We function as an extension of your organization, setting strategies and executing to your major milestones. We embrace the dynamic nature of the medical device industry.
Your goals are at the center of everything we do. Whether we serve as your virtual staff or perform discrete project work, we ensure alignment with your primary objectives. We are your strategic partner.
Our unique, client-responsive consulting model adjusts to meet your program requirements. For companies looking to outsource major elements of their operations, we integrate appropriate resources into the organization. Our virtual staffing approach allows for additional resourcing during peak activity periods as well as minimized scope efforts per project dictates. We function as an extension of our clients, seamlessly increasing or decreasing our activity level as required to satisfy strategic priorities.
Virtual team advantage
- Seamless integration
- Dedicated resources
- Industry acumen
- Robust relationships
- Productive efficiency
- Reduced overhead
Project support value
- Team extension
- Supplemental resources
- Subject-matter experts
- Scheduling flexibility
- Peak-period capability
- Fine-tuned performance
Medical device expertise
We embrace technology. We have been actively involved with FDA’s Innovation Pathway programs from the start and have helped commercialize paradigm-changing devices to improve patient care. Our clients’ products encompass all major areas of clinical practice. The technologies we support include traditional medical devices and IVDs, software-only devices and combination products (devices with drug and/or biologic elements).
- Implantables and active implantables
- Disposables and reusables
- Delivery systems
- Software-only devices/mobile medical apps
- Instruments (laser, robotic, ultrasound, radiation, manual)
- In vitro diagnostics
- Regenerative devices
- Combination products
Anatomy of experience
We are involved with most every area of clinical practice, supporting diagnostic, monitoring and/or therapy devices. We work closely with the various CDRH Divisions during premarket review to ensure meaningful communications regarding appropriate device testing. We support Notified Body selection for our clients to ensure proper understanding of the clinical need addressed by the technology. We work closely with health care professionals—as investigators, scientific advisors and entrepreneurs to improve patient care. Our team regularly attends physician society conferences to remain abreast of industry advancements.
In addition to the medical specialties shown in the graphic, we support devices for digital health, pain management, women’s health and aesthetics.
Our clients include Fortune 100 companies – global medtech firms and consumer giants involved in the regulated space. We also partner with spinouts from universities, incubators and venture-backed teams. We perform due diligence, support funded enterprises and represent companies through acquisition.
We maintain the strictest confidentiality for all client information. Our staff is trained and held to the highest standards for non-disclosure. We do not publicize our client list – discretion is essential.