Regulatory complexity and a
tightening market have made
getting medical devices and
combination products to market
increasingly di�cult.
High Regulatory Burden
• Increased testing requirements
• Higher rejection rates
• Increased validation requirements
• More regulatory actions
Competitive Marketplace
• Increased pricing pressures
• Slow VC/PE investment
• Shrinking budgets
evolving environmentYou are facing a regulatory path that is more
complex and time-intensive than ever
before. Not only are the regulations o�cially
changing, the interpretation philosophies
are changing as well. Careful planning of
your sterilization management process has
become crucial as the agencies demand
more proof of validation. And agencies are
now requiring that biological evaluations
have integrated data sets and be submitted
with full risk assessments.
US FDA
ISO
MHLW
TGA
CFDA EMEA KFDA
testing and guidance to
help you get from concept
to commercialization
DESIGNPRODUCT-SPECIFICPROGRAM
CONDUCTTESTING
PROVIDERESULTS
Consider regulatory expectations
Customize to product
Perform preliminaryrisk assessment
Discuss draft data
Create report packages
Link data
Generate risk assessments
WuXi AppTec’s testing program process is easy and e�cient…
CONSULT
Discuss project needs
Gain understanding of the product
Draft study designsand protocols
Perform tests per customized program
Communicate progress
Flag key results
Getting your device through development to the
clinic is demanding. The number of challenges
you face continues to grow and the regulatory
bodies continue to raise the bar.
challengesDeveloping validation plans
Designing testing plans
Integrating data
Submitting cohesive packages
Meeting aggressive milestones
Managing validation control programs
WuXi AppTec’s comprehensive testing programs and expert guidance help speed devices and
combination products to market. Our industry-recognized experts o�er manufacturers the
support they need to make smart development and regulatory testing decisions – from product
concept through commercial release. And our wide menu of R&D, GLP- and GMP-compliant
testing programs can be tailored to suit particular needs at every stage of product development.
expert guidance and comprehensive testing
Materials Selection & Evaluation
Product E�cacy & Materials Performance
Materials Characterization
Risk Assessment
Biocompatibility
Toxicology
Sterilization / Inactivation Validation
Package Integrity Validation
Raw Material Veri�cation
Lot Release Testing
DEVELOPMENT REGULATORY SUBMISSION LOT RELEASE
MATERIALS SELECTION & EVALUATIONWuXi AppTec provides screening assays
– from basic chemical analysis to in-vitro
models – to provide preliminary data
estimating the safety and e�cacy of
your product.
PRODUCT EFFICACY &MATERIALS PERFORMANCEAdvanced surgical skills are used
in innovative testing programs, as
well as established antimicrobial and
orthobiologic e�cacy and wound
healing studies.
MATERIALS CHARACTERIZATIONQuantitative analytical methods can be
tailored to determine the extractable
and leachable compounds present in
your product, supporting R&D and
submission e�orts.
RISK ASSESSMENTHighly experienced sta� toxicologists
will help you interpret and link your
in-vitro and in-vivo biocompatibility
assays and chemistry testing to ensure
the clearest interpretation of biological
safety.
BIOCOMPATIBILITYA comprehensive menu of in-vitro,
in-vivo, and genotoxicology testing
services includes all the tests related to
the ISO/FDA test modalities frequently
used to study the biological safety and
biocompatibility of devices and
combination products, as well as tests
that may be required for Japanese
(MHLW) submissions and other
regulatory submissions worldwide.
TOXICOLOGYOur toxicology programs are specially
developed to accurately assess the
toxicological questions presented by
medical devices and combination
products. Specialized dose regimens
are available, including surgical
implantation in a variety of species.
STERILITY ASSURANCEWuXi AppTec scientists can help prove
the e�cacy and strength of your
product and process, including: clean
room design and validation; process
validations for cleaning your product
and your environment; microbiology
and endotoxin programs; sterilization
validations; and package testing.
PACKAGE INTEGRITY VALIDATIONOur ISTA-certi�ed laboratory provides an
array of services to test your packaging,
including package/seal integrity,
accelerated aging, simulated
distribution, and shelf life/stability.
RAW MATERIAL VERIFICATIONAnalytical methods – including
elemental analysis through ICP, FTIR
�ngerprinting, and liquid or gas chroma-
tography – can be used to screen the
materials coming into your processes, as
well as provide critical characterization
data for your regulatory submissions.
LOT RELEASE TESTINGA full range of lot release testing services
– from bacteriostasis/fungistasis to
sterility and endotoxin testing – is
available to provide reassurance and
proof that your processes are reliable
and sound.
R&D, GLP- andGMP-compliant
testing programs
expert guidanceNavigating through complex testing options can be daunting. Knowing which choices to make and what the regulatory bodies expect can mean the di�erence between staying on course for product development or having to re-route and re-do testing.
Trust the experts at WuXi AppTec to guide you in the most appropriate testing programs throughout your entire product development process, from research to proof-of-concept to commercial launch.
At WuXi AppTec, we take pride in our deep
understanding of the global regulatory
environment. Many of our scientists actively
participate in the committees/working groups
that devise the guidances used by regulatory
bodies. That means the expertise we provide
incorporates the most up-to-date requirements
and regulations.
WuXi AppTec has worked with clients making
successful submissions to regulatory bodies
around the world.
Integrated Services
• Programs for every life-cycle stage
• Comprehensive testing options
• Smart study designs
• Centralized program management
know what
the regulatory
bodies expect
Industry Experience
• Over 20 years of experience
• In-vitro, in-vivo and chemistry expertise
• Long history of working in small molecule, biologics, and medical device industries
• Global presence
Services for Combination Products
The testing needs for combination products
are unique, and WuXi AppTec is unmatched
in our ability to o�er clients an alignment
of expertise that comes from our many
years of providing superior testing and
manufacturing services for medical devices,
tissue products, cellular therapeutics,
biologics, and traditional pharmaceuticals.
Our broad range of high-quality testing
options includes advanced programs
in safety, claims, e�cacy, and lot release.
Safety Testing Capabilities
Biocompatibility
Toxicology
Materials evaluation
Materials characterizartion
Stability storage &analytical testing
Sterilization validation
Microbial contamination
Packaging integrity
Pathologic tissue analysis
Identification & quantitationof agent distribution
E�cacy Testing Capabilities
Model development
Device / drug infection models
Device-delivered drug response
Device-delivered nanoparticle
Collagen bioabsorption
Efficacy of a device-delivereddrug (insulin, antibacterial)
Bone defect
Spinal fusion
Chronic inflammation reaction
Biodistribution
ST. PAUL2540 Executive Drive
St. Paul, MN 55120
651.675.2000
ATLANTA1265 Kennestone Circle
Marietta, GA 30066
770.514.0262
PHILADELPHIA4751 League Island Blvd.
Philadelphia, PA 19112
215.218.5500
www.wuxiapptec.com • [email protected]
PS802-13-02.01.15
services formedical devices
Specialized programs are o�ered for all types of devices and combination products. Our extensive experience includes providing comprehensive services in numerous product areas, including:
PRODUCT EXPERIENCEEXPERTISE
Device & Drug / Biologic / Tissue Combinations
Permanent Implants
Single-Use and Reusable Devices
Hemostasis / Wound Healing
Orthopedic Devices
Cardiovascular Devices
Laparoscopic / Endoscopic Devices
Neurostimulation Devices
Surgical Devices
Dental Devices
WuXi AppTec’s many years of experience in applying testing schemes to medical devices – including innovative and complex products – has made us a leader in the �eld. In recognition of our expertise, WuXi AppTec scientists actively participate in and advise regulatory groups responsible for the testing guidances.
We understand fully how important it is to select the right testing scheme – from the very beginning of product development – and we work with your design team to help ensure successful regulatory submission.
WuXi AppTec’s approach is tailored to �t your needs as well as evolving regulatory requirements for completely integrated programs. No matter your type of product, our services will help you at every step – from concept to commercialization.