There is an explosion of novel and emerging healthcare technologies that could meet unmet clinical needs, improve patient outcomes, and enhance a patient’s quality of life. Innovative healthcare technologies are emerging globally from the US, Europe, Asia, and Latin America.
New technologies have different requirements than traditional drug therapies. However, planning for the successful development and approval of a new technology is based on the same guiding principles as any new treatment and includes a clear understanding of what the unmet clinical need is for the technology, how it will be approved, and how it will be reimbursed.
Determining the unmet clinical need begins with understanding how all stakeholders including patients, healthcare providers, regulatory bodies, and payers would like to see outcomes improved. Talk with patients to understand how you can help them better manage their health. Physicians will share how they are involved in bringing more safe and effective treatments from bench to bedside. Today, regulators are open to discussing early clinical programs and how these programs can later align with regulatory pathways for approval. Engage payers early on to understand the interests in reducing healthcare costs and possible reimbursement strategies.
Bringing a novel healthcare technology to market successfully requires different knowledge and skills than a traditional therapeutic drug. To maximize success and minimize hurdles, a strategic global approach to select the right development pathway that demonstrates a benefit to patients is critical. Novel technologies will be adopted if the technology is proven to be clinically safe and effective, if it is easy to use, and payers see value in covering the cost.
Developing a product concept
A critical first step is to develop a product concept that clearly outlines the clinical unmet need the technology will address. The product concept should include the following:
- Whether the novel technology is a medical device, biopharmaceutical, or combination
- The intended indication and patient population for the novel technology
- How the technology is used and its risk-benefit analysis
The answers to these initial questions will begin to clarify the development needs for bench testing, pre-clinical, and clinical studies; as well as provide an indication of the level of risk in developing this technology.
Determining a development pathway
Once the product concept is developed, the next step is to prepare a development plan to prove the concept and answer important questions before entering pre-approval and approval phases. The development plan should outline key product concept development activities, a global regulatory strategy, pre-clinical work, early proof of concept studies, and clinical studies.
The goal of the development plan is to demonstrate with strong and high-quality data how the technology will make an improvement on the target patient population. The development plan is a good place to include country-based regulatory approvals that will be sought, high-quality bench testing, non-GLP vs GLP work, deep risk-based analysis, and alignment of quality management systems with clinical outcomes.
Planning is an important process, but success will not be achieved unless action is taken. There are many steps along the path to develop a novel technology and see it through regulatory approval. It can be overwhelming to keep the development process focused on activities that will accelerate clinical development and regulatory approval. I have four recommendations including:
- Stay focused—Develop global regulatory and reimbursement strategies that support the product concept. It’s easy to get sidetracked on secondary uses, which can extend the timeline for development and approval.
- Make plans—Outline the study design elements with a timeline to ensure regulatory and reimbursement strategies are met.
- Be selective–Country, site, and investigator selection are critical. Most sites are suited for specific types of studies whether it is based on indication, type of technology (ie, device or therapeutic), or phase (ie, bench, pre-clinical, clinical studies) Not all the sites are capable of handling all types of studies.
- Engage technology—Streamline study processes and data collection by using electronic tools to ensure processes are followed and data is collected in an efficient and credible manner.
It is an exciting time to be developing new emerging technologies—there is so much genuine interest from stakeholders and so many possibilities. Having a clear understanding of what the unmet clinical need is for the technology, how it will be approved, and how it will be reimbursed will help inventors and companies determine the next steps needed to bring the technology to market. Additionally, don’t hesitate to engage partners with the expertise needed and local footprint to guide and assist in developing the new technology.
What do you think? Please share your thoughts and experiences in developing new healthcare technologies. What hurdles did you run across? Were you successful in engaging partners? Share your thoughts in the comments section below.