Medical devices are inventive products that help improve people’s well-being and save lives. Developing medical devices is similar to creating new pharmaceuticals. There are strict regulatory requirements to fulfill and extensive care must be applied to create the safest and most reliable solutions.
Thanks to medical device product development, we can easily perform all kinds of medical procedures that would otherwise be extremely complicated. Medical devices are used in all areas of healthcare, including hospital care, first aid, dentistry, paramedics, and by laypersons at home. From bandaging a sprained ankle to diagnosing a viral infection, medical devices are used in all kinds of health activities.
Depending on the type of device, it may be useful for the prevention, diagnosis, or treatment of illness and disease. Likewise, medical devices are used for detecting, measuring, restoring, correcting, or modifying the structure or function of the body for health purposes. Medical devices are developed for purposes that can’t be achieved by pharmacological, immunological, or metabolic means.
According to the World Health Organization (WHO), there are an estimated 2 million different kinds of medical devices worldwide and these fall under more than 7000 categories. A medical device may be an instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material, or other similar or related article (source).
It is considerably complicated to develop medical devices. Not only is it necessary for medical device companies to implement utmost care when developing medical devices, but it is also important to always comply with the rigid requirements set by regulatory agencies such as the FDA and the MDR. To allow medical devices to be both effective and safe to use, a series of unique phases must be followed.
The FDA ascertains that the medical device development lifecycle involves five distinct phases. Together, these form the quality system regulation (QSR). The QSR is meant to govern the methods for the design, manufacturing, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. In addition, it also oversees the facilities and controls that will be used during medical device development (source).
The stages of development of medical devices outlined by the FDA are:
However, different regions have different legislative requirements and standards for the development of medical devices. For instance, the EU’s MDR doesn’t include specific articles for design and manufacturing, as these are regulated under article 10 of the MDR.
A medical product should be developed to address the requirements for its intended use. Nonetheless, five general steps can be outlined in the development lifecycle of any medical device:
The development of medical devices begins with risk analysis operations. The purpose of these is to determine whether it is safe to proceed to the next phase. An initial design and development plan must be settled.
A design and development plan must consider the following steps:
Outline the intended use of the medical device.
Analyze the current market to find similar or equivalent products.
Determine the demands of the product’s target demographic and market differentiation in order to make it appealing to consumers.
Gather data about user needs to use ad inputs during the design process.
Determine how the typical user will use the product. During this step, factors such as the device’s classification, technical documentation, and verification should be planned.
Create a comprehensive design and determine project milestones such as initial design, prototyping, user feedback, accelerated life testing, tooling fabrication, reliability testing, and clinical trial.
It is important to note that a risk and benefit analysis must be conducted after the completion of each phase. This analysis must be updated as the research and development process continues.
The second phase oversees the feasibility of the medical device in various ways and ends with the creation of a product prototype. During this phase, a formal risk assessment is performed. Regulatory and customer requirements are collected.
Information about customer needs is gathered by collecting feedback from surveys and research on patients and clinicians. Likewise, analyzing the competition can also produce valuable insights. Once customer needs are thoroughly documented, the initial design and development work can start. A product prototype is created as a proof of concept. This prototype will serve to update information on customer needs.
In addition, a feasibility study is conducted. This study must:
Once the third phase is reached, design outputs must be created. Design outputs must include product drawings, components, materials, parts, pieces, specifications, bill of materials (BOM), work instructions, user guides, and similar information. The final product prototype is created, but design work can be complemented by the creation of more prototypes.
Inputs from user needs and regulatory requirements must be listed, and outputs based on those inputs must be checked. Prototypes must be tested based on all the requirements determined in the previous phases. During this phase, it is required that planning, design, review, and approval occur continuously.
An auditable record of the actions taken to reduce the risk of illness, failure, and end-user harm must be created. To guarantee the safety and reliability of prototypes, a series of validation procedures must be performed. If clinical trials have been deemed necessary for the proper development of the medical device, then these must be initiated at this phase.
Medical products should be set up with a traceability system and registered with the UDI (Unique Device Identification) database of the EU or the FDA. Traceability is a critical procedure to improve user safety. It promotes the accurate reporting of adverse events, a reduction in medical errors, and more effective handling of recalls and complaints.
When phase 4 arrives, a medical device should have completed operational qualification (OQ) and performance qualification (PQ). However, these processes should keep going. It is advisable to complete three small-scale manufacturing pilot runs and collect critical-to-quality data for statistical analysis with each of them. This will confirm a medical device’s process capacity.
If pilot runs are performed in the worst conditions possible, such as low process inputs with high control limits, valuable information about the “process window” will be gathered. This will help create a more acceptable final product. Gathered data can be used to confirm what attributes are critical-to-quality, and thus devise how they will be kept under control during mass production.
It is necessary to plan for everything that will help keep the manufacturing process under control. For instance, device manufacturers must consider the maintenance of equipment and the training of staff. Additionally, component suppliers should be monitored to make sure they work according to the required specifications. The studies and reports related to the V&V (validation and verification) of a medical device must be passed. All evidence of testing like biocompatibility and electrical safety must be gathered alongside other essential parts of technical documentation like stability testing and shipping trials. The literature documentation must support all the collected evidence and all technical documentation must be ready for review/audit from competent authorities.
Before delivering a medical device to the market, it must first have a validated and verified production plan. This will help deliver safe and high-quality products on time and within budget. All plans should continue to be verified in accordance with regulatory requirements.
Regular inspections and audits are to be conducted. It is imperative to notice any issues from batch-to-batch variation. Checking production and QMS processes guarantees technicians will be able to detect any discrepancies more accurately.
Once products are available in the market, customer data should be gathered from users, patients, hospitals, technical operators, distributors, and other relevant entities. The MDR requires that Post-Market Clinical Follow-Up (PMCF) and Post-Market Surveillance (PMS) activities be conducted. These confirm the accuracy of the benefit-to-risk profile and ensure product safety, performance, and lifetime.
Depending on the nature of the device, documentation must be created to help users operate it following relevant guidelines and regulatory requirements. These documents may be user guides, IFUs, training manuals, or commercial brochures. If the medical devices are to be manufactured by a third party, they must have access to all the information required for production.
It may take between three to seven years for a medical device to go from development to approval. This process includes the entire device lifecycle, including research, development, and testing. Thanks to TechSlice’s accelerator program, you can significantly reduce the time it takes to develop a medical device. Our team has developped medical devices in as little as 1.5 to 3 years.
Medical devices are exceptionally varied and the exact price of medical device development fluctuates according to what kind of device is created. For example, the development costs of a defibrillator will be very different from those of a tongue depressor.
Regardless of the type of medical device being developed, it must still undergo a thorough development, design, and testing process. Device manufacturers must be able to certify they’re using the right technology, industrial design, safety, usability, proof of concept, manufacturability, packaging concepts, and many other factors, and the certification process is bound to accrue heavy fees.
While providing an exact figure for medical device development is difficult, the total funding costs for a Class 2 medical device (a device that poses a moderate to high risk to the patient/end-user) are estimated to be around $30 million. The engineering and development costs of such a device may be around $2-5 million.
All medical devices meant for use in the US market must undergo some level of FDA clearance. The required regulatory control depends on the type of medical device.
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