Updated: Jun 28
TECHFIT Digitally Integrated Surgical Reconstruction Platform - DISRP ®-
The medical device industry is experiencing significant growth, and it's not hard to see why. With the average life expectancy increasing globally , thanks to advancements in biomedical technology that have improved patient outcomes and reduced hospital stays, the demand for medical devices is on the rise. Additionally, the growing elderly population and ongoing healthcare improvements in developing countries are contributing to the continued growth of the medical device market.
Our last blog was regarding the dimensional validation process for TECHFIT Orthognathic Surgical Guides. TECHFIT Orthognathic Surgical Guides are patient specific devices that are manufactured by rapid prototyping from Biocompatible Clear Resin. Those guides are 3D design planning on CAD software. There are several platforms available that allow medical doctors to interact with 3D designs and then manufacture them. These platforms typically use computer-aided design (CAD) software to create 3D models, which can then be modified and customized by case planners with the support of medical professionals.
DISRP is one of the platforms that includes tools for medical devices that can be customized to fit individual patients.
TECHFIT DISRP has functionalities that include, uploading medical images (such as DICOM and optical scan STL), and a scheduling feature where surgeons and sales representatives can schedule meetings and video conference calls with case planners. This system also allows physicians to inspect and approve planning and device design through an interactive viewer of their 3D medical images.
What is DISRP?
The Digitally Integrated Surgical Reconstruction Platform (DISRP) is a web-based collaboration software for digital surgery case flow management and surgery planning that reflects the production process and allows for the interaction of multiple users: surgeons, sales representatives, and the TECHFIT case planning staff (case planning assistant, case planners, and operations director), using multiple devices. It allows easy collaboration in the planning process. Being web-based allows immediate and convenient sharing without the installation or maintenance of the application at the user’s end.
The Digitally Integrated Surgical Reconstruction Platform (DISRP) has three different modules:
1. Case management
It provides comprehensive information of the case status such as case ID for traceability (surgeon, hospital, surgery date, type of solution requested), quoting, manufacturing process, meeting planning, design. The left menu presents a drop down list that gives you access to your cases. Additionally, community, records and support buttons are available for the users. The main screen shows your ongoing cases and gives you access to create new ones.
Once you clic in "create a new case" you will be able to select the product from our portfolio. Consider your location, not all products are commercially available in the U.S.
2. 3D viewer and planning module
The 3D viewer and planning module was developed to assist surgeons in the digital planning for reconstructive surgeries, allowing to eliminate the need for traditional model surgery.
The DISRP 3D viewer and planning module includes measurement and transformation tools (rotation and translation) to assist the end user in creating their surgical plan.
The software allows multiple users over multiple devices to exchange annotations, add anatomical landmarks, do 3D anthropometric landmarks, digitally correct malocclusion, review different design proposals, assess potential surgical situations, and approve the design of splints and surgical guides.
3. Community – Digital surgery network
It is a virtual medical community where surgeons can share their anonymized cases worldwide to exchange feedback, for instance, by “liking” the case or contacting the case surgeon.
Why digital surgical planning?
Digital surgical planning is a rapidly growing field that has become increasingly common in recent years. It involves using computer-aided design (CAD) software and medical imaging data to create a detailed plan for a surgical procedure. This allows surgeons to visualize the patient's anatomy in detail and plan the surgical procedure accordingly.
Digital surgical planning has many advantages over traditional surgical planning methods, including greater precision and accuracy, faster and more efficient surgeries, and better outcomes for patients.
The global market for digital surgical planning software is expected to continue to grow in the coming years, driven by factors such as the increasing prevalence of chronic diseases and the growing demand for minimally invasive surgical procedures.
The software development process is a crucial part of medical device manufacturing, and it's crucial to regulate it properly. From TECHFIT, we give thanks to Cohesive Maufacturing for helping developing this amazing project.
Medical device manufacturers must follow to the software development and verification activities outlined in IEC 62304  to achieve this. These activities include design planning, software description, software requirements specifications, requirement analysis, architectural design, software design, unit implementation and verification, software integration and integration testing, system testing, and software release. The software development life cycle also involves risk management, configuration management, and problem resolution processes, which are guided by IEC 62304 at each stage of the software development process .
 https://ourworldindata.org/, “Life Expectancy - Our World in Data.” https://ourworldindata.org/life-expectancy (accessed May 03, 2023).
 International Standard IEC, “Medical device software-Software life cycle processes.” [Online]. Available: www.iec.ch/online_news/justpub
 N. Carroll and I. Richardson, “Software-as-a-Medical Device: demystifying Connected Health regulations,” Journal of Systems and Information Technology, vol. 18, no. 2. Emerald Group Publishing Ltd., pp. 186–215, 2016. doi: 10.1108/JSIT-07-2015-0061.