At Boulder iQ, we know that every company and every product is different. What’s the same? Creating products that are commercially successful.

Designing with the focus on product launch

When we’re involved in the design stage of a product’s development, it’s all about creating a simple, elegant and compliant design that’s focused on a successful launch.

• Ideation and concept generation
• Design for manufacturing, commercialization
• Concept development, rapid prototyping
• Regulatory compliance
• Ergonomics design, human factors research and development

Engineering for results

The medical device experts, industrial designers, and mechanical and manufacturing engineers on our in-house team take products from the ideation stage through testing.

• Mechanical and electrical engineering
• Production release documentation
• Verification and validation testing (compliant with FDA Quality System Regulation)

FAQs

We field many questions from prospective clients looking to work with us in the design and engineering of their product. Here are some of the ones we see most frequently – and one we’d like to be asked more frequently. If you have a question about developing your product, and don’t see the answer here, drop us a line here.

How long will it take?

As you would expect, development work varies greatly by product. Scoping a project revolves around knowing what we can and can’t control. For instance, we can control how long it takes to do required documentation, but we can’t control how long it will take for biocompatibility testing. Once we have a design that meets minimally viable product requirements, we can predict how long validation and verification will take. On the other hand, we can’t control supply-chain issues or timeframes for third-party vendors.

We look at the landscape and make choices that represent a path of quickest time and least resistance. For example, we’ll schedule documentation activities requiring extensive literature research at the beginning of a project, making sure that the associated processes and protocols will be ready to execute when appropriate. We’ll design with high-volume, readily available materials. In short, we make smart choices that allow you to meet your schedule and budget – while planning for increased efficiency.

How long will it take with the FDA?

For a 510(k), the average time is about six months. In general, the FDA will come back with questions about 90 days after submission. The more we can anticipate those questions, and the quicker we can answer them, the faster the process will go. Sometimes, though, those questions require more testing, which can result in a longer-than-average timeframe (particularly if involving a third-party vendor).

How much will it cost?

Again, it varies by product and project. We usually can accurately predict several costs upfront, including sterilization, packaging and shipping validations, and normal biocompatibility testing. Beyond that, it depends on how far along the product and the science behind the product is. The closer things are to starting from scratch, the more time, complexity and cost typically will be required.
Why does a product development project involve so much documentation?

While documentation serves many purposes, the driver is generally the requirements of the FDA. The quality system documentation the FDA requires has proven beneficial in preventing mistakes and recalls, and generally represents sound business and quality practices.

What is Boulder iQ’s “think smart” approach?

It means going beyond the traditional phase-gate approach in product development. We begin the design process with the end in mind, concentrating on the goals of end users and your business. We do not spend substantial time in development until we have clear insight into the end user’s needs and requirements.

The “think smart” approach also means planning and scheduling to ensure that we begin tasks which will take longer to execute as early as possible to reduce foreseeable delays.

What kind of results do you get from your approach to product development?

• Increased accuracy of product requirements and specs
• Decreased number and depth of iterations
• Reduction in time to market of 10-60%

 

The question we wish we’d get asked

To make the design and engineering of a product go as smoothly and cost-efficiently as possible, a smart question from a developer would be: “What are the best things for us to do, and the best things for Boulder iQ to do?”

That way, we can make sure both companies are utilizing their skill sets to the max, and we can optimize development timelines. When a developer overestimates capabilities or underestimates time requirements, costs can escalate quickly and projects can start to fail. While we’re happy to step in, we’d like to see products get to market as quickly as possible and start making a difference to developers, providers and patients.