THANK YOU FOR SUBSCRIBING
Innovation and successful new product development in any industry requires efficiently converting capital into corporate assets, which can then be sold to customers. Making the innovation process efficient gives businesses a competitive edge over their competition. Therefore, determining the viability of a new product idea should occur as rapidly as possible; this “derisks” the concept and allows for a timely decision to either allocate more capital resources to the project or to dedicate resources elsewhere.
Outside the MedTech industry, the concepts of ‘rapid prototype iteration’ and ‘minimally viable product’ allow businesses to quickly evaluate new product ideas and rapidly make feature changes based on market feedback. These iterative product development systems work in industries from fast food restaurants to software start-ups, but can these systems be used in the development of medical technology?
Where ‘rapid prototype iteration’ focuses on making changes to product features, the ‘minimally viable product’ concept focuses on what features sell the product. Even though medical device development occurs in a highly regulated environment, these customer-centric processes can still be used. Regardless of whether the product is under development in a start-up or established business, utilizing these processes requires focusing on eventual customers and capturing end user information with the goal of understanding that a final product will have a practical market.
Market testing any product idea is key to derisking the development of the product for a business. Therefore, understanding your customer and involving them as early as possible in the testing process is critical. If the end user is a medical professional, patient or a combination of many groups, customers need to be asked if they would buy the product. In order to test the product, getting out of the virtual conference room and into the real world with the customer is a must. Derisking the marketability of the product also includes communicating with the U.S. Food and Drug Administration (FDA) and should focus on cybersecurity and the clinical study strategies discussed below.
FDA Programs That Derisk and Expedite Market Entry
The U.S. FDA has several available programs that allow manufacturers to work with the agency as a partner during the product development process in an effort to ensure efficient and timely market approval. The FDA regulates medical devices, biologics and drugs including products that are some combination of these three categories. Medical devices and device-led combination products are regulated by the FDA’s Center for Devices and Radiological Health (CDRH).
In addition, the CDRH has several programs that can help companies during the product development process. The Q-Submission program allows MedTech organizations to present information to the FDA and ask questions to validate their regulatory pathway and test plan (there are no fees associated with Q-submissions). Utilizing this program helps ensure that a company is conducting product evaluations efficiently as they work towards regulatory approval.
For devices that are expected to treat, diagnose or mitigate diseases or conditions that are life-threatening, the FDA has developed a program intended to expedite these devices to market. It is called the ‘Breakthrough Devices Program,’ which is voluntary. This program allows for Q-Submission interactions with the FDA to occur in a timeframe that is faster than normal. There is additional managerial oversight with this program, and the FDA considers carefully what information is needed for market approval versus what can be gathered in the post-market phase.
“Even though medical device development occurs in a highly regulated environment, these customer-centric processes can still be used.”
For devices that are expected to significantly improve the safety of available treatments or diagnostics targeting a disease or condition less serious than those eligible for the Breakthrough Devices Program, the FDA has created a program intended to expedite these devices to market as well. It is called the ‘Safer Technologies Program (SteP),’ which is also voluntary. This program allows for the same advantages mentioned above for the Breakthrough Devices Program.
Derisking SaMD through Cybersecurity
Another development consideration for manufacturers is performing security risk management on all medical devices that contain software, firmware, programmable logic and software as a medical device (SaMD). Security risk management for cybersecurity must consider both the platform that the software runs on and the infrastructure that the software/platform operates in.
Healthcare is rapidly becoming digitalized and the number of systems used for providing care is equally increasing. As more health IT systems are introduced, their functionality has been extended, which often requires them to be connected to other systems, even via the Internet. This need for connectivity brings great advantages, but also risks in that systems can be more easily influenced by the IT environment and by people who either accidentally, or with malicious intent, disrupt or block access to IT systems or copy data from systems for financial gain or other motives.
Product safety and performance can be affected by security. Regulatory authorities expect manufacturers to address these cybersecurity concerns by considering using a secure product development framework to achieve the goal. The secure product development framework encompasses all aspects of a product’s lifecycle. Using the framework may prevent the need to re-engineer a device when connectivity-based features are added after marketing and distribution, or when vulnerabilities resulting in uncontrolled risks are discovered.
Cybersecurity testing like fuzz testing, vulnerability scanning, threat modeling and penetration testing should be conducted on systems configured in accordance with their intended operational use environment. This is essential to verify and validate not only the software, but also the technical and/or organizational use environment. Cybersecurity testing can be discussed with the FDA using the Q-Submission program, and should occur concurrently with user acceptance testing to minimize the product development cycle time.
Derisking Clinical Research
Many medical devices require human subject clinical research to gain regulatory approval and to develop evidence to drive adoption of new technologies. Smaller first-in-human and feasibility/pilot clinical studies can provide initial data to derisk a larger pivotal study, which are often required for regulatory approval. The initial clinical data can provide important insights leading to refinement of either the product or the pivotal trial design. Modern approaches to trial design can even seamlessly integrate pilot and pivotal phases into a single clinical trial to avoid duplicating expenditures required to get a clinical study up and running.
Other considerations for derisking a clinical trial include using a flexible trial design that makes use of accumulating data to verify assumptions made at the time of trial design. Assumptions such as the enrollment rate, event rate, measurement variability and expected performance of the new medical device all impact the number of patients required for a clinical study and can influence the chance of success. Using accumulating data can make a trial more robust, but requires careful planning and guidance from experienced Biostatisticians to prevent bias and ensure regulatory acceptance of final evidence. Gaining agreement with the FDA on trial design through the Q-submission process is of the utmost importance to ensure that the evidence will be sufficient for FDA to grant market approval.
A Final Note
By the time a marketing application has been developed, documented and is ready to be submitted to the FDA, knowing that the market is ready to buy the final product makes sound business sense. Testing market acceptance as early as possible, and derisking the idea throughout the development process, is essential to maximizing the use of an organization’s limited resources. This not only limits business risk, but also maximizes the potential for success of a product and the company.