What the Volkswagen Scandal Teaches About the Value of Compliance Management

For years industry analysts and software developers have affirmed the value of tracking compliance as a product design data element, but there is nothing like a big international scandal to change the discussion. Volkswagen was recently caught cheating on emissions tests on diesel engines sold in the US, and has set aside €6.5 billion ($7.3 billion) to deal with the aftermath. International bank Credit Suisse thinks the damage will more likely cost VW €78 billion ($87 billion) over time, in the indirect form of lost sales from its damaged reputation as well as the direct form of fines, legal fees, and possible sales bans. (more…)

Read More

Fighting Medical Regulatory Bureaucracy with PDM

MedicaMetrix is a US-based startup in the medical devices industry. It is an industry notorious for chewing up and spitting out small companies like a monster finding bad grapes in a vineyard. Founder-CEO Christopher LaFarge says investors in his industry look for leaders “who will run through brick walls head first” among other attributes. “Somehow, they are going to end up in the market with something that makes money,” no matter what it takes.

One of the frustrations in developing new medical devices is the “alphanumeric soup” of regulatory and compliance agencies. There is the FDA in the US, and an equivalent agency for European Union nations. Each agency wants an incredible amount of documentation, presented their way. While there is some overlap, they both want schematics and circuit board designs, CAD file prints of the product, and all the accompanying documentation generated in word processing, spreadsheets, accounting, and other software presented in a specific way. (more…)

Read More

Cringe-Free Engineering Change Orders

Talk to engineers or search the Web about Engineering Change Orders (ECO) and you will quickly realize you have stumbled into dreaded territory. People who engineer either the design or the manufacturing processes generally love their jobs, but universally cringe at the thought of having to request, document, and implement changes to their work after the fact.

One reason engineering team members cringe in reaction to ECOs is because they instinctively recognize inefficiency when they see it. In this era of computer-based automation and efficiency, ECOs seem to have been left behind. They are usually created on spreadsheets then processed manually and informally using nothing more sophisticated than Windows Explorer and email. It is a process offering no chance for department-wide visibility, no way to automate the surrounding information flow of alerts, status, and approvals, and no way to create a useful audit trail for future reference. (more…)

Read More

Measuring the ROI of Information Access

In my previous blog post for Synergis, I ended it by saying, “Don’t measure the ROI of having a place to put your CAD stuff; measure the ROI of creating digital business processes for product development.” So let’s take a look at an engineering company that has taken the time to figure it out.

Calculating Return on Investment is fairly simple when one buys a product wholesale and sells it retail. When the purchase is a software product that guides crucial operations, the calculations get more intricate. For example, if you don’t know how long it takes your team to work with information, you can’t measure the benefit of automation. In a report entitled “Validating the Possible” CIMdata calculates the potential for savings in specific processes, including:

  • Time to find information—75% to 90% time reduction;
  • Engineering changes process—10% to 70% time reduction;
  • Design review process—50% to 80% time reduction;

(more…)

Read More