Medical Product Design Services

35+ Years of Medical Product Design Experience

When developing a new medical aka MedTech device, you shouldn’t have to do it alone. Whether you’re creating a diagnostic biosensor or a minimally invasive surgical implant tool, you need a partner who specializes in medical device design services and development to help bring your vision to life. At Kablooe, we specialize in both, with 35+ years of experience working with MedTech startups, Fortune 500 companies, and everything in between.

Medical Device Design Services: Ideation

Coming up with a novel idea for a medical device isn’t easy, but it is the easiest part of getting that idea to market. Unless you have someone in mind that wants to buy your idea right out of your head, you’ve got a long road of medical product development work ahead of you. Mind if our medical device design engineers take the wheel on that one?

Comprehensive Medical Device Design Solutions

Kablooe’s solutions keep you at the forefront of healthcare innovation. We leverage our decades of industry experience with medical device design in order to take many of these tedious and time-consuming product development tasks off of your plate.

Formative & Summative Studies

From developing a study script and moderating sessions to analyzing data and generating a report, we can ensure your involvement in the initial research process is as simple, streamlined, and straightforward as possible.

Usability Documentation

When a product is intuitive and easy to use, it reduces frustration and stress – helping patients feel more at ease and supported throughout their experience. Our UI/UX design experts keep this top of mind, thoughtfully balancing form and function in the development of our medtech devices.

Risk Management

Since the FDA will only approve devices that are safe and effective, mitigating risk is one of the cornerstone activities in medical product design. That’s why we place such a big emphasis on anticipating and avoiding the many risk-related challenges faced in this demanding market.

Regulatory Compliance

Leading healthcare OEMs trust Kablooe because we know what it takes to design and develop successful MedTech devices. Our products can be fully compliant with the following standards: HE75, ISO 9001, ISO 14001, IEC 13485, IEC 60601, IEC62366, and FDA Class II and III.

Cloud Data Collection

Our team of cloud and IoT experts will help you with all your backend technology needs, from wearable data collection to AI sorting—all while providing the advanced security you need to protect sensitive EMR.

Verification & Validation

Our rigorous medical product design process ensures your device fulfills its intended purpose by catching and correcting any potential problems before they arise. This serves to cut costs, shorten the time to market, and deliver the highest quality patient experience.

Are You Ready To Make Products People Love?

Devices should delight users in ways they’d never expect. We do that.

We Handle the ‘Not So Fun’ Stuff Too

Most devices these days are highly regulated, particularly those in the medical field. So let our human factors consulting team take many of these tedious and time-consuming compliance tasks off your plate. This ensures your involvement in the approval process is as simple, streamlined, and straightforward as possible.

Our HFE core competencies include:

Submitting HFE files to the FDA
Supporting risk management
Conducting formative and summative studies
Ensuring HE75 and IEC62366 compliance
Following HFE design protocols
ISO 13485 Quality Management

Let’s Work Together

David, AtriCure

I’ve worked with Kablooe on a number of med device R&D projects over the years. They’ve always been responsive, thoughtful, and innovative in their efforts…