October 6, 2015

Why Do Medical Device Businesses Fear Modern Electronic Documentation?

meddev_managerequirementsAccording to the 2014 State of Medical Device Development Survey, most medical device businesses continue to use older tools and manual efforts to manage their product development documentation. Some of these businesses focus so much on the document that they lose sight of the related records and the data necessary to key decision-making—particularly where it concerns design assets. It’s not like the technology for managing product development documentation is new. Software tools have been around for several years, and the FDA provided guidance on using electronic documentation in 1997—18 years ago. Medical device businesses manufacture some of the most advanced technology on the planet, so why are they still using antiquated systems to document their development activities? Microsoft Word, Excel, shared folders, and binders of printed documents, stored in row upon row of filing cabinets—it’s seriously outdated technology, and it’s painful to manage.

The Roots of Electronic Documentation

To understand the hesitation to adopt modern product development solutions, let’s look at the evolution of electronic documentation. Until the late 1980s, paper documentation was the rule. That changed when personal computers landed on every employee’s desk, and early word processors (remember WordStar?) and spreadsheet software were used create documentation. The final version still was printed and stored in a binder, but the shift to electronic documentation had begun. By the 1990s, businesses were scanning older documents and storing them electronically. Technology solutions began to emerge. Electronic document management for all businesses led to product lifecycle management (PLM) for product development and manufacturing. Quality management systems (QMS) for regulated businesses came next, and then knowledge management (KM) for research. None of these solutions efficiently and conveniently trace within the document or other assets, making it difficult to perform data and other development analysis. Just how these emerging tools could be used to maintain compliance was unclear. Industry professionals, consulting firms, and software vendors offered differing interpretations of regulations and how technology could potentially solve compliance issues. Quality standards and international certifications talked principles and theories, but offered no concrete guidance. The FDA’s Safe Medical Device Act of 1990 (as well as subsequent regulations and guidelines) took a similar approach. Essentially, the FDA wanted medical device businesses to validate intended use and to trace key decisions through product release — and to defend every decision in an audit, if requested.

Electronic Documentation Today

With the dawn of the 21st century, product development software tools have grown more powerful. These tools have richer feature sets and offer benefits that word processors and spreadsheet software do not, like versioning, traceability, automated reporting and analysis, and more. As a result, electronic records have transformed into relational data sets that can be broken down into individually traceable assets. This transformation gives businesses the ability to manage a product from cradle to grave. The regulatory landscape also has changed, with the FDA providing additional guidelines and clarifications to earlier regulations for electronic documentation. In 21 CFR Part 11, for example, the FDA outlines its requirements for electronic records and electronic signatures.

Why Businesses Cling to Paper

Are you starting to wonder why medical device businesses have been slow to shift to electronic documentation and records software? In some cases, it’s an overly literal interpretation of “documentation,” leading businesses to think they need to print everything. But, in most cases, it’s fear: fear of change, fear of violating regulations, and fear of the unknown. These fears are unwarranted, and they’re holding these businesses back. By clinging to paper, they’re losing days or even weeks of productivity. They waste days creating a traceability matrix. They waste hours because they’re trying to do change management with Word—only to have Word crash in the middle of their work. During audits, these businesses are digging through stacks of binders or searching through directories every time the auditor asks for proof. Meanwhile, the auditor’s confidence in the business diminishes, his scrutiny increases, and he comes up with additional items to request.

It’s Time to Evolve

The tools have evolved, and it’s time for medical device businesses to do the same. Electronic documentation’s benefits far outweigh its costs, offering better traceability, easier change management, and more risk reduction. Today’s electronic documentation and records software even can help identify project delays while there’s still time to do something about them. The automated reporting and traceability features in these tools leave businesses better prepared for an audit. No more digging for proof while the auditor thinks up other areas to investigate. Some businesses are afraid they’ll have to change to their entire process if they adopt one of these tools, but that’s simply not true. If a vendor tries to push a company to change, that’s a good indicator their tool is not a good fit for the business. Take the time to find a solution that fits the way the business works; don’t change the process to fit a tool. Don’t forget to validate, either. There are plenty of vendors who imply or outright claim their software is fully compliant with International Electrotechnical Commission (IEC), International Organization for Standardization (ISO), and FDA regulations, but it’s ultimately the buyer’s responsibility to validate against their intended use.


Unfortunately, fear of change and a literal interpretation of documentation have created stagnation within the medical device sector. Most medical device businesses are afraid of doing something wrong, even though FDA guidelines for managing electronic documents and records have been around for almost 20 years. The fundamental technology to solve electronic document problems has existed for nearly two decades. Companies need to figure out how the business should operate, how their processes should flow, how they should defend an audit, and how they should share and relate things. Fear, internal bureaucracy, and departmental silos—not regulations—are getting in the way of progress.   Note: This blog post was first published on Med Device Online.