CDRH has come under intense criticism over the past several years for being slow to approve medical devices under both the PMA and 510(k) programs.   From 2006 to 2010, the number of devices cleared through the 510(k) process has dropped steadily from 85.8% to 73.6% of submissions, while the average review period prior to clearance has steadily increased from 96 to 135 days (additional information).  As a result, medical device companies are increasingly executing strategies to launch their products outside the US first and worry about the FDA (and the US market) later.   This means that millions of Americans are waiting for medical diagnoses and treatments that are already benefiting the health of citizens in the rest of the world.  Here at Key Tech we are seeing this trend firsthand.  About 63% of our current medical device programs are being strategically positioned for approval outside the US first.

Dr. Shuren acknowledged that one of the reasons for the slow pace of approvals at the FDA is culture.  He doesn’t agree, however, with the popular notion that the FDA culture is too risk-averse.  He offered instead that the slow pace is due, at least in part, to an ingrained culture of self-sufficiency among FDA reviewers.  The reviewers feel they should independently resolve most of the identified issues on the path to clearance themselves.  They literally “get stuck” instead of reaching out to others for help.  Increased collaboration among FDA reviewers and contracted outside experts, he says, should help break this logjam.

Dr. Shuren enthusiastically presented the FDA’s new Innovation Pathway program, a new review process aimed at reducing time and cost for review and clearance of higher-risk, newer-tech submittals, as well as increasing collaboration within the FDA and between FDA staff, inventors and outside experts.  The program was initiated in 2010, as a pilot program focused on solutions to End Stage Renal Failure, and has been revised already to “version 2.0” in April 2012, to incorporate new methods and tools developed during the first version of the program. These tools include decision support rubrics, IT collaboration environments, and other process accelerators.   Another feature of the new “Innovation Pathway 2.0” is very early collaboration between inventors and the FDA, even before  pre-market submission.

It remains to be seen whether the Innovation Pathway will accelerate reviews and increase collaboration in a way that can be rolled out across the organization and to the pool of submittals seeking 510(k) approvals.  However, the tenets of this program and Dr. Shuren’s passion for it surely are promising.

About 9 years ago, we were looking to move our company.  We were small, but had outgrown our old space.  We were literally hours away from signing a new lease deal in a nondescript building, replete with florescent lights and elevators, when we stumbled on a classic, old vaudeville theater built in 1911.  It was open and inviting, with 35 ft ceilings and the original wood stage where performers once sang and danced.  Granted, it had been destroyed over the years and was in terrible disrepair, but with just a little imagination you could see its potential.

We never looked back.  We took out loans, renovated and moved in over the course of the next 18 months.   We only needed about 7,000 sq ft back then, which is about half the total space.  We leased the other half to several private companies, even as space got cramped at Key Tech.

There is an old saying for any business that you either grow or die.  I guess you could say we are lucky there too; we have continued to grow at about a 20% yearly pace.  We are happy to announce that as of June 1 (next month) we will be expanding into the rest of the theater.  The new space will let us continue to grow, expand, collaborate, inspire and create.  For a company that develops new products, what more could you possibly ask.

The theater before……..

2002 View After Renovation

Current View

Sometimes we can forget all of the astounding feats of engineering, and design that are everywhere around us in our world today.  Camden Yards is quite the accomplishment housing close to 46 thousand seats.  This year we even have high hopes that the O’s will be crushing the likes of the Red Sox and making good use of the seats with more orange in the stands (GO O’s!).

During the construction in the early 90’s over 2,000 people manually scrubbed over 5 million bricks in the revitalization of the B&O Warehouse, once the longest brick building on the East Coast.  Now the warehouse is home to the Maryland Stadium Authority and used as offices, gift shops.  The upper floors can even be rented out for high school proms and weddings.

Perhaps the most interesting part of the park is their beer distribution.  Stored in a central cooled location dozens of lines of cool fermented grandeur are dispersed throughout the park to each concession stand.  Although still $5 a pop, the behind the scenes workings of the extensive beer tap network now provides a bit more utility to those 16oz of golden fluid perfection.

After the tour we all enjoyed food and drinks at the famous Ropewalk Tavern in Fed Hill.  It’s always important every now and then to step back and enjoy the company of those we work with.  It’s an honor and a pleasure to work in such a hardworking, fun environment at Key.  Although our products are small in comparison to the large feats in our engineered world today, we continually strive to create devices that are user friendly, innovative, and elegant while helping to improve peoples lives.

Picture taken by Josh Mull

As an engineer with a product design company like Key Tech, I tried to extract the “design realm” from the presentations and exhibits.  As its name implies, the conference delves heavily into manufacturing on impressively small scales – micro injection molding (MIM) of parts with 0.0015” wall thicknesses, 0.10^o draft angles, and so on.  The conference also has a strong academic and research contingent that speaks to the future of micro and nano technology – an “atomic rover” made out of single carbon atoms, MEMS technology for measuring in the femto (10^-15) – and atto (10^-18)- amperes, and so on.  Since good, profitable product design bridges these two realms whenever possible, I listened intently.  After I had absorbed what I could, the truly difficult challenge was filtering info that is practical to Key Tech right now, from the futuristic, sci-fi, “Petri dish” successes and processes that are a long way from practical application – call it, “present-dependent forward-thinking”.

After much diluting, a few of the micro / nano technologies that Key Tech could realistically incorporate into their designs today include:

• parts impregnated with antimicrobial nanoparticles for increasing shelf-life and time between sterilizations
• tools and parts with micro surface finishes that produce macro results, like drastically improved wipe down “cleanability”, reduced coefficients of friction, and altered optical behavior
• parts and features, machined, etched, cast, stamped or molded, on the micro scale

I’d like to extend my thanks to the SME for hosting this event, and if you’d like to learn more, visit the event homepage here , and check back for updates on the 2013 event to be held in Minneapolis.

I asked my fellow Key Techers and got a myriad of responses.  Some of us had engineers as parents and saw their love of the field.  We were told, “Engineering is a steady career field.”  Several of us were influenced by the familiar equation that plays out early in school:  good at math + good at science = engineer

Other replies focused on things engrained in our personalities.  How many times as a kid did we take things apart just to see how they worked (and the thrill we got with the bonus challenge of putting them back together again!)?  For us at Key Tech, that curiosity lives on.  As engineers, we see that “imagination is necessary as well as scientific knowledge” (Sir William Halcrow).  We enjoy the challenges that our engineering skills meet and how great ideas spawn from experimentation.  And there’s nothing quite like the joy of building something:

“I became an engineer because I always enjoyed seeing a real-world output of my imagination.  I would imagine building a roller-coaster that I could route through my entire house as a child, but realized the next best (and more realistic option) was to create a mini roller coaster out of K’nex and mount a digital camera to the car, record video, and then play it back to see my coaster from the rider’s perspective.”

We’ve learned that engineering reveals that equations are more than just numbers and symbols: they show how the physical world works.  We’ve seen the role engineers play in the world: positively influencing people’s lives through tools and technologies that help them overcome challenges of all types throughout the globe.

Within the answers to this question is a glimpse into the cross-section of our personalities, dreams, and motivators.  Too deep for a first date?  Then be careful when you ask us the innocent, seemingly simple question, “Why engineering?”

Photo Credit: jimmyjam2K

This year after much deliberation, we choose March Madness as our holiday.  WELCOME TO THE BIG DANCE.  Key Tech’s version of the March Madness bracket isn’t quite the same as the version floating around your office.  Our selection Sunday played out quite a bit differently, and instead of Duke versus North Carolina or Michigan vs Michigan State; Key Tech pitted fierce contenders against each other such as Stress versus Strain and Battery Life versus Performance.  Our bracket is filled with day to day decisions and considerations that go into the products we design, and the outcomes create some difficult decisions.  Who will win the showdown of Caffeine versus Gravity in the Elite 8?  I mean, how can you predict when you have the world’s best pick me up versus the invisible force holding us down?  THIS IS GOING TO BE A NAIL-BITER TO THE END!!!

With the basketball theme, what better way to feature the Key Tech team than classic basketball shots?  A quick trip to the sporting goods store and an afternoon photo shoot later, each Key Techee now has a personalized basketball card.  Engineers in 70’s basketball gear, I mean, it could only happen during BRACKET MADNESS!

Even in fun and games, a winner must be chosen.  Key Tech took the liberty of filling out the majority of the bracket, but the championship game is left up to YOU!  Respond in the comments with your selections for the two teams to meet in the finals and the ultimate victor.  Remember, March is when champions are made!  Full Bracket

Snapshots from the photo fun:

It seems almost too simple to be viable, but the treatment—which Novocure calls Tumor-Treating Fields (TTF)—has shown promising results in phase III clinical trials, and has even been approved by the FDA for treatment of recurrent glioblastoma. Most noteworthy, however, is how TTF compares to chemotherapy from a quality of life perspective.  Chemotherapy can extend the life of a cancer patient, but the often crippling toll that its side effects can have beg for a less taxing alternative.  Based on a study of two groups of cancer patients, each of which were treated with either TTF or chemotherapy, Doyle explained that the life expectancies of both groups is the same, but pointed out that “the Tumor-Treating Field group suffered none of the side effects typical of chemotherapy patients.”

This kind of development is exciting for two reasons:  First, it represents a fascinating intersection of scientific disciplines—in this case, electromagnetism and cell biology.  Second, it exemplifies the power that technology and medicine have to transform human lives for the better.  TTF is just one example of countless new technologies that are on the cusp of changing the lives of millions of people.  This type of progress is part of what makes working in the biotech industry such an exciting and rewarding endeavor.  I and the rest of Key Tech continue to be excited by new medical technologies being developed every day, and look forward to playing an active role in transforming those raw technologies into finished products.

Check out the TED video here

To submit your resume to join the team click here.

They’ve published videos that show both the fabrication techniques and some success at flying. While they don’t appear to have great flying technique, yet, they’re well on their way.

This fabrication technique certainly has applications much broader than robotics. I look forward to seeing a breadth of creative micro-scale components in the micromanufacturing realm. Has anyone seen other examples of novel micromanufacturing techniques?

Keith up on the roof of Key Tech with our new addition!