The Journey to Commercializing a Medical Device: Key Milestones and Considerations


May 2023

From conception to commercialization, the development of medical devices is a complex procedure involving a number of steps. In the United States, 75% of medical device startups fail, and 30-40% of investors lose their entire initial investment.

The cost of bringing your product to market will include obtaining regulatory clearance or approval. Medical device manufacturers spend an average of $31 million to bring a device to market through the 510(k) clearance pathway, according to a survey conducted by the Medical Device Manufacturers Association (MDMA). For devices that require premarket approval (PMA), the average cost is significantly higher, at $94 million.

This procedure can take several years, necessitate a substantial financial investment, and involve a multidisciplinary team of specialists. This blog will examine the key phases of medical device development, the challenges and opportunities presented at each stage, and the most recent developments in this rapidly evolving field.


The concept for the device is generated during the ideation phase of medical device development. This phase can be difficult because it requires developers to identify a market need that is not currently being met. According to a Green Light survey, 70% of people who work in development roles think that investing in the right tools and resources for design and development is what drives innovation in the medical device field.

Many businesses are turning to open innovation, a process in which they generate new ideas in collaboration with external partners. This strategy can assist businesses in leveraging the expertise of a wider range of stakeholders and increasing the likelihood of identifying unmet market needs. For instance, the Mayo Clinic’s Center for Innovation has collaborated with medical device manufacturers to develop new products based on patient and healthcare provider feedback.

Concept Formation

Once an idea has been conceived, concept development commences. During this phase, the device’s design is refined, and an initial understanding of its functionality is developed. This phase can include initial prototyping, testing, and design refinement. A study published by Starfish Medical estimates that the average cost of developing a concept (including proof of concept) for a 510k cleared medical device is approximately $3.8 million

One of the greatest obstacles during this phase is ensuring that the design complies with regulatory requirements. In recent years, there has been a greater emphasis on human factors engineering, which entails the creation of devices that are simple to use and reduce the likelihood of user error. The FDA has issued guidance on human factors engineering for medical devices, advising manufacturers to consider user characteristics, use environments, and user interface design when developing products.

Design Management

The design control phase entails the creation of detailed design specifications, including schematics, drawings, and other documentation. This documentation serves as a blueprint for the device and is essential for ensuring that it is safe and effective and complies with regulatory requirements. Design control documentation for medical device manufacturers must include “design input,” “design output,” “design review,” “design verification,” and “design validation,” per FDA guidelines.

During this phase, ensuring that the design documentation is accurate, complete, and up-to-date is one of the greatest obstacles. Especially for larger medical device companies with multiple product lines, this can be a daunting task. Some businesses are turning to automated design control solutions to address this issue.

Evidence of the Concept

In the stage of proof of concept, the device is tested in a laboratory to ensure that it functions as intended. This may involve bench testing, testing on animals, or additional preclinical studies. During this stage, ensuring that testing protocols are rigorous and reproducible is one of the greatest obstacles. This can be especially difficult when testing complex medical devices that interact in a variety of ways with the human body. Before beginning clinical testing, some companies are utilizing simulation and modeling techniques to predict device performance and identify potential failure modes.

Design Verification

During the design verification phase, the device is tested under controlled conditions to ensure that it conforms to its design specifications. This may include performance, safety, dependability, and durability testing. Failures in design verification are expensive and can result in the rejection of submissions, warning letters, recalls, loss of market share, or, in the worst-case scenario, patient harm. Design verification is one of the most frequently cited sections in recent FDA warning letters that contain findings pertaining to particular sections of the Design Control regulation.

One of the greatest obstacles at this stage is ensuring that the testing is exhaustive and accurately reflects the intended use of the device. This can be especially difficult for devices intended for use in a variety of clinical settings or by a variety of healthcare professionals. In order to overcome this obstacle, some businesses are turning to virtual testing environments, which can simulate real-world scenarios and identify potential problems before clinical testing commences.

Clinical Trials

Most times, before a medical device can be approved for commercialization, clinical trials will be required by regulatory agencies such as the FDA. In clinical trials, the device is evaluated on human subjects to determine its safety and effectiveness. According to a study published in the JAMA network, clinical trials account for approximately 40% of a medical device’s total development costs.

Recruiting patients to participate in the clinical trial is one of the greatest challenges faced during this phase. This can be particularly difficult for devices designed to treat rare diseases or conditions. Some companies are turning to patient advocacy groups and online patient communities to assist in the identification of potential trial participants.

Regulatory Approval

Before a medical device can be introduced to the marketplace, regulatory approval is the final hurdle in its development and our medical device consulting helps you. The regulatory approval process varies from country to country and can be intricate and lengthy. In the United States, the FDA regulates medical devices, and the approval process can take years.

Depending on the type of device and regulatory requirements, this procedure can take several months to a few years. First, it is essential to comprehend the various regulatory approval or clearance pathways for medical devices in the United States. The two most prevalent routes are the 510(k) route and the premarket approval (PMA) route.

The 510(k) pathway is a process that enables device manufacturers to demonstrate that their new device is “substantially equivalent” to a legally marketed device in the United States. This pathway typically requires fewer clinical data points than the PMA pathway and is frequently used for moderate-risk medical devices. When a device completes the 510(k) regulatory process, the device is referred to as “cleared”.

In contrast, the PMA pathway requires more extensive clinical data to demonstrate the safety and efficacy of a medical device. This pathway is typically reserved for higher-risk, not-yet-marketed devices. When a device completes the PMA regulatory process, the device is referred to as “approved”.

According to the FDA’s Center for Devices and Radiological Health, the average time between submission and clearance for a 510(k) submission is 177 days or just over 6 months.  However, identifying the appropriate consulting agency to assist with this process is critical to achieving this timeline, The average time between submission and approval for a PMA submission is 243 days, as per a report by FDA. Likewise, the identification of the optimal agency to support this regulatory process is even more critical.

One of the greatest obstacles during this phase is ensuring that the device complies with regulatory requirements. This can be especially difficult for devices intended to treat rare or complex diseases, for which there may be insufficient data to support their safety and efficacy. In order to overcome this obstacle, some companies are utilizing real-world evidence, such as data from electronic health records, to supplement clinical trial data and support regulatory approval.


The final stage of medical device development commences once a device has been approved for commercialization. This phase involves bringing the device to market and ensuring that healthcare professionals and patients adopt it.

Obtaining reimbursement from payers, such as insurance companies and government healthcare programs, is one of the greatest obstacles encountered during this phase. This can be especially difficult for devices intended to treat rare diseases or conditions, for which there may be limited data to support their cost-effectiveness. Some companies are turning to value-based healthcare models, which focus on improving patient outcomes while reducing costs, to address this challenge.

In summary, the development of medical devices is a complex and difficult process that requires significant expertise and resources. Each stage, from conception to commercialization, presents its own opportunities and challenges. Medical device companies can overcome these obstacles and create innovative products that improve patient outcomes and advance the field of healthcare by utilizing cutting-edge technology and collaborating with a diverse group of stakeholders.

Strategy Inc., a leading medical device development consulting firm, offers a vast array of services to assist businesses in bringing their products to market efficiently and effectively. With these services, Strategy Inc. assists businesses in streamlining the medical device development process, lowering costs, and bringing products to market more quickly. Our team of experts has in-depth knowledge of the industry and a track record of success, making them the ideal partner for companies seeking to bring innovative medical devices to market.


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