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.

Talking to the RISD sophomores. Photo Credit: Jeremy Savage

Every year, Industrial Designers come together for one weekend to attend the regional IDSA (Industrial Design Society of America) conference.  This year, the North East chapter was held at the Rhode Island School of Design in Providence Rhode Island, and Jeremy Savage and I made the trip.

In addition to the IDSA event, Jeremy and I were asked to give a talk to the RISD sophomore industrial design class.  The first part of the talk focused on life as a designer at Key Tech and how integration is crucial in the product development cycle.  The second half of the presentation consisted of a sketching demonstration in which techniques and tips were projected live in front of the audience.  The talk finished with a Q&A session, and a tour of several of the advanced studios.

Attendees at the IDSA conference are made up of both students and professionals. The weekend is planned around several speakers, mixers, and workshops.  This year’s theme was “Design 4 Humans” and the talks discussed the role of design in our modern world.  The keynote speakers were RISD’s John Maeda, and MNML’s Scott Wilson; their discussions ranged from design education, and design entrepreneurship respectively.   Other talks were held by Smart Design, Altitude, and Ximedica.  Topics ranged from the integration of design and business, talking about design with non designers, and designing in context. It was inspiring to hear the message of the presenters was consistent with our mission as designers at Key Tech.

There were also several workshops which showcased new software, as well as mixers where both professionals and students could meet.  The weekend culminated at a gala event held at Ximedica and featured music, food, and lots of Narragansett.

Overall it was a great weekend and a great experience for two of Key Tech’s designers.

Jeremy Savage and I presenting to the RISD sophomores group. Photo Credit: Carly Ayres

Conceptual inhaler design I did as a sketch demo

Yes, you can build your own website, but a professional can likely do it better (and faster). They can add dynamic elements, maybe a backend database, custom style sheets, a mobile interface, and a graphical layout that speaks to professionalism and substance. If you want to learn how to do all of these things, you probably can. However, are you trying to be a web designer or is there something else you’re trying to accomplish?

Of course, where to draw this line changes frequently, and it’s not always easy to evaluate. When you have extra time, it doesn’t cost anything to give it a try (no opportunity cost). But, when you’re busy doing what nobody else can do for you, that’s where your time is best spent. Go develop your strategy, raise funding, layout the business plan, and let someone else take care of the website (just to continue the example). Just because it needs to be done doesn’t mean you need to be the one to do it.

Of course, if you really don’t know how to build a website or design a prototype, it could be worth the investment even when you have the time. A great first impression can be worth a lot.

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.

Think your user interface is “intuitive”? Ask your grandma to use it. Ask a doctor (if your grandma is a doctor, don’t cheat – ask another doctor… or another grandma). Ask a teenager. Take it across borders and ask again.

Did you include the right features? Not if you ask enough people.

Could you have solved that technical challenge another way (a better way)? Most definitely! If only you had the same list of priorities that your detractors do.

I’m not advocating that a device needs to be all things to all people. But, if the customer base includes various demographics and nationalities, it’s going to be helpful to know how the customers differ instead of only using my own judgment and beliefs.

Now this is a blog about product engineering, but I have a feeling this idea can spread to just about everything in my life. We just don’t want to discuss politics, religion, or sports teams here. How about you? Have you ever had your preconceptions shattered?

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.

• Uniform wall thickness
• Radii on the corners
• Sufficient draft
• Bosses
• Ribs
• Choice of parting lines
• And many more

Learning how to design a perfect injection molded part can take a long time and could require years of learning lessons the hard way. There are many books on the subject, but sometimes a great resource is the downstream vendors themselves. I’ve said it before, and I’ll say it again, it never hurts to work closely and early with vendors when designing custom parts. They’ll be designing the tooling and controlling the process parameters, so they can help you understand what works best.

ProtoMold is a rapid injection molder – they turn soft-tools and injection molded parts around quickly. To help designers make the most out of their services, they’ve provided a Design for Moldability reference with a few of the most fundamental concepts discussed. While their capabilities are slightly limited to provide such quick turn-around, their guidelines provide several sound ways to improve an injection molded part, resulting in less expensive tooling and a better performing component. (Registration required to view the document)

Disclaimer: Key Tech is not connected in any way with ProtoLabs or their affiliates and was not compensated in any way for pointing out this guide to you. We just like their work.

In this video, Atul starts off with an interesting explanation of how a skyscraper is built. In the old days of construction, a master builder was the central control with thorough knowledge about each detail of the building and responsibility for coordinating every operation.  Modern buildings have gotten so complex that it becomes impractical for a single person to attain that amount of knowledge.  Instead, today buildings are built by a team of skilled craftsmen; involved in up to 16 trades.  The project manager would rarely know much about any of the trades involved.  Atul asked the question, how is it that a group of specialists with a manager who isn’t an expert in any of these fields can build a complex structure and meet a very strict safe code.  It’s interesting to find out that the secret lies in two checklists, which are essential in the success of the construction business.  One checklist details every task that needs to be done in the short term for scheduling and coordination.  Another checklist involves the necessary parties required to communicate when problems arise.  Problems arise in construction just like in any other fields and the problems are always unexpected, otherwise, they wouldn’t be problems to start with.  The second checklist doesn’t try to make cookie-cutter solutions, but simply makes sure that the appropriate parties are involved when problems arise.  As a result, dynamic group decisions can be obtained for each problem based on inputs from all shareholders.

Atul further goes on to talk about the “Miracle on the Hudson” an emergency landing made by US Airways Flight 1549 last January.  He argued that the real miracle in this case was the entire crew acted as one and followed procedures (another word for checklists) in this situation.  Sure, luck was on their side, but by following procedures and going through the checklists designed for such situations, the crew ensured the best survival chances.

Atul finally went on to discuss his experience of implementing a checklist in the OR at 8 different hospitals around the world.  The result is significant.  By following a simple 19-step list, some steps being as simple as introducing surgeons and nurses, teams who followed the checklist was able to reduce complications by 30% overall.

Come to think about it, it made intuitive sense.  A checklist enforces the user to be regimented and diligent about the process and thus, has the effect of minimizing human errors when these regiments are implemented.  Another example that I can think of where a checklist is vital is during space shuttle launches.  I’m sure everyone has heard those familiar announcements such as “T minus 10: heater control exit; T minus 9: pressurize first tank; … T minus 0: blastoff”.  What NASA does is follow a monster checklist to ensure that every aspect of a shuttle launch has been checked.  If the rocket scientists think checklist is worth using, Atul might be onto something here.

The video is a bit long (74 minutes), but I’d recommend it since it provides food for thought.  Have you read the Checklist Manifesto?  Do you agree with Atul?  What other scenarios do you recognize that benefit from using a checklist?

When connected to two dissimilar metals (such as copper and zinc), the lemon transforms into a battery, producing a small voltage potential.  A new found use of lemons is discovered, much to the delight of kitchen scientists everywhere.  For us here at Key Tech, it illustrates the positive use of a usually avoided event: Galvanic corrosion.

The process: break it down

Galvanic corrosion occurs when dissimilar metals are in the presence of an electrolyte, such as salt water (or citric acid in the case of lemons).  One metal forms the anode and the other metal forms the cathode. The anode is more active (less corrosion resistant) and the cathode is less active (more corrosion resistant). When they are electrically connected, a current is produced which causes a change in the corrosion properties of the metals:

• The more active anode corrodes faster than it would by itself
• The less active cathode corrodes slower than it would by itself

These metals must be in electrical contact and they must be exposed to an electrolyte. This type of corrosion will not occur if the metals are completely dry or electrically insulated from each other. Galvanic corrosion is a common enemy of ship builders, but this destructive process is of interest to any designer where metals and alloys interface, such as at fastener locations.  Material choice as well as surfacing options become critical at these junctions for the life and structural integrity of the system.

Welcome to the Galvanic Series (in seawater)

For those of us who love tables, galvanic series were developed to list metals and alloys based on their corrosion potential in a specific electrolyte.  In seawater, these materials are listed from most cathodic (inactive/resistant to corrosion) to most anodic (active/ease of corrosion).  The further apart the metals/alloys are in a particular series (thus the most dissimilar they are), the higher the risk of galvanic corrosion.

Least Active (Cathodic)

• Platinum, Gold, Graphite, Titanium, Silver
• Stainless Steel (passive)
• Brass/Bronze
• Stainless Steel (active)
• Chrome
• Nickel
• Steel
• Aluminum
• Zinc
• Magnesium

Most Active (Anodic)

How to prevent or minimize galvanic corrosion

• Choose metals close together on the galvanic series for mating parts and fasteners.
• Never place a small area of active metal on a large area of inactive metal (e.g. a zinc-plated fastener on stainless steel part).
• Use coatings or other means to prevent electrical contact between parts:
  • Anodize
  • Chromate conversion (iridite)
  • Phosphate
  • Electroless nickel
  • Paint
  • Lubricants
  • Insulating tape
  • Non-absorbent washers
• Use a sacrificial anode (e.g. galvanized steel)

Rules of Thumb: Know Your Environment

Where the metallic components will reside should be considered when designing your overall system.  The Anodic Index can be found here.  These anodic index values provide the comparison needed when deciding what type of fastener material to use in your designs to prevent galvanic corrosion.  The basic rules of thumb are (taken from corrosion-doctors.org):

• Harsh Environments (outdoors, high temp, high humidity): the difference in Anodic Index should be less than 0.15V
• Normal Environments (storage warehouses or non-temperature and humidity controlled environments): the difference in Anodic Index should be less than 0.25V
• Controlled Environments (temp and humidity controlled): up to 0.50V difference in Anodic Index can be tolerated

A couple great resources for more detailed information on this subject are the ASM Metals Handbook (Vol 5 and 13) and “Handbook of Corrosion Engineering” by Pierre R. Roberge (2000).

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