keyblog - Our thoughts on Engineering, Design, and everything else
Chet Larrow

TED Talks: Designing for the Real World

09.12.2012 by Chet Larrow

TED Talks over the last couple of years has published many inspiring and informational pieces and has become a staple for those working in creative industries.  The relevance of the one floating around the KeyTech office this past week was no exception.  The clip features Timothy Prestero, the CEO of a Boston based non-profit studio, and focuses on the challenge of creating products for the developing world.   He quickly goes through a very short overview of the NeoNurture, an award winning mobile incubator.  Despite the number of awards and wide recognition that it received the product failed to do what Prestero had imagined.   The NeoNurture became the beautiful “concept car” that never reached the intended market.   As a young designer in the product development industry, I was impressed with Prestero’s analogy of the NeoNurture to the “concept car”.   All too often young designers in school are only exposed to those “concept car” award winning design stories and designers rather than learning to do what designers are expected to do: design for the real world.   Maybe this is because designing for the real world is extremely challenging as Prestero himself found out.  With the NeoNurture, Prestero wanted the design to inspire.   He imagined that a beautiful product would convince manufacturers to take the idea and grow it, but he quickly found that simply trying to create changes through inspiration in the medical industry isn’t the most applicable solution.  After learning from NeoNurture’s recognition and failure, Prestero’s next project, the FireFly, was designed with the intention of generating outcomes and not inspiration.   Rather than making a product too beautiful for its own good, he made sure to focus on all the stakeholders.   He kept manufacturing and distribution involved through the process, addressing the “looks like” dilemma, and kept the “correct way of use” at the forefront during the design process.   With attention to detail in each of those areas Prestero was able to avoid another “concept car” and arrive at a viable real world solution for the problem at hand.   At the same time he was rewarded with seemingly the same, if not more, recognition.   There is, after all, so much more than just pleasing the eye.

 

Here is the link to the You Tube clip

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jcowperthwaite

Portable Electronics and the Wicked Witch of the West

08.31.2012 by jcowperthwaite

Neither does great with water. I dropped my iPhone in a lake this summer and while the phone was recovered, functionality was not.  After shaking out a bit of water I pursued the traditional remedy of stashing my phone in a bag of rice and letting it sit for a day. No luck. Fortunately, I was due for an upgrade so it was off to my carrier to buy a replacement.

I could not help but wonder if Apple products are so great why they wouldn’t figure out a way to make their devices waterproof.  Furthermore, if we are trending toward digital lives centered on more compact, portable devices shouldn’t they be able to survive a dip in the pool? Not to mention marginal events such as a spilled drink or getting caught in a rainstorm.  I have a few thoughts on why we aren’t there yet.

This summer I also oversaw IPx7 testing of a new product developed at Key Tech. If you are new to ingress testing, the ‘7’ indicates that the device must survive immersion 1m underwater for 30 minutes. There is one higher class, IPx8, which consists of continuous immersion underwater for a depth and duration defined by the manufacturer. At this point we are basically talking about hermetically sealing the device. (For those curious, the wicked witch failed IPx4, splashing water from any direction).

Key Tech has developed a handful of products with strict water ingress requirements and the challenge always comes back to one rule; compromise.  The device aesthetics, features, usability, and manufacturability all run up against creating a watertight enclosure.  Every port, switch, button, screw, vent, and seam are battles waiting to be fought.  Sure there are waterproofing components and techniques that get the job done, but they aren’t always pretty.  Ever look for a waterproof USB connector? How would Jony Ive feel about adding a rubber plug to the iPhone audio jack?

My recommendation for designing a waterproof device is to start with an enclosure having a perfectly continuous surface and no ports, seams, or access points. Then resist all attempts to add any of these.  This generally will not work, so the next approach is to limit these features and spend a lot of time contemplating and testing their waterproof characteristics early in the design process.  Often you will end up relying on gaskets, doors, flaps, and plugs.  And if this is not enough then manufacturing may lean on grease, caulking and a prayer to get the job done.  Finally, the finished product may exude a characteristically “rugged” design language whether desired or not. No wonder that the favored device of 2012 (iPhone) has not greatly surpassed the popular device of 1982 (Sony Walkman) in the area of water ingress.  Good waterproof design is not easy.

The positive news is that mainstream waterproof portable electronics may not be far away.  In fact, over 90% of cellphones sold in Japan are already waterproof.  Most modern phones have embedded batteries, which eliminates an access port.  Touch screens plated with glass are inherently waterproof so long as the perimeter is well sealed.  Inductive charging is finally gaining traction and data is increasingly pushed to the “cloud” via wireless transmission, eliminating power and data ports.  Gore and others have developed acoustic vents for getting sound out of enclosures while maintaining a watertight seal.  It’s often much easier for the end user to replace a device than open it up for debugging, so manufactures have no problem  gluing or cementing joints to eliminate a major ingress concern.  A few trailblazing companies are even advertising invisible nano-coatings that are capable of waterproofing all surfaces (inside and out) on the molecular level.

Something to think about. And when you purchase your next cellphone you might consider the choice between a phone that talks to you versus one that stands up to the water hazards of daily life.

 

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Alex Flamm

IDSA Annual Report

08.22.2012 by Alex Flamm

The Industrial Designers Society of America (IDSA) just held their annual international conference in Boston, MA.  Jeremy Savage and I attended the 4-day event and had the pleasure of listening to some great presentations, ranging from the informative to the inspirational.

It has always struck me how important it is to have an integrated team of engineers and designers to create successful products, especially in the medical device field that is evolving with new FDA regulations relating to usability.  So as a mechanical engineer by training, I always enjoy gaining exposure into the industrial design field.  It allows me to turn off my engineering brain that focusses on specific components or system functions and think about the bigger picture of how people interact with devices.  After all, I love working in the medical and life-sciences field because I get to work on products that help people.

One of the more inspirational presentations at the IDSA conference was given by Bob Schwartz from GE Healthcare.   He emphasized that when designing medical devices it is essential to consider the entire use experience, not just how individual features affect use.

As an example, he discussed GE’s Adventure series of MR suites. While over the last couple decades design has certainly “beautified” MR Scanners, it has done little to actually improve the experience.  With the claustrophobic spaces, loud clanking noises and vibrations, an MRI scan can still be a truly terrifying experience for an adult; image how it is for a young child.

Imagine if it were possible to somehow take advantage of those perceived “negatives” from an MRI scan and turn them into a fun adventure.  Well that’s exactly what GE did by designing the entire MR suite to be a complete experience – an exciting spaceship experience! Now the claustrophobic experience of laying on a bed being slid into a tight MR Scanner bore was transformed into sitting in the cockpit of a spaceship.  The loud noises and vibrations of a scan are integrated into the experience of blasting off into deep space.  The sterility and lack of humanism was erased from the experience and replaced with a fun filled, imaginative adventure for a child.

Bob Schwartz relayed a particularly moving anecdote about one of the first children to experience the new MR suite.  After the scan (err… I mean deep space adventure) had finished, the child jumped off the bed, ran over to his mother and begged, “Mommy! Mommy! Can I please do that again??”

GE’s new design has managed to turn a dreaded medical procedure into an adventure that a child actually begs his mother to do again by considering and designing for the entire experience of use.  Now that’s some inspiration for an engineer and designer.

Photo courtesy of GE

 

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Ben Lane

Engineering the Crab Feast

08.01.2012 by Ben Lane

Early in July, Key Tech hosted our annual crab feast on a farm north of Baltimore.  This event started more than a decade ago when the company had less than 10 employees, and now hosts nearly 100 employees (current, past, and future), family, friends, clients, and vendors. For those readers not familiar with a traditional Maryland crab feast, the event typically occurs outdoors at tables covered with newspaper, accompanied by beer and corn on the cob. Picking crabs is a laborious task, at best calorie neutral (not including the beer), and the real focus of the event is the socializing that occurs over a pile of crab carcasses.

Over the years, Key Tech’s crab feast has evolved from a simple, traditional Maryland crab feast to an event that provides us with a creative outlet for our engineering minds. A few of these engineering inspired activities are described below:

  • Early in the evolution of the Key Tech crab feast, a ~1000ft zipline was built that carries screaming participants from the top of a hill, over pastures, fences, and farm animals, and eventually threads its way between trees before stopping short of a large tree deep in the woods. Prior to purchasing the wire ripe, trolleys, and harnesses, a number of calculations were performed to size the rope, estimate speed, and ensure that riders would stop prior to meeting that large tree at the end of the line. After installing the line, a test dummy (consisting of a 5-gallon bucket of rocks) was launched down the line to test cable tension, the droop in the line, and other critical aspects of the installation. The bucket hit the tree at the end of the line with such force that rocks were thrown literally hundreds of feet in all directions. After a few minor adjustments and tests, the zipline was deemed ready for use and has been a source of great entertainment ever since.

 

  • Dry ice (frozen carbon dioxide) is a fun and fascinating substance that has made appearances at several crab feasts over the years. Mixing dry ice and water causes the dry ice to sublimate (turn to gaseous carbon dioxide) at a rapid rate, and this behavior provides fodder for several fun activities. It turns out that dry ice makes a great propellant for makeshift rockets fabricated from 2-liter soda bottles. The momentum transfer calculation to predict the speed and altitude of the soda bottle is straightforward; however convincing a soda bottle to travel in a straight line is a challenge. We are still working on improvements to this design – comments and suggestions are welcome. Dry ice, water, and soda bottles can also be combined to generate very loud and powerful explosions. Indeed, explosions fueled by dry ice can lift metal trashcans many feet in the air. We also learned the hard way that a dry ice explosion can actually blow ceramic tiles off of the side of a swimming pool!

 

  • Over the years, several massive devices were built and tested at the crab feast for the purpose of launching fruit and vegetables into the woods that surround the fam. Watermelons, cantaloupes, pumpkins, and potatoes are a few examples of the organic materials launched by multiple potato cannons, giant slingshots, and a 30’ tall trebuchet designed and built by Key Tech employees for entry into the 2001 and 2002 Pumkin Chunkin contests held every fall in rural Delaware.  The trebuchet project alone provided many hours of engineering distraction for our employees, with design, analysis, fabrication, and testing activities.

There are many other activities that provide enjoyment at the Crab Feast (Zorb ball, jousting on a huge inflatable mat, volleyball, frisbee, and swimming to name a few) but the activities that inspire us the most are those that push us to exercise our engineering minds in the preparation and implementation of those activities. And we derive the most enjoyment when we can share these activities with our friends and family on a beautiful afternoon in the picturesque farmland of Baltimore County.

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Dave Hershey

Engineering Beer

07.18.2012 by Dave Hershey

A few weeks ago, Murph wrote about how engineering has influenced his cooking.  Like Murph, many of us leverage our engineering skills and curiosity in our personal lives – in some cases, we even win awards!

Brewing beer is an interest for many of us at Key Tech.  For the scientific mind, brewing is a fascinating activity – chemistry, biology, physics, and engineering are equally important to crafting the perfect pint.  During a typical brew day we have to check the water chemistry and adjust accordingly, maintain the appropriate mash temperature to extract the desired sugars (a few degrees makes a huge difference!), increase the wort temperature at a controlled rate, and then drop the boiling wort to 55°-75° F as quickly as possible. Throughout the day, we take meticulous notes so we can improve the process and recipe for the next iteration. Between brews, we brainstorm and  implement equipment improvements.

Some would say that a large supply of hand-crafted beer would be rewarding enough, but we weren’t satisfied.  We decided to take it to the next level and entered the 2011 Maryland Microbrewery Festival’s homebrew competition.  Despite a few process and carbonation issues, we submitted 2 beers for judging – a Belgian-style Dubbel and a Traditional Bock.  The Dubbel placed 2nd in the Ale category and the Traditional Bock won Best of Show!

Our Best of Show recipe  - dubbed Wünder Bock - was brewed by Dog Brewing Company (a few pictures of brew day below) to be served at all Buffalo Wild Wings locations in Maryland and sold at liquor stores near Baltimore.  We also qualified to compete in the Pro-Am competition at the 2012 Great American Beer Festival (GABF) in Denver, CO.

We plan to submit 3 or 4 entries to the homebrew competition at the 2012 Maryland Microbrewery Festival and hope to repeat as Best of Show winners.  Look for us there and at the 2012 GABF in Denver.  If all goes well, you’ll find our beer on tap and in liquor stores again!

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Josh Mull

Pinhole Camera to Venus

06.29.2012 by Josh Mull

On June 5, Venus passed between the Earth the sun causing a rare celestial event. This event caught some of us at Key Tech by surprise, and at the same time we felt the need to see this event that will not happen again until 2125. As such, we spent part of our afternoon trying to devise ways to stare at the sun without hurting our eyes, and the best option we found was to build ourselves a pinhole camera.

The basic theory behind a pinhole camera is well document (See Wikipedia here). With a very small hole, you can let in a very small amount of light, thus offsetting aiming the camera directly at the sun. But for the images you capture to be clear, the hole must be very, very small. For Key Tech, this is a perfect engineering challenge. What do we have lying around that can make an extremely small hole that is still round? Soon a competition was in order, who could find the best solution to this challenge.

The simple answer is to find the smallest drill bit possible, which around our office is 18mils. But this hole proved too large for clear images. A better option was to use copper tape which is fully opaque, and poke a very small hole through the center. Keith and Frank got into a bit of a competition finding the smallest objects to poke holes, and in the end they both did a good job at creating holes in the range of 5-7mils. The picture below shows the very small holes on the camera lens covers.

We put our pinhole camera to the test, and found that it worked better than expected. Images came out a bit blurry, but the concept was definition working. The image below shows Keith Frank and I with our makeshift camera. Unfortunately, when we aimed it at the sun we found that without magnification it was impossible to see the small black dot that was Venus in the middle of a bright sun. But the pinhole camera was a success none the less.

As for the transit of Venus, as it turns out the local Maryland Science Center was giving out special viewing glasses that allowed direct viewing of the event. Those, combined with a zoom lens on one of our cameras produced the images below, which captures the transit pretty well. In the end we ended up with two successful projects, both capturing the transit on camera, and also overcoming the challenges of building a pinhole camera with nothing but the basic tools we had lying around. Check out the images below to see our success on both accounts!

 

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Brian Murphy

Why Being an Engineer Makes you a Better Cook

06.20.2012 by Brian Murphy

I find pleasure in understanding the world around me and how it works.  And thus, I’m an engineer.  But I also cook and cook often.  Eating delicious and eclectic food isn’t enough.  I crave the desire for gastronomical creation, the collision of nature’s gifts with heat and pressure which transforms the merest of ingredients into a delight for the senses.  I grow it.  I chop it.  I sauté it.  I devour it.  But in every one of these steps towards an incredible meal, I can’t turn my engineering brain off.  The same mind that craves understanding of why rainbows exist also feels the need to understand why steak turns grey when you cook it.

Consider the simple act of applying heat to cook an egg, an act which contains, for those who are interested, a full lesson in thermodynamics, biochemistry and surface tension.  We start with a pan.  A metal pan.  A well seasoned pan.  A pan built of a thick enough layer of high thermal conductivity aluminum that as the heat from the concentrated gas burners hits the bottom, a thermal gradient is setup which results in a uniform heating of my cracked egg.  I apply a splash of olive oil, which at first rests high on the pan, initially content to sit in discrete splotches, unaware that in seconds the transmitted heat will lower the surface tension (and viscosity) allowing the oil to create a thin film over the entire pan.  The whites and yolk of my egg applied next, I watch in wonder at the quick transformation of a transparent white into an opaque cooked mass that better reflects its name.  Does the egg realize that its proteins are changing shape due to the heat, an effect which alters how light passes through the protein matrix and thus explains the color change?  Does it realize that high heat pulls the proteins even tighter, resulting in a tough rubbery meal and thus the need for gentle heat when cooking eggs?  No matter.  I understand, and I enjoy the science of the process as much as I enjoy the subtle jab of the fork edge which spills golden yolk down the side of my toasted bread.

Bread baking also pulls at the inquisitive mind.  Mix wheat flour, water and salt with a small colony of bacteria and yeast, add time and heat in the right proportions and if all goes as planned you end up with a crispy crust and a crumb filled with a mix of large and lovely holes.  Bakers obsess over the temperatures of their ovens, the thermal mass of their baking stones, the humidity around the bread which allows the crumb to expand encumbered, without the crippling oppression of a prematurely hardened crust.  I’ve experimented with allowing bread to rise at various temperatures, curious as to how the bacteria and yeast reproduce disproportionally, in one case producing a lofty loaf (due to lots of yeast activity) and in another producing a true “sour”-dough (high bacterial acid production).

And finally I eat.  Without the culminating act, the cooking would seem to be a mere tease.  Who doesn’t relish the act of sipping a spoonful of hot and rich chowder or the slight tug needed to pull the meat from a slow cooked pork rib.   But as my stomach gains satisfaction, my engineering mind hasn’t quieted.  I think about the fact that my fridge temperature pâté tastes under salted, realizing that I had forgotten to compensate in the cooking process for the fact that the perception of salt decreases with temperature.  Next time, I’ll review my physics textbook alongside my cookbook, hoping to better harness the physical world in search of the next great meal.

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Aaron Pearl

Welcoming a New Generation of 3D Printers

06.06.2012 by Aaron Pearl

Here at Key Tech, we often use physical prototypes in our design process to literally get a feel for the part.  While 3D computer models can be helpful, there is simply no substitute for actually holding a part in your hands and feeling it. 3D printing is often a great option for an initial prototype, especially for complex parts that are difficult to machine.  Essentially, 3D printers work by printing many thin 2D cross-sections of a part on top of each other, bonding each layer to the previous one as they go.  For more complex parts, special support structures may be required to keep the part from falling apart during the printing process, but the process is essentially the same.

Some 3D printers are now completely automated, allowing users to upload 3D part files via a website and receive the completed parts the next morning.  This ability to automatically transform a part file into an actual object in less than a day is extremely powerful and a major advantage that 3D prototyping holds over competing methods, such as CNC machining.  However, 3D printing has had a few major drawbacks that have prevented it from reaching its full potential. Most current 3D printers can only print with a few materials, and often only one or two per part.  In addition, the resolution on 3D many printers is not fine enough for intricate or tightly toleranced parts. Finally, the part size is limited by the tray size in the 3D printer, meaning that larger parts cannot be fabricated in one piece.

A new generation of 3D printers, such as Objet’s Connex500, aim to overcome these traditional limitations and make 3D printing a more flexible prototyping option.  The Connex500′s most impressive feature is its ability to print down to a resolution of 16 microns (.00004″), which is orders of magnitude finer than many traditional 3D printers.  Many of this new generation of 3D printers can also print with more than a dozen materials in the same part.  This allows for prototypes that work and feel more like the finished project will, and allows for much greater flexibility in the design and prototyping processes.  While some 3D printers are aiming at making things smaller and more detailed, others are aiming at making parts larger.  By increasing the tray size and allowing the print head more range of motion, some manufactures have made 3D printers that can print parts over a foot long in each direction.

These advances mark a significant improvement in the capabilities of 3D printers and a major step forward in the world of design.  We are now closer than ever to being able to turn virtually any idea or concept immediately into an exact physical reality.  That power has major ramifications for not only the design industry, but for society as a whole. We at Key Tech are very excited about this technology and seeing what the future of 3D printing will hold.

 

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Scott Corey

Do you want an iHeart Pump?

05.23.2012 by Scott Corey

It seems that people will buy any of Apple’s “i” products. While some of this is driven by fashion, most of the craze for Apple’s products is the result of a string of exceptionally well designed products. The user delighting design of these products was not by accident. Rather, they stem from Steve Jobs’s passionate belief that great products result from unwavering insistence on simple, intuitive, user focused designed. This belief will be Steve Jobs’s legacy much more so than his products.

Most technology based products are designed by teams of engineers and designers. Typically, engineers are more focused on the technological aspects of the design and designers are more focused on the aesthetics and user experience. The normal model for developing new technology products is that the product design is driven by the technology and therefore engineering trumps design.

Consider the original IBM PCs. Their designs were clearly focused on delivering computing power to the business market in a distributed fashion. While they succeeded quite well at their primary goals, they were not simple, intuitive or a pleasure to use. Imagine someone releasing a product today with an MS-DOS like user interface. It would obviously flop despite the fact that users today are much more technically adept than the target market of the IBM PC in the 1980s. Arguably the Apple and Mac are to blame for the change in expectations.

The Mac was the first of Steve Jobs’s products at Apple. True, Apple had released the Apple and Apple II before the Mac but they were really designed by Steve Wozniak. Jobs led the design of the Mac with a commitment to creating a great user experience that would become the hallmark of future Apple products. The Mac’s graphical user interface succeeded in making Macs so easy to use that Apple had to battle the perception in the business community that they were toys.

Jobs’s success with the Mac was the result of putting design ahead of engineering. It is interesting to note that if you ask the masses what they think about Apple’s products, most will use the word innovative in their description. Yet the reality is that most of Apple’s products, from an engineering perspective, have not brought new technology to market nor have they had superior specifications to competing products.

The Mac’s graphical user interface(GUI) was implemented years before by Xerox, but Xerox failed to put it together in a complete product and ultimately licensed the technology to Apple. Sony and others tried for years to make a successful iPod-like product before Apple introduced the iPod. Even the first iPhone didn’t really invent many new features. All of these products were blockbuster successes because they made technology accessible to users. It is somewhat like the adage about a tree falling in the forest with no one around to hear it: Good technology only becomes great when it can be effectively accessed by users.

So with Apple’s history delivering game changing consumer electronic products, should we be lobbying Apple to design some sort of iHeart Pump? Maybe not. Allowing design to trump engineering at Apple resulted in excesses that were often acceptable for consumer electronics but that would not be acceptable in a medical device. For example, the iPhone4 was released by Apple knowing that if people held the phone in a particular way, it would drop a call. This flaw arose from the choice to make the rim of the phone from uncoated stainless steel. There were several simple solutions but the impact on the look of the phone was considered unacceptable and the phone was released with the flaw.

Despite this flaw, the iPhone4 was a huge success. Think about that a minute. One would think that the first and foremost job of a phone is to be a phone. Yet Apple decided it was OK to compromise the phone functionality for the details of aesthetic and the market validated that decision. Now let’s imagine that instead of the iPhone4 it was the iHeart Pump. Clearly, no one would think compromising the function of the heart pump would be acceptable for an aesthetic improvement. For that matter, the function of a heart pump would trump most of the attributes that set Apple products apart.

Medical devices must be safe and effective above all else. Consequently, design cannot trump engineering in the development of medical devices. However, problems also arise when engineering trumps design. Unfortunately, patients are hurt every day as a result of medical devices with poorly designed user interfaces. In addition, poor usability of many home health care products (e.g. insulin injectors) results in poor patient compliance. The 3rd edition of IEC60601 and the June 2011 guidance from the FDA reflect a recognition by the industry of this problem.

Truly great medical products result from design processes that weigh both engineering and design equally. This includes involving users throughout the design process and carefully considering usability/human factors in the risk analysis and mitigation process. This challenge will become even more critical as more medical devices are introduced into the home health care market, where users will have little or no training. Our challenge as medical device designers and engineers is to design products that would make both Steve Jobs and Thomas Edison smile.

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Jenny Regan

Innovation at the FDA – Cultural Changes

05.17.2012 by Jenny Regan

A few weeks ago I had the pleasure of moderating the Q&A session for a Women in Bio event in DC.  This installment featured Dr.  Jeffrey Shuren, Director of FDA’s CDRH, which is responsible for reviewing and approving medical devices for use and sale in the US.

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.

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