中国国际医疗器械设计与制造技术展览会(Medtec China)2021

专注于为医疗器械研发与生产服务

2022年8月31-9月2日 | 上海世博展览馆1&2号馆

Self-Administration: What Drug-Delivery Device Manufacturers Should Know

2020-06-17

Staff shortages, financial pressure and a growing ageing population are the three key drivers pushing forwards the current trend of self-administration of injections for patients suffering from chronic illnesses. By 2060, there will be over 95 million Americans aged 65 and over – nearly double today’s number- and with old age comes greater likelihood of chronic illnesses.1

Hospitals have taken matters into their own hands by ‘outsourcing’ this low-risk medical procedure that drains both precious healthcare professionals’ time and limited space – and handing the baton over to home carers or patients themselves who are able to perform such drug injections in the comfort of their own homes. However, even healthcare professionals carrying out injections within hospital settings continue to be subjected to the risk of needlestick injuries with potentially contaminated needles. It is therefore of utmost importance that the safety of the medical devices being used for injection, as well as the best practices surrounding their usage, be strengthened both within traditional healthcare environments and these newly emerging sites for home-administration. Up until now, most drug-delivery devices for injection have been designed for healthcare professionals as their primary users, but manufacturers will increasingly need to adjust their products to a new breed of clientele, including both patients and home-based carers.

 

Self-Administration Trend Drivers

Part of the underlying reason self-administration has increased in recent years is the wave of biological therapies entering the market, which are specifically suited to treatment by subcutaneous injection for patients with chronic diseases such as multiple sclerosis or rheumatoid arthritis given that they require frequent and regular injections. When not required to make frequent trips to the clinic and rely on the expertise of nurses, patients are empowered to play a bigger part in their own treatment and disease management, which they can more easily fit around their personal lives.

 

Sharps injuries from unprotected needles have certainly declined since the introduction of the US Needlestick Safety and Prevention Act (NSPA) almost twenty years ago, yet we continue to see an average of 1,000 injuries reported every day in US hospitals.2 Given that an estimated 50% of non-hospital settings are deemed non-compliant with Occupational Safety and Health Administration (OSHA)3 self-administrating patients are at a much higher risk of contracting a needlestick injury. This risk extends to their family members and other residents if improper safety measures and disposal techniques are applied. With non-users being far less likely to be aware of the contamination of a device, or even know the risks presented by contaminated devices more generally, self-administration leaves non-patients particularly vulnerable to such exposures.

 

Designing with Self-Administration in Mind

While the general population can be made more aware of these risks, manufacturers can also make a huge difference through device design and should accommodate their devices to patient capabilities. Safety devices should be intuitive and easy to use, requiring minimal effort to activate and inject. Most importantly, manufacturers must be sure to integrate needlestick prevention features into their devices. For example, devices with hollow-bore needles or syringes which retain an exposed needle after patient use present a heightened risk, while retracting and needle shielding mechanisms are much safer.4 Given that safer features of drug delivery devices can reportedly reduce needlestick injuries and contaminations by up to 80%5 it is no surprise then that the safety prefilled syringe market has taken off in recent years. In 2018, global spending on safety syringes reached $772 million, and this is expected to grow an impressive 8.1% CAGR, reaching $1.137 billion by 2023.6 Going one step further, pre-filled safety syringes meet these safety requirements while also having the added benefit of reducing the risk of dosage errors. These instruments not only substantially reduce risks but are especially well-suited to a growing self-injecting patient population.

 

As self-administration continues to take off, it is important to consider the risks that come with exporting potential needle exposure outside of their typical clinical setting. In some ways, this trend acts as a useful reminder and a prompt to solidify the safety foundations across all healthcare systems and locations. By making self-administration a viable alternative and enabling older and less dextrous patients to securely operate the device without assistance, pre-filled safety syringes and autoinjectors are providing users with a level of independence that would otherwise be unavailable to them were they reliant on hospital staff for medication, while also reducing the risks associated with unsupervised care. With homecare successfully reducing pressure on healthcare systems, manufacturers will play a key role in ensuring the continued upward trajectory of self-administration by continually adapting their drug delivery devices to the evolving healthcare landscape.

 

From:MDDI

 

伴随着人工智能兴起,起步较晚的国产医疗机器人正在加快发展,逐步扩大应用场景。5月26日,第十一届中国生物产业大会在武汉光谷发布本土健康企业的7项最新成果,首先推介的便是武汉兰丁公司的宫颈癌检测智能机器人。

 

《每日经济新闻》记者在大会现场了解到,多家企业正在推广医疗机器人,应用范围涵盖胃镜检查、腹腔手术、美容抗衰等,并且已有成熟产品进入国内医院,打破进口机器人在医院应用的垄断局面。

 

 

据主办方介绍,“LANDING”机器人通过筛查样本拨片进行自动化诊断,每月有108万例的样本检测能力,效率远远超过人工。目前,武汉兰丁公司与阿里巴巴的合作,使“LANDING”机器人在中国各地基层终端收集的大量细胞特征参数及数据,在云平台上完成分析诊断工作。

 

 

科技颠覆想象力,机器人在医疗领域的应用范围更加广泛。《每日经济新闻》记者注意到,多家企业在生物产业大会上重点推介医疗机器人产品。

 

患者吞下一粒胶囊,在胃里变成机器人进行螺旋式扫描,将检查图像实时传输至医生电脑,这便是安翰光电技术(武汉)有限公司研制的磁控胶囊胃镜机器人。该公司展位负责人程先生介绍,目前全国已有1000多家医疗机构应用了胶囊胃镜机器人,包括三甲医院、大型体检中心等,涵盖专业医疗和常规健康体检领域,年消耗量达50万粒。

 

据了解,这粒胶囊仅重5G,但包含了80多项科技创新专利,集成400多个精密元器件。上述负责人表示,在检查方面,胃镜机器人可以替代传统的电子胃镜,不过电子胃镜可以做小型的腔镜手术、切片等,胶囊机器人还不具备这些功能,但在进一步研发中。

 

苏州康多机器人有限公司则在大会上重点推介腹腔镜手术机器人系统,该公司展位负责人张辉介绍,这款手术机器人由医生控制台、支撑臂、手术器械三部分组成,通过机器人操作可以起到防止手抖、放大病灶视野等精确治疗的效果。

 

其实,在“机器换人”升级过程中,国产医疗机器人起步虽晚,但发展很快,不少上市公司将其作为下一风口进行布局。

 

2015年,制造装备公司楚天科技(行情300358,诊股)(300358,SZ)表示正在研发医药机器人和医疗机器人,一年后,首台医药无菌生产智能机器人下线,步入医药装备4.0时代;2017年11月,科大讯飞(行情002230,诊股)(002230,SZ)研发的医疗机器人“智医助理”通过临床执业医师综合笔试,目前已进入合肥基层卫生中心,辅助全科医生进行诊疗;2017年,埃斯顿(行情002747,诊股)(002747,SZ)收购美国Barrett 30%股权,全面进军康复医疗机器人市场,并计划与Barrett共同出资在中国境内成立一家新的合公司。

 

国产机器人拥有成本优势 在多家企业布局的背后,是医疗机器人巨大的市场潜力。普华永道中国发布的《医疗机器人宏观应用趋势与研究方向》显示,2014年,全球医疗机器人的市场价值是26亿美元,到2020年预计会达到76亿美元。

 

人均可支配收入的增加会促使高质量医疗需求的增长,而医疗机器人正好有出血少、精准度更高,恢复快的优势。整个发展趋势显示医疗机器人市场潜力巨大。

 

目前,国内医院的医疗机器人仍依赖进口,最为广泛应用的就是美国直觉外科公司制造的达芬奇手术机器人,2016年国内手术量突破1.5万台。

 

但是,进口医疗机器人价格昂贵,使得医疗费用也居高不下,如一台达芬奇机器人在国内售价2000万元左右,附带长期的耗材费用。

 

“进口机器人就算不用,一年的保养费都得80~100万元,每天开机费用就达1万元左右。”张辉表示,国外的机器人设备,主要包括维修费、保养费、耗材费等费用,所以价格居高不下。

 

随着国产医疗机器人发力,这一局面有望打破。此前,楚天科技研发的医药无菌生产机器人定价500万~600万元,而国际同类机器人定价800万~1000万元左右。

 

张辉告诉《每日经济新闻》记者,国产医疗机器人的优势是小型化、便捷化,还有国内的服务体系,针对三甲医院、县级医院等机构,可以实现分级应用,因此价格应该会比进口设备低一半左右,降低医疗成本。

 

来源:每日经济新闻

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