Key Tech predominately develops medical devices. About 80% of our work is electro-mechanical medical device development. The majority of the remaining 20% continues to be electro-mechanical hand-held and laboratory instruments, just not in the medical industry. In all cases, our design process is governed by an extensive quality assurance protocol that is currently certified to both ISO9001:2008 and ISO13485:2003 standards.

Our medical portfolio of more than two dozen devices includes in vitro diagnostics, molecular diagnostics, therapeutic instruments, and drug delivery devices. Some examples of our work include:

• ­ Laparoscopic surgical instruments
• ­ Delivery instrument for cryotherapy treatment of esophageal cancer lesions
• ­ Drive system for pediatric autism training robot
• ­ Automated dose activation system for innovative biologic with time-sensitive stability
• ­ Automated multiple syringe control system for OR drug delivery
• ­ Microwave heat delivery for targeted cancer treatment biologic
• ­ Suite of 21 physical therapy tools: wireless conversion and data collection management
• ­ Redesign of infant incubator components
• ­ Respiratory flow sensor for monitoring mild spectrum sleep apneas
• ­ Diagnostic vein location system
• ­ Continuous wearable glucose monitoring system
• ­ Blood hematocrit meter and disposable cuvettes design
• ­ Blood multi-analyte meter
• ­ Cassette redesign for reagent-based MRSA detection
• ­ Microfluidic sample preparation and handling: multiple projects
• ­ Molecular diagnostic chip design and chip interface design and prototyping
• ­ Molecular diagnostic microprocessor-based control and detection algorithms
• ­ Molecular diagnostic – industrial design of instrument user interface
• ­ Multi-well array for cancer detection via electrophoresis

More information, pictures, and detailed product development case studies are available in our online Portfolio.

The concept of “personalized medicine” is based on the targeting of specific factors that make one individual more receptive to a therapy than another. Pharmaceuticals can alleviate symptoms and cure disease. However, many drugs  only help fewer than half of the people who take them, and many come with the small chance of side-effects – everything from diarrhea or drowsiness  to death. The idea of personalized medicine is that patient populations can be tested to verify before prescription that a drug will be effective for them and that side effects will be minimal.  Tests may be based on a genomic marker or a biological cell structure.

Key Tech has been designing and developing diagnostic devices, both point-of-care and high throughput, for over 10 years now.  In recent years, we’ve been conceiving and developing new drug delivery devices as well and we are witnessing the growing market for patient-friendly medicine delivery and the companion diagnostics that qualify a patient population for targeted drugs.  We’re looking forward to watching this approach to medicine develop and mature.

In The Innovator’s Prescription, Clayton Christensen discusses how disruptive solutions are the evolutions that take the status quo to the next level. They may or may not be technical leaps, but they are new business models that take Blue-Chip titans by surprise, knocking them from #1 and leaving them trying to catch up. Think Canon taking printing business from Xerox by moving it from the giant mega-machine to the desktop. Christensen’s book specifically addresses the business models of health-care, but many of the concepts can be easily transported to other industries.

Here are two examples of the DIY mentality creating some disruptive, and hopefully game-changing, solutions to common problems.

Michelle Khine is an Assistant Professor at UC Irvine working on microfluidics and nanotechnologies. As part of their research, she and her team developed a technique to create microfluidic chips quickly and cheaply using Shrinky Dinks®, an oven, and a printer. Although she was just trying to get her lab up and running quickly, she ended up creating a breakthrough technology that resulted in her being named one of MIT’s TR35, an award given to top innovators under 35 years old. Yes, the toys of childhood are now the research tools of the future. So, if your boss asks you why you have Rock ‘Em Sock ‘Em Robots on your desk, you can point to this.

Technology Review 2009 – A children’s toy inspires a cheap, easy production method for high-tech diagnostic chips

Chemistry students at Harvard University devised a $2 device to separate plasma from blood using an egg-beater and a few other parts. The resulting plasma is more than sufficient to detect diseases such as Hepatitis B and cystercosis. While not quite ready for the major laboratories, the device would be useful to doctors in remote locations without the financial resources to send blood off to a lab for testing.

$2 egg-beater could save lives in developing countries

Photo credit: Malancha Gupta

Further advances in microfluidics technology development will educe the most profound breakthroughs in medical diagnostic and therapeutic devices — and ultimately improve patient care. Microfluidics chips enable miniaturization of common macro-scale diagnostic devices down to microliter-level hand-held “lab-on-a-chip” devices. Smaller devices enable use at the point of care, and in certain cases, at home with the patient.

The technical advantages of lab-on-a-chip devices, as commonly known, include smaller sample size, higher throughput, faster analysis, and improved accuracy. Certainly, microfluidics diagnostic devices exist on the market today, but there still is significant untapped potential. For example, recent advances in micro fabrication techniques will enable micro pumps and valves to be located directly on the microfluidic chip, instead of requiring macro-scale components to drive the microfluidic flow.

The challenge for microfluidics is bridging the complex gap between R&D and production. Aside from the basic science employed to monitor the analyte, such as ultrasound or advanced optics, the primary challenge is miniaturizing the surrounding electronics and fluid controls, then integrating them seamlessly with the backbone of the device, the microchip.

For microfluidics devices to be successful, it is imperative for design teams to incorporate experts at all points along the value chain, from concept to design to manufacturing, such that the common mishaps associated with transitioning a design from the micro chip level to the macro world are overcome.