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.

The life cycle approach is made possible by collaborating with an experienced team that’s been conducting MD&D trials for more than 3 decades—since 1985.

5-year experience (2014-2019) includes:

  • more than 500+ MD&D studies
  • over 5000+ investigator sites
  • reaching excess of 110,000+ patients worldwide
Drug lifecycle management image

Integrate your approach – and advance from product idea to market seamlessly

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

Photo of a vial
  • Biocompatibility testing
  • Non-GLP & GLP (acute and chronic)
  • Experimental surgery & model development
  • Imaging equipment and capabilities
  • Cadaver studies with physician/sales training

Regulatory & Consulting

People talking in a meeting
  • 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
  • Training

Clinical Trials

Clinical trial doctors
  • Protocol development
  • Feasibility/Pilot & Pivotal
  • Global clinical trials development plan
  • Diagnostic analysis
  • Site & patient recruitment/qualification
  • Centralized lab testing
  • Manufacturing support

Commercial

Photo of a couple looking at a smartphone
  • Health economics
  • Reimbursements
  • Real-world evidence studies
  • Post Market Surveillance
  • Post Marketing Clinical Follow-up

Harmonized Rx & Dx Development for In Vitro Diagnostics (IVDs)

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)
Therapeutic Expertise Where You Need It

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.

  • Cardiovascular

    Dermatology

    Endocrinology

    Neuroscience

    Oncology & Immuno-oncology

    Orthopedics

    Opthalmology

  • Radiology (nuclear science)

    Women's health

    Vascular

    Gastrointestinal

    Wound healing and traumatic injury

    Tissue engineering

    Urogenital

101759_14746486_XXL1
Tap into Equipment & Surgical Suites to Facilitate Your Research

Equipment

  • 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
  • IVUS
  • Cardiopulmonary Bypass
  • Audio / Video Conferencing Center

Surgical Suites

PreclinicalSurgicalLab

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:

DeviceStentiS178423545web
  • 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.