早期数字健康创业公司的有效要求工程
Marius Gerdes1, Sascha Noel Weimar1, Florian Mazura1
1Karlsruhe Institute of Technology, Karlsruhe, Germany.
Studies in health technology and informatics
|May 17, 2025
概括
本案例研究介绍了数字健康初创公司的四阶段需求工程过程. 资源有限的初创公司可以实施这一过程,以确保软件作为医疗器械的监管合规性.
科学领域:
- 数字健康数字健康
- 软件作为医疗设备 (SaMD)
- 监管合规性符合性 监管合规性
背景情况:
- 早期的数字健康初创公司在开发软件作为医疗设备 (SaMD) 方面面临着挑战.
- 整合需求工程与产品开发对于监管部门的批准至关重要.
- 创业公司的资源限制可能会阻碍稳健的流程实施.
研究的目的:
- 检查在早期数字健康创业公司中实施需求工程流程的实施情况.
- 展示SaMD开发的实用,四阶段的过程.
- 为了证明有效的需求工程对于资源有限的初创企业来说是可行的.
主要方法:
- 案例研究方法.
- 开发一个四阶段的需求工程过程.
- 在产品开发生命周期中整合需求收集.
主要成果:
- 拟议的四阶段过程在早期数字健康创业公司中成功实施.
- 该过程有效地将需求工程与产品开发相结合.
- 创业公司能够建立支持未来监管合规的流程.
结论:
- 资源有限的数字健康初创公司可以实施有效的需求工程流程.
- 展示的过程支持软件作为医疗器械的监管合规性.
- 这种方法可以作为其他寻求监管批准的数字健康初创公司的典范.
相关概念视频
Methods Of Healthcare Delivery System
3.5K
At the different levels of the healthcare system, we see varying methods of healthcare used. These methods include managed care systems, case management, and primary healthcare.
Managed Care System:
The managed care system is designed to control the cost while maintaining the quality of care. The patient's care from admission to discharge is planned by the primary care provider or the case manager, also known as the gatekeeper. In a managed care system, the number of care providers is...
Managed Care System:
The managed care system is designed to control the cost while maintaining the quality of care. The patient's care from admission to discharge is planned by the primary care provider or the case manager, also known as the gatekeeper. In a managed care system, the number of care providers is...
3.5K
Issues And Trends In Healthcare Delivery System
5.8K
The issues and trends in healthcare delivery are constantly changing. The COVID-19 pandemic is one recent issue that wreaked havoc on healthcare systems, causing a shortage of healthcare workers, high demand for medicines and supplies, and increased medical expenditure due to a lack of insurance. Other issues include rising healthcare costs and care fragmentation.
Cost Containment
Payment for healthcare services has historically promoted adoption of costly and often unnecessary or inefficient...
Cost Containment
Payment for healthcare services has historically promoted adoption of costly and often unnecessary or inefficient...
5.8K
Methods of Documentation VII: EMR
913
Electronic Medical Records (EMRs) primarily center around electronically documenting patients' health information within a single healthcare organization or practice. They contain essential clinical data related to a patient's medical history, diagnoses, medications, treatment plans, lab results, and other pertinent information relevant to the specific encounter or episode of care. EMRs are designed to streamline documentation and workflow processes within individual healthcare...
913
Health Information Technology and Healthcare Information System
917
Health Information Technology (HIT)
Health Information Technology, commonly called HIT, integrates advanced information systems and technology in healthcare settings. Its primary functions include:
Health Information Technology, commonly called HIT, integrates advanced information systems and technology in healthcare settings. Its primary functions include:
917
Clinical Trials: Overview
3.4K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
3.4K
Preclinical Development: Overview
4.8K
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
4.8K


