Chrissy Bell, Global Business Leader – Inhalation and Connected Health, 3M Drug Delivery Systems
Many of today’s pharmaceuticals are delivered by a specialized device. To explore all the considerations that go into bringing such complex products to market as well as the potential benefits for patients, MD+DI checked in with Chrissy Bell, Global Business Leader – Inhalation and Connected Health, 3M Drug Delivery Systems, and asked her a few questions.
How are drug delivery manufacturers and pharmaceutical companies working together these days to develop devices?
Bell: Generics are having a major impact on how pharmaceutical and drug-delivery entities work together. Foremost, pharmaceutical companies are faced with the challenge of differentiating their branded drugs from competitors who are selling the same formulations. One very important differentiator is how the drug is delivered. If Product A creates a better patient experience than Product B, making it easier and more efficient for patients to administer the medication, we theorize that Product A will be in higher demand in the marketplace.
Moreover, with the arrival of generics comes the growing need for increased speed and flexibility in order to compete in a fiercely competitive space. In the generics world, a successful business model is dictated by three main factors: being the first to arrive on the market, offering the lowest cost option for consumers, and maintaining the quality expected from the brand-name product. Due to that, all parties involved are facing significant price pressure. They must produce a high-value product at a low cost.
These realizations can be daunting for pharma companies that have little to no experience with alternative delivery systems. In these situations, working with a partner that is seasoned in development and manufacturing of niche delivery methods is critical to the success of the project, and it can make the development and regulatory path much smoother. By working in partnership with drug-delivery providers, pharmaceutical companies can quickly determine if an alternative delivery form is technically feasible for a drug.
Moreover, as scientists and engineers begin drafting new designs for drug-delivery methods, they are now starting with the patient at the ground level and working their way up. Historically, that has not been the case, and it has caused a disconnect that has inadvertently left patient circumstances out of the equation. The benefit of this new approach is the ability to first understand patient circumstances and the challenges they present. Technology makes it easier to address those issues on the front-end, with the goal to ensure better results on the back-end.
Overall, market dynamics are making it more advantageous for pharmaceutical companies to closely partner with drug-delivery manufacturers to solve evolving needs in a complex industry.
Are such devices evolving into digital and/or connected devices? What are the opportunities and challenges?
Bell: Technological breakthroughs could drastically change the scope of drug delivery. Inhalation technology, in particular, has experienced pivotal development in recent years. By identifying new ways to more accurately and efficiently deliver drugs to the lungs, we’re on a promising path toward improving patient outcomes across the board.
For instance, a 2008 research report showed that up to 94% of patients make mistakes when using their inhalers, and these were the dry-powder inhalers that were intended to be easier to use. 1 Additionally, up to 60% of patients don’t adhere to their medication. When patients forget to dose themselves or inadvertently use their inhalation devices incorrectly, it doesn’t matter how great the drug is—it will be less effective.
Digital health is helping to solve these usability and adherence issues. For example, the 3M Intelligent Control Inhaler (ICI), which is currently in development and not available for commercial sale, is breath-actuated so that patients do not have to coordinate their in-breath with triggering of the device. It can provide feedback and tips on the user’s technique to encourage and promote correct use. The device could also send reminders to a patient, to help empower patient adherence.
The improved delivery of drug to the lungs in the right dose and at the right time has the potential to be game-changing. By addressing adherence and usability, we theorize that digital health devices could one day aspire to improve the lives of patients by helping to reduce complications related to asthma and COPD, which in turn could also have an impact on health care costs. Other advancements include finding more effective and efficient ways to run clinical trials, which will reduce the cost of development and allow pharma to invest even more resources into research and development. Also, there is the added benefit of reducing development cycle time, allowing life-changing medicines to be brought to the patient much sooner.
In regard to challenges, we know that whenever a new technology is introduced, growing pains are inevitable. For example, in surveys, doctors have revealed that technology is often one more thing standing between them and their patients. The challenge is to make sure the newest drug delivery devices help the doctor-patient relationship, rather than hinder it. Learning how to use a new device takes time. As high-tech drug delivery devices arrive on the market, a big part of our job is doing everything possible to make sure patients, providers, and payers view such learning curves as short-term investments that can yield long-term gains of efficiencies and improved care.
What are some of the regulatory challenges faced when developing such devices, and how can they be overcome?
Bell: As technology changes and evolves, so does the regulatory process. Regulating drugs is entirely different than regulating electronics and software, but these are now more and more intertwined. Regulators are working to stay ahead of the curve, as well as the rest of us. Because of the speed at which electronics and software technology advances, we all need to move at a quicker pace. It’s a new way of working for this industry. We also need to police ourselves to act with integrity and to be proper and productive stewards of patient data.
What are some of the technical challenges faced when developing such devices, and how can they be overcome?
Bell: Protecting patient privacy must be a top priority. There are tremendous opportunities ahead for collecting, sharing, and analyzing data generated by digital delivery devices; however, we need to instill trust in patients from the very beginning. To do that, we need to make sure patients understand how and why we’re using their data, and we need to clearly demonstrate how they will benefit from the use of their data.
Additionally, security, privacy and data strategy can’t be afterthoughts. These factors all need to be part of the design process on the front end, as opposed to trying to retrofit a secure solution. It is critically important to determine the data strategy before going into design and development.
How can such devices be made user-friendly?
Bell: Technological advancements are offering new opportunities to more accurately and efficiently deliver drugs throughout the human body. Getting medication to the lungs in the right dose on a consistent basis can be tricky. Not only can technology help solve that issue, it has the ability to empower patients to take control of their own health and manage their conditions more effectively. When instant feedback is in the palms of their hands, patients will have more opportunities to be engaged and in control of their own health.
Any other concerns or opportunities?
Bell: I believe digital drug delivery could empower patients to become better stewards of their own health and ultimately improve the quality of their lives. Sometimes simple behavior changes can go a long way to helping improve someone’s health, and companion apps could serve as a coach and guide to empower patients to achieve their goals. Novel technologies are particularly helpful for patients with chronic conditions that require a long-term commitment to staying on track.
Digital solutions could also help doctors monitor patients between visits and identify individual health trends over the course of months and years. They could also assist caregivers, like parents of children with asthma, in administering treatment and monitoring conditions. By encouraging and empowering the caregivers of patients, digital solutions could help reduce their stress and could help improve their quality of life, as well.
It is exciting to be a part of this new wave of innovation and partnership between pharmaceutical and drug delivery organizations. By working together, we are continuing to not only drive better business models, but also creating devices that are more effective and improve patient outcomes.
1. "Effect of incorrect use of dry powder inhalers on management of patients with asthma and COPD," Lavorini et al., 2008. Respir. Med. 102(4):593-604.