PDS & Monocryl PLUS Suture Product Development
PDS & Monocryl PLUS Suture Product Development
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Timeline: September 2024 - Present
Goal: Implement packaging design changes to increase the production capability of current synthetic antibacterial suture products.
Project Background Information
Project Background Information
Ethicon manufactures over 5 million sutures a week and over 200 million sutures every year, representing 38% of global suture production. Synthetic absorbable sutures are increasingly replacing natural materials, with a market growth rate of 5-9% (CAGR).
PDS PLUS & Monocryl PLUS Antibacterial Absorbable Sutures
The larger objective of this initiative is to eliminate surgical site infections (SSIs) by establishing PLUS anti-bacterial sutures as the global standard of care. Suture product families will be upgraded and non-PLUS sutures will be discontinued by the end of 2028. This strategy is estimated to drive an 170% increase in sales volume (65 million units) for synthetic absorbable sutures (PDS and Monocryl PLUS). To facilitate this change, design changes were necessary to increase production efficiency and expand capacity.
Antibacterial Suture Manufacturing Process Workflow
Previous suture manufacturing methods used Tyvek reservoir patches dosed with Triclosan active pharmaceutical ingredient (API) to coat the suture surface. These manufacturing processes are manual and require operator assembly of suture packaging.
Skills
Skills
Combination Medical Device Development
Injection Molded Component Development (SolidWorks)
Component & System Failure Analysis (FMEA)
Regulated Design Change (DHF, Verification, Process Validation)
Cross-functional collaboration with internal/external teams
Collaborators
Collaborators
Component Supplier: Alltrista Plastics LLC.
Regulatory: FDA, BSI, PMDA
Clinical Surgical Stakeholders
Internal development teams:
R&D, Quality, Engineering, Supply Chain, Marketing, Regulatory
3 manufacturing sites
Methodology
Methodology
Design Change Overview
Design Change Overview
Changed design of anti-bacterial PDS & Monocryl PLUS sutures packaging trays by:
Converted all suture product packaging trays to "enclosed-racetrack" form factor for use in automated suture winding equipment.
Eliminating the Tyvek patch API reservoir and compounding Triclosan directly into the HDPE resin of the plastic tray packaging component.
Characterized and qualified suture manufacturing processes using new tray components components.
Suture Packaging Change Overview
Product & Process Characterization
Product & Process Characterization
Developed tray component injection molding process parameters with external supplier.
Determined dosed-tray suture manufacturing process window and dosage limits (DOE & capability analysis via Minitab).
Conducted application, design, and process FMEA assessments to evaluate change impact and potential failure modes.
Performed design verification testing including subjective handling evaluation in clinical setting.
Conducted sterilization efficacy studies, evaluating EO/ECH residual dissipation.
Started product shelf-life studies to evaluate long-term change impact.
On-site visit!
Automated production of Monocryl PLUS suture product samples
Manufacturing Process Qualification
Manufacturing Process Qualification
Designed process qualification strategies (OQ/PQ) and generated acceptance sampling plans.
Traveled to three production sites to lead qualification activities.
Manufactured 112,651 product samples and established by objective evidence that process control limits produce suture that meet all acceptance criteria.
Performed capability analysis (Minitab) to qualify dosed-tray manufacturing processes.
Example Dosed-tray DOE Regression Results
Given figures are representative and do not contain actual data for IP confidentiality purposes
Example OQ Capability Analysis
Results
Results
PDS PLUS:
US Regulatory approval (FDA 510k) received for PDS PLUS (2025) and Monocryl PLUS (February 2026).
Manufactured 2,803,214 sutures under build protocol in PLM software system to support the official PDS PLUS product launch in May 2026.
Monocryl PLUS:
Monocryl design change documentation (DHF, FMEA, etc.) completed July 2026, product launch scheduled for Q4 2026 .
Pre-market promotional material
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