Tom KraMer
Twin Cities–based medical-device design firm Kablooe Design will get its first new chief executive in 34 years this summer. Founder Tom KraMer will step aside on August 17, and move into a strategic-account role.
His successor, Fred Sklenar, is a 37-year product-development veteran who joined Kablooe after running his own consultancy and teaching design-for-manufacturing courses. Sklenar holds graduate degrees in design and an MBA, and has led projects spanning surgical tools to consumer wearables.
The hand-off comes five years after Forward Industries bought Kablooe for $1.6 million to deepen its medtech services portfolio. Since the acquisition, Kablooe has added IoT and human-factors engineering work for clients such as Medtronic and Boston Scientific.
From an R&D vantage point, this news is a signal that Kablooe is repositioning its design toolkit closer to the front end of medtech R&D.
“Coming in August, this move will free me up to focus more on my passion by taking on a role as a Kablooe strategic account executive where I will be able to strategize with innovators to make their visions become realities, something I have a lot of fun doing!” KraMer said on LinkedIn.
Kablooe’s portfolio spans wearable biosensors, blood-pressure monitors and other connected-health devices, plus surgical and consumer products.
Over the years, Kablooe has touted a human-factors-first ethos. For instance, in a blog series titled How to Make the FDA Happy, Kablooe notes: “A Human Factors Engineering (HFE) plan will help you think through how people will use your device in the real world and can help you avoid costly redesigns down the road.”
Recent how-to guides from the company tackle IoT, cloud integration, firmware trade-offs and companion-app strategy.
This leadership transition is salient as medtech R&D faces intensified FDA scrutiny on human factors engineering (HFE) and device usability. Deficiencies in these areas are a common trigger for FDA probes during 510(k) reviews, which can spur costly delays. The mandatory adoption of the FDA’s eSTAR submission template ups the stakes with its emphasis on comprehensive HFE documentation from the outset.
Kablooe was founded in 1991.