All kidding aside, this satirical Onion article is a lighthearted reminder that the FDA approval process can be a time-consuming and complex process.  But remember also that it is an exceedingly necessary process given the nature of our work.  At Key Tech and elsewhere, engineers, biologists, and researchers are lucky to be developing products that affect peoples’ lives.  But the reality then is that we are developing products that have the power to affect peoples’ lives!  I find it reassuring that our industries are subject to the measures the FDA puts in place if it means safe and efficacious end-results for the consumer.  In a 1940’s comic strip entitled Pogo by cartoonist Walter Kelly, the title character exclaims, “We have met the enemy and he is us”.  I would say that Kelly – who died of complications of diabetes in 1973 – would agree that his words could also be applied to any field involving human health and safety as, “We have met the end-user and he is us”.

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.

Dr. Favardin, a strong proponent of entrepreneurship and an advocate for technology commercialization, talked about the various programs the university currently offers that help drive economic growth in the state of Maryland.  The Maryland Technology Enterprise Institute (Mtech) supports the state’s technology economy by educating the next generation of technology entrepreneurs, creating successful technology ventures, and connecting Maryland businesses with university resources.  Mtech has had a $22.5 billion economic impact within the state since 1983.  Specifically, some high profile products such as MedImmune’s Synagis and Hughes Communications’ HughesNet, and billion dollar companies such as Martek Biosciences, and Digene Corporation all found its start from the university programs.  Recently, the entrepreneurship programs offered by the university were ranked 11^th nationwide by the U.S. News and World Report.

Key Tech already has strong ties with the academic powerhouse.  Two out of the four founders graduated from Maryland, and Key Tech currently employs seven Maryland alumni from the Clark School of Engineering, which accounts for roughly 30% of the staff.  In addition, Key Tech CEO Jenny Regan currently serves as the chair for the Women in Engineering (WIE) Advisor board at the university.

Besides the existing relationship, Key Tech looks forward to an array of future collaboration opportunities with the school, and welcomes any suggestions on how to facilitate tech commercialization between the university and small businesses like Key Tech.

A special thank you to the event planners on the UMD side: Asante, Ted & Jess!

Frank Regan has just made the long trek to Jinja, Uganda with The Giving Circle to help bring needed resources to a Wanyange village orphanage, the Koi Koi House. Since March of this year, the nonprofit has been working to build a permanent home for orphans afflicted with AIDS. So far, the group has purchased land and already helped dig a well. Among other things, Frank will be working to bring electricity to the village by designing and building a small windmill. We’re following their progress on their blog.

This is a very worthy cause. Of course, back at the office, that gives us two weeks to setup a few practical jokes.

Good luck, Frank.

On Wednesday, Maryland Governor Martin O’Malley was awarded BIO’s “Biotech Governor of the Year” and used his acceptance speech to point out some of the reasons why.  Last year, the Governor launched BioMaryland 2020, a 10-year, $1.3 billion strategy for moving Maryland’s bioscience industry forward.

Maryland has always been a powerhouse of basic scientific research, home to global leaders like the NIH, Johns Hopkins University, the University of Maryland, and more.  Driving this tremendous amount of basic research to commercial success has historically been a challenge in Maryland, but that’s beginning to change.  Maryland has a growing commercial biotech industry and the BioMaryland 2020 program has already infused the industry with $100 million.

Much of this funding is going to research and academic institutions, but one of the effective industry infusions has been the Biotechnology Investor Tax Credit.  By offering a credit for qualified investors in biotech businesses, this program has already enabled dozens of Maryland start-up biotechnology companies to raise nearly $50 million from investors.

The state’s biotechnology sector is growing at a rate more than 10% per year, more than twice the national average, and Maryland is already home to more than 500 bioscience companies and employs the highest concentrations of PhD’s in the US.  Key Tech is seeing this growth and is already participating in the translational research and product development that will catalyze more commercial success.

Go Maryland!

Photo Credit: Thadz

As anyone attempting to build a mechanical perpetual motion machine can attest, getting it started can be tough. However, the Blizzards of 2010 helped ease the burden. Our building roof is roughly 100 meters long x 35 meters wide and 20 meters from the ground. We used the immense Potential Energy of 1.5 meter (60”) deep snow (~30kg/m³) from the blizzards to start the machine by fabricating a pulley lift system and simply shoveling the heavy snow onto a platform which naturally lowered to the ground.

That shoveling effort generated over 30 million Kilo-joules of energy, which was enough to get the machine started – and instigate a few snowball fights – and it has been running smoothly since February 12th. The next version of the machine is currently in development and is expected to be able to power a small city (without the dependence on weather phenomena to get it started). Key Tech has entered into contract negotiations with a “large power utility” to license the technology for applications worldwide.

Photo credit: John Nyberg

Key Tech enjoyed a private after-hours tour of some of the museum’s highlights including the “Chamber of Wonders” exhibit, an eclectic display which inspired our staff to consider including pinned insect cases, unicorn horns, child sized armor and animal skulls in their next home decorating project.

We would like to thank our program coordinator Cynthia Roberts and our expert tour guides, the museum’s Director Dr. Gary Vikan, and the Director of Exhibitions, Nancy Zinn.   If you are traveling to the Baltimore area we highly recommend a visit to the Walters, located downtown and now offering free admission.

Clearly, you’ve found our new Blog. Here, you’ll find tips and insight related to product development, advice for engineers, and news relevant to you.

We’ve also greatly expanded our About Us page to include individual profiles and pictures of our staff. Now, you can put a face to an email address or a voice and get an inside look at the people you work with at Key Tech. (Can you pick out the lonely Pittsburgh Steelers fan?) 

We’re just getting started, but you can keep up to date with the latest updates by having them delivered straight to your inbox or as an RSS Feed inyour favorite reader. We look forward to your comments, and we hope to learn more about you, too.