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?

Market consolidation in the clinical testing instrument business was evident on the show floor, with many exhibitors displaying families of instruments recently acquired from other smaller businesses.  From the looks of it there is more consolidation in store; the lure of the personalized medicine business has generated a large number of new companion diagnostics instruments and assays, and it appears the number of PCR instruments far exceeds what the market could demand.

Also evident on a walk-around is the increasing trend away from large central lab instruments and toward smaller footprint satellite lab and portable instruments.  This trend is likely fueled by increasing interest in lower cost and quicker turnaround point-of-care diagnostics coupled with ready mini-electronics and battery design arising from the consumer electronics industry.

Another trend shown in recently years is the influx of new players from emerging markets such as Latin America and Asia Pacific.  The IVD market is expecting a compound annual growth rate of 6.6% for the next 5 years with the Asia Pacific and Latin America regions leading the way, according to the expo issue of the Clinical Laboratory News July 2011.  Not only are the demands from these markets are growing, confirmed by the number of international participants walking the floor, but also the technology innovation from these regions is forecast to surpass the U.S in the coming decade.  This year, there were 55 Chinese biotech companies and manufacturers showcasing lab devices, assays, manufacturing components, and even a CAP-accredited clinical lab network.  The fact that most manufacturers claim ISO 13485 certificate and CE mark shows the sophistication and competitiveness of the Asia Pacific biotech sector.  The shifting landscape of both major market places and innovation drivers will be interesting and a challenge for U.S. companies in the coming decade.

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.

Layer built processes create a single part by building up  a series of 2D cross-sections. Different methods require different layer heights and have different means of supporting the layers that are hollow underneath. Of course, one advantage of this process is that parts can be made that could never be fabricated by traditional production methods, such as hollow spheres or even an assembly of multiple integrated parts in a single build that come out of the machine assembled (such as the links of a chain).

SLA (Stereolithography) – Liquid photopolymer (resin) is cured with a laser in layers. After each layer is laid down, the platform lowers further into the resin by the layer thickness, and the laser cures the next layer of material. The part is then post cured with UV light. SLA was one of the first additive rapid prototyping technologies and is still the gold standard.  It is good for general pupose form and fit protoypes and when parts require high resolution, smooth surface finish, or optical clarity.

A part manufactured by SLA (Photo Credit: Key Tech)

SLS (Selective Laser Sintering) – SLS builds layers similar to SLA, except instead of using UV light and a liquid photopolymer, a powdered material (real plastic or metal) is heated and fused together by a laser as a series of 2D cross-sections. SLS is a good choice for functional testing with real materials when smooth surface finish and fine resolution are not required.

A part manufactured through SLS (Photo Credit: Key Tech)

FDM (Fused Deposition Modeling) – Similar to a precision hot glue gun, long strands of real plastic material (ABS, PC, and others) are fed into the nozzle, melted, and deposited in a series of 2D cross-section layers. FDM layers are generally the thickest of the various processes, which limits feature size, but it usually provides better strength and robustness in comparison. FDM is good for prototyping functional parts without small features where surface finish is not important.

A part manufactured through FDM (Photo Credit: Key Tech)

Polyjet – Using inkjet printing technologies, UV-curable materials are effectively “printed” on top of the previous layer to create a 3-dimensional part. Polyjet can produce high resolution parts with decent surface finish, is generally cheaper and faster than most other processes, and is one of the only additive prototyping processes that can produce flexible parts.  It is a good process for small parts requiring good resolution and a decent surface finish, or when flexible parts need to be prototyped.

A part manufactured through Polyjet (Photo Credit: Key Tech)

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!

Wireless Protocols

Wi-Fi / 802.11 a, b, g, n / Wireless Ethernet

802.11x uses unregulated radio signals to transmit large amounts of data quickly. It is very popular for home and business computer networks and can be secured using various techniques including complex encryption, making it a very good method for portable devices to reach the internet. The protocol is mesh-networking capable (messages hopping along several intermediate nodes to reach a destination as opposed to point-to-point). The radio signals utilized for this technology penetrate walls, which is useful when line-of-sight communication is not possible.

From a design standpoint, however, this is a more complicated solution than other wireless protocols. The associated electronics are complex and draw a lot of power, so wi-fi can be expensive and battery intensive for a handheld device.

Table 1 Different flavors of the 802.11 wireless protocol

Proprietary (e.g. Radiotronix Wi232)

Some companies create their own radio-frequency (RF) wireless protocols. Lots of point-to-point “garage door” protocols, for example. This is because it is very easy from a design standpoint.

• Point-to-point, not mesh
• Low power
• Long range
• Low data rate

ZigBee

ZigBee is an open protocol used to create a network of devices that can communicate with each other. The premise is similar to wi-fi, but it has optimized performance for different applications such as battery-powered handhelds. Example products are building controls and sensors. Performance features include

• Extremely low data rate (for individual sensors or switches)
• Low power
• Long range (~100 yards)
• Mesh networking capable (transmitting data through various nodes to the central control unit which greatly extends the range of a network)

Bluetooth

Bluetooth is an open radio-frequency protocol for transmitting data over short distances, generally less than 30 feet, although the protocol can be used for longer ranges with higher power output. It is most useful for connecting multiple devices together such as laptops with mice, remote controls, and mobile phones.   Bluetooth is designed as a low configuration, easy to use option.  The newest revisions of Bluetooth are also opening much higher speed data transmissions and even lower power usage.

900Mhz, 2.4Ghz

These are just frequencies, but people might call their protocol as such to identify that they use RF signals instead of infrared or that they are not part of the wi-fi platform.

• 900 Mhz is old school, longer range / lower data rate.
• 2.4 Ghz is new school, shorter range / higher data rate / may interfere with nearby wi-fi networks

Infrared (IR or IrDA)

IR is most popular with remote controls because it is cheap and easy to implement. This is a line-of-sight technology, meaning that the infrared light emitted from the remote must travel to the sensor to transmit the command. It can be reflected around a room, but not from room to room. For this reason, it is also used in security systems, position sensors, and level switches to detect localized movement via interference with the line of sight.

IrDA was once used to transmit data on Palm Pilots and laptops for a time, but it has a very low data rate compared to current competitive technologies and a very short range.

What makes wireless cheap or expensive?

Cheap to develop

• Point-to-point, one-way, garage door opener.
• Messages sent are simple, and all of the same type and purpose. A layman could easily define each message in English in a spec.
• A network that doesn’t need to be “managed” (think about devices joining and leaving, think about multiple networks in same air space, think about distinguishing IDs of senders and receivers)

Expensive

• Mesh networking
• Network reconfigurable (by user or automatic – both a pain.)
• Variety of message types and purposes
• Two-way communication or authentication
• Pushing the limits of range or power. Or, lack of line-of-sight.
• Application is sensitive to interference or garbled messages
• High speed data access, or continuous network access

Based on the phrasing of the opening question, you’ve probably already guessed the answer.  An RTOS provides a host of benefits to embedded developers with a very reasonable memory footprint.  At Key Tech, we find that these benefits generally justify the cost of an RTOS, particularly for medium and large-scale software projects.

Drivers & Software Stacks

Most RTOS implementations ship with board support packages (BSPs) for supported microcontrollers.  BSPs provide low-level software support for most microcontroller functionality, which immediately benefits software schedule by cutting out the development and debug time typically spent on driver development.

Some RTOS vendors also provide software stacks for complex functionality, such as USB or Ethernet.  These also cut out a lot of development and debug cost/time that would otherwise be spent on these modules.  Most vendors today offer a la carte peripheral options so that the RTOS selection can be optimized for performance and cost.

Multitasking

Perhaps the most beneficial feature of modern day operating systems is the ability to run multiple programs at once, or at least give that appearance (depending on the underlying hardware architecture).  RTOSes are no exception – they permit developers to easily separate the software into logical units, increasing the readability and maintainability, and improving the overall efficiency of the development effort.

Future feature additions also become easier – the developers can often write a new software module and execute it as a separate process in the OS.  This directly translates to reduced cost and schedule.

Safety & Security

Software bugs are feared for their ability to crash the entire device, particularly in mission-critical and safety-critical situations.  Typically, an RTOS includes a heavily tested and validated kernel (the core of the OS) that helps mitigate the effect of software failures by limiting their scope and preventing them from affecting the rest of the software.  Several vendors provide RTOSes certified for military, avionics, and medical applications, such as Green Hills, Micrium, Wind River, Mentor Graphics, and QNX.  Getting FDA 510(k) approval with an RTOS is becoming more common, and vendors can often provide documentation and procedures to assist you with that effort.

Selection

RTOS selection can be an overwhelming process, to say the least.  What level of certification do you need?  Does your application require a kernel optimized for speed, size, or something in between?  Do you need the highest level of security, or do you want something a little more flexible to speed up software development?  Based on your design requirements, vendors and designers can work together to select the best RTOS for your application.

Our staff of cross-disciplinary engineers, an industrial designer, admin support, and interns all work together to create remarkable solutions every day. We usually have 5-10 projects going on simultaneously, so it’s tough to stay current on everything that’s going on outside of my own projects. Just recently, I was getting the 10-second tour of a prototype when I started asking about a robotic end-effector densely packed with numerous individual pneumatic actuators and complex linkages.

“Oh, that? Yeah, we had to make almost all of those parts ourselves – just the pneumatic cylinders and screws are stock. Assembled, the density of the tips is probably twice anything we could find off the shelf.”

Seth Godin writes about having one or two Linchpins that can make a company. These are the indispensible go-to people that are creative, willing to be unconventional, and passionate about their work. They make their work personal and are not satisfied until it’s done right. I don’t know anyone at Key Tech that doesn’t act this way.
Most of our work is highly confidential, so remarkable work rarely gets remarked upon outside of these walls. But, internally, annual reviews often include feedback from peers and project managers that looks like this:

“I’ve worked with him on the ************* project and it has been awesome. He has been handling the many headaches of designing, re-designing, and re-re-designing the critical [custom hardware] for the various systems. Additionally, it has been a pleasure working with him the whole way. He is always in good spirits, does his work in a very timely fashion, and still finds time to host things like ASME meetings. Very impressive. No criticisms what-so-ever.”

So, thanks. You rock! It’s pretty cool to work with all of you.

If you’re not the one being wheeled in, when you enter an operating room you’ll see a lot of duplicate hardware. Multiple displays and computers, various sensors and diagnostic devices to monitor the patient. And, none of it knows what the other devices are doing. If every device could communicate over common protocols, at least some of that hardware could be eliminated. This could cut the cost of the devices and reduces the clutter in an already cramped space. Communication could also improve the techniques by which health care is administered. But, is it possible to verify and validate the safety and efficacy of medical devices if they could be connected to unknown current and future products?

In the current system, the answer is probably “No”. But, if inputs and outputs could be strictly enforced and regulated, as is the case with FDA-regulated medical devices compared to the “wild west” of computer and home theater peripherals, perhaps it wouldn’t be so difficult to imagine a future with compatible tools.

The medical device industry has not ignored the potential of device interoperability. In fact, it is a recognized issue. There have been many conference presentations and on the subject, and an FDA held a workshop this past January focused on working out these exact issues. While I don’t expect the solutions to arrive overnight, I do look forward to seeing developments coming down the pipeline.

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.