Testing and

expertise from

concept to

commercialization

services for medical devices

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 • info@wuxiapptec.com

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.