technology & product experience - rcri€¦ · technology & product experience •ablation...
TRANSCRIPT
Expert advisors. Exact practices.
O V E R V I E W
Regulatory and ClinicalResearch Institute, Inc.
technology & product experience• ablation products• bioelectric devices• biologic devices• combination products• critical care• device delivery systems• dental implants• dermal fillers• imaging technologies• implantable devices• IVD• IVF products• wound healing: meshes/fabrics• neurostimulators• neurovascular devices• orthopedic/spine implants• pacing leads• peripheral vascular devices• pulmonary products• stents• surgical instruments• surgical technologies• tissue adhesives & sealants• urinary incontinence bulking agents
therapeutic area experience• cardiology/ cardiovascular disease• chronic disease• CNS/PNS• dental/oral health• dermatology• diabetes• ENT• genetic disease• gastroenterology• hematology• nephrology• neurology• nutrition and weight loss• obstetrics/gynecology• oncology• ophthalmology• orthopedics• pain management• pulmonology/respiration• urology• trauma• wound healing
Expert.
Exact.
Effective.
5353 Wayzata Blvd. ■ Suite 505 Minneapolis, MN 55416
(1) 952-746-8080
rcri-inc.com
MS101.050418
Our consultants are among the most experienced in the industry.
With advisors in a variety of disciplines, we help you achieve your product
Expert advisors. Exact practices.
Are you asking the right questions?Be sure your strategies work to align your evidence development plans with your product goals.
The device life cycle is interconnected.
Why aren’t your strategies?
good technology in today’s environment. Compelling
strategies to get the most from each step in the development process. And – as evidence is gathered – it should be used to inform and iterate regulatory, reimbursement, and clinical and post-market strategies.
Design & Development
Evidence Development
Funding
Regulatory Submission
Market Development
Obsolescence
ASSESS STRATEGIZE EXECUTEDevelop & evaluate evidence
Determine plan &
those goals
Define product & its
set business goals
Audits • Risk Management
QualitySystems
• Device Claims Development • Labeling • Design Control • Regulatory Submissions: RegulatoryAffairs
• Strategic Reimbursement Assessments • Strategic Planning • Clinical Study Design
• Health Economics Tool Development • Study Budgets • Reimbursement for Medical Devices • Medical Coding • Payer Insights and Payer Mix Analysis • Pricing Strategies
Health Economics &
Reimbursement
• Clinical • Product • Regulatory • Evidence Development Plans • Medical Device
and Management • Transparency Requirements • Business Compliance Infrastructure
Device Consulting
• Site Monitoring Services • Database Development & Management • Data Management
Management • Data Safety Monitoring Board (DSMB) Management • Clinical Events
ClinicalSciences
Our consultants are among the most experienced in the industry.
With advisors in a variety of disciplines, we help you achieve your product
Expert advisors. Exact practices.
Are you asking the right questions?Be sure your strategies work to align your evidence development plans with your product goals.
The device life cycle is interconnected.
Why aren’t your strategies?
good technology in today’s environment. Compelling
strategies to get the most from each step in the development process. And – as evidence is gathered – it should be used to inform and iterate regulatory, reimbursement, and clinical and post-market strategies.
Design & Development
Evidence Development
Funding
Regulatory Submission
Market Development
Obsolescence
ASSESS STRATEGIZE EXECUTEDevelop & evaluate evidence
Determine plan &
those goals
Define product & its
set business goals
Audits • Risk Management
QualitySystems
• Device Claims Development • Labeling • Design Control • Regulatory Submissions: RegulatoryAffairs
• Strategic Reimbursement Assessments • Strategic Planning • Clinical Study Design
• Health Economics Tool Development • Study Budgets • Reimbursement for Medical Devices • Medical Coding • Payer Insights and Payer Mix Analysis • Pricing Strategies
Health Economics &
Reimbursement
• Clinical • Product • Regulatory • Evidence Development Plans • Medical Device
and Management • Transparency Requirements • Business Compliance Infrastructure
Device Consulting
• Site Monitoring Services • Database Development & Management • Data Management
Management • Data Safety Monitoring Board (DSMB) Management • Clinical Events
ClinicalSciences
Expert advisors. Exact practices.
O V E R V I E W
Regulatory and ClinicalResearch Institute, Inc.
technology & product experience• ablation products• bioelectric devices• biologic devices• combination products• critical care• device delivery systems• dental implants• dermal fillers• imaging technologies• implantable devices• IVD• IVF products• wound healing: meshes/fabrics• neurostimulators• neurovascular devices• orthopedic/spine implants• pacing leads• peripheral vascular devices• pulmonary products• stents• surgical instruments• surgical technologies• tissue adhesives & sealants• urinary incontinence bulking agents
therapeutic area experience• cardiology/ cardiovascular disease• chronic disease• CNS/PNS• dental/oral health• dermatology• diabetes• ENT• genetic disease• gastroenterology• hematology• nephrology• neurology• nutrition and weight loss• obstetrics/gynecology• oncology• ophthalmology• orthopedics• pain management• pulmonology/respiration• urology• trauma• wound healing
Expert.
Exact.
Effective.
5353 Wayzata Blvd. ■ Suite 505 Minneapolis, MN 55416
(1) 952-746-8080
rcri-inc.com
MS101.050418