Over 30 Years of Life-Saving Results
When developing a new 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 medical instrument design and development partner to help bring your vision to life. At Kablooe, we specialize in medical product design, with over 30 years of experience working with MedTech startups, Fortune 500 companies, and everything in between.
Coming Up With a Novel Idea For a Medical Device Isn’t Easy
But it is the easiest part. Like it or not, unless you have someone that wants to buy your idea right out of your head, you have a long road of medical product development ahead of you. Do you mind if we take the wheel?
Comprehensive Solutions to Keep You at the Forefront of Healthcare Innovation
Kablooe leverages its decades of industry expertise to take many of these tedious and time-consuming product development tasks off 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
If a product is easy to use, it results in less frustration and stress, which can go a long way toward making a patient feel less “sick.” Our UI/UX design experts keep this front of mind as they simultaneously blend form and function in the design 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.
Ready to Make MedTech Devices People Love?
Medical devices should delight users in ways they’d never expect. We do that.
