Boulder iQ | Top Medical Device Consulting Company 2019

MedTech Outlook Magazine

Boulder iQ
A One-Stop-Shop for Medical Device Development

Jim Kasic, President & CEO, Boulder iQJim 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.

Top 10 Medical Device Consulting Companies - 2019

Company
Boulder iQ

Management
Jim Kasic, President & CEO

Description
Boulder iQ is a medical equipment consultation and service provider that uses a three-legged approach to balance design, manufacturing, and quality for medical device organizations. With a strong understanding that medical device testing demands careful planning and attention to detail, Boulder iQ digs deep into the product’s design input and output, verification, validation, manufacturing and later, the market release. Based on a series of criteria that need to be met, such as feasibility, concept definition, and refinement, and finally, the prime concept is fed into the design controls. Boulder iQ also uses its quality and regulatory expertise for full implementation of quality management systems to compliance submissions

Boulder iQ News

Boulder iQ Division Introduces Contract Chlorine Dioxide Sterilization for Medical Device Products

Boulder Sterilization to operate largest contract CD chamber in world
BOULDER - Boulder Sterilization, a division of Boulder iQ, will introduce contract chlorine dioxide (CD) sterilization services this summer.
The addition will make Boulder Sterilization the sole contract sterilizer in the world to offer both CD and ethylene oxide (EO) technologies for medical devices and in-vitro diagnostic products.
In offering both services, Boulder Sterilization will be able to meet sterilization needs for almost every type of product, according to Jim Kasic, chairman and founder. “The ability to be flexible and adaptable, handling virtually any sterilization needs for device developers, is crucial today,” he says. “Speeding medical devices to market is both critical and challenging. Boulder Sterilization is helping to meet these demands and get devices into the hands of providers, and patients, as soon as possible.”
The new CD sterilizer, a 270-square-foot chamber (size of two pallets), is the largest contract CD sterilization chamber in the world, says Kasic. It will provide the capability to handle batches and products of almost any size, and allow Boulder Sterilization to meet urgent and immediate-service requests.
Quick-turn, low-cost service
Boulder Sterilization will extend its quick-turn, low-cost sterilization service to CD service. Whereas standard validations in the industry may take 8-10 weeks, Boulder Sterilization has developed a method to complete them in as little as 4 weeks. “By conducting multiple cycles simultaneously, at different set points, we can handle sterilizations more efficiently while mitigating the risk of issues that can occur in the initial cycle,” explains Kasic. “It’s one example of the ‘think smart’ approach we use.”
• Reduction in validation timeline by 80% – at a 75% cost savings
• Validations: 8-10 weeks
• Single-lot release: 5-7 weeks
• Engineering R&D sterilization runs: 4 business days
• Production cycles: 4-business day turnaround
Chlorine dioxide sterilization
The CD sterilization method uses the versatile, environmentally friendly chlorine dioxide gas for effective product sterilization. CD works at room temperatures, is low-impact, non-cancerogenic, nonflammable and leaves no post-treatment residuals. It is compatible with nearly all materials, including plastic components and electronics.
As a true gas, chlorine dioxide possesses superb distribution attributes, as it will naturally fill any space evenly and completely. Able to penetrate surfaces and organic matter, the colored gas is accurately measured and monitored. Quick-aeration ability means no condensation on surfaces, and minimal absorption into materials.
“As the market moves increasingly toward safer “green” options of sterilization, we have made the commitment to be there for the industry, leading the way,” explains Kasic. “Our company has always stood at the forefront, meeting the needs of the fast-paced medical device development world. This is one more step along the way.
Boulder iQ is an expert contract firm that provides life sciences companies all the services they need to bring products to market. With specialties in regulatory affairs, quality assurance, design, engineering and manufacturing, the company’s single-source program speeds product development. The Boulder Sterilization division provides quick-turn ethylene oxide and chlorine dioxide sterilization, final assembly and packaging services.
Based in Boulder, Colorado, Boulder iQ is ISO 13485:2016 certified through Boulder BioMed. The company’s Boulder Medical Device Accelerator provides equity investment in start-up companies seeking product development services, expert mentoring and infrastructure support.

Boulder iQ Names Jeremy Anderson Director of Business Development

BOULDER - Boulder iQ has named Jeremy Anderson director of business development.
Anderson brings nearly two decades of experience to the expert contract consulting firm, with a solid background in project and operations management, resource planning, and project scoping and estimating. Boulder iQ provides design engineering, development, turnkey manufacturing and sterilization for consumer, high-technology and medical products, and regulatory, clinical and quality management system services for the medical device and in-vitro diagnostic industries.
Most recently, Anderson worked at ERIGroup, Inc. in Golden, Colorado, where he held positions including director of operations, product development and program delivery. He also served as an engineering manager and mechanical engineer at the company. Previously, he was a staff scientist and engineer with Neumann Systems Group, Inc., in Colorado Springs.
Anderson holds a Bachelor of Science from the University of Colorado at Colorado Springs. He holds a patent in the indirect and direct method of sequestering contaminates.
"Jeremy's in-depth knowledge of the full product development process for medical device companies, coupled with his engineering expertise and business acumen, will help us align our services with developers' needs," says Jim Kasic, chairman and founder of Boulder iQ and its Boulder Sterilization division. "With demand for Boulder iQ's medical device product development and sterilization services at an all-time high, Jeremy will be invaluable in expanding our business in a strategic, effective manner."

Boulder iQ Division Increases Chlorine Dioxide Sterilization Capacity for Medical Devices

Boulder Sterilization sees greater demand for CD sterilization after EPA final rule
BOULDER - To address medical device developers' concerns about sterilization in the wake of the U.S. Environmental Protection Agency's final ruling on ethylene oxide (EO) commercial sterilization, Boulder iQ is expanding its chlorine dioxide (CD) sterilization capacity.
Boulder Sterilization, a division of Boulder iQ, has converted another one of its EO chambers to CD. This smaller, 8-cubic-foot chamber is in addition to its existing 270-cubic-foot CD sterilizer. "Many developers are concerned about the future of EO after the EPA ruling," says Jim Kasic, president and CEO of Boulder iQ. "Once they understand the benefits of CD sterilization, they are anxious to make the move."
In April, the U.S. Environmental Protection Agency (EPA) issued a final rule that will put in place the strongest measures to date for EO commercial sterilization facilities] – a rule that will impact virtually all medical device contract sterilization companies, and that has the possibility to significantly decrease the supply of EO sterilization facilities and increase EO sterilization prices.
The chlorine dioxide alternative
"Medical device developers used to sterilizing with EO are understandably concerned about its viability and availability going forward," says Kasic. While the EPA is not eliminating EO sterilization, but rather working to reduce EO exposure, he states that CD offers one of the best alternatives available. "It's an effective, efficient, clean method of sterilization with a long and successful history," he explains.
CD also is an environmentally friendly option appropriate for a majority of medical devices. It is non-carcinogenic and nonflammable, and has no post-treatment residuals. It can sterilize at room temperature, making it ideal for novel materials and plastics.
Safe EO sterilization
Boulder Sterilization will continue to operate six small EO chambers. "EO will still be the best sterilization choice for some products," Kasic says. The company uses small, single-use EO canisters to provide simple, safe loading and unloading – eliminating the risks that come with large quantities of potentially dangerous-to-handle EO gas. The contract sterilization organization has also equipped its EO sterilizers with abators (catalytic converters) that reduce emissions by more than 99.9%, already in compliance with the new EPA standards.
"The options we offer, and the variety of CD chamber sizes, are allowing us to meet the market need for different volumes and sizes of product," says Kasic. "Along with our fast-turn service – completing standard validations in as little as four weeks – we can help medical device developers get their products to market faster and more efficiently than ever with whatever type of sterilization works best for them."