About Alex Waller, MS - Engineer

Alex comes to EMCI with an extensive background in mechanical engineering. He holds a Bachelor's in Biological Engineering from the University of Missouri - Columbia, and a Master's in Mechanical Engineering from the University of Kansas and is a patent holder. Alex started his career with Henderson Engineers, Inc. and then moved to MRI Global where he was responsible for device design, prototyping, and testing for clients with national defense interests. He also served as program manager and principle investigator on multiple internally funded projects. During his time at MRIGlobal, Alex designed a wireless EKG technology now being commercialized by EMCI. He has been a guest lecturer for scholarly events and was listed in Ingram's Magazine's "20 in Their Twenties, Class of 2011."

Blog: Are You Sure?

Seven years of engineering, and especially the last two in the medical device space, has taught me that this is the most important question an engineer can ask. It doesn’t matter if you are a design engineer, a manager, or even a quality or testing engineer.

Successful engineering requires you to interact with a complex mix of industry experts in a variety of roles, including quality managers, vendors, coworkers, bosses, partners, suppliers, contractors, and engineers at other companies. In all these cases, you are asking the other party to provide some sort of expertise. And in each of these cases, the success of a project depends on that expertise being real.

There’s nothing insulting about asking someone if they are sure of their opinion. You are asking them to be accountable, to prove that their opinion is actually based on fact. You are challenging them to produce data, past experience or references, which will corroborate the expert’s advice to you. Asking them “are you sure?” means they must back up their claim, and if they can’t, you realize that the opinion they gave you was based on presupposition and/or illusion. In an age where self-promotion is king, where self-assurance is currency, getting beyond bravado is crucial for long-term success.

We’ve had our fair share of this at EMCI. On one project I was leading, our “FDA Expert” turned out to be more of an “FDA Guesser.” His assurances that a clinical trial was not needed for the device and that a bench-top study would be sufficient turned out to be exactly wrong. It delayed market entry by more than a year, and cost us thousands of dollars and hundreds of man-hours in wasted resources. If only we had asked “Are you sure?” when the “FDA Expert” outlined the regulatory path…

More than once, an inventor has come to us with a medical device they think will have a $10 billion/year market and will need little or no further development from the prototype in their briefcase. “It works,” they assure us, “and it costs almost nothing to manufacture.” We have quickly learned that asking “Are you sure?” must be the first three words out of our mouths with these folks.

Machine shops have told me parts aren’t machineable. Coworkers have told me deadlines are impossible. Suppliers have told me lead times are immovable. In all these cases, asking “Are you sure?” quickly tests the passion and reality of their stance.

Asking “Are you sure?” helps an engineer break down dangerous assumptions as well. Thus, constantly asking themselves this question is critically important. For example, I took over a project mid-stream that had been designed by an inventor in collaboration with a machinist. When I took over the project, I was instructed by my manager to get the inventor to stop making design changes so we could wrap up the project quickly. So I did, we closed the design phase, and when we went to the testing phase, the device didn’t work. I’d never asked anyone “Are you sure the design is done?” I’d never asked myself “Are you sure what they came up with is sound engineering?” Because of that, we had to go back and redesign several components of the device. Time, and money, were lost.

Another time, we were told by a distributor that they would be ordering roughly the same amount of product the following year as they had the current one. “Sales are good, we expect only a minor dip,” they told us. And we hoped they knew how to forecast. And our hopes were dashed. Their sales dropped by almost two thirds in the next year.

Certainly, asking “Are you sure” won’t break down every illusion. Once in a while, someone will simply lie to your face. Whether they are malevolent or clueless doesn’t matter, what matters is you have asked them “Are you sure?” and they confidently say “Yes.” And then they turn out to be wrong. So you have to dig. You have to follow up “Are you sure” with a second question: “How are you sure?” Press people until they give up their illusions. Until they admit what was known fact and what was assumption. Then right down the assumptions. These are the things you must test.

For example, we had a device that needed additional certification and the regulatory authority told us the device had failed to meet required specifications. Rather than figure out how to redesign the device and make it compliant, I started by asking the regulatory authority “Are you sure we aren’t compliant?” Then I asked how they were sure. They told me they had referenced a specific document. Reading the document, I realized they had tested our device against the wrong standard. When I pointed this out to them (politely), they agreed, and tested our device against the correct standard. It passed. We estimated redesign and recertification would have taken 6 months and cost at minimum $12-15,000 – and it was saved with two simple questions.

So start asking everyone, especially yourself “Are you sure?” At first others might be annoyed at your constant skepticism (very different, I should point out, from cynicism). But soon enough, those who interact with you daily will learn to come prepared. And they won’t bring any assumptions with them.

New Joint Venture with Cardioptimus

EMCI has signed a new Joint Venture with Cardioptimus of Columbia, MO.

Read the full press release here.

EMCI Reaches Deal With IPI

EMCI announced today it has reached a long-term, multi-product license arrangement with Innovative Products, Inc. to expand its footprint into the dental market space. The two companies were introduced by the Kansas Bioscience Authority, where IPI received proof-of-concept funding to develop one of the new products, the Flexi-Lume.

Read the full press release.

Peter Lucas on Kansas City’s “Power Lunch”

Chief Operating Officer Peter Lucas joined host Krista Klaus on 1660 AM in Kansas City Friday to discuss EMCI’s new partnership with ASP Medical, LLC as well as its progress towards Kansas Bisocience Authority grant milestones. Listen to the interview:

Peter Lucas on 1660 AM Power Lunch, 8/17/12

EMCI Adds Nine Jobs in Kansas

EMCI has achieved its first milestone as part of its Expansion & Attraction grant from the Kansas Bioscience Authority by adding nine new employees.

A variety of positions were added in August including engineering, quality, and manufacturing. EMCI expects to add 140 jobs over the next 5 years as part of their grant.

Read the full PRESS RELEASE.

EMCI Renews Venture Accelerator Lease

EMCI has renewed its lease for R&D lab space at the Kansas Bioscience Authority Venture Accelerator.

In addition to their R&D labs, EMCI has its corporate headquarters in Mission, KS, and it’s manufacturing operation in Grain Valley, MO.

COO Peter Lucas Interview, 1660 AM

Chief Operating Officer Peter Lucas joined host Krista Klaus on 1660 AM in Kansas City today to discuss EMCI’s recent grant award from the Kansas Bioscience Authority. Listen to the interview:

Peter Lucas on 1660 AM Power Lunch, 6/21/12

EMCI Featured in KC Business Journal

EMCI was featured in the Kansas City Business Journal after receiving investment committee approval for their grant.

Read the Full Article.

EMCI Receives Preliminary Grant Approval

Kansas Bioscience Authority today gave preliminary approval to $1.6M in funding for EMCI.

If approved, the grant will include $1M for expansion and attraction into Kansas, and $600,000 towards research & development on two neurological products currently in development at EMCI. Read the full article.

Patent Issued for EMCI Innovation

EMCI is proud to announce issuance of a United States Patent for our UltraDerm.

The UltraDerm is a Dermatome with Ultrasonic Cutting Blade, which is internally cooled and has precise width and depth mechanisms for accurate graft removal. This device is a significant improvement over prior dermatomes both in robustness and in its ease of operation.

Read the full patent HERE.