Top 10 Mistakes Diagnostic Manufacturers Make With Raw Materials — And How to Avoid Them?

Mrunali Dave
May 21
3 min read

In the world of diagnostics, the quality of a finished test is only as good as the raw materials behind it. Yet many manufacturers — from startups to seasoned players — keep repeating the same costly errors. Here are the top 10 mistakes to watch out for and how to fix them before they hit your bottom line.

Prioritizing Price Over Performance

Choosing the cheapest cellulose or glass fibre pads can cripple test sensitivity and reproducibility. Low-cost pads often have inconsistent pore sizes, fibre distributions, or absorption rates that make your assay unreliable—killing regulatory approval chances.

Always request performance data sheets and run comparative trials before bulk purchasing.

Ignoring Lot-to-Lot Consistency

Even from the same supplier, pad or filter paper properties can shift between production batches. If you're not tracking lot numbers and running incoming quality checks, you risk sudden assay failures mid-production—an expensive surprise.

Insist on Certificate of Analysis (CoA) documentation for every lot and run a standard QC protocol on arrival.

Using Generic Pads Not Designed for IVD

Not all cellulose or polyester pads are created equal. Industrial-grade materials often contain binders, wetting agents, or contaminants incompatible with biological samples, leading to signal interference or false results.

Source IVD-specific pads that meet purity and chemical compatibility standards for diagnostic applications.

Neglecting Whole Blood Separation Requirements

Lateral flow tests that work on whole blood demand precise separator pads. Manufacturers often underestimate the science behind plasma separation efficiency. A poor separator pad leads to hemolysis, red cell interference, or sample flow issues.

Validate your whole blood separator pad's separation efficiency, flow rate, and protein retention under real sample conditions.

Not Testing Raw Materials Under Real Conditions

Many manufacturers test materials in perfect lab settings, then face failures in field conditions — high humidity, temperature swings, or varying sample matrices. Your raw material must perform under the conditions your end users will actually face.

Run stress testing: humidity, heat, cold, and sample variability before finalizing your raw material selection.

Overlooking Customization Needs

Off-the-shelf pad sizes often force compromises in device design. Many manufacturers squeeze their cassette design around available materials rather than sourcing materials that fit their optimal design—limiting performance and increasing waste.

Work with suppliers who offer customized sizes and shapes tailored to your device architecture.

Single-Supplier Dependency Without a Backup

Over-reliance on one raw material supplier is a serious supply chain risk. Disruptions — whether geopolitical, logistical, or due to supplier capacity issues — can halt your entire production line.

Qualify at least two suppliers for critical materials and maintain a strategic safety stock buffer.

Poor Storage and Handling of Raw Materials

Even the best filter papers and pads degrade quickly if stored improperly. Humidity, UV exposure, and temperature fluctuations alter fiber structure and absorption characteristics—silently corrupting your next production run.

Follow supplier-recommended storage conditions (temperature, humidity, packaging) and implement a FIFO inventory system.

Skipping Supplier Audits and Quality Certifications

Trusting a supplier's marketing claims without verifying their quality management system is a gamble. Many manufacturers skip audits to save time, only to face regulatory headaches when auditors probe their raw material traceability.

Partner with ISO-certified suppliers and conduct periodic audits or request third-party quality reports.

Failing to Involve Raw Material Experts Early in Development

Raw material selection is often treated as an afterthought — a procurement decision made after the assay chemistry is locked. This leads to reformulation cycles, delays, and cost overruns when materials don't integrate with the chosen chemistry.

Bring your raw material supplier in as a technical partner from the R&D phase, not just at scale-up.

Your Diagnostic Test Deserves Better Raw Materials

V-Kards Associate is a leading India-based manufacturer and exporter of cellulose pads, polyester pads, glass fibre pads, whole blood separator pads, and filter papers—purpose-built for the IVD, healthcare, food & beverage, chemical, cosmetic, and oil industries. Every product is backed by rigorous quality control, available in custom sizes and shapes, and supported by a growing global market presence.