作者Matthew J. Allaway，Do，创始人兼首席执行官，可叙事学
Nearly a decade ago, I came up with the concept for a new medical device that could transform the way urologists, including myself, perform prostate biopsies. But as with many great ideas, there were several significant obstacles I needed to overcome before turning this concept into reality and many challenges to face during the journey of developing a new medical device and diagnostic procedure.
我的教育和professional background are in medicine and urology, including prostate cancer specifically. I did not have the formal experience in biomedical engineering that would allow me to design and develop a new medical device alone. There was also no predicate device that could serve as a useful reference or foundation for building a new device for improved prostate biopsy procedures. As is the case for most practicing clinicians, nearly every minute of my work week was dedicated to clinical responsibilities and patients, leaving little or no time for anything else, let alone planning for and producing this device. My challenge involved taking my concept and turning it into a device that could enable urologists to perform a prostate biopsy using this technique – referred to as a transperineal biopsy.
In the past, researchers, executives, and other professionals in the medical technology sector with a new idea would partner with a medical device engineering company to bring a concept to reality, often first by building an injection mold (injecting plastic materials molten by heat into a mold, and then cooling and solidifying them) with the desired characteristics. This process, even for a low production mold, could cost at least $30,000. It is also likely that the first mold would not be the final version and many iterations would need to be built before producing an ideal device, running up costs even more. As with many individuals or startups, I did not have the bandwidth for this endeavor. Also, in 2014, 3D printing was still a relatively challenging proposition – 3D printing patents were strictly enforced and purchasing a printer would be cost prohibitive. In addition, there are specific CAD software skills needed to design the files that feed a 3D printer to develop injection molds and a final product.
The Challenges Of 3D Printing
在将工作转移到具有专业知识的医疗设备设计咨询公司之后，一年多了，超过12个迭代后，最终产品开始浮出水面。在整个过程中，3D打印的最大挑战之一是用来打印设备的树脂与注射模具中使用的最终基板不同。最终产品将包括四种类型的材料，每种材料具有各自功能所需的特征。尽管可以在3D打印中使用多个树脂，并在印刷公司传达了团队所需的不同材料，除了有限的技术和3D打印功能外，还非常复杂。在一个示例中，为设备上的可调节夹具机理选择了尼龙材料。该夹具旨在拟合各种现有的直径不同的超声探针。此功能将使泌尿科医生使用现有设备从经直肠转移到跨性活检。夹具的柔软，柔性尼龙还衬有柔软的橡胶式垫片材料，可确保夹具紧紧固定在任何超声探针上。不幸的是，3D打印的零件使用了没有执行这些各种功能的树脂。也无法使用3D打印组件进行任何验证或公差测试。 In fact, there was no available 3D printed resin that would resemble the required materials of the final product.
We were not able to overcome these limitations and proceeded with conventional injection mold production and testing. However, despite the limitations at the time, the 3D printing technology still provided exceptional value. And currently there are more resins available that can be used to make components of the device, including ones that can be sterilized and implanted into patients safely.
Once a final design is agreed upon from 3D printed parts and adapted into an injection mold, engineering testing must be done. Due to the classification of this device, prior to any regulatory filing in either the U.S. or European Union, the design had to go through a battery of testing to ensure the design outputs (device performance, usability, etc.) met the design inputs; this is commonly referred to as design verification and validation. Given that the 3D printed materials of our new device could not be validated with these essential tests, we collaborated closely with the FDA throughout the early stages of development, including in clinical trials, to ensure it had sufficient oversight and could provide guidance regarding additional testing that might be needed and the order of testing. It was important to maintain transparency throughout the entire design and clinical trial processes and get the FDA’s valuable insights to ensure that we ultimately had a safe, effective, and validated product to bring to patients.
About The Author:
Matthew J. Allaway，DO是可叙学院的创始人兼总裁。该公司对患者护理的许多哲学和态度是由于阿拉维（Allaway）自己与癌症的个人斗争所致，包括他成为泌尿科医生的决定。他一直是马里兰州坎伯兰郡泌尿外科协会的执业泌尿科医生和执行伙伴，已有20年了，重点是前列腺癌和女性泌尿科。他完成了泌尿外科和手术的居住以及在西弗吉尼亚大学的实习。Allaway获得了中西部大学的博士学位，并从伊利诺伊州本笃会学院获得了理学学士学位。