The idea for new medical devices, like most new product innovations, often stems from the discovery of an unmet market need — in this case, products that can help people better monitor and manage their health, aid providers in improving care delivery, or devices that enable better treatment administration. User needs are abstract, using words like “easy,” “better,” and “simple.” This is a good way to state user needs, because it keeps things broad enough to tweak during the process. It is intended to be a reference text that will be on your desk, right next to your iPad and cellphone. Contrary to popular belief, engineers don’t typically invent medical devices on their own. Suite 103B 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 … Of all the design control activities, developing a solid foundation of requirements is the most important. When a team is involved, you get everyone’s experience and opinions, which will make the effort stronger. 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. Design inputs is one of those times. Design inputs have been described by the FDA as the most important part of the entire design control process. Union, NJ 07083, Phone: 1.800.472.6477 . Design inputs will make or break your project, and mastering the art of writing good ones will take some time. Sources for Design Inputs can be: 1. 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. This is referred to as acceptance criteria. Remember that design verification methods include testing, inspection, and analysis. it is a team effort. Ah, that reminds me, I must apologize to those in the UK. Think of your design inputs as a contract of sorts. :bigwave: I have read some very good posting about Design Input!! Design Inputs 2. The Lewin Group. 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. With design inputs, it’s time to get concrete. All of your validation activities become part of your design history file (DHF). Would like to hear what are some of the best practices as to writing User Needs and Design Input … Wording User Needs or Design Inputs can be challenging but do not have to be. Becoming A Design Input Artist Remember that everything you establish during your design input phase will have to be proven during design verification. Your validation activities should address the needs of all stakeholders including patients, health-care workers, installers/servicers, and the physical healthcare environment itself. Design controls for medical devices are regulated by the FDA under 21 CFR 820.30. We will explain more about that later. However, there is a key difference between user needs and design inputs. There are two common types of validation. It is your job to figure out how to define these so that all are clear and objective. The requirements that make up the design inputs establish a basis for performing subsequent design tasks and validating the design. The engineers and designers responsible for developing the medical device use the design inputs as the criteria. Government sources are usually more cost efficient and contain nationally representative populations so that national estimates can be determined. Process validation uses objective evidence to make sure a process consistently produces the same result. Solid Design Inputs makes the rest of medical device product development easier too. 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. The requirements which form the design input establish a basis for performing subsequent design tasks and validating the design. Design Input Requirements 4. First, let me spend a few minutes on providing some background on Design Inputs. In simple terms, design verification proves that you built the device correctly according to all specifications. Introduction. The medical device industry is a heterogeneous, innovative, and dynamic sector. This is vital, because all design verifications and validations are matched to customer needs and related technical requirements. Optimal Design of Medical Devices . Clifford Goodman, Ph.D. Senior Scientist. Only now develop your medical device according to this design input. You need to consider all aspects of the medical device you are designing and ensure that you have defined all design inputs. Verification testing proves conformance with documented design outputs and inputs, whereas production testing determines whether the unit being tested has been manufactured correctly. Predicted values of responses such as stress, deflection, flux, temperature, flow, pressure, etc. Design verification proves you designed your medical device correctly. The engineers and designers responsible for developing the medical device use the design inputs as the criteria. You need to define criteria for features of your medical device so that you know the product performs as expected. What does “defined operating conditions” mean? The first iteration is likely to be ambiguous and vague. They must be implemented by manufacturers of class II or III medical devices (and some class I devices). For this reason, medical device developers should define clear, measurable, and objective Design Inputs, that aid medical device development down the line. 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). The fourth edition was issued by the International Electrotechnical Commission (IEC) in February 2014. User needs are a starting point for building the foundation of your medical device. During this process, you will ensure that all of your design outputs meet the design inputs. Design output requirements are intended to apply to all stages of the design process, and to characterize important aspects of the design. In simple terms, verification challenges the design throughout its development to see if you designed the device correctly. Depending of the type of design, input can come from the customer, market research, feasibility study, medical standards, past projects, FDA, ISO, etc. User needs (also known as customer attributes) 2. Defining a comprehensive list of design inputs is one thing. Earlier (in a previous post) we addressed the importance and necessity of design control planning. Also, design input can change based on needs … |, 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. The Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) has identified both government and private sources of medical device data (Table 1). Sometimes a design input can be verified by means other than just testing. Let’s get going deep into the design challenges faced in the manufacturing of medical devices. 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. 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. Medical Technology or MedTech, as it clearly implies, is the integration of technological developments into the field of medicine and healthcare. Validation is a summation of those efforts to ensure that your design meets user needs and intended uses. As you define inputs, it is important that you properly identify the customers using your device. Having the ability to establish design inputs with design verification in mind is definitely an art. Primarily, you should pull from your user needs to define the design inputs. Jon Speer is the cofounder and VP of QA/RA at, a software company that produces beautifully simple quality management software exclusively for medical device companies. A good practice is to make a prototype and to do some informal bench testing to help make design inputs clear and objective. design a medical device for sale within the global medical devices community – be that a simple scalpel or an MRI scanner. As for timing, the design validation is completed after clinical evaluation is complete. This collateral standard to the IEC 60601-1 medical safety standard specifies the electromagnetic compatibility (EMC) requirements for medical devices and systems. cure, mitigation, treatment or prevention of disease” and are not absorbed or metabolized by the body.1 The term applies to Becoming A Design Input Artist Verification can be accomplished using one or more of the following: Your design verification records, by the way, need to include the date and person who performed the verification as well as methods, acceptance criteria, and any statistical techniques used. Medical Device Design Input includes the features, requirements and performance criteria of a medical device. In a nutshell, design inputs define all the performance criteria, requirements, and features of your product. Your design validation process must include initial production units. Your clinical evaluation may include a clinical trial but is more likely to consist of safety testing, literature searches, etc. Modify Design. OUTPUT. 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. They ultimately bear responsibility for translating needs into a set of requirements that can be validated prior to implementation. And no one person on the team should have the sole responsibility for design inputs. The design of medical devices requires an understanding of a large number of factors, many of which are difficult to teach in the traditional educational format. 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. or which performance target to relax . 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. The Design Input Examples. Jon explains, in very clear language, how to go about drafting design inputs and outputs so they capture the critical factors that will ensure your medical device design will meet quality standards. 8 Design Input 21CFR 820.30(c)• Design inputs are the physical and performance characteristics of a device that are used as the basis for device design. Are they lay consumers? 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. There are a few goals to consider while approaching Design Inputs: Defining great design inputs is an art form. Production testing is rarely comprehensive enough to verify the design. 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