Rimsys+2023年医疗技术监管绩效报告-17页-WN9.pdf

2023Medtech RegulatoryPerformance Report群内每日免费分享5份+最新资料 群内每日免费分享5份+最新资料 300T网盘资源+4040万份行业报告为您的创业、职场、商业、投资、亲子、网赚、艺术、健身、心理、个人成长 全面赋能！添加微信，备注“入群”立刻免费领取 立刻免费领取 200套知识地图+最新研报收钱文案、增长黑客、产品运营、品牌企划、营销战略、办公软件、会计财务、广告设计、摄影修图、视频剪辑、直播带货、电商运营、投资理财、汽车房产、餐饮烹饪、职场经验、演讲口才、风水命理、心理思维、恋爱情趣、美妆护肤、健身瘦身、格斗搏击、漫画手绘、声乐训练、自媒体打造、效率软件工具、游戏影音扫码先加好友，以备不时之需扫码先加好友，以备不时之需行业报告/思维导图/电子书/资讯情报行业报告/思维导图/电子书/资讯情报致终身学习者社群致终身学习者社群关注公众号获取更多资料关注公众号获取更多资料Table of ContentsIntroductionWhy a performance study?What did we find?Survey Approach and Respondent Demographics Product profileRegulatory Team Size and StafngFilling the gap with consultantsFuture stafng expectationsRegulatory Activities and PerformanceA strong self-assessmentRegulatory workloadProcess inefcienciesNon-complianceTechnology AdoptionUneven productivity gainsImplications and RecommendationsRecommendations and next stepsP.3P.3P.3P.4P.5P.6P.7P.8P.9P.9P.10P.10P.12P.14P.15P.16P.162023 Medtech Regulatory Performance Report Insights and process benchmarks from 200 medtech regulatory professionals.IntroductionWelcome to the inaugural Medtech regulatory performance report.This ebook explores key findings from a new survey of 200 regulatory professionals across the medical technology industry including medical devices,in vitro diagnostics,software as a medical device,and combination products.Why a performance study?This report is intended to be a usable reference for medtech regulatory organizations,meaning that it should provide truly helpful information that organizations can use to assess the efectiveness of their teams and processes.While numerous studies explore the state of the regulatory profession,or areas of specific technology adoption,fundamental questions remain unanswered.What does it mean to work efciently?What is the right level of resources for a regulatory afairs team?How long should it take to complete a registration or license renewal?Is my organization ahead or behind?This study tries to address these questions by looking at the specific performance of regulatory teams and processes in the medtech industry.It covers team setup and size,common regulatory activities,issues and compliance,and,yes,technology.Beyond adoption,it looks to the impact of technology on productivity and performance,helping teams see the real outcomes associated with their investments.What did we find?Medtech regulatory teams are often understafed relative to their workload.22%of enterprise companies(with revenue greater than$500 million)have 15 or fewer regulatory employees.38%of front line RA employees feel under-resourced.Resourcing decisions and headcount are rarely allocated based on planned workload.Consultants are(over-)used to make up the gaps.Regulatory teams(especially leadership)self-assess their capabilities and performance highly.A majority believe that they outperform their peers in both planning and execution.Yet over 60%reported a major non-compliance issue/incident in the past 2 years.Theres clearly a disconnect between perceived and actual performance.Technology can make a diference,but not all tools add value.64%of companies that specifically invest in regulatory information management report significant productivity gains,and all complete projects more quickly.P.3Survey Approach and Respondent DemographicsData in this study was collected through phone interviews with 200 regulatory professionals at medical technology companies across North America and Europe.Respondents represented companies headquartered in 14 diferent countries,with annual revenue ranging from$10 Million to more than$5 Billion.Respondents varied in seniority from front-line professionals(individual contributors and managers),executives(VP and Director-level),and C-Suite leadership.Respondents work in multiple departments within their companies including Regulatory Afairs,Quality Assurance,Information Technology,and Operations.Why not focus exclusively on Regulatory Afairs departments?Not all companies have dedicated regulatory departments(the function is often bundled with quality),and members of other teams often spend a significant amount of their time on regulatory activities.All survey respondents included in the results reported spending more than 50%of their time on regulatory projects or processes.Headquarters locationUnited States59.5%European Union3%Canada37.5%Company sizeMedium($20M$100M)37.5%Large($100M$500M)32.5%Small($500M)30%Regulatory afairsQuality assuranceOperationsInformation technologyManufacturing/supply chainC-Suite/Sr,Leadership29.5%26%14%12%10.5%8%Manager/SpecialistVP/DirectorC-Suite50.5%38.5%11%Respondent departmentsRespondent seniorityP.4Product ProfileAll companies represented in the survey are primarily medical technology companies(those that produce medical devices in-vitro diagnostics or medical software).Of those,most were device manufacturers,with about a third producing diagnostic and software products respectively.71%produce medium or high-risk products,meaning they are subject to regulatory approval before they can be marketed or sold in a given market.Most companies manufacture a pretty broad array of products.Nearly half of respondents have more than 500 regulated products,and 16%have more than 2,500.These products are distributed broadly.40%of respondents companies distribute their products to more than 50 countries.Medical devices(non-IVD)Combination productsIn vitro diagnosticsMedical software(SaMD)Biologics81%48%34%33%31%45%39%33%Product typesRisk classLow Risk/Class IMedium Risk/Class IIHigh RIsk/Class IIINumber of regulated productsLess than 1010 to 4950 to 99100 to 249250 to 499500 to 9991000 to 24992500 to 49995000to 999910000 to 1999920000 to 4999950000+1.5%3.5%0.5%0.5%1.5%13.5%14%12%9.5%9.5%16.5%17.5%P.5Regulatory Team Size and StafngThe number of products and breadth of distribution that survey respondents reported indicate a lot of complexity,and a significant amount of regulatory work.And teams definitely reported having a high workload,which is covered in more detail in the next section.Yet at the same time,most respondents reported that a fairly small number of employees within their organizations were dedicated to regulatory activities.56%of respondents indicated that their companies had less than 10 full-time employees focused on regulatory afairs.71%had less than 15.Naturally,the number of regulatory employees grows with company size,but even the largest companies reported a relatively small number of full-time regulatory employees.22%of enterprise companies(with more than$500 million in revenue)have 15 or fewer regulatory employees.Why the discrepancy between stafng and workload?Part of the reason seems to be how regulatory headcount are allocated within organizations.Headcount planning and resource allocation rarely take into account the actual anticipated workload.Instead,teams are assigned primarily based on device class or markets served.This approach may be due in part to a lack of visibility into upcoming projects or needs on the part of regulatory leadership.Countries distributed to2 to 45 to 910 to 1920 to 4950 to 7475 to 99100 to 1491150+2%3%9.5%11.5%18%19.5%14.5%14%8%6%5%7.5%5.5%1.5%2.5%3.5%3%32%18%15.5%Full-time regulatory afairs team members1 to 45 to 910 to 1415 to 1920 to 2425 to 4950 to 74075 to 99100 to 149150+P.6Filling the Gap with ConsultantsConsultants play an outsized role across the life-sciences industry,and theyre especially prevalent in medtech regulatory afairs.90%of respondents indicated that their company relies on external consultants to complete regulatory work,and those that didnt were overwhelmingly small companies.Naturally,the number of consultants used grows with company size,but theyre not only heavily used by large organizations.40%of small and medium medtech companies employ 5 or more full-time consultants to support regulatory afairs.Consultants are a fairly expensive way to get regulatory tasks completed.With hourly rates running from$150 to$300,the cost of using consultants can pile up quickly.Survey respondents reported pretty significant annual expenditures on consultantsespecially in large and enterprise companies.45%of enterprise companies spend more than$1 million per year on consulting,and 37%spend more than$2 million.How regulatory afairs stafng is allocatedWe allocate headcount based on expected number of new market/product submissions and regulatory license updates/renewalsWe allocate headcount based on the risk level of our regulated productsWe allocate headcount based on the number of countries/regions we have to supportWe allocate headcount based on the number of regulated productsWe allocate headcount arbitrarily based on available budget32%30%20.5%13%4.5%30%20%10%Consultants used1 to 45 to 910 to 1415 to 1920 to 2425 to 4950 to 74075 to 99100 to 149150+SMB($500M)P.7Future Stafng ExpectationsDespite what seems to be understafed regulatory teams,respondents were generally satisfied with resourcing within their regulatory departments.58%of respondents felt that their companies were investing the right level of resources(including budget,stafng,and tools)in regulatory afairs.However,there is a satisfaction gap between regulatory leaders and front-line employees.Front-line employees were much more likely to report feeling under-resourced than those in leadership roles.SMB($500M)30%20%10%Annual contractor budget$10Kto$24K$25Kto$49K$50K to$99K$100K to$199K$200K to$499K$500Kto$999K$1Mto$1.9MLess than 10K$2M+22.2%37.6%63.6%52.5%14.1%9.9%Current regulatory resources leaders vs front-line employees Under-resourcedDevoting the right amount of resourcesOver-resourced/over-spending30%58%12%Current regulatory resources all respondentsUnder-resourcedDevoting the right amount of resourcesOver-resourced/over-spendingLeadership(C-suite/VP/Director)Front-line EmployeesP.8It may be that leaders are seeing the results that come with extensive spending on consultants,while front-line employees are managing the added complexity of trying to staf projects,and managing information hand-ofs with consulting teams.And perhaps there is some understanding that current full-time stafng levels may not be sustainable.The majority(50.5%)of respondents expect that their regulatory teams will grow in the coming year.Regulatory Activities and PerformanceThe study looks at regulatory performance from 2 dimensions.Respondents were asked to self-assess the performance of their regulatory teams compared to their peers.They were also asked to detail their regulatory activities,how they complete their jobs,and issues faced.The results showed a significant discrepancy between how teams perceived themselves and how they actually perform.A strong self-assessmentRespondents were generally confident in all aspects of regulatory performance,believing that they have the capabilities and processes in place to execute efectively.Over 50%of respondents felt that they were easily able to access the information they need,had adequate viability into upcoming expirations,and did a good job of measuring and assessing the efectiveness of their regulatory processes.50.5%40%9.5%Regulatory team growth in 2023I expect our regulatory afairs team to growI expect our regulatory afairs team to stay the sameI expect our regulatory afairs team to shrinkP.9When asked to compare their regulatory performance to peer organizations,respondents were similarly confident.Over 50%of respondents believed that their regulatory afairs team was able to plan more efectively and execute more quickly than teams at similar organizations.Apparently everybody in regulatory afairs is above average.22.5%20.5%44.5%24.5%23%34%34.5%40.5%28%9%8.5%10.5%Regulatory self-assessmentMy regulatory afairs team is easily able to access the information they need to do their jobsMy regulatory afairs team has clear visibility into upcoming regulatory projectsMy regulatory afairs team regularly measures and assesses the efectiveness of regulatory activitiesStrongly agreeAgreeDisagreeNeither agree or disagree17.5%13.5%43%30.5%11%2%39%29.5%14%Performance compared to peer organizationsRate your regulatory afairs teams ability to plan efectively compared to teams at other organizationsRate your regulatory afairs teams ability to execute quickly compared to teams at other organizationsMuch betterBetterWorseMuch worseNeither better or worseP.10Regulatory WorkloadDespite the relatively small team size,respondents reported completing a large amount of regulatory work in the past year.On average companies completed 50 license renewals,50 license updates(notifications and amendments due to design,software,legal entity,or manufacturing updates),and 10 new market submissions(market clearance or approval applications).The volume of workload relative to team size would seem to validate the strong self-assessment,but did their processes allow them to complete these activities efciently and without errors?On average new submissions took the most time,with 65%of respondents saying it takes their organizations more than 4 months to complete a submission,and 36%reporting more than 6 months per submission.However more than half indicated that it also takes their regulatory teams more than 4 months to complete a license renewal or update.3.5%6%36%35.5%35%23.5%7.5%31%23.5%3%0.5%1.5%27.5%23.5%33.5%8%4%Activities completed in the past yearNumber of license renewalsNumber of license updatesNumber of new market submissions0-910-49100-199200-299300+50-9911%5%30%29.5%22.5%13%2%38%38%41.5%20.5%30.5%18.5%Time to complete regulatory activities1-3 weeks1-3 months6-12 monthsMore than 12 months4-6 monthsAverage time to complete a license renewalAverage time to complete a license updateAverage time to complete a new market submissionP.11Process InefcienciesWhat drives the long completion times for regulatory activities?Naturally these are complicated processes,so its not surprising that theres a significant amount of work involved.However,there were some clear process inefciencies that surfaced in the survey results.First,much of the work is manual.70%of respondents said that their regulatory afairs team spends nearly half their time on repetitive,administrative tasks.Secondly,poorly managed or incomplete information requires a lot of back and forth with health authorities.Half of all new market submissions require more than 7 turn-arounds(correspondence,requests for additional information,etc.)with regulatory authorities.Non-ComplianceSurvey respondents also reported a surprising number of non-compliance issues.61%reported that their companies had received a CAPA or audit result showing significant process issues from health authorities,had withdrawn products from a specific market due to an expired registration,or accidently marketed products into a region where they did not have clearance in the past 2 years.0%8%36.5%34.5%16.5%4.5%Regulatory turn-arounds per market submission0 to 12 to 45 to 67 to 89 to 10More than 1031%23.5%18.5%Non-compliance issues