Recently I attended “The Convergence of Medical Devices and Drugs” sponsored by MassBio and MDG Boston. The meeting was well attended as many pharmaceutical and device companies, large and small, seek to figure out how to efficiently take combination products to market.
Combination products are products that deliver a drug through a medical device. A simple example is a band aide that has bacitracin right on the pad. Other examples are the subcutaneous insulin pump for diabetics. Numerous devices that combine a device, drug and technology tracking methods are currently in development.
Twenty years ago, the FDA did not have requests for approval for combo products so no process was established. Now the biggest area of growth is for combo products – either for new drugs, new devices or for finding new ways to administer generic drugs with devices.
The speakers gave valuable advice.
- Have an IP strategy – for both devices and the drug - comprehensive research must be done in both areas in all countries to avoid problems. Even if a company positions the therapy as one or the other (a drug or a device), know how others might position a similar product.
- Know the landscape – For example, Cocoon Biotech is developing delivery methods with the use of silk (yes, the fabric). Cocoon Biotech knows of many other companies developing synthetics but sees opportunities for differentiation here by using a natural fiber.
- Develop a strong team – include people knowledgeable in the drug, biologic, device, engineering, and technology aspects of development during the process, to explore possibilities and avoid pitfalls.
- Define the ownership – As David Dykeman of Greenberg Traurig said, make sure to define ownership at the start. All is easy when it’s going well, but you want it clearly defined upon break-up. Just as 50% of marriages break up, so do partnerships. Plan for this.
- Have a regulatory strategy for both – Just as with IP, a company needs to meet regulatory requirements for both the drug and the device. The processes are different so bring both representatives to the meetings early in the process.
Laura Indolfi of PanTher Therapeutics told about their decision to focus on the biologic FDA approval since they knew in the future they would want a large pharmaceutical company to take their product to market. Repeatedly, the speakers talked about going to market strategies while still in the early stages of development.
In addition, the speakers talked about the importance of developing early and ongoing dialogue with the FDA. In all meetings, take good meeting minutes, agree to clear timelines, and get the attendees to agree to what was said. This becomes important as there is frequent turnover in personnel and you don’t want this to be the reason for delays.
Obtaining capital in the industry has shifted – venture capitalists are investing more money in fewer companies. This affects the combo products the most as VC’s tend to specialize in either the pharma or device side. The speakers recommended other sources of funding – physicians that understand the disease, athletes, foundations, angels, hospitals, and philanthropies. In addition, they offered suggestions on how to keep capital needs down by leveraging other studies, and understanding approval needs – for example the FDA looks for safety and efficacy whereas the payors need to see the benefits for use such as back to work, faster healing, cost savings. All these things need to be considered at the start of development.
US companies struggle with the FDA approval process for combo devices, but compared to other countries, the US is more advanced. There is discussion for harmonization internationally for an approval process, but this still seems far away.
Raina Dauria and Diane Francis of Ethicon both elaborated on the go to market strategy and the importance of clarifying this early in the process. Companies must clearly identify your value proposition such as faster recovery, quicker return to work, easier to administer and be compliant AND understand the TPP (target patient population). Prior to spending the development costs, companies must know this information for the US and global markets that they consider pursuing. Since there is no harmonization, research must be for all the separate countries.
Rapport International can help with expansion into global markets by providing not only translation services for packaging, information leaflets, instructions, etc.; but we can also provide globalization and localization services and consultations. Our expertise can be invaluable when bringing your combo product to market in a new country. Contact us to discuss any questions about this or about The Convergence of Medical Devices and Drugs conference.