The path of regulatory approval can be filled with complications and pitfalls for med-tech companies blissfully unaware of the rules. In the ever-changing healthcare climate, it's commonplace for procedures to change, and past laws to be reinterpreted.

One need only look at the recent outcome of Riegel v. Medtronic, which has sent shockwaves through the med-tech industry.

Can patients sue for faulty devices implanted in them? Just how much product liability does the company really have?

Part of the impetus behind 2008 International Medical Device Compliance Code Compendium a 200-page guidebook designed by the Huron Consulting Group (Chicago), is to give med-tech companies a significant leg up in understanding the different rules and regulations for different compliance issues as well as any changes in the law.

"Medical device companies that do business internationally must comply with strictly enforced, complex national rules that govern the way they interact with healthcare professionals. The compendium provides regulatory guidance regarding interaction with healthcare professionals in 65 countries," Mark DeWyngaert, Phd, co-leader of the Life Sciences Practices at Huron, told Diagnostics & Imaging Week.

The guide was released last week at the International Medical Device Compliance Congress in Paris.

"Things that may have been acceptable practices five or six years ago aren't anymore. And it's certainly no secret that there has been an increased amount of regulatory oversight," DeWyngaert said. "I think the compendium is the best source of information to help give companies the understanding of all the ins and outs surrounding compliance."

In addition to analyses of medical device codes and comparisons between codes, the compendium includes pharmaceutical codes that are affected by medical devices making it what Huron calls the single best source available for answering a company's compliance questions.

"Let's say a new company just received CE-mark approval, they need to know that the way a device is marketed might be acceptable in one place, but to meet compliance it would have to go through a different set of guidelines in another place," DeWyngaert said. "It's good for companies to have a handbook to refer to."

The compendium also contains a listing of all med-tech regulatory and governing agencies in the 65-country radius that it covers. It also has a provision about grants, and which grantmaking agencies are available to med-tech companies. Not only that, but it discusses the reimbursement process in each different country.

Although the compendium is for all med-tech companies it could be especially beneficial to companies just starting, according to Huron.

"The med-tech community is highly fragmented with a few big players — but mostly smaller companies — and the compendium is certainly helpful to those companies just starting out," DeWyngaert said.

"The idea of the compendium was first developed out of a discussion with King & Spalding and Advanced Medical Technology Association (AdvaMed, Washington) last year. "Huron then had a small team work on compiling the information for the compendium over a period of eight months. During the 2007 AdvaMed meeting, we presented the [first] compendium.

The first document was a little more than 160 pages, with the current just bulging past the 200-page mark.

"The document is available on CD and is free of charge for companies to obtain, we're doing this as a public service," DeWyngaert, said.

There also promises to be a link from AdvaMed's web site to view the document.

To date, the experience with the compendium has been very positive and Huron plans to expand the document to include more regulatory agencies next year.

"This is something that we plan to continue each year," he told D&IW. "We want to show how valuable a partner Huron can be and how the company can assist the needs of medical device companies."

Huron was founded six years ago and is a publicly traded firm. Its healthcare sector makes up 40% of its clientele.