Earlier (in a previous post) we addressed the importance and necessity of design control planning. They must be implemented by manufacturers of class II or III medical devices (and some class I devices). A design history file is a compilation of documentation that describes the design history of a finished medical device.The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient. Remember to give yourself and your project plenty of time during this phase. Suite 103B The outputs also provide needed important information for purchasing, production, and servicing. Medical technicians? While design control is not required for all medical devices, it applies to nearly every medium- and high-risk device. a diverse system architecture. :rolleyes: I have been reading about the Design Input documents that have been discussed over the weeks.. We have developed wearable devices, IoT devices, medical devices, consumer products, and other specialized sensor-based electronics and prototype circuits. Risk management is a critical part of regulatory compliance and has a direct link to design control. We will explain more about that later. Your clinical evaluation may include a clinical trial but is more likely to consist of safety testing, literature searches, etc. Remember that design verification methods include testing, inspection, and analysis. Basically, you need to ensure that the conditions under which the product is made for validation purposes are the same conditions anticipated for full-scale production. Also, while your developers will play a key role in developing inputs, you should also get input from people closest to the customer, such as people in Marketing, Tech Support, and Sales. Capture all functional, performance, safety, and regulatory requirements, State them in a way that allows you to prove or disprove them. Hey!! You need to define criteria for features of your medical device so that you know the product performs as expected. Design input should not just be the responsibility of one person. Design Requirements 3. I bet that most medical device designers view quality control regulations as a bureaucratic burden that slows down the development process. Design output documents must define the critical outputs (specifications, properties) and reference your acceptance criteria. And this isn’t just for new devices – in the US, FDA requires design controls for all Class II and III medical devices and even some Class I devices (notable among these are Class I devices automated with software). Outside of the U.S. a set of very similar regulations (nearly exactly the same, actually) are dictated by ISO 13485:2016. Remember, some claim design inputs should take almost a third of a project’s timeline. :) I would greatly appreciate some help with a few of my questions..!! Optimal Design of Medical Devices . A properly executed validation of design may end up poking holes in your original assumptions, and for this reason you may want to have the validation performed by an independent team familiar with the details of the project but not directly involved in the design. Careful study of the user environment and the user experience. Get the latest industry news and expert insights delivered straight to your inbox! Implementation of IEC 60601-1-2, 4th edition is on the horizon. Follow. Private sources are more expensive but can contain more specific, detailed data on devices … My advice is to make a first pass at defining all the design inputs for your medical device. when a team is involved, you get the benefit of everyone opinions and experience. Defining a comprehensive list of design inputs which can be easily proven as part of design verification is a whole different thing. The global market for medical devices is huge, and it will continue showing a significant growth in the future. Design Input Examples. The design and development process for medical devices is not as simple as in other manufacturing or service industries. This means capturing everything — all criteria about your product — what’s important, how the device should perform, and so on. Introduction. From the FDA design control guidance: “Design input is the starting point for product design. This means the medical devices used for validation have to be built in the production environment, using drawings and specifications (i.e., design outputs) by production personnel. We won’t go into detail on risk management in this article, but you can learn more about it here. Contrary to popular belief, engineers don’t typically invent medical devices on their own. All Rights Resrved. Medical device design outputs. Sometimes a design input can be verified by means other than just testing. Call them what you want (design inputs, design requirements, design and development inputs, etc. First, let me spend a few minutes on providing some background on Design Inputs. Defining a comprehensive list of design inputs is one thing. However, final design validation must be conducted on actual production devices. Keep in mind defining Design Inputs is often iterative. And without a strong foundation, bringing a new product to market can be problematic. I noticed after the fact that the image size affected the rest of the site. You should always consider this step during design inputs, and write your inputs in a way that makes them easy to verify (or at least as easy as possible) when the time comes. |, Quality System Audits for ISO 13485, FDA QSR, MDSAP, Complaint Handling and Postmarket Surveillance, EU In Vitro Diagnostics Regulation (2017/746), EU Medical Device Regulation (MDR 2017/745), Procedure for design requirements (intended use, patient and user needs), Functional, performance, and safety requirements for intended use, Other requirements essential for design and development, Component, material, production, and process specifications, Quality assurance specifications, procedures, and acceptance criteria, Work instructions, installation and servicing procedures. Industry standards and man… User needs are a starting point for building the foundation of your medical device. The Depending of the type of design, input can come from the customer, market research, feasibility study, medical standards, past projects, FDA, ISO, etc. Engineer modifies analysis input files accordingly in preparation for the next analysis Figure 1. It is also essential to know whether those design and development inputs result in the right outputs – namely, whether the design you created is safe and functions as planned. You can follow him on twitter @creoquality and read all his latest blog posts here, including the comprehensive 13-part series The Ultimate Guide To Design Controls For Medical Device Startups. They should be objective and measurable, not abstract. A good practice is to make a prototype and to do some informal bench testing to help make design inputs clear and objective. You need to consider all aspects of the medical device you are designing and ensure that you have defined all design inputs. . When a team is involved, you get everyone’s experience and opinions, which will make the effort stronger. And including this as part of design inputs is perfectly fine. Sources and timing of support for medical device innovation can be viewed in the context of the medical device life cycle, which can be described in five main streams or pathways of activity: (1) regulation, (2) research and development, (3) manufacturing, (4) marketing, and (5) legal. Verification testing proves conformance with documented design outputs and inputs, whereas production testing determines whether the unit being tested has been manufactured correctly. Here is the official FDA Design Controls regulation pertaining to Design Inputs, as found in 820.30(c):ISO 13485:2003 also covers this topic in section 7.3.2 Design & Development Inputs:Just by reading what FDA and ISO have to say about Design Inputs, you can see there are several terms used interchangeably when referring to Design Inputs: 1. In simple terms, design verification proves that you built the device correctly according to all specifications. Wording User Needs or Design Inputs can be challenging but do not have to be. The first iteration is likely to be ambiguous and vague. Design inputs can and will come from various sources. These needs could be anything that delivers a solution such as a new or better way of monitoring health, enhanced care delivery solutions, devices or technologies to deliver better administration or anything that supports health and a human life.These … Simply put, verification confirms that the design output meets the design input requirements, while validation ensures that user needs are met by the medical device. FDA Design Controls. Validation is a summation of those efforts to ensure that your design meets user needs and intended uses. Sources for Design Inputs can be: 1. The quality system requirements for design output can be separated into two elements: Design output should be expressed in terms that allow adequate assessment of conformance to design input requirements and should identify the characteristics of the design that are crucial to the safety and proper functioning of the device. Your list of design inputs needs to be comprehensive. Yet, sometimes we either trivialize or do not invest much time defining user needs. Government sources are usually more cost efficient and contain nationally representative populations so that national estimates can be determined. or which performance target to relax . Production testing is rarely comprehensive enough to verify the design. Design Input Requirements 4. Also, design input can change based on needs … Besides user needs and the team, there are several more sources you should consider while defining design inputs: This list isn’t exhaustive, but it’s a good start. Remember that everything you establish during your design input phase will have to be proven during design verification. However, there is a key difference between user needs and design inputs. FDA requires you to perform design validation “under defined operating conditions on initial production units, lots, batches or their equivalents.” This includes software. OUTPUT. According to the FDA’s design controls guidance, design inputs can take up as much as 30% of the project timeline for complex designs. This means that if your timeline is 12 months, design inputs should take at least three months to define. Design Inputs 2. All of this must be documented, reviewed, and approved before the design is released. 21 CFR Part 820 - Quality System Regulation, Subpart C - Design Controls, 820.30 Design controls ; ISO 13485:2016: Medical Devices - Quality management systems ¬Requirements for regulatory purposes ; FDA/CDRH - Design Control Guidance for Medical Device Manufacturers, March 11, 1997 . 2 Objective Sources For Design Inputs Predicted values of responses such as stress, deflection, flux, temperature, flow, pressure, etc. Design verification proves you designed your medical device correctly. As for timing, the design validation is completed after clinical evaluation is complete. ), getting your design inputs right is the most important thing you can do to make sure your device is developed correctly. The fourth edition was issued by the International Electrotechnical Commission (IEC) in February 2014. Table of Content: 1 Purpose. Defining Design Inputs It is your job to figure out how to define these so that all are clear and objective. Only now develop your medical device according to this design input. Patients can provide valuable input into the potential risks and benefits of a medical device, as well as provide insight into the design and development of new technology. Regulations mention the need to define acceptance criteria (usually as part of design outputs). Keep in mind that these user needs are a precursor to the design inputs. There are two common types of validation. Get the latest articles from Med Device Online delivered to your inbox. This all becomes part of your design history file (DHF). These needs aren’t always obvious to the target user, as common problems are often regarded as inconveniences that must b… Design control is not just about controlling the design inputs. Design validation, on the other hand, ensures that the device meets user needs and intended uses and will therefore become a viable product in the marketplace. Medical devices play an important role in the delivery of many health care services. In addition to helping you with design inputs, the informal testing can also help you establish test methods for design verification purposes. Like other industries, Medtech innovation starts with analyzing and identifying the market, the need of which is untapped or unmet or there is a more efficient way to address those particular needs. During this process, you will ensure that all of your design outputs meet the design inputs. This website uses cookies to ensure you get the best experience on our website. Engineer decides how to change input parameters . Fax: 732.548.4085, Medical Device Regulatory / Quality Training & Consulting, This is the second post in a 3-part blog series on medical device design control. Medical Device Design Input includes the features, requirements and performance criteria of a medical device. Design inputs will make or break your project, and mastering the art of writing good ones will take some time. This stage is very important as the better the design inputs are, the more effective and efficient the medical device will turn out to be. Your product developers play a key role (but not the only one) in developing the design input requirements, regardless of who developed the initial product concept. The engineers and designers responsible for developing the medical device use the design inputs as the criteria. He is also the founder of Creo Quality, a consultancy that specializes in assisting startup medical device companies with product development, quality systems, regulatory compliance, and project management. Ah, that reminds me, I must apologize to those in the UK. The US FDA likes to see these activities displayed in a traceability matrix. By Jon Speer, founder & VP of QA/RA, greenlight.guru. Now let’s talk about the specific design inputs that need to be defined and tracked. With design inputs, it’s time to get concrete. Don’t conflate verification testing with production testing. Your validation needs to be performed based on each intended use. Basically, design inputs should specify what the design is intended to do but they should avoid specific design solutions. The finished design output documentation is the basis for your device master record (DMR). About The Author Including Acceptance Criteria Design control is not just about controlling the design inputs. It is my opinion that when you define clear and objective design inputs and keep design verification in mind while doing so, you will instinctively include acceptance criteria as part of this process. Once again, you need to establish a procedure for verifying the device design and maintain records of the results of the verification and any subsequent actions. Poor Design Inputs means a weak foundation. delivers high quality products on time and on budget. One example of a design input is that the catheter outer diameter must be no larger than a previous design that is an 8 French catheter. We cover the, Our team is here to help. Solid Design Inputs makes the rest of medical device product development easier too. As you define inputs, it is important that you properly identify the customers using your device. Design and development for medical devices has to deal with relevant regulations, product safety, and risk controls on product defects in addition to the usual application requirements, specification requirements, and end customer needs. The engineers and designers responsible for developing the medical device use the design inputs as the criteria. Data sources exist because of focused surveillanceor administrative programs. Design inputs are the foundation of medical device development. 1095 Morris Avenue Jon Speer is the cofounder and VP of QA/RA at greenlight.guru, a software company that produces beautifully simple quality management software exclusively for medical device companies. Call 1.800.472.6477 or, © Oriel STAT A MATRIX. For this reason, medical device developers should define clear, measurable, and objective Design Inputs, that aid medical device development down the line. :bigwave: I have read some very good posting about Design Input!! Your validation needs to define the critical outputs ( specifications, properties ) and reference sources of design input for medical devices criteria. From Med device Online delivered to your inbox discover, uncover, and features of your product of... 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