Device Discovery and Concept
FDA classifies medical devices based on the risk posed by a device. Medical devices can change classification systems depending on the results of scientific data.
Class 1 devices pose the least amount of risk to consumers. These low-risk devices, such as oxygen masks or surgical tools, are subject to “general controls.” General controls ensure the safety and effectiveness of devices once they’re manufactured. General controls consider the following factors:
- Good manufacturing practices
- Standards and reporting adverse events to FDA
- General recordkeeping requirements
Class 2 devices pose more risk to consumers than do Class 1 devices. Therefore, Class 2 devices are subject to special controls in addition to general controls. Special controls include:
- Labeling requirements (information that must be included on a product label)
- Device-specific mandatory performance standards
- Device-specific testing requirements
Class 2 devices are also subject to general controls.
Usually, Class 3 devices support or sustain life, are implanted in the body, or have the potential for unreasonable risk of illness or injury. Examples include pacemakers, breast implants, and HIV diagnostic tests. As a result, Class 3 devices require premarket approval. To receive this, a manufacturer must prove that a device is safe and effective. Class 3 devices are also subject to general controls.
Development & Concept
Medical device development follows a well-established path. Many of these steps overlap with each other as scientists invent, refine, and test the devices.
Typically, the development process begins when researchers see an unmet medical need. Then, they create a concept or an idea for a new device. From there, researchers build a “proof of concept,” a document that outlines the steps needed to determine whether or not the concept is workable. Many times, concepts are not practical. The concepts that do show promise move to the later stages of development.
Preclinical Research – Prototype
Researchers build a device prototype, or an early version of a medical device. At this stage, the device prototype is not for human use. Researchers test the prototypes in controlled laboratory settings. Refining the prototype provides researchers with important information about the product’s potential use for people. The prototype process attempts to reduce risk of harm in people. However, it is not possible to eliminate risk entirely.
Pathway to Approval
The pathway to approval for a medical device depends on its risk classification.
Device Application Process
Because there is so much variation in the classification of devices, developers have a variety of options.
Federal Food, Drug, and Cosmetic Act, section 513, established the risk-based device classification system for medical devices. Each device is assigned to one of three regulatory classes: Class 1, Class 2 or Class 3, based on the level of control necessary to provide reasonable assurance of its safety and effectiveness.
As device class increases from Class 1, to Class 2 to Class 3, the regulatory controls also increase, with Class 1 devices subject to the least regulatory control, and Class 3 devices subject to the most regulatory control.
Device Pathways to Market
Special Controls – E.g., meeting FDA-recognized performance standards, postmarket surveillance, patient registries.
Device “types” that have never been marketed in the U.S., but whose safety profile and technology are now reasonably well understood.
Devices for orphan diseases
Intended to benefit patients in diagnosis and/or treatment of disease or condition affecting or manifested in fewer than 4,000 patients per year in the United States.
The regulatory controls for each device class include:
Requires proof that the device is substantially equivalent (SE) to a legally marketed device that is not subject to Premarket Approval (PMA).
A device is considered substantially equivalent if it has the same intended use and the same technological characteristics as a legally marketed device. A legally marketed device was:
- Legally marketed prior to May 28, 1976 (“preamendments device”), for which a PMA is not required, or
- Reclassified from Class 3 to Class 2 or Class 1, or
- Found substantially equivalent through the 510(k) process
Applicants must compare their device to one or more similar legally marketed devices and make and support their substantially equivalent claims. If the device is substantially equivalent to an approved medical device, it is placed in the same class. If it is not substantially equivalent, it becomes non-SE and is placed into Class 3.
Examples of 510(k)s include x-ray machines, dialysis machines, fetal monitors, lithotripsy machines, and muscle stimulators.
Premarket Approval (PMA)
PMA refers to the scientific and regulatory review necessary to evaluate:
- The safety and effectiveness of Class 3 devices or
- Devices that were found not substantially equivalent to a Class 1 or 2 predicate through the 510(k) process
PMA is the most involved process. To reasonably determine that a device is safe and effective, PMA requires:
- Scientific evidence that the possible benefits to health from the intended use of a device outweigh the possible risks
- That the device will significantly help a large portion of the target population
Independence is an important concept for PMAs, meaning that each PMA should establish the safety and effectiveness of the device under review, and that data about one device cannot be used to support another.
Examples of PMAs include digital mammography, minimally invasive and non-invasive glucose testing devices, implanted defibrillators, and implantable middle ear devices.
FDA Device Review
If medical device developers have enough information on a device’s safety and effectiveness, they can file an application to market the device to the public. The type of application they file depends on the device’s class.
- Humanitarian Device Exemption
Humanitarian Use Devices benefit patients by treating or diagnosing a disease or condition that affects fewer than 4,000 people. Before they can market a Humanitarian Use Device, developers must submit a human device exemption and must demonstrate that there are no similar, legally approved devices on the market and that there is no other way to bring a Humanitarian Use Device to market.
- Premarket Notification or 510(k) – Class 1, 2 and 3 Devices
Premarket Notification, also known as a 510(k), indicates that the Class 2 medical device is similar to others on the market. To support the claim, the developer compares the new device to one or more similar, legally marketed devices.
- Premarket Approval Application – Class 3 Devices
Premarket Approval applications must be submitted for Class 3 devices and must include data from all nonclinical studies and clinical studies. During the approval process, FDA will inspect the manufacturing laboratories and facilities where the device will be made to check for good manufacturing practices.
If appropriate, FDA will consult an Advisory Committee at a public meeting. FDA Advisory Committees consist of groups of experts who provide FDA with independent advice on an issue. The panels recommend whether a product should be approved or not.
After the Advisory Committee meets, FDA decides whether the device is approvable or not approvable, or request additional information. By law, FDA must publish its decision with all supporting evidence in the Federal Register.
FDA Post-Market Device Safety Monitoring
Although premarket clinical trials provide important information on a device’s safety and effectiveness, it is possible that new safety concerns will emerge once the device is on the market. As a result, FDA continues to monitor device performance after a device has been approved.
FDA officials conduct routine inspections of medical device manufacturing facilities across the United States. Manufacturers may be informed of inspections in advance, or the inspections may be unannounced. Inspections may be routine or caused by a particular problem. The purpose of these inspections is to make sure developers are following good manufacturing practices. FDA can shut down a manufacturing facility if standards are not met.
- FDA has several programs that allow manufacturers, health professionals, and consumers to report problems associated with approved medical devices.
- MedWatch, FDA’s adverse event reporting program, is a gateway for reporting problems with medical products (drugs and devices) and learning about new safety information. You can subscribe to regular MedWatch safety alerts.
- Medical Product Safety Network (MedSun), an adverse events reporting program, monitors the safety and effectiveness of medical devices. FDA recruits 350 health care providers throughout the United States to report any medical device problems that result in serious injury or death. Each month, FDA publishes the MedSun newsletter. The newsletter gives consumers important information about medical device safety.
Under the Sentinel Initiative, FDA is developing a new national system to more quickly spot possible safety issues. The system will use very large existing electronic health databases–like electronic health records systems, administrative and insurance claims databases, and registries–to keep an eye on the safety of approved medical products in real time. This tool will add to, but not replace, FDA’s existing postmarket safety assessment tools.
This is a general overview from the point of view of the FDA and what a manufacturer will need to do overall. Omnica’s role usually begins toward the end of Phase 2 and extends through Phase 3.
Within that scale, however, product development methods can differ significantly, and there has been a constant area of research and systems all slated to assist in product development. These include
- Waterfall Process
- Agile / Scrum
- Phase Gate Systems
- IDEO Model
- Booz, Allen and Hamilton Model (BAH)
A recent study from NIH concludes the following:
The findings of the selected studies show that the comprehensive MDD life cycle comprises five phases: opportunity and risk analysis phase, concept and feasibility phase, verification and validation phase, product launch preparation phase, and product launch and post-launch assessment phase. These individual MDD phases are linear and separated by gates that are characterized by certain set criteria that must be met before MDD can proceed further. That is why the whole MDD process is also called a linear stage-gate process, which is the most commonly used process in the development and innovation of medical devices.
However, Goldenberg and Gravagna (6) identified several gaps in the traditional stage-gate product development process. They point out that the stage-gate approach is linear, without a full life cycle plan and that companies, especially smaller ones, mainly focus on regulatory approval milestones than on providing significant returns to potential stakeholders. They suggest implementing an integrated customer engagement roadmap approach that identifies all stakeholder requirements/needs and device-specific marketing messages for product differentiation. Furthermore, detailed information on budget, timeline for data studies, and communications and marketing is included. Overall, a global launch strategy is implemented.
In addition, Cooper and Sommer (33) proposed the hybrid “agile-stage-gate” approach, which can be integrated into the traditional stage-gate model for the following benefits:
- It is built on customer needs in a cost-effective way.
- It reacts quickly to needs.
- It copes with uncertainty and ambiguity that are typical of innovative developments.
- It deals with resourcing issues more directly.
Furthermore, the sources of risks that can threaten the whole MDD process, in terms of price, timing, and quality, should be carefully considered to avoid failure. The key issue is meeting user needs. As far as the legislation aspects are concerned, the key issues are consistency in the classification of devices in the EU countries, as well as the transparency of the approval process worldwide.
Individual MDD phases are closely connected with risks (50–54) that the individual steps bring about. For example, developing a new medical device is quite costly and risky (36); its success significantly relies on the application of accurate processes (9). Product designers and developers attempt to reduce these risks; however, tough competition encourages them to investigate the sources of risks during the MDD process, which can threaten the MDD process in terms of price, timing, and quality (38, 41). Aguwa et al. (55) reported that medical technology is quite unsuccessful (90%) during the first prototype test, which should be carefully considered by any MDD company. Some researchers have evaluated risks in medical device design. Privitera et al. (38) indicated the integration of human factors as one of the methods to reduce risks during the design stage of the MDD process; however, challenges exist because of the implementation of standards. These challenges can be solved if both parties, medical device developers and users, cooperate. Schmuland et al. (56) provided practical ideas to allow medical device manufacturers to evaluate residual risk of their devices. Risk analysis (ISO 14971) and failure analysis (FMEA) were combined by Chan et al. (57) to ensure device quality in the design phase of the MDD process, with a case study of a ventilation breathing circuit. Rane and Kirkire (41) summarized the key risks into three main groups: user-related sources of risks, internal sources of risks, and third-party-related sources of risks. User-related risks include poor translation of user requirements or unmet user needs/requirements. Internal risks are due to the lack of application of adequate standards to check device performance; poor consideration of the effect of labeling and packaging; or poor communication among device developers, end users, and marketing. Third-party-related sources of risks may include lack of training for end users; improper or poor assessment of progress by reviewers; and poor planning for regulatory and clinical approvals and tests. Their findings indicate that the most important source of risks is unmet user needs, which means that user needs should be met to successfully market any device.
The detection of risks and their sources in the MDD process plays a significant role, because it can prevent a lot of adverse effects of the use of medical devices by end users, save a lot of time on design and development of the medical device, and reduce costs during the MDD process.
You can obviously do a lot of research yourself on the topic. However Omnica has developed its own niche in the medical device development world by simplifying rather than increasing the amount of process and hierarchy applied to the process. Some important factors include:
Omnica has remained a staff of approximately 30 people for over 30 years. We have found this to be optimal. The reasons that as organizations grow, additional process and communication must be implemented that inherently slow things down. It is simple, our customers come to us because we are more efficient and experienced and get things done. Anything that stands in the way of that seems superfluous to us.
In that vein, we have developed extensive prototyping and modeling capability within our organization. (See our video tour.) We can build most prototypes internally without sending them out to shops or service providers. This serves to greatly reduce the time needed to iterate a design as well as reduces opportunities for miscommunication.
Omnica has been able to retain key employees for long periods of time. In fact, as of this writing, the average tenure of Omnica employees is 18 years! This contradicts conventional wisdom where people are cogs in the organization that are easily switched out for someone else. We understand that experience in creative pursuits is critical to speed and success. We do this, among other things, by limiting the number of projects that we work on at one time we do not work on everything that comes our way. We make sure we have the resources available without overworking people, and we make sure that the work is interesting, creative and that we are working with customers are a pleasure to work with. (Not always a perfect process to be sure.)
While the rest of the world is obsessed with growth, we are very happy to focus on profitability and success of our projects, and contentment of our employees. These are some of the things that have been lost in our money-/growth-obsessed society.
The Omnica Way
We are a group of people who love to innovate, build and test things. Therefore our process reflects that. We generally work in 3 phases, sometimes 4.
This phase is only necessary if a customer does not have clear documentation of what they intend to make. If we believe we can assist with this process, we will propose a phase 0. Usually the output of phase 0 would be a product requirements specification with details on exactly what we intend to develop. We might explore some-high level industrial design concepts in this phase as well.
Phase 1. Concept Development
After identifying risk areas within the design, we immediately begin to attack those and build and test them to ensure that we have solutions for the technically risky aspects of the system. We will then integrate the subsystems into a fully working alpha prototype that can reliably perform all the desired functions. We will test this system and collect data to prove it and plan the subsequent design of the final product.
Phase 2. Design and Development
We will design and build several Beta prototypes of the final manufacturable design. This will be built and tested, including prescreens for electrical, safety etc. These beta units will be fully functional and look like the final product. They may not, however, be produced from production tooling.
Phase 3. Design Transfer
Generally, when the product moves to higher volume production, we will work with our customer or their chosen manufacturer to begin the design transfer process. This will include producing the entire drawing package, test plans for sub systems, assembly demonstrations, work instructions, test fixture design, etc.
All along the way we make certain to communicate at least weekly. These more formal reviews are accompanied with presentations that indicate the progress of the project. Along with that we issue weekly billing statements or invoices that track the budget. Keeping the progress reports closely tied to the billing ensures that there are no misunderstandings.
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