs have been made on napkins. However, to take a design from ideation to fruition, the approach needs to be holistic to save time and increase productivity. This is especially true in the case of designing and manufacturing medical devices and equipment.
In a market with tight timelines and stringent compliance regulations, emerging medical device companies face the struggle of implementing their ideas. As most providers offer siloed services for product design, manufacturing or compliance consultancy, companies lose time, energy, and resources in coordinating between the different consultants and ensuring that they communicate with each other. “To end this, we use a three-legged methodology that comprises design, manufacturing, and regulatory services,” begins Jim Kasic, president and CEO at Boulder iQ, a medical device consulting firm and service provider.
When a client brings in a product or patent, Boulder iQ starts by focusing on the product’s design. The process starts at “Phase Zero,” with prerequisites. The Boulder iQ team reviews feasibility and concept definition, makes refinements, and puts the initial concept through rigorous design control procedures.
Understanding that medical device testing demands careful planning and attention to detail, the Boulder iQ team provides medical device expertise in a wide range of business and technical services: product design and development, including prototype builds; global regulatory submissions; marketing clearance or approval; transfer to manufacturing; market launch; and post-market support. Carrying out each task is a team of professionals with extensive knowledge in business and management systems, scientific and technical support, design and development, and manufacturing for the medical device sector.
We use a three-legged methodology that comprises design, manufacturing, and regulatory services for medical device organizations
In the process of preparing a medical device for commercialization, Boulder iQ’s compliance team incorporates industry best practices and quality management systems to streamline processes and support devices from pre-market to manufacturing and support. Experts collaborate to ensure clients get their devices to market as quickly and cost-effectively as possible.
By offering all services under a single roof, Boulder iQ can drastically reduce the amount of effort and time a client must use to coordinate between different functions. When large-scale manufacturers conduct the process, product design refinement to market launch can take 12-20 weeks, with significant time involved in packaging, validation, and implementation. With Boulder iQ, that can fall to just four to six weeks.
A recent example of a Boulder iQ success story is a firm that employed a large-scale manufacturer to develop a specialized catheter. In the first batch of products produced—10,000 units—none functioned properly. Rectifying the situation could have taken up to 18 months. The firm came to Boulder iQ for help. Boulder iQ’s team redesigned the product and had it back on the market within six months.
A key factor that differentiates Boulder iQ is the company’s interest in helping innovators and entrepreneurs. Boulder iQ formed the Boulder Medical Device Accelerator to make seed-level angel investments in medical device companies. The company supports medical device entrepreneurs with a financial investment as well as space, infrastructure, and discounted services.
Boulder IQ incorporates on a what/how/why approach, says Kasic. The “what” is providing soup-to-nuts medical device design, quality, regulatory and manufacturing services. The “how” is utilizing expert talent to do so. The “why” is the focus on making clients successful.
With aspirations to spread the Boulder iQ reach, Kasic hints at plans to expand physical space by purchasing a new building for manufacturing. The company also plans to begin offering sterilization services, eliminating dependency on external vendors.
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