COVID-19在全球范圍內(nèi)凸顯了快速診斷的力量。據(jù)FIND報(bào)道，自新冠疫情開始以來(lái)，已經(jīng)進(jìn)行了65億次COVID檢測(cè)。在疫情過(guò)后，整個(gè)生態(tài)系統(tǒng)的參與者（包括醫(yī)療技術(shù)創(chuàng)新企業(yè)、知名全球IVD研發(fā)企業(yè)、學(xué)者、醫(yī)療服務(wù)提供者和付費(fèi)者）都致力于尋求快速診斷可以有效發(fā)揮作用的其他領(lǐng)域。大家認(rèn)識(shí)到，快速診斷可用于廣泛的適應(yīng)證，以應(yīng)對(duì)當(dāng)今醫(yī)療服務(wù)的一些挑戰(zhàn)。
因此，即時(shí)檢測(cè)（POCT）和直接面向消費(fèi)者的檢測(cè)（DTC）市場(chǎng)預(yù)計(jì)將迎來(lái)強(qiáng)勁增長(zhǎng)（直接面向消費(fèi)者的檢測(cè)（DTC）由消費(fèi)者自行采集樣本，然后寄送到檢測(cè)機(jī)構(gòu)進(jìn)行檢測(cè)和分析，或由消費(fèi)者自行完成檢測(cè)）。到2030年，即時(shí)檢測(cè)（POCT）市場(chǎng)預(yù)計(jì)將以7.9%的復(fù)合年均增長(zhǎng)率（CAGR）增長(zhǎng)至710億美元；而到2031年，居家檢測(cè)市場(chǎng)預(yù)計(jì)將以10.5%的復(fù)合年均增長(zhǎng)率（CAGR）增長(zhǎng)至456億美元。
快速診斷市場(chǎng)的增長(zhǎng)受新興護(hù)理模式（例如虛擬病房、居家醫(yī)療（HAH）、自我護(hù)理）的影響。在美國(guó)，自2021年4月以來(lái)，聯(lián)邦醫(yī)療保險(xiǎn)和醫(yī)療補(bǔ)助服務(wù)中心（CMS）批準(zhǔn)的提供居家醫(yī)療服務(wù)的醫(yī)院數(shù)量增長(zhǎng)了118%。2023年1月，英國(guó)政府將虛擬病房的月覆蓋率從10,000名患者上升到了50,000名患者。我們?cè)谧罱l(fā)布的“Healthier at Home”報(bào)告中，探討了轉(zhuǎn)向居家護(hù)理所創(chuàng)造的價(jià)值。
要想把握快速診斷的市場(chǎng)機(jī)遇，還需應(yīng)對(duì)一系列復(fù)雜的挑戰(zhàn)，特別是與監(jiān)管相關(guān)的挑戰(zhàn)。獲得監(jiān)管機(jī)構(gòu)的批準(zhǔn)是產(chǎn)品市場(chǎng)準(zhǔn)入的必要條件，然而對(duì)監(jiān)管環(huán)境的把握正變得日益復(fù)雜：監(jiān)管機(jī)構(gòu)不斷出臺(tái)新法規(guī)，而監(jiān)管體系難以追平法規(guī)更新的速度，從而導(dǎo)致了嚴(yán)峻的監(jiān)管能力問(wèn)題。此外，獲得監(jiān)管機(jī)構(gòu)的批準(zhǔn)是一個(gè)漫長(zhǎng)的過(guò)程，通常會(huì)產(chǎn)生較高的費(fèi)用。那么IVD研發(fā)企業(yè)和醫(yī)療技術(shù)創(chuàng)新企業(yè)如何才能成功把握復(fù)雜的監(jiān)管環(huán)境并獲得產(chǎn)品市場(chǎng)準(zhǔn)入資格，從而使醫(yī)療保健系統(tǒng)和患者受益呢？我們概述了5個(gè)關(guān)鍵要素供IVD企業(yè)參考，助其快速順利獲得產(chǎn)品市場(chǎng)準(zhǔn)入資格。
1、深入了解市場(chǎng)，精準(zhǔn)定位產(chǎn)品價(jià)值
COVID-19席卷全球，波及各類人群，相關(guān)快速檢測(cè)試劑也應(yīng)用于各種場(chǎng)景。展望未來(lái)，快速檢測(cè)試劑將以高度細(xì)分的方式用于多種場(chǎng)景、疾病、用戶群體和環(huán)境。IVD研發(fā)企業(yè)很可能會(huì)受到不同使用場(chǎng)景下檢測(cè)頻次的影響，而檢測(cè)頻次反過(guò)來(lái)又會(huì)決定生產(chǎn)量，并最終決定銷量。在考慮更廣泛的適應(yīng)證時(shí)，IVD研發(fā)企業(yè)必須了解其解決方案將要解決的實(shí)際問(wèn)題是什么，以及誰(shuí)將從這些解決方案中受益。
在時(shí)間緊張的情況下，快速檢測(cè)所帶來(lái)的臨床受益是顯而易見的。例如，肌鈣蛋白檢測(cè)可以在緊急情況下排除“靜默”心臟病發(fā)作的可能性。流感檢測(cè)等快速檢測(cè)試劑可以在特定情況下實(shí)現(xiàn)分診，從而控制感染。此外，快速檢測(cè)可以幫助長(zhǎng)期慢性病患者進(jìn)行自我監(jiān)測(cè)，并可減少患者臨床就診的需求，從而為患者和醫(yī)護(hù)人員節(jié)省時(shí)間，并提供更好、更方便的檢測(cè)體驗(yàn)。膽固醇的定期監(jiān)測(cè)就是一個(gè)很好的例子。
IVD研發(fā)企業(yè)必須深入了解市場(chǎng)，對(duì)衛(wèi)生健康狀況、當(dāng)前上市途徑、當(dāng)前使用的檢測(cè)技術(shù)、當(dāng)前實(shí)踐中的痛點(diǎn)以及解決方案所能提供的價(jià)值進(jìn)行調(diào)研，從而精準(zhǔn)定位產(chǎn)品價(jià)值并確保市場(chǎng)接受度。
2、洞悉監(jiān)管機(jī)構(gòu)的觀點(diǎn)，與監(jiān)管機(jī)構(gòu)協(xié)作
快速診斷領(lǐng)域的創(chuàng)新為監(jiān)管機(jī)構(gòu)帶來(lái)了新的挑戰(zhàn)，監(jiān)管機(jī)構(gòu)現(xiàn)在需要考慮新的復(fù)雜性，比如：1）缺乏同類產(chǎn)品；2）目測(cè)結(jié)果而非定量結(jié)果；3）檢測(cè)結(jié)果的校準(zhǔn)和質(zhì)量保證；4）檢測(cè)由非專業(yè)使用者或缺乏診斷檢測(cè)經(jīng)驗(yàn)的醫(yī)護(hù)人員進(jìn)行；5）檢測(cè)在非臨床環(huán)境中進(jìn)行；6）結(jié)果的數(shù)字化上傳。監(jiān)管機(jī)構(gòu)重點(diǎn)關(guān)注的是患者安全，涉及到快速診斷時(shí)，其密切關(guān)注的是臨床和可用性證據(jù)、特定檢測(cè)環(huán)境的影響、使用者的資格和培訓(xùn)、以及結(jié)果讀取和結(jié)果記錄方法。關(guān)鍵在于，IVD研發(fā)企業(yè)需要深入了解監(jiān)管機(jī)構(gòu)的關(guān)注點(diǎn)，并與監(jiān)管機(jī)構(gòu)合作確立上市許可途徑，并就可接受的證據(jù)基礎(chǔ)達(dá)成一致。
監(jiān)管機(jī)構(gòu)也面臨著壓力，需要通過(guò)自身實(shí)踐的創(chuàng)新來(lái)為創(chuàng)新產(chǎn)品的上市許可途徑提供支持，確保患者最終能夠從行業(yè)創(chuàng)新中受益。為此，監(jiān)管機(jī)構(gòu)也在通過(guò)意見征詢等方式來(lái)獲取外部利益相關(guān)者的意見，并推出新舉措來(lái)應(yīng)對(duì)創(chuàng)新帶來(lái)的挑戰(zhàn)。例如，美國(guó)FDA啟動(dòng)了“突破性醫(yī)療器械計(jì)劃”，對(duì)于符合該計(jì)劃條件的器械，在研發(fā)階段為企業(yè)提供反饋并對(duì)其上市許可申請(qǐng)進(jìn)行優(yōu)先審查。美國(guó)FDA還就“增加患者居家使用醫(yī)療技術(shù)的可及性”公開征求意見，并指出“臨床護(hù)理環(huán)境之外的器械可及性可將醫(yī)療服務(wù)直接帶給患者（無(wú)論患者身在何處 - 家中、工作場(chǎng)所、城市、農(nóng)村社區(qū)），有助于彌合差距。擴(kuò)大居家使用醫(yī)療技術(shù)可及性的舉措與美國(guó)FDA致力于推進(jìn)健康公平性的戰(zhàn)略目標(biāo)是一致的。”
英國(guó)藥品和健康產(chǎn)品管理局（MHRA）已經(jīng)建立了新的“創(chuàng)新器械準(zhǔn)入途徑”（IDAP），將監(jiān)管和技術(shù)評(píng)估相結(jié)合，旨在消除準(zhǔn)入途徑中的不確定性，從而為患者帶來(lái)能夠改善健康結(jié)果的創(chuàng)新技術(shù)。
我們期待看到全球監(jiān)管機(jī)構(gòu)與外部利益相關(guān)者（如衛(wèi)生技術(shù)評(píng)估機(jī)構(gòu)、IVD研發(fā)企業(yè)、臨床醫(yī)生、學(xué)者和患者）之間的更高程度的合作，共同努力開發(fā)監(jiān)管途徑的創(chuàng)新方法。
3、以用戶為中心，盡可能降低或消除風(fēng)險(xiǎn)
許多快速診斷解決方案是為受過(guò)醫(yī)學(xué)培訓(xùn)的專業(yè)人員在傳統(tǒng)臨床環(huán)境中使用而設(shè)計(jì)的。若直接將這些檢測(cè)方案應(yīng)用到其他環(huán)境中（包括社區(qū)檢測(cè)中心、零售環(huán)境、養(yǎng)老院、學(xué)校和其他家庭環(huán)境），會(huì)增加使用錯(cuò)誤的風(fēng)險(xiǎn)。
檢測(cè)頻次在使用者行為和檢測(cè)準(zhǔn)確性方面起著重要作用。例如，每天進(jìn)行的檢測(cè)可以成為一種習(xí)慣，重復(fù)檢測(cè)可以提高熟練程度。另一方面，針對(duì)不常進(jìn)行或一次性進(jìn)行的檢測(cè)，可能需要適當(dāng)設(shè)計(jì)特定的操作說(shuō)明。
使用說(shuō)明書并不總是用戶友好的。IVD研發(fā)企業(yè)可通過(guò)以下措施設(shè)計(jì)出可以降低和緩解這些風(fēng)險(xiǎn)的檢測(cè)解決方案，包括：1）減少組件數(shù)量；2）減少檢測(cè)步驟；3）設(shè)計(jì)適用于一系列樣本類型（不止血液樣本）的檢測(cè)方案；4）設(shè)計(jì)用于特定的非臨床環(huán)境；5）改進(jìn)包裝和處理步驟；6）改進(jìn)結(jié)果讀取和記錄方法（包括借助數(shù)字解決方案）；7）為非專業(yè)人員提供用戶友好、容易理解的說(shuō)明。在新環(huán)境下，以用戶為中心的設(shè)計(jì)可以減輕監(jiān)管機(jī)構(gòu)對(duì)患者安全的擔(dān)憂（上文第2點(diǎn)有提及），從而為上市許可申請(qǐng)?zhí)峁┲С?。不過(guò)，這需要IVD研發(fā)企業(yè)在以用戶為中心的設(shè)計(jì)和人因工程方面具備世界一流的能力。
4、按需實(shí)現(xiàn)綜合臨床決策
在適用的情況下，快速診斷檢測(cè)能夠以數(shù)字化的形式連接到更廣泛的衛(wèi)生系統(tǒng)，以確保做出適當(dāng)?shù)呐R床決策。例如，患有長(zhǎng)期慢性疾病的最終用戶可能需要針對(duì)特定分析物進(jìn)行定期自測(cè)。對(duì)于護(hù)理人員來(lái)說(shuō)，了解檢測(cè)頻次和結(jié)果以做出最佳臨床決策可能很重要。鑒于初級(jí)和二級(jí)醫(yī)療中已建立的數(shù)字系統(tǒng)的異質(zhì)性，這給IVD研發(fā)企業(yè)帶來(lái)了巨大挑戰(zhàn)。這是IVD研發(fā)企業(yè)需要具備的另一種能力。對(duì)于最終用戶和醫(yī)療服務(wù)提供者來(lái)說(shuō)，創(chuàng)建另一種專有的結(jié)果記錄工具（如專用的電子設(shè)備）并不總是會(huì)增加價(jià)值。利用無(wú)處不在的消費(fèi)者設(shè)備（如iPad和智能手機(jī)），而不是專用設(shè)備，可能更方便，因此更有可能鼓勵(lì)采用且具有可擴(kuò)展性。但另一方面，使用個(gè)人設(shè)備來(lái)執(zhí)行諸如記錄、分析、存儲(chǔ)和傳輸患者結(jié)果的任務(wù)可能并不總是被醫(yī)療保健系統(tǒng)所接受。
5、進(jìn)行衛(wèi)生技術(shù)評(píng)估，證明價(jià)值并支持采用
在快速診斷解決方案旨在作為醫(yī)療保健系統(tǒng)的一部分的情況下，衛(wèi)生技術(shù)評(píng)估（HTA）是證明價(jià)值和支持采用新檢測(cè)技術(shù)和現(xiàn)有技術(shù)新用途的寶貴工具。衛(wèi)生技術(shù)評(píng)估（HTA）的主要目的是為政策制定者提供基于證據(jù)的信息，以便其能夠制定出安全、有效、以患者為中心、成本效益高的衛(wèi)生政策。國(guó)家當(dāng)局還通過(guò)衛(wèi)生技術(shù)評(píng)估（HTA）來(lái)幫助決定在國(guó)家層面應(yīng)該對(duì)哪些技術(shù)進(jìn)行補(bǔ)償。衛(wèi)生技術(shù)評(píng)估（HTA）是補(bǔ)償決策途徑中的重要一環(huán)。
最近，人們開始重新關(guān)注衛(wèi)生技術(shù)評(píng)估（HTA）。例如，一項(xiàng)新的歐洲法規(guī)將從2025年1月開始施行，該法規(guī)將取代目前由歐盟資助的成員國(guó)之間基于項(xiàng)目的衛(wèi)生技術(shù)評(píng)估合作體系。該法規(guī)將為聯(lián)合工作引入持久性框架，該框架還將涵蓋聯(lián)合科學(xué)磋商、新興衛(wèi)生技術(shù)的識(shí)別、自愿合作以及聯(lián)合臨床評(píng)估工作。英國(guó)國(guó)家衛(wèi)生與臨床優(yōu)化研究所（NICE）最近與來(lái)自三大洲的其他五家全球HTA機(jī)構(gòu)建立了合作伙伴關(guān)系，就一系列主題展開合作，旨在幫助世界各地的人們獲得醫(yī)療保健服務(wù)。這些合作伙伴將就共同優(yōu)先事項(xiàng)協(xié)同努力，針對(duì)一些共同面臨的挑戰(zhàn)確定解決方案。優(yōu)先事項(xiàng)包括：1）面向未來(lái)的HTA體系；2）與監(jiān)管機(jī)構(gòu)合作；3）可能使用彼此的HTA信息；4）探索聯(lián)合臨床評(píng)估試點(diǎn)。
結(jié)論
雖然快速診斷技術(shù)的應(yīng)用有望強(qiáng)勁增長(zhǎng)，但我們預(yù)計(jì)，要確保成功推廣和廣泛采用，還需要克服多重障礙。為了克服這些障礙，需要整個(gè)生態(tài)系統(tǒng)中的多個(gè)參與者的參與，特別是與監(jiān)管機(jī)構(gòu)建立密切的工作關(guān)系，以設(shè)計(jì)出具有明確風(fēng)險(xiǎn)緩解要求和證據(jù)基礎(chǔ)的審批途徑，以確保產(chǎn)品能夠獲準(zhǔn)上市。這需要一種全新的產(chǎn)品設(shè)計(jì)和開發(fā)方法，且需要在技術(shù)文件中和上市許可申請(qǐng)時(shí)加入新的內(nèi)容。至關(guān)重要的是，快速診斷器械制造商之間需要建立合作伙伴關(guān)系，且需要具備新的能力，以支持這種上市許可批準(zhǔn)的新方法。
考慮到預(yù)期的市場(chǎng)紅利規(guī)模，我們預(yù)計(jì)會(huì)有高水平的競(jìng)爭(zhēng)、一些創(chuàng)新合作以及一些新進(jìn)入者在這個(gè)充滿活力的市場(chǎng)領(lǐng)域建立份額。
英文原文
5 Key Factors To Gain Regulatory Approvals for Innovative Rapid Diagnostic Devices
By Valerie Phillips, PA Consulting; and Ben Jacoby, Cambridge RA Ltd.
COVID-19 demonstrated the power of rapid diagnostics on a global scale. FIND reported that 6.5 billion COVID tests have been performed since the beginning of the pandemic. In the aftermath of the pandemic, players across the ecosystem, including medtech innovators, established global in vitro diagnostic (IVD) developers, academics, and healthcare payers and providers, are committed to finding other areas where rapid diagnostics can be effectively deployed. All recognize that rapid diagnostics can be deployed for a wide range of indications to meet some of the challenges of healthcare delivery today.
Consequently, strong growth is anticipated in both point of care testing and direct to consumer testing, which includes a consumer self-collecting a sample, which is then processed remotely, or a consumer undertaking and completing the test themselves. The point of care testing market is estimated to grow at a CAGR of 7.9% to $71 billion by 2030, while the at-home testing market is forecast to grow at a CAGR of 10.5% to $45.6 billion by 2031.
Growth in rapid diagnostics is influenced by the deployment of new care models, such as virtual care wards and hospital at home schemes, as well as a shift toward self-care. In the U.S., the number of Centers for Medicare and Medicaid Services (CMS)-approved hospitals offering hospital at home care has increased by 118% since April 2021. In the U.K., the government increased its coverage of virtual wards to 50,000 patients a month in January 2023, up from 10,000. Creating value from this shift to home care is explored in our recently published Healthier at Home report.
A range of complex challenges need to be overcome to realize the market opportunity for rapid diagnostics, especially in the regulatory space. Gaining regulatory approval is imperative for market access, yet navigating the regulatory landscape is becoming increasingly complex: regulators are bringing in new regulations and the system is finding it difficult to play catch-up, leading to huge capacity problems. Moreover, gaining regulatory approval is a lengthy and often expensive process. How can IVD developers and medtech leaders successfully navigate this complex territory and gain market access for the benefit of the healthcare systems and patients? We outline five key factors for leaders to consider enabling efficient, smooth regulatory approval pathways.
1. Obtain Deep Market Understanding To Inform “Value”
COVID-19 was a worldwide problem, across all demographics and use cases. Going forward, use of rapid tests will be deployed in a highly segmented manner across multiple use cases, diseases, user groups, and settings. IVD developers are likely to be influenced by the frequency of testing across use cases, which in turn can determine manufacturing volumes and, ultimately, sales. When considering a wider range of indications, it is key for developers to understand the actual problem their solution will address and who will benefit from their proposed solutions.
A rapid test can provide a clinical benefit in a situation where time is key. For example, a troponin test can rule in/out a “silent” heart attack in an emergency, while a rapid test such as flu testing can support triage in a specific setting and enable infection control. Rapid testing also enables patient self-monitoring for long-term chronic conditions and may reduce the requirement for in-person clinical visits, thereby saving time for both patients and healthcare professionals, as well as providing an enhanced, more convenient testing experience. An example is regular cholesterol monitoring.
It is imperative that IVD developers gain a deep market understanding of the health conditions, current pathways, current testing technologies in use, pain points in the current practices, and value their solutions can provide to understand “value” and ensure market acceptance.
2. Recognize The Regulator’s Point Of View And Collaborate With The Regulator
Innovations in the rapid diagnostics space are introducing new challenges for regulators, who now need to consider new complexities, such as lack of predicates, visual rather than quantitative results, calibration and quality assurance of test results, tests being performed by lay users and healthcare professionals with less experience with diagnostic testing, tests being used in non-clinical settings, and digital uploads of results. The regulators’ key concerns are for patient safety and when it comes to rapid diagnostics, they will have a keen eye on clinical and usability evidence, impact of specific test settings, the qualification and training of users, and methods for results reading and results recording. It is key that IVD developers gain an in-depth understanding of the regulators’ concerns and work with the regulators to establish pathways and agree on an evidence basis that is acceptable.
Regulators are under pressure themselves to innovate their practices to support innovation pathways and ensure that, ultimately, patients can benefit from industry innovations. In response, the regulators are launching consultations to obtain external stakeholder input and are bringing in new initiatives to respond to the pace of innovation. For example, in the U.S., the FDA has launched the Breakthrough Devices Program, which offers feedback to the developer during the development of the device and offers prioritized submission review, once the device qualifies for the program. The FDA has also announced a public consultation on Increasing Patient Access to At-Home Use Medical Technologies, stating that “access to devices outside a clinical care setting may help bridge the gap by bringing health care directly to patients, wherever they are – at home, at work, in cities, in rural communities. The effort to expand access to home use technologies is consistent with the FDA’s strategic aim focused on advancing health equity.”
In the U.K., the MHRA (the Medicines and Health products Regulatory Agency), has announced a new Innovative Devices Access Pathway, iDAP, combining regulation and technology assessment that aims to take uncertainty out of the route to access, thereby bringing innovative technologies to patients that can transform health outcomes.
We expect to see a higher degree of collaboration between global regulatory bodies and external stakeholders such as health technology assessors, IVD developers, clinicians, academics, and patients, all of whom will work together to develop innovative approaches for regulatory pathways.
3. Design User-Centric Solutions To Reduce Or Eliminate Risk Where Possible
Many rapid diagnostic solutions have been designed for use by medically trained professionals and in traditional clinical settings. By moving these tests into alternate settings, including community testing hubs, retail settings, care homes, schools, and other home settings, there is a higher risk of use error.
Frequency of testing plays a significant role in user behaviour and accuracy of testing. For example, tests that are performed daily can become routine and repetition may encourage proficiency. On the other hand, specific tailored instructions may need to be designed appropriately for tests that are undertaken infrequently or on a one-off basis.
Instructions for use are not always user-friendly. There is an opportunity for IVD developers to design testing solutions that reduce and mitigate these risks, including reducing the number of components, reducing the number of testing steps, designing tests that incorporate a range of sample types (beyond blood), designing for use in specific non-clinical settings, improving packaging and handling steps, providing improved reading and recording of results, including via digital solutions, and providing user-friendly, easy to follow instructions for laypersons. As we mentioned in point 2, user-centric design will support regulatory submissions by allaying regulators’ concerns for patient safety in new settings. However, this places a demand on IVD developers to develop world-class capabilities in user-centric design and human factors engineering.
4. Enable Integrated Clinical Decision-Making Where Required
Where applicable, rapid diagnostic tests can be digitally connected to the wider health system to ensure appropriate clinical decision-making is enabled. For example, an end user suffering from a long-term chronic condition may have a requirement to self-test for a specific analyte on a regular basis. It may be important to the caregiver to have visibility of testing frequency and outcomes to enable optimal clinical decision-making. Given the heterogeneity of established digital systems in primary and secondary care, this poses a huge challenge to IVD developers. This is another capability that IVD developers will need to develop. Creating yet another proprietary result recording tool such as a dedicated electronic device will not always add value for the end user and care provider. Utilizing ubiquitous consumer devices, such as iPads and smartphones, rather than dedicated devices, can be convenient and therefore more likely to encourage adoption and scalability. On the other hand, the use of personal devices to carry out tasks such as recording, analyzing, storing, and transmitting patient results may not always be accepted by healthcare systems.
5. Undertake A Health Technology Assessment To Evidence Value And Support Adoption
In instances where rapid diagnostic solutions are intended to be used as part of the healthcare system, health technology assessments (HTAs) are valuable tools in evidencing value and supporting adoption of novel testing technologies and new uses of existing technologies. The main purpose of HTAs is to provide policymakers with evidence-based information, so they can formulate health policies that are safe, effective, patient-focused, and cost-effective. They are also used by national authorities to help make decisions on which technology should be reimbursed at national levels. HTAs form a critical component of reimbursement pathways.
Recently, there has been a renewed focus on HTAs. For example, a new European regulation will apply from January 2025 that supersedes the current system of EU-funded project-based cooperation between Member States on health technology assessments. It introduces a permanent framework for joint work that will also cover joint scientific consultations, the identification of emerging health technologies, and voluntary cooperation, as well as work on joint clinical assessments. In the U.K., NICE recently established partnerships with five other global HTA bodies from three continents to collaborate on a range of topics that will benefit people accessing healthcare around the world. These partners will work together on shared priorities to identify solutions to some of the common challenges. Their priorities include future proofing HTA systems, collaborating with regulators, and potentially using each other’s HTA information and exploring pilots for joint clinical assessments.
Conclusion
While strong growth is widely anticipated in the uptake of rapid diagnostics, we anticipate there are several barriers to overcome to ensure successful rollout and widespread adoption. To overcome these, there will need to be participation by several players across the ecosystem and, in particular, close working relationship with regulatory bodies to design approval pathways with clear requirements for risk mitigation and evidence basis to ensure approval. This will require a fresh approach to product design and development as well as new content built into technical files and regulatory submissions. Critically, rapid diagnostic manufacturers will need to build partnerships and acquire new capabilities to underpin this fresh approach to market approval.
Given the anticipated size of the prize, we anticipate a high level of competition, some innovative collaborations, and some new entrants establishing a share in this dynamic market sector.
https://www.meddeviceonline.com/doc/key-factors-to-gain-regulatory-approvals-for-innovative-rapid-diagnostic-devices-0001
來(lái)源：MED DEVICE ONLINE
作者：Valerie Phillips（PA Consulting）、Ben Jacoby（Cambridge RA Ltd.）
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