Soapbox

Paper Processes: Three Reasons It’s a Costly Business Move

By Jon Speer
March 6, 2020


• Categories: 03-Manufacturing Execution, 05-Quality/Regulatory, Business Analysis, Soapbox

When businesses plan to cut costs, they’ll often take measures like cutting department budgets or downsizing office space. But one of the costliest factors that most businesses are unaware of, especially medical device companies, is their reliance on paper-based processes.

A single ream of paper might only cost around $10, but when you’re relying on it as a medical device quality management system (QMS), that cost can quickly get out of hand.

Some medical device manufacturers have realized the costs associated with paper and shifted to “digital paper” QMS solutions like spreadsheets and cloud file storage. While this system can be considered an improvement in some ways, digital paper can be just as expensive as physical paper, if not more.

Both paper and digital paper are outdated approaches to medical device quality management. If you’re still not convinced, here are three ways paper ends up costing your organization more than you may think.

The Basic Cost of Paper

The first and most straightforward way paper can end up costing your organization is when it is overutilized.

The FDA’s application for premarket approval (PMA) is lengthy and requires numerous elements, including alternative practices, clinical study data, a detailed description of the device and marketing history. A proper PMA application can include hundreds of pages, and the FDA requires six copies of the form. Add in printing costs, binding and postage along with last-minute edits and the manual removal and replacement of pages, and this quickly becomes one expensive document.

Digital solutions, including modern medical device quality management systems (MDQMS), compile all documents into a single source of truth that can be used to file and submit any PMA or 510(k) applications using digital media. This strategy saves your team valuable time and also saves your company the overall cost of a paper application.

Lost Capabilities

One of the fastest-growing areas in the medical device landscape is software as a medical device (SaMD). The ability for software and hardware to work in unison to predict and recommend treatment for a patient is genuinely groundbreaking. Many companies have caught on to the trend and have made significant investments in this area, including wrist-based EKG devices from Apple and Google.

SaMD devices are not only innovative but also incredibly sophisticated. Anything that includes SaMD elements alongside hardware and firmware requires design controls for all components and subcomponents, which can number in the hundreds of thousands. Both physical sheets of paper and digital spreadsheets are incapable of effectively managing this level of complexity.

As these complex devices become more commonplace in the industry, medical device companies will be forced to make critical decisions: Lose market share to competitors by neglecting these capabilities or make the transition to a modern MDQMS before amassing thousands of documents that need to be uploaded, revised and tracked.

A Hard Hit to Valuation

A few years ago, I interviewed medtech industry veteran and investor Ronny Bracken, executive and principal at Paladin Biomedical Consultants. We chatted about the common mistakes he’s seen medical device startups make.

Aside from his insights on M&A activity in the industry, Ronny shared a personal story about an early-stage medical device manufacturer seeking investment that was using a general-purpose QMS for its design controls. Ronny and his team found that the organization’s inadequate design controls and quality system were too risky for investors and cut the company’s overall valuation by $20 million.

For startups seeking funding, a substantial valuation early on is critical. While saving money on tools when the business is still getting started can seemingly make sense, this isn’t a long-term growth strategy: Saving thousands of dollars now can cost millions in value down the road.

High-quality systems and high-quality tools showcase high-quality products. While paper-based systems fulfill compliance, the real purpose of an MDQMS isn’t just to manage compliance, but also to enable and manage quality activities and outcomes. To set a high bar for the end product, you must set a high bar for the tools used to create it.