Over 30 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 over 30 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
Kabblooe’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
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.