Medical Device and Diagnostic Development
A Unique Life Cycle Solution
The medical device and diagnostic (MD&D) industry is experiencing a transformational era due to huge advances in technologies such as AI, robotics, apps, drug/device combination products and patient-enabled diagnostic tests. These advancements also bring a fresh set of challenges, including a more stringent regulatory environment (EU Medical Device Regulation [MDR]), more complex trials with longer development timelines— increased reimbursement pressure and healthcare budget constraints in bringing new medical products to market.
Now, a new life cycle approach to medical device & diagnostic development is available to streamline the process, making it easier and more effective overall. It begins with a strong insightful regulatory strategy that integrates all stages of the medical product life cycle: preclinical, clinical and post-market. What’s more, this simplified product development can be accomplished with one research and development partner with solutions that span the life cycle continuum to make it even simpler.
This specialized and unique approach enables MD&D manufacturers to manage their overall development portfolio holistically—from biocompatibility testing and conducting clinical trials, to regulatory submission and medical post-market surveillance.
Preclinical & Surgical
- Biocompatibility testing
- Non-GLP & GLP (acute and chronic)
- Experimental surgery & model development
- Imaging equipment and capabilities
- Cadaver studies with physician/sales training
Regulatory & Consulting
- Global strategic, QA and regulatory consulting
- IDE, PMA, HDE, BLA, 510(k), de Novo 510(k), CLIA Waiver
- MDR, IVDR, CDR, CE Mark & Design Dossier/Technical File
- Registration & Submissions
- CER writing
- Protocol development
- Feasibility/Pilot & Pivotal
- Global clinical trials development plan
- Diagnostic analysis
- Site & patient recruitment/qualification
- Centralized lab testing
- Manufacturing support
- Health economics
- Real-world evidence studies
- Post Market Surveillance
- Post Marketing Clinical Follow-up
Develop your In vitro diagnostic test at the same time as your therapeutic compound solution
Integrating your approach to development across all phases of the development lifecycle can reduce your overhead and enable you to develop your in vitro companion diagnostic (IVD) at the same time as your therapeutic compound—making it possible to be patient-ready on Day 1.
What’s more, you’ll collaborate with the most experienced CDx team in the industry—one that has supported ~15 of the 19 FDA-approved companion diagnostics on the market today:
- Biomarker identification & development
(165+ companion diagnostics in the last 5 years)
- Assay feasibility, proof of concept and validation
(15k+ individual protocols)
- Global clinical trial testing
(70+ countries with patient access)
- Premarket approval application (PMA)
(80+ PMA or 510(k) submissions)
In the past 5 years alone (2014-2019*), our team of medical device and diagnostic specialists have collaborated with device and diagnostic manufacturers on more than 500 studies, involving over 500 investigator sites, and reaching in excess of 110,000 patients worldwide across the following key therapeutic areas.
Oncology & Immuno-oncology
Radiology (nuclear science)
Wound healing and traumatic injury
- Philips Cath Lab – Allura Xper FD20
- Fluoroscopy / OEC 9800 and OEC 9900
- GE Visual IQ with 4D TEE & ICE
- OCT Intravascular Imaging System
- Endoscopic Towers (Olympus)
- Laparoscopic Towers (Stryker)
- Boston Scientific Galaxy
- Cardiopulmonary Bypass
- Audio / Video Conferencing Center
Surgical Suites and Training Facility
Conveniently located in the San Francisco Bay area, our AAALAC-accredited research facility is designed with experimental surgery and you in mind. This is a research space to accommodate both large and small groups while giving you the feel of being in your own office.
For post-market, we can also help with your cadaver training programs for sales and physicians—enabling you to ramp up quickly as part of your product launch efforts.
The Power Propelling the Life Cycle Solution
Gain a complete solution for medical device and diagnostic development. The combination of Covance (research and development) and LabCorp (diagnostic testing) with a series of strategic MDD-related acquisitions – comes together in a powerful new way. Acquisitions include Chiltern (including the device-focused business of Theorem), Preclinical medical device Innovations (PMI, preclinical and surgical solutions), Regulatory and Clinical Research Institute (RCRI, expanded regulatory and clinical depth) and ENVIGO (biocompatibility and preclinical testing). Now together as Covance – you have access to an experienced medical device and diagnostics team, ready to help you navigate your product’s entire life cycle development path—in a way you can’t find anywhere else.
With the integrated life cycle solution, you can:
- Collaborate with a single strategic partner across preclinical, clinical and post-market, all driven by a solid regulatory strategy.
- Develop an in vitro companion diagnostic test in conjunction with a therapeutic drug—to bring both to market in unison and be patient-ready Day 1.
- Easily deliver device/drug combination products under a single, cohesive development program.
- Stay on top of the ever-evolving MD&D regulatory landscape while also streamlining timelines and mitigating product development risks.
Contact us to receive a dedicated device and diagnostic development experience, tailored to your company’s unique development goals.