Design engineering is a “tool” every medical device venture should take seriously.  Before searching for funding or lining up office space, your design must be thoroughly evaluated in its intended use.  Key Tech is the perfect partner for this, having spent the last 13+ years developing medical products.

Brian Lipford, VP of Strategic Development at Key Technologies kicked off the Tool Box Day by presenting an introduction to Key Tech.  His presentation is below:

After the presentations, we met with medical students, residents, researchers and some early-stage start ups.  Our advice to each of these entrepreneurs was the same:  Prior to engaging with Key Tech, you need to do your homework!

1. IP – Take a look at the patent landscape to see if your idea is unique.  At the very least, spend some time on Google poking around; it could save a lot of time and heartache.  It’s no surprise that without solid IP coverage, the deck is stacked against you.
2. Risks – What are the technical risks associated with your product?  What are the risks to the patient?  Medical device development is a risk-based business, so be comfortable with discussing this.
3. Funding - How will you obtain funding?  Key Tech may be interested in a joint venture arrangement with the right companies who are well funded.  If your idea has enough merit, Key Tech may be open to pursuing an SBIR grant.
4. Regulatory - What is your FDA regulatory strategy?  Does your technology fall into the streamlined 510k process, or is it going to be a more lengthy PMA application?  What are your potential reimbursement codes, because without them, you have no market!
5. Competition - Scope out your competitors.  Is it possible that they could be developing similar technology to yours?  Are you willing to compete with them?

Key Tech enjoys attending events like these because it gives us a chance to interact with researchers and professionals on the front lines of medicine.  Without their expertise, we are often times left doing needs assessments in a box, which isn’t very effective.  We love solving problems, but it takes partnerships with the right people to identify those problems.

Aris Melissaratos, Senior Advisor to the President of Johns Hopkins, spoke at the event about the $1.4 billion research budget at Hopkins.  He mentioned they are looking to improve their “return on investment” by spinning out more companies and ideas from the university stemming from their research.  We see this as a perfect opportunity for Johns Hopkins to reach out to the business community, and for the community to do the same to bring product innovation up to par with research at the university.

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.