Gynecology Case Studies

Case Study 1: Engineering a Minimally Invasive Solution for Uterine Care

A surgical system designed to remove uterine fibroids, polyps, and/or retained products of conception (RPOC) using a minimally invasive hysteroscopic approach with no incisions.

The procedure is quick and straightforward, allowing most patients to return to regular daily activities within a few days. Hysteroscopic techniques are also the preferred treatment for polyps and fibroids in women of child-bearing age.

Industry

Gynecology

Impact

Supported our client’s first-in-human studies.
Scaled production to meet rapidly growing market demand.
Enabled the launch of a differentiated, single-use hysteroscope in a competitive gynecology market.

Challenge

The client sought to develop a handheld, single-use hysteroscopic system incorporated with fluid management and distention to offer a minimally invasive solution for the removal of uterine fibroids, polyps, and retained products of conception (RPOC). The device had to be intuitive, safe, and suitable for outpatient procedures without requiring incisions or anesthesia and products from other manufacturer.

Solution

As a contract developer and manufacturer, our team partnered with the client from concept through commercialization. We:

Supported early product ideation and prototyping.
Led the design for manufacturing (DFM) process.
Conducted preclinical and early clinical validations of the newly developed system in collaboration with Semmelweis University, Budapest.
Developed key subassemblies of the controller for scalable production.
Transitioned to full commercial manufacturing as demand grew.

Case Study 2: Advancing Endometrial Ablation Technology

A next-generation surgical system designed for the controlled ablation of the endometrium, the innermost layer of the uterus. The device operates by ionizing argon gas to create plasma within a silicone membrane at the distal tip, which is then used for precise power delivery for tissue ablation. This approach offers a safer and less invasive treatment option, aiming to reduce the need for full hysterectomies.

Industry

Gynecology

Impact

Supported regulatory submission for FDA approval.
Accelerated the development process from prototype to commercial production.
Delivered a safer, minimally invasive treatment alternative for women’s health.

Challenge

The client aimed to develop a surgical system for controlled endometrial ablation that was both effective and less invasive than traditional methods and better outcome for the patients. The device needed to be safe, intuitive, and capable of reducing the number of patients requiring hysterectomy, while meeting strict regulatory requirements.

Solution

As a contract development and manufacturing partner, we:

Collaborated from the first prototypes through final testing.
Developed the handheld unit and controller with gas management.
Manufactured devices for initial tests and clinical studies.
Supported the compilation of regulatory documentation to secure FDA approval.
Produced the first generation of the device and managed the manufacturing transfer process for large-scale production.

Case Study 3: Innovating Fibroid and Polyp Removal

A next-generation surgical system designed for the hysteroscopic removal of fibroids (myomas) and polyps. The device combines bladeless resection with intrauterine pressure-regulated saline filtration and circulation, offering a safer and less invasive alternative to common surgical approaches, while preserving fertility.

Industry

Gynecology

Impact

Achieved FDA clearance in less than 24 months from project start.
Manufactured approximately 1,000 devices for testing and clinical trials.
Contributed to a successful acquisition by a major medical device company.

Challenge

The client sought to develop a surgical system capable of removing fibroids and polyps in a way that minimized patient risk and preserved reproductive health. The system needed to integrate bladeless resection technology with advanced fluid management, meet strict regulatory requirements, and move quickly from concept to market readiness.

Solution

As a contract development and manufacturing partner, we:

Designed and developed the handheld probe, controller, and fluid management system.
Created the first prototype and carried it through to clinical study stage.
Manufactured ~1,000 devices for testing and clinical trials.
Supported clinical studies at Semmelweis University, Budapest.
Provided full documentation for regulatory approval, resulting in FDA clearance in under 24 months.

Direct Clinical Access

Our direct access to clinical facilities greatly enhances our R&D efforts. Thanks to our partnerships with esteemed institutions globally we can complete pre-clinical and clinical studies in an efficient and reliable way enabling timely product market entry.

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