George Washington Crile MD, an Ohio-born surgeon and co-founder of the Cleveland Clinic, was an innovative surgeon who performed the first direct blood transfusion in 1906 and made important contributions to the literature on shock and anesthesia. He found that shock and blood loss during surgery contributed to high mortality rates and ultimately developed the concept of nerve-block anesthesia or a concept that is now known as pre-emptive analgesia.
Dr. Crile would go on to perform over 25,000 thyroidectomies in his career, and his idea of operative anesthesia, or “pre-emptive analgesia”, has been proven to minimize postoperative complications and enhance recovery; it is now common practice in the surgical world. Medical innovation has come a long way since pre-emptive analgesia, but the thought process behind medical innovation remains the same: provide a practical solution that addresses a problem or a need to help provide better care.
On a practical level, the innovation process has evolved. Whether it be the patent process, FDA Approval/Clearance or eventual market penetration, there are hundreds of steps for modern innovators to take to bring an idea to fruition. Nevertheless, key innovation fundamentals remain the same.
Vision: The First Ingredient of Innovation
All medical innovations start with an idea. Great ideas are generated by those that have the most fundamental innovation ingredient: vision. Visionary medical device innovators have a deep understanding of the medical field and a strong grasp of their marketplace, available competitive solutions and direction in which the industry is moving. Visionaries have the ability to identify true pain-points within the industry and can then create innovative solutions to address them. For example, obvious pain-points are safety issues that potentially put either patients or medical professionals at risk. Less obvious pain-points come from current solutions that clinicians are already using. If health providers aren’t satisfied with the cumbersome or inefficient tools or methods at their disposal, then there is room for innovation.
Boldness, Adaptability and Inspiring a Culture of Innovation
The next fundamental is boldness and flexibility. Identifying a need or an issue and conceptualizing its solution is meaningless if innovators don’t have the courage to invest in that solution. For large or globally established players, taking a leap and investing in an idea or a solution that addresses a specific pain-point can be difficult. These companies may have hundreds of new ideas to consider each year and the need to correctly identify which projects to put their financial resources behind is usually based on risk aversion. These decisions can be easier for smaller companies, which usually have fewer choices to consider and higher risk tolerances. A smaller, more agile player can often be bolder in this arena and push innovation at a faster pace.
In order for boldness to persevere, leaders must commit to inspiring a culture of innovation, a passion for problem-solving and allay the fear of risk of failure. Team members need to understand just how daunting medical device innovation is and be prepared for the long haul. This process can take years to complete and will most likely be shaken up by pivots and design changes that can occur spontaneously, even after the device hits the market. Team members need to have the foresight to recognize that answering this medical need can impact patients’ lives and have the patience and perseverance to see it through.
Innovating a Product That Customers Want and Need
The development process is lengthy and can take years to complete. Innovations under consideration need to be worthwhile, addressing a serious pain-point within the industry that will excite customers and make them want to spend precious limited resources on the product. Gauging pain-point importance is best accomplished by having direct access to the end-user environment, allowing innovators to study health provider actions and motions in live scenarios. This access leads to interactions with physicians and other medical staff and lets innovators hear their opinions on specific issues or problems that they encounter. A scoring system measuring the significance of the pain point and relative satisfaction of current market offerings to address the job can be helpful.
The design and development process is far more complicated today than it once was. In order to meet regulatory requirements, companies must document and build risk reduction into the design, develop a safety assurance case, consider use environments and validate human factors (e.g., use error related to instructions for use, training, and other user interface issues), as well as develop robust verification and validation data. Developing a comprehensive design involves a multi-disciplinary team with a deep understanding of the regulatory, user and competitive environments.
Maneuvering Through The Patent Process
Once all these fundamentals are in place, the patent journey can begin. There are two necessary criteria for maneuvering through the patent process: developing an innovative product that customers want; having a patent team that believes in the product and understands the competitive landscape.
When the idea is in the early phases, employing a good patent attorney who is experienced in the appropriate market niche is paramount to developing a strong patent claim. This process usually begins with a freedom to operate search that evaluates the existing patent landscape. As the design progresses a skilled patent attorney will craft the broadest claims possible to secure a fence around the list of ideas. It is important to note that the claims anticipate not only the anticipated designs, but also as many practical alternatives adjacent to the final design.
Device Feedback After Market Penetration
Device feedback from customers is crucial and can lead to additional innovations and helpful adaptations and upgrades to the device. A few years ago, my team and I created a disposable infusion device that enables physicians to directly apply anesthetic to precise areas during and after surgery as an alternative to prescribing opioids. After our device entered the market, I attended a lung dissection surgery, notorious for being one of the most painful surgeries, to see how a surgeon was using our device. Surprisingly, the surgeon poked holes in the catheter using a scalpel so that the anesthetic infused into a larger surface area, not just the designed catheter exit point. Observing this improvisation in real-time opened our eyes to new uses for our device and eventually led to design covered by many additional patents.
The medical device innovation journey is long and difficult and requires a culture of commitment and foresight that goes beyond the immediate team, extending to all disciplines within the business. Combining this culture with an experienced team is the best recipe for innovating tools that medical professionals need to improve care and provide better treatment for their patients, resulting in elevated patient safety and experience.
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