About Peter B. Lucas, MBA - Chief Operating Officer

Peter B. Lucas, MBA, is a medical-device patent holder who co-founded EMCI with James Lucas in Kansas in 2006. Pete serves as EMCI’s Vice President & COO. In his current role, he is responsible for both project management oversight of new product development and for all day-to-day operations. Prior to his work at EMCI, Pete spent 10 years at Herff Jones, a leader in academic recognition products, where he managed their state-of-the-art digital imaging department. Pete received both his MBA in operations management and supply chain logistics, and his undergraduate degree in business and economics from the Bloch School of Business & Public Administration at the University of Missouri, Kansas City, recently ranked the # 1 business school in the United States for entrepreneurship. He has also taught Master's level operations management courses at the Bloch School, and recently finished a four year term on the Bloch School Alumni Board.

Blog: The FDA

The regulatory environment has clamped down in the USA in recent years. The FDA is ramping up its efforts in the medical device space, and the requirements are rapidly changing, and in most cases, increasing.

Take for example the 510k process. For many years, it was common practice to use multiple predicates to show substantial equivalency. That is no longer a method the FDA is in favor of seeing. Instead, they want a single predicate, and data to mitigate risks that fall outside of equivalence with that single predicate device.

Clinical data requirements for medical devices are generally not well defined by the FDA, at least not publicly. Instead, it falls upon the filing party to present sufficient data (in its own estimation) with enough statistical significance to satisfy the requirements. Occasionally a filed 510k may get a reviewer that is willing to help guide clinical data collection, but as a corporate strategy, it isn’t safe to rely on it.

Getting past the hurdles of properly filing the required documents and having your application accepted are only the minimum steps required to gain approval. If your goal is to be approved without further clarifying submissions at their request, your plan needs to be comprehensive in scope and scale. Even then, the FDA may find reason to question your claims beyond what you anticipate.

Take for example a recent 510k filing by EMCI. Our application was complete and accurate, and in line with what predicate filings for the device class had used. However, the FDA had just gotten a smattering of adverse events from a product with the same device class… thus, they required us to go back and perform additional clinical trials to mitigate this newly-discovered risk. Had we filed the identical 510k three months earlier, very likely it would have been approved without any additional data.

We have regulatory experts and ex-FDA reviewers at our disposal to use as a resource, and still, we are often surprised by the particular claim that sticks out to the FDA. The key to keep in mind is that once they request information the clock is ticking. If you can’t collect the necessary data before the application expires, you’ll have to refile from scratch, with no guarantee that you will get the same reviewer. A new reviewer may have completely different information requests, and the process can become a vicious circle without careful planning.

The FDA’s role in keeping a lid on unsafe drugs and devices is incredibly important. Indeed, as a device company our goals are not at odds with those of the FDA. We want to provide human health advancing technologies without introducing any unexpected consequences for the patient or physician. It’s a goal we share with those that regulate us.

The information provided through this blog is not a substitute for legal, regulatory or other professional advice where the facts and circumstances warrant. If anyone in your organization requires legal, regulatory advice or other professional assistance, they should always consult his or her own legal, regulatory, or other professional advisers and discuss the facts and circumstances that apply to their specific project.

Advisory Board Announced

EMCI has formed a new advisory board to help guide the company. The board includes notable doctors, surgeons, engineers, researchers, and business professionals from the Kansas City region. To read bios of the board, click HERE

Prometheus Solutions License

EMCI is happy to announce a new license agreement with Prometheus Solutions, a Kansas company focused on medical device development. The new license will bring an affordable, compact, portable diagnostic suite for use with Bluetooth enabled smartphones and tablets.  Read the full press release.

Welcome to EMCI’s Blog

The medical device industry is fraught with peril. There are a million ways to misstep, lose your shirt, or even hurt or kill an end user.

There are numerous regulatory bodies with an interest in protecting the public (and their own credibility), and by their very nature, they are extremely risk averse.

There are patents to file, fight, and defend. There are prototypes, bench trials, clinical trials, sterilization validations, packaging discussions. And even when your product is proven, ready to manufacture, and has regulatory thumbs up, there are still countless pitfalls in things as simple as the wording on the instructions for use.

One small comment in a marketing piece that makes a claim beyond the scope of the FDA approval (even if it’s widely used by doctors for that purpose off label) will get you a visit from, at best, an FDA inspector, and at worst, federal marshals.

This is not an industry for the risk averse. But it’s also nothing to fear if you have the right partner. EMCI has dealt with all of these pitfalls, worked with federal regulators and certifying bodies, seen patents through from start to finish, and manufactured a wide array of medical products.

You don’t have to start a new company when you come up with an innovative medical device. You need a partner you can trust to walk you through the process and help you avoid all of the pitfalls. That partner is EMCI.

This Commercialization Blog will be an ongoing source of information written by the experienced members of EMCI’s commercialization team. We hope that you find the information you read here helpful, informative, and practical.

The information provided through this blog is not a substitute for legal, regulatory or other professional advice where the facts and circumstances warrant. If anyone in your organization requires legal, regulatory advice or other professional assistance, they should always consult his or her own legal, regulatory, or other professional advisers and discuss the facts and circumstances that apply to their specific project.

EMCI Signs Partnership with ASP Medical

EMCI has signed a long-term partnership agreement with ASP Medical, LLC (a Kansas company).

The two companies are commercializing a thoracic surgery device that will help to prevent cardiac tamponade in heart surgery patients. This device is awaiting FDA approval and is expected to be approved and available in March, 2013.

Read the full PRESS RELEASE.

EMCI Awarded $1.6M KBA Grant

EMCI was today awarded a $1.6M grant by the Kansas Bioscience Authority.

The grant will help the company to expand by nearly 140 employees over the next 5 years, and will aid in commercialization of current projects, TAC-Cell and OroSTIFF.

Read the official KBA Announcement.

EMCI Licenses OroSTIFF

EMCI (Epic Medical Concepts & Innovations, Inc.) announced today that it has licensed new technology, the OroSTIFF, developed by Dr. Steven Barlow at the University of Kansas. EMCI plans to commercialize the technology and sell the product worldwide.

“The OroSTIFF represents yet another breakthrough from KU for patients suffering from degenerative diseases,” says Peter Lucas, COO of EMCI. “This technology will take much of the guesswork out of treatments.”

Read the full press release

EMCI Licenses TAC-Cell

Epic Medical Concepts & Innovations, Inc. today announced that it has licensed new technology, the TAC-Cell, developed by Dr. Steven Barlow from the University of Kansas. EMCI plans to commercialize and sell the product worldwide.

“We are pleased to license a KU technology to a regional medical device company to assist the area in building its bioscience presence” said Jim Baxendale, Executive Director of the KU Center for Technology Commercialization.

Read the full press release

EMCI Improves Vertical Integration

EMCI today announced it has added new manufacturing capabilities to its manufacturing facility in Kansas City.

EMCI can now do type II anodizing, bright dip anodizing, Copper plating, Nickel Plating, and Reprochrome Plating as well as laser engraving. Having these processes in house will allow tighter quality controls and faster turnaround times.

The company plans to continue to expand its capabilities in this area over the next 12 months by adding additional plate options.