Pulse of the Medical Devices Market Report
Literature Review Automation Adoption Insights and TrendsFindings indicate that organizations who have invested in literature review software platforms are significantly more confident in their ability to meet regulatory requirements compared to those relying on manual spreadsheet-based processes. We also observed a shift in evidence management practices to leverage data reuse within an organization to reduce redundant work.
I hope this report provides you with valuable insights into the importance of investing in new technology and automation to streamline evidence management practices.
Peter O’Blenis
CEO, DistillerSR
Executive Summary
01
Literature Review Software Users Are Two Times More Confident in Their Regulatory Submissions
Sixty-six percent of the respondents who invested in a literature review software platform are more confident that their regulatory submissions will be approved versus 38% of the respondents who are currently using spreadsheets and conducting literature reviews manually. Ensuring timely and compliant regulatory submissions remains a challenge for global medical device companies. Rejected submissions result in unforeseen costs and negatively impact planned product launches and device availability.
02
Seventy-three percent of Literature Review Software Adopters Trust the Quality of Their Data
Almost three quarters of the respondents using literature review software platforms are confident in the quality of their literature reviews while only thirty-seven percent of the ones still using spreadsheets trust the quality of their data. Manual literature reviews are time consuming, error-prone and resource intensive. These errors lead to omitted references, mistakes, and regulatory submissions likely to raise red flags with notified bodies.
03
Literature Review Software Adoption Is Enabling Real-time Data Traceability for Sixty Percent of the Respondents
Over 60% of the survey respondents who adopted a software platform trust their ability to track literature reviews in real-time and the traceability of included and excluded references versus only 4% of respondents who use spreadsheets. Data traceability throughout literature reviews results in audit-ready, compliant regulatory submissions and effective project management practices.
04
Manufacturers Are Integrating Literature Reviews Throughout the Medical Device Development Lifecycle
Literature reviews bring together research and literature related to a particular topic or subject. Different types of literature reviews can be used throughout the medical device lifecycle, from ideation through post-market surveillance. They are time consuming, labor intensive and complex but the outcome is a source of truth that is reliable, trustworthy and serves as the cornerstone of policies and regulations that ensure the safety of medical devices. All respondents are utilizing literature reviews through different stages of the device lifecycle: to inform product development deliverables and market access policies, and to comply post-market surveillance regulatory requirements.
05
Continuous Data Collection is Driving Efficient Evidence Management for Sixty-four Percent of Literature Review Software Users
Sixty-four percent of the respondents who have implemented a literature review software solution are continuously collecting and analyzing evidence compared to thirty-five percent of spreadsheet users. Systematic and proactive evidence monitoring is critical to complying with rigorous post-market surveillance regulatory requirements.
06
Data Reuse Is Reducing Redundant Work for Half of Literature Review Software Adopters
Over half of the respondents who have adopted a literature review software are employing data reuse to reduce redundant work and accelerate completion rates versus only thirty-eight percent of spreadsheet users. For research professionals, the burden of searching and analyzing growing volumes of scientific literature is compounded by the time-consuming effort of repeatedly collecting data from the same references across multiple projects. Leveraging an integrated data warehouse for evidence management will benefit an entire organization and result in cost savings, improved productivity and efficient processes.
07
Regulatory Compliance is the Main Driver for Literature Review Software
Adoption
Implementing a single source of truth such as a cloud-based software solution enables data audit-ability and timely regulatory submissions, streamlining compliance. Over half all respondents chose regulatory compliance followed by improved literature review quality as the top motivators for adopting a literature review software platform.
08
Cost Remains the Top Barrier for Software Adoption
People, processes and technology are the three most important components of a successful organizational transformation. Adopting a new technology is not easy, especially for manufacturers already chasing the clock to comply with regulatory timelines. Cost was mentioned by over half of all respondents as the main barrier to adopt a literature review software platform.
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Introduction
What You’ll Find in This Report This inaugural edition of the Pulse of the Medical Device Market Report is based on the findings from an industry survey conducted by DistillerSR in partnership with Citeline and on observations from various customer touch points and interviews conducted throughout 2022 to explore how literature review automation and software adoption impact:
- Confidence in regulatory submissions and faster path to compliance
- Literature review data quality
- Continuous and efficient evidence management practices
- Standardized and repeatable organizational processes
Market Survey Overview
Methodology
The market study referenced in this report was conducted by Citeline, on behalf of DistillerSR, surveying the medical device and in-vitro diagnostic industry throughout September 2022 and generated 146 responses from global professionals. The purpose of the study was to understand overall organizational preparedness, literature review management maturity, as well as barriers and motivators to adopt automation and implement literature review software solutions.
146 respondents from medical devices and IVD industry
Key Findings
Part 1: Literature Review Software Adoption is Driving Confident Regulatory Submissions, Trust in the Quality of Data and Standard Evidence Management Practices
66% of literature review software platform adopters are confident in their regulatory submissions.
73% of literature review software platform adopters trust the quality of their literature review data.
Over half of all respondents are implementing standard evidence management practices.
Literature Reviews Are Used From Product Ideation Through Post-Market Surveillance
- Product Development 60%
- Clinical Evaluation Reports 41%
- Health economics and outcome research 39%
- Competitive market intelligence 37%
- Post-market surveillance 37%
- Market research 35%
- Submissions to other jurisdictional regulatory authorities (FDA, China, Japan, Canada, etc.) 30%
%
Integrate literature reviews early in the medical device lifecycle
Spreadsheet Users Struggle to Manage Literature Reviews Lifecycle and Are Less Confident in Their Regulatory Submissions
- Are confident that their regulatory submissions will not be rejected 38%
- Trust the quality of their literature reviews 37%
- Are able to track their literature reviews in real-time 35%
- Trust the traceability of inclusions/exclusions 45%
- Are continuously collecting and analyzing literature review evidence 35%
- Are employing data reuse to reduce redundant work 38%
%
Are confident in their regulatory submissions
Literature Review Software Adopters Are More Confident in Their Regulatory Submissions
- Respondents using literature review software 66%
- Respondents using spreadsheets 38%
%
Are confident in their regulatory submissions
Literature Review Software Automates and Manages the Entire Literature Review Lifecycle = Greater Confidence in Data Quality
- Respondents using literature review software who are confident in the quality of their literature reviews 73%
- Respondents using spreadsheets who are confident in the quality of their literature reviews 37%
2x
more confident in the quality of their literature review data
Literature Review Software Adopters Are Implementing Standard Evidence Management Practices
- Trust the quality of their literature reviews 73%
- Are confident that their regulatory submissions will not be rejected 66%
- Are able to track their literature reviews in real-time 65%
- Trust the traceability of inclusions/exclusions 62%
- Are continuously collecting and analyzing literature review evidence 64%
- Are employing data reuse to reduce redundant work 51%
Are employing cross-functional evidence management practices
Automated Evidence Management Lowers Product Development Costs and Manages Enterprise-wide Research Consortia
| Challenges with Research Data | Business Problem | Business Impact | Automated Evidence Management | ||
|---|---|---|---|---|---|
| Multiple Systems | Centralizing all data to support a medical device from pre-market approval through post-market surveillance is difficult to achieve. | Repeat Questions from Notified Bodies | Regulatory Delays | Costly Management of Evidence | Quickly identify previously reviewed, screened, and appraised data |
| Massive Volume | Misalignment of Evidence and Outcomes | Duplicated work between departments | Inconsistent results between departments | Continuously updated to keep up with latest evidence | |
| Inconsistent Structure | Misalignment of efforts and failture to leverage research data that may be ongoing in other deparments. | Lengthy Reimbursement Profitability | Save time and effort in regulatory compliance process | ||
| Fragmented Management | Lack of Data Traceability | Inadequate Payer Support Pricing | Compromised Data Integrity | Evidence database that can be reused for medical devices with similar intended purpose | |
How? By Creating a Dynamic Knowledge Center to Continuously Manage Evidence-Based Data
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Part 2: Literature Review Software Adoption is Tied to Enterprise-Grade Security, Cost, and Integration with Internal Tools
Top Barriers: Literature Review Software
- Cost
- Ease of use
- Lack of security controls and compliance with IT requirements
- Lack of integration with internal tools
- Lack of support with upper management
Top Barriers: Spreadsheet Users
- Lack of security controls and compliance with
IT requirements - Cost
- Lack of integration with internal tools
- Ease of use
- Lack of appropriate skills
Cost, Ease of Use, and Integration with Internal Tools Are the Top Literature Review Software Adoption Barriers
| 0 | #1 | #2 | #3 | #4 |
|---|---|---|---|---|
| Cost | 32% | 12% | 10% | 54% |
| Ease of Use | 14% | 10% | 13% | 37% |
| Lack of software integration with other internal | 10% | 9% | 10% | 29% |
| Lack of security controls and compliance | 9% | 8% | 10% | 27% |
| Lack of appropriate skills | 8% | 15% | 10% | 33% |
| Organizational structure, corporate culture or | 7% | 8% | 10% | 25% |
| Lack of certainty about return on investment | 6% | 12% | 11% | 29% |
| Lack of support from upper management or | 6% | 9% | 8% | 23% |
| Organization and processes are too siloed and | 5% | 9% | 10% | 24% |
| My organization has not purchases or | 3% | 10% | 9% | 22% |
| 1st | 2nd | 3rd |
Barriers for Enterprise-Wide Literature Review Software Adoption Suggest a Desire for Greater Platform Integration
- Lack of security controls and compliance with internal IT requirements 19%
- Cost 17%
- Lack of integrations with other internal tools 17%
- Ease of use 11%
- Lack of appropriate skills 11%
%
of respondents using literature review platform mentioned lack of security controls and compliance with internal IT requirements as the top barriers for adoption
Spreadsheet Users Considering Literature Review Software Should Ensure Enterprise-wide Integration and Proven ROI
- Cost 50%
- Ease of use 20%
- Lack of support from upper management/C-suite 11%
- Uncertainty about return on investment (ROI) 8%
- Organizations and processes are too siloed and complex for standard software 8%
%
of respondents using spreadsheets mentioned cost as the top barrier for literature review platform adoption
Regulatory Compliance, Better Project Management, and Improved Quality of Data Are the Main Literature Review Software Adoption Drivers
| 0 | #1 | #2 | #3 | #4 |
|---|---|---|---|---|
| Regulatory compliance | 19% | 18% | 14% | 51% |
| Better project management | 17% | 10% | 17% | 44% |
| Better review quality | 16% | 23% | 17% | 56% |
| Reduced Costs | 15% | 10% | 9% | 34% |
| Improved reviewer productivity | 11% | 11% | 11% | 33% |
| Faster literature review completion rate | 10% | 10% | 17% | 37% |
| Reduced submission risk | 7% | 9% | 8% | 24% |
| Monitor market/competitive intelligence | 4% | 9% | 7% | 20% |
| 1st | 2nd | 3rd |
No Surprise: Productivity and Cost Reduction Are the Main Business Motivators for Enterprise Users
- Reduced costs 22%
- Better literature review quality 20%
- Better project management 20%
- Regulatory compliance 16%
- Faster literature review completion rate 9%
Spreadsheet Users Are Early in the Adoption Curve: Regulatory Risks Largely Shape Adoption Motivation
- Improved reviewer productivity 19%
- Regulatory compliance 15%
- Reduced submission risk 15%
- Better review quality 15%
- Better project management 15%
Part 3: Budgets and Training Funding for Literature Review Software Adoption Will Remain Steady for the Next 12 Months
62% of all respondents expect literature review software management budget to increase.
41% of all respondents have standard evidence management practices in place.
56% of all respondents are investing in training.
Literature Review Management Budgets Are Generally Expected to Increase in the Next 12 Months
- Will increase a lot 11%
- Will increase moderately 51%
- Stay the same 36%
- Will decrease 1%
%
Expect a budget increase
Budget Consideration: Expand Centers of Excellence and Standard Evidence Management Practices Enterprise Wide
- Yes, there is a center of excellence and/or standard corporate practices for the application and evaluation of literature 41%
- Yes, but it’s all managed at the business unit or group level and not corporately 34%
- No, but we are planning to implement these in the next 12 months 13%
- Not something our organization currently does 7%
- No, we outsource literature reviews to trusted third-party vendors (e.g. Contract Research Organizations – CROs) 5%
%
Of organizations surveyed have a center of excellence for literature review evaluation
Budget Consideration: Expand Training Investment with Standard Evidence Management Practices
- Almost Always 15%
- Often 41%
- Sometimes 30%
- Seldom 11%
- Never 3%
%
Respondents report that training for new software tools will be a priority over the next 12 months
Prioritize Budget for Analytics Readiness: Respondents Expect Literature Review Software to Integrate with at Least One Existing Application
- Statistical software packages (e.g. SPSS, SAS, etc.) 40%
- Business intelligence dashboards or visualization (e.g. IBM, Cognos) 37%
- Data warehouse (e.g. a centralized management for literature reviews) 37%
- Reference management (e.g. EndNote) 36%
- Artificial Intelligence (e.g. standalone or bundled with different vendors) 25%
%
Expect a literature review software to integrate with statistical software packages
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Customer Spotlights
Spotlight on Philips
Philips Achieves Faster, More Accurate Literature Reviews for CER Submissions with DistillerSR
Faster, More Accurate Screening
The clinical evaluation team at Philips cut down title and abstract screening by 74%, full text screening by 70%, and flowcharts/diagrams creation by 50%.
Consistent, Auditable CER Submissions
More Time to Focus on Research
Since implementing DistillerSR, Philips reported gaining 3 extra days per literature review to focus on research, rather than the mentally-burdensome task of shifting through references.
Read the full case study
Spotlight on Geistlich
Geistlich Pharma Completes Literature Review Screening 85% Faster Than Manual Methods Using DistillerSR
Audit-Ready CER Submissions
Faster Literature Review Screening
AI-powered screening prioritized relevant references and dramatically decreased title & abstract screening time by 85% from nearly 4 minutes to 35 seconds per reference when compared to manual processes.
Repeatable, Configurable Processes
DistillerSR’s configurable platform generated custom templates and reusable forms, creating a reproducible literature review management process that can be replicated across a large medical device portfolio.
Read the full case study
Spotlight on NuVasive
NuVasive Streamlined Literature Reviews for More Efficient CER Submissions with DistillerSR
Consistent, Repeatable Processes
Audit-Ready CER Submissions
Always Available Data Company Wide
Read the full case study
Spotlight on Global Eye Care Device Manufacturer
DistillerSR Enables Sixfold Increase in Literature Review Completion
Faster, More Efficient Screening
Before DistillerSR, the clinical evaluations team completed 15 literature reviews every year. Since implementing the platform, with a modest increase in headcount, they have completed 100 reviews annually.
Consistent, Audit-Ready CER Submissions
Cost Savings and Decreased Chance for Errors
Read the full case study
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Appendix: Survey Demographics
Country
| Africa | 29% |
| Asia Pacific | 35% |
| Africa | 29% |
| Central America & Caribbean | 31% |
| Europe | 71% |
| Middle East | 34% |
| North America | 66% |
| South America | 29% |
Organizational Function
| Clinical and/or Evidence-Based Research | 32% |
| Product and Engineering | 29% |
| Quality Assurance | 16% |
| Health Economics | 10% |
| Regulatory Affairs | 8% |
| Market Access | 3% |
Purchasing Role
| Authorize expenditures | 17% |
| Recommend or select products to purchase | 38% |
| Qualify vendors’ products bids/proposals | 14% |
| Influence purchasing decisions | 23% |
| None of the above | 8% |
Organization Size
| Under 1,000 | 32% |
| 1,000 – 4,999 | 21% |
| 5,000 – 9,999 | 16% |
| 10,000 – 49,999 | 12% |
| 50,000 or more | 20% |
Seniority
| Senior executive responsible for clinical evidence and/or regulatory affairs | 20% |
| Literature review and clinical evidence program manager | 21% |
| Individual practitioner responsible for conducting literature reviews | 28% |
| Functional unit area supervisor reporting to the most senior executive | 32% |
Medical Device Segment
| Immunology | 33% |
| Cardiovascular | 29% |
| Diabetes Care | 23% |
| Neurological | 23% |
| Gastroenterology | 20% |
| Gynecological | 19% |
| Orthopedic | 19% |
| Hematology | 18% |
| Diagnostic Imaging | 18% |
Demographics
The sample included manufacturers operating across all regions of the globe but predominantly in Europe and North America.
Organization Size
Small organizations (under 1,000 employees) account for a third (32%) of the sample, while organizations (50,000+ employees) account for a fifth (20%).
| Under 1,000 | 32% |
|---|---|
| 1,000 - 4,999 | 21% |
| 5,000 - 9,999 | 16% |
| 10,000 - 49,999 | 12% |
| 50,000 or more | 20% |
%
Under 1,000 has the highest employee representation
Organization Function
A variety of organization functions are represented in the sample, most commonly Clinical and/or Evidence-Based Research (32%) and Product and Engineering (29%).
- Clinical and/or Evidence-Based Research 32%
- Product and Engineering 29%
- Quality Assurance 16%
- Health Economics 10%
- Regulatory Affairs 8%
- Market Access 3%
%
Clinical and/or Evidence-Based Research
Level of Seniority
Functional unit area supervisors account for just under a third (32%) of the sample, followed by individual practitioners (28%).
| Senior executive responsible for clinical evidence and/or regulatory affairs (e.g. Chief Medical Officer, SVP Quality Assurance, EVP Regulatory Affairs) | 20% |
|---|---|
| Literature review and clinical evidence program manager (e.g. Group Principal or Manager, Head of Scientific Communications) | 21% |
| Individual practitioner responsible for conducting literature reviews (e.g. Medical writer, Scientific Communications) | 28% |
| Functional unit area supervisor reporting to the most senior executive (e.g. VP, Director) | 32% |
%
Individual practitioner conducting literature reviews
Purchasing Role
Purchase recommenders/selectors account for over a third (38%) of the sample, while authorizers account for just under a fifth (17%).
| Authorize expenditures | 17% |
|---|---|
| Recommend or select products to purchase | 38% |
| Qualify vendors' products bids/proposals | 14% |
| Influence purchasing decisions | 23% |
| None of the above | 8% |
%
Recommend or select products to purchase
Medical Device Segment
A variety of medical device segment areas are represented in the sample, most commonly Immunology (33%) and Cardiovascular (29%).
- Immunology 33%
- Cardiovascular 29%
- Diabetes Care 23%
- Neurological 23%
- Gastroenterology 23%
- Gynecological 19%
- Orthopedic 19%
- Hematology 18%
- Diagnostic Imaging 18%
- General surgery 17%
- Urology 17%
- Ophthalmic 15%
- Dental 14%
- Radiology 14%
- Nephrology 13%
- IVD 13%
- Wound 12%
- MIS 8%
- Other 13%
%