Her presentation entitled “Homeward Bound: Medical Devices as Home Appliances” summarized some of the trends and design challenges related to the movement of medical devices from the hospital and central lab to the home.  The talk drew the largest audience that the university has experienced for the series, and the audience was very engaged and asked great questions.

One Section of the Audience

A video broadcast of the lecture in its hour-long entirety can be viewed here.  There are about 40 minutes of presentation and 20 minutes of Q&A.  You’ll need to download Silverlight Player, but this only takes a few minutes.

Jenny Addressing Questions

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.

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.

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?

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.

There’s little commitment while the design is still in my head. Anything can be changed in an instant.

There’s also little education. I don’t learn anything new from examining a design for the 23rd time. I might catch something based on a mistake I made in the past or other engineers might suggest improvements during an independent design review or impromptu brainstorming session. Everything we see in the design stems from what we already knew, and a few educated guesses.

Once I’ve put it all together in my mind and gotten input from my peers, the only way I can learn more is by building. Put it together, figure out the problems, make improvements. I created the design based on my experience, but the design is still changing. I’m sure I missed something

Maybe the first version isn’t perfect, but I can make it work. Test it. Find the flaws and make a list. Keep going. There’s more to learn.

I make improvements to this design and file away what I’ve learned for next time.

I build a second prototype. There’s more to learn.

Excise Tax

The excise tax has been a hot topic of conversation ever since it was proposed. It did make it into the bill as a tax of 2.3% of the price of the device. It will go into effect for the 2013 tax year, but unlike most excise taxes, it appears to be deductible. New companies that have yet to make a profit will be at more of a disadvantage with the excise tax since it taxes revenue from any sales, not just profitable ones.

Reference: Foley Hoag, LLP

Research Tax Credit

The Healthcare Bill also has a provision, referred to as the Therapeutic Discovery Project credit, that will likely offset that disadvantage to new companies. This is a 50% credit for qualified expenses related to projects designed to

“treat or prevent diseases or conditions by conducting pre-clinical activities, clinical trials, and clinical studies, or carrying out research projects, for the purpose of securing approval of a product under section 505(b) of the Federal Food, Drug, and Cosmetic Act or section 351(a) of the Public Health Service Act.” – Section 9023 of HR 3590 EAS/PP, pg 2019.

The credit is limited to ventures with less than 250 employees, and it will be disbursed in a grant-like structure. There is $1B in the pot and an application process. Once the funds are gone, they’re gone, and the credit can be taken starting with the 2009 tax year, so get your pencils ready. Once the regulations come out in a month or two, you’ll want to submit your application right away. Dean Zerbe at Forbes.com has a much better, and much more detailed, analysis of the Therapeutic Discovery Project credit.

Disclaimer: I am not providing tax advice. I’m just pointing these issues out so you can discuss them with your own professional tax advisors.

Key Tech outsources for prototype components and then assembles, details, and tests in-house. Prototyping capabilities are full service, including SLA, SLS, thermoforming, urethane, epoxy and silicone casting, polyjet, CNC machined parts, full electrical prototyping including microprocessor selection (in-house), board design (in-house), population and testing, user interface screen mock-ups with display software, and more.

Read more about the symbiosis of modeling and prototyping (PDF) for designing microscale parts in an article I wrote that was published in MICROmanufacturing Magazine this month, page 33 (Jan/Feb 2010, Volume 3, Issue 1).