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.

If you’ve had even the slightest inkling of initiative but have been stifled by fear or doubt or something else, I recommend reading Seth Godin’s new book, “Poke the Box“. It might give you the push off the branch you need to really fly. It’s well-written and a quick read. It’s really his manifesto calling people to action with the thesis that everyone can be innovative. Well, not everyone, but innovative people can exist anywhere, from those with authority over a Fortune 500 company to those with barely authority over the mail room. Your job description doesn’t matter. Initiative and the ability to overcome fear is what matters.

Poke The Box from Seth Godin on Vimeo.

Have you read the book, yet? What did you think?

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.

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!

Health Savings Accounts

The Health Savings Account (HSA) is a rather new invention that pairs a high-deductible insurance plan with a pre-tax savings plan for medical expenses. The HSA covers more than just deductible-using doctor’s visits. One can also use it to buy vitamins, toothbrushes, over-the-counter medication, and more, making them pre-tax expenditures. And, money that isn’t used stays in the HSA where it can be rolled into an investment account for retirement. Has this new financial innovation impacted the development of medical devices?

Non-reimbursable medical expenses

So, how does having an HSA change one’s purchasing decisions? As an HSA user myself, I find that I’m less likely to consider the long-term implications of spending a few extra dollars on medical expenses, which is precisely the opposite of what the HSA is supposed to accomplish. I know I’m supposed to be asking about the costs of medical products and services, but it almost feels inappropriate. So, I asked Ben Lane whether he found it was any different for his family. Is his family asking how much a test costs or limiting their doctor visits due to the expense?

“I have been living in the traditional culture of insurance for so long that I just continue to operate in that same mode. That means I pretty much do what the doctor says without much discussion of cost. Ultimately, I want my family to be healthy, and I don’t want costs to impact my medical decisions, even though maybe they should. In addition, it’s very difficult and time consuming to be informed about medical costs. It’s not like I can comparison shop very easily. Seems like this needs to change and maybe it already is.”

Ben tends to agree with me. In the end, I can’t use the money to buy the kids video games (okay, they’re for me), and I haven’t saved enough to be able to invest the money, yet. So, perhaps my tolerance for purchasing more expensive medical devices, like this toothbrush, is higher than it would be for, say, a $300 24-volt drill. However, I think I lack the psychological background or introspective skill to really understand my sub-conscious mind.

How this affects device design

Whatever price point the market will bear has a major impact on the performance and features of a device. Metal gears, LCD’s, and wireless charging stations all cost money, money that has to be added to the retail price. If consumers are willing to spend more on a medical device you’re designing because they’ll be making that purchase via an HSA, that’s going to affect the design specification.

Am I off base? If you’re using an HSA and/or designing medical devices, I’d love to hear how this new innovation has affected your spending habits and design constraints.

The concept of “personalized medicine” is based on the targeting of specific factors that make one individual more receptive to a therapy than another. Pharmaceuticals can alleviate symptoms and cure disease. However, many drugs  only help fewer than half of the people who take them, and many come with the small chance of side-effects – everything from diarrhea or drowsiness  to death. The idea of personalized medicine is that patient populations can be tested to verify before prescription that a drug will be effective for them and that side effects will be minimal.  Tests may be based on a genomic marker or a biological cell structure.

Key Tech has been designing and developing diagnostic devices, both point-of-care and high throughput, for over 10 years now.  In recent years, we’ve been conceiving and developing new drug delivery devices as well and we are witnessing the growing market for patient-friendly medicine delivery and the companion diagnostics that qualify a patient population for targeted drugs.  We’re looking forward to watching this approach to medicine develop and mature.

It’s true that engineers have a particularly packed class-schedule, thus squeezing in classes outside their major seems superfluous. My undergraduate engineering program at UMCP required about 15 more credits than other curricula, so I, like other engineers, spent many evenings stressing over classes that I didn’t think were needed for my future in engineering.

It’s likely this student couldn’t relate macroeconomics to his own life (this was Summer 2008). However, since then, we’ve watched the failures of a few huge businesses send economic waves throughout the world. Companies, cities, states, and countries have gone bankrupt. Inflation and deflation are both serious worries. It’s a good time to understand a little about macroeconomics.

Engineers are notorious for falling somewhere between “a little nerdy” and “socially awkward”. A look around Key Tech does nothing to dispel that stereotype. But, it’s a fun crowd with interests in theoretical physics (admittedly, still nerdy), business, photography, nature, travel, cooking, brewing, farming, athletics, web development, and more. These interests developed when we were exposed to something  beyond the world of engineering.

Something that starts out as a chore might turn into a hobby or even shape a career path. It’s too early to discount the impact of a well rounded education on the rest of your life.