Best Practices in Postmarketing Surveillance and Complaint Resolution Management at Medical Device Firms

Industries Profiled:
Health Care; Pharmaceutical; Diagnostic; Medical Device; Biotech


Companies Profiled:
Abbott; Accelerate Diagnostics; Alcon; AstraZeneca; Avedro; Baxter Healthcare; Beckman Coulter; Boston Scientific; C. R. Bard; Edwards Lifesciences; ICU Medical; Marian; Medtronic; MicroPort; MID Labs; Needle Tech Products; Ortho-Clinical Diagnostics; PerkinElmer; Stryker; Zimmer Biomet

• Complaint Sources and Reception
• Complaint Triage
• Complaint Workflow
• Complaint Follow-Up
• Complaint Identification and Analysis
• Complaint Recording
• Complaint Timing
• Compliance Levels
• Outsourcing, Training and Development
• Quality Financial Resources and Staffing

• Complaints are primarily received by email and phone calls and are generally about device malfunctions.
• The number of open complaints at any given time is around 5100 while companies receive 4400/month indicating the number of open complaints is growing. This problem will only continue with more rigorous reporting requirements from the FDA. Companies must be more efficient in closing complaints to combat the rising numbers.

• Medical safety reviews are conducted before MDR submission in most cases, and are performed in cases of death, serious injury, and potential for harm. Medical review teams vary significantly from company to company from teams of only Doctors, Nurses or other staff, to mixed teams containing all three groups.
• Respondents investigate ~75% of all complaints.

I.	Executive Summary	pgs. 3-9
	Research Overview	pg. 4
	Respondents Background	pg. 5
	Key Insights	pgs. 6-7
	Study Segmentation	pg. 8
II.	Group Structure, Roles and Responsibilities	pgs. 9-14
III.	Adverse Events and Complaint Sources / Reception	pgs. 15-21
IV.	Complaint Triage	pgs. 22-28
V.	Complaint Workflow	pgs. 29-38
VI.	Complaint Follow-Up	pgs. 39-42
VII.	Complaint Identification and Analysis	pgs. 43-47
VIII.	Complaint Reporting	pgs. 48-50
IX.	Complaint Timing	pgs. 51-54
X.	Compliance Levels	pgs. 55-58
XI.	Outsourcing, Training and Development	pgs. 59-65
XII.	Quality Financial Resourcing and Staffing	pgs. 66-69
XIII.	Business Demographics	pgs. 70-72
XIV.	About Best Practices, LLC	pg. 73

• Structure employed for managing complaints within participating organizations – total benchmark class and large companies vs. small to mid-sized companies
• Groups having primary leadership role and support role for listed complaint management activities
• Interview narratives on harmonization of complaint systems across business units/therapy areas
• Interview narratives on creating standard SOPs for more efficient integration of new business units into the complaint system

• Sources from which benchmark companies received product-specific quality complaints in the past 90 days
• Whether benchmark partners proactively mine social media (Facebook, Twitter etc.) for complaints?
• Social media resources mined by benchmark partners
• Classification of complaints regarding medical devices
• Total complaint volume: Average number of complaints received by benchmark companies from all channels
• Number of open customer complaints processed by participants at any given time
• Number of open complaint investigations processed by benchmark partners at any given time

• Functional responsibility of listed facets of complaint resolution process – total benchmark class and large companies vs. small to mid-sized companies
• Automation of complaint resolution process – total benchmark class and large companies vs. small to mid-sized companies
• Automated facets in complaint resolution process
• Interview narratives on automation of complaint resolution process

• Employee groups responsible for assessing complaints
• Timing of medical review - before or after MDR submission
• Types of medical safety review – total benchmark class and large companies vs. small to mid-sized companies
• Number of doctors and nurses comprising the medical safety review team
• Medical reviews conducted by doctors or nurses – total benchmark class and large companies vs. small to mid-sized companies
• Percentage of complaints investigated versus percentage of complaints not investigated but justified using documented rationale such as a white paper or engineering study (known issue)
• Whether medical team actively updates the risk file based on reviews?

• Percentage of follow-up activities for medical device complaints conducted via e-mails, telephone/ call center and other mediums
• Percentage of follow-ups conducted by medical professionals
• Methodology used to investigate single incidents
• Methods used to combine/group complaints into common issues for later investigation

• Reporting of regulatory/MDR/MDV complaints from the diverse sources
• Complaint closure time and reporting time frame

• Major impacts identified as a result of the new EU 15-day reporting time frame
• Lifecycles monitored by benchmark partners and the acceptable cycle times
• Frequency of monitoring the cycle times

• Compliance level (in percentage) attached to the internal process performance target or goals
• Whether action taken on complaints having a lengthy cycle time, even if the company has reached acceptable compliance levels?
• Frequency of sharing metrics with management at management reviews

• Most common activities contracted out to third-party vendors
• Department responsible for adverse event training
• Adverse events training methods
• Measuring the effectiveness of training – total benchmark class and large companies vs. small to mid-sized companies
• Effective tactics and approaches for using the complaints process to generate business improvements

• Estimated total spend of the Quality function in 2016 for medical devices and related services
• Percentage of total Quality (GCP, GLP, GMP, GxP) function budget and FTEs (full-time equivalent employees) allocated to critical Quality channels
• Role of Quality function in funding and managing listed nonconforming activities
• Total number of FTEs engaged in medical device operations/businesses in 2016