Custom Preclinical Medical Device Studies

Regulatory Guidance & Custom Program Design

WuXi AppTec has developed a process to match current regulatory expectations with state-of-the-art science. With every study designed by our experts, current regulations are taken into consideration. Intimate knowledge of regulations worldwide, enables us to design the most relevant studies from the very beginning, saving you time and money throughout the testing process.

Custom Medical Device Testing Program Features & Capabilities

WuXi AppTec’s experienced scientists can design customized studies across a broad range of disciplines to support your R&D, regulatory, and marketing requirements.

Features

• • Studies custom designed with sponsor for each project
  • Models developed to target specific product applications
  • On-staff veterinarians, veterinary pathologists, and toxicologist
  • Ability to combine efficacy and safety endpoints into one study
  • Ability to link in vitro assay design requirements to surgical endpoint studies
  • Strong background in GLP, non-GLP, and research and development/ pilot studies
  • Regulatory and consulting services available to support sponsors

Infrastructure

• • State-of-the-art animal facility featuring BSL-2 animal suites
  • Multiple operating rooms with experienced staff surgeons and support for sponsor surgeons
  • Selection of small animal models

Small/Large Animal In-Life Studies

• • Toxicology for medical devices (Part 6, Part 11, Combo)
  • Microbial studies – AMEs (Dosing/efficacy for rabbit subcutaneous pocket model)
  • Wound creation and healing
  • Cardiovascular
  • Bone repair/fusion
  • Toxicology for cell therapy, gene therapy, vaccines, and other biologics
  • Tumorigenicity
  • Tendon repair
  • Nerve repair
  • Dural repair
  • R&D studies

In Vitro Studies

• • Modified standard models
  • Some in vitro microbial studies (AMEs) and R&D studies

Other Services

• Histopathology
• Hematology
• Clinical chemistry
• Coagulation
• Cell production
• Radiography
• Standard for the Exchange of Nonclinical Data (SEND) in vitro testing

Custom Designed Toxicology Studies 

Toxicology testing programs should be designed to address the unique challenges specific to evaluating the safety of a medical device, combination product, or biologic. 

With a thorough understanding of your product and the related regulations, WuXi AppTec helps you design studies that are tailored to provide the data required to support your preclinical regulatory submissions. Our team of experts includes Ph.D. toxicologists and material specialists, as well as highly experienced surgeons and pathologists.

Acute Toxicity Studies

• • Range finding
  • Fixed dose
  • Local tolerance

Repeat Exposure (in vivo)

• • Range finding
  • Subacute
  • Subchronic
  • Chronic

Implant Toxicology

Pharmacokinetics/Toxicokinetics

• • Blood and tissue sampling

Antimicrobial Studies 

As a leader in the field of antimicrobial studies, WuXi AppTec has the experience and expertise to help you determine the best testing options. Our comprehensive antimicrobial program encompasses screening, in vitro, and in vivo models.

In Vitro Antimicrobial Studies
Quickly evaluate activity of antimicrobial agents using Zone of Inhibition (ZOI) and Minimum Inhibitory Concentration (MIC)

In Vivo Antimicrobial Studies
Evaluate antimicrobial effectiveness of final product candidates in a biologic system.

Orthobiologics Studies

WuXi AppTec’s orthobiologic program helps researchers explore the possibilities of an orthobiologic product.

Providing product efficacy through defect repair and fusion studies is critical to regulatory approvals. Multiple endpoints can be evaluated with both qualitative and quantitative measurements. Histomorphometry and microCT are also available.

Defect Repair Studies
Defect studies are designed to examine how well a product performs to heal defects. Both drill defect and segmental defect studies are available.

Fusion Studies
Fusion studies are designed and performed to prove the efficacy of a product to induce a fusion event in the spine.

Wound Healing Studies

By using an assay designed specifically to challenge the effectiveness of your product, data can be generated to prove your product’s improved efficacy in managing tough clinical problems like wound infections or diabetic wounds. Strong supporting data can ease the regulatory process and provide the marketing edge that puts your product ahead.

WuXi AppTec offers wound healing models designed to target the most critical clinical needs, such as wound models with or without bacterial infection (incisional, excisional, and partial and full thickness).

Preclinical Implant Studies

WuXi AppTec can perform a variety of customized implant studies to meet your preclinical testing needs:

• • Variations of ISO 10993-6 (Biological evaluation of medical devices – Part 6: Tests for Local Effects After Implantation), such as additional animals, different implant sites, and additional histology stains and/or analyses.
  • Test article resorption studies.
  • Multiple implant site options, including intra-/inter-muscular, subcutaneous, and other clinically relevant sites (e.g., soft tissue, orthopedic, dural).
  • Multiple species, including rat, rabbit, pig, sheep, and immuno-deficient rodents
  • Clinically relevant defect models (e.g., dural, partial or full hernia, orthopedic, Achilles tendon).