Challenge

A medical device sponsor developing a next-generation delivery system sought to better understand the materials and coatings used by a leading competitor in their connectors and housing components.

The competitor’s product demonstrated excellent clinical usability and product longevity, and the sponsor wanted to gain insights into material selection, potential surface treatments, and manufacturability strategies to inform their own design and sourcing decisions. However, publicly available documentation (IFUs, patents, regulatory summaries) lacked the specificity needed to answer key design questions.

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Chemva’s Solution

Chemva designed and executed a custom reverse engineering plan targeting both bulk materials and surface coatings of the competitor’s connector and delivery components.
Our approach integrated advanced analytical testing with polymer forensics and material performance interpretation.

1. Visual and Structural Assessment:
   • Conducted macroscopic and microscopic examination of the device components, including cross-sectional imaging and surface topography via SEM to assess material interfaces, weld lines, and any multi-material bonding regions.
   • Isolated key subassemblies such as male/female connectors, flexible tubing, and actuation interfaces for targeted analysis.
2. Bulk Material Identification:
   • Performed Fourier-transform infrared spectroscopy (FTIR) and Raman spectroscopy to identify the polymeric backbone of each component (e.g., polycarbonate, PEEK, PETG, or proprietary blends).
   • Used Differential Scanning Calorimetry (DSC) and Thermogravimetric Analysis (TGA) to evaluate thermal properties, crystallinity, and filler content.
3. Surface Coating Investigation:
   • Conducted contact angle measurements to detect lubricious or hydrophilic coatings and quantify surface energy changes.
   • Used FTIR to detect general coating chemistry.
4. Strategic Insights and Reporting:
   • Identified that the competitor used a PC-ABS blend for structural connectors, likely to balance impact strength and chemical resistance.
   • Surface analysis suggested a thin hydrophilic coating, consistent with off-the-shelf or lightly modified commercial lubricious coating technologies.
   • Recommended commercial analog materials and coatings for the sponsor’s team to evaluate.

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Impact Delivered

The client incorporated the findings into their design history file (DHF) and moved forward with a refined material and coating strategy grounded in real-world competitive intelligence.
Chemva’s reverse engineering analysis:

• Enabled the sponsor to benchmark competitor material choices and identify functional design intent not obvious from public sources.
• Provided material formulation insights that informed their own selection of materials and coatings.
• Accelerated their development timeline by reducing trial-and-error sourcing and testing cycles.