Lessons from three successful translations (product on the market)

Introduction

Health care professionals generally see many problems that they can envisage a solution for if someone could help overcome some limiting aspect. Academic scientists, engineers, and others could help with such problems if they understood them well enough. In addition, both groups often lack an adequate understanding of the regulations and market issues that are needed to move a technology forward to general use. Commercial enterprises are usually very aware of such market issues, but such understanding varies greatly in small start-up companies. These communities exist near each other at many universities, but contacts are weak.

What is the basis for this weak collaboration, and how can a CTSA promote a better partnership?

Three examples of taking an idea to a commercial reality are given in the links. Each took much longer to achieve success (defined here as having a product on the market) than desired, but the common causes of delays can indicate how to improve the process. There are many more unsuccessful examples which are also instructive, but are not examined here. Many of the unsuccessful examples are a potentially rich source of untapped technologies that could be both useful to improve patient care, and profitable for the developers, if the CTSA’s can find effective ways to promote cooperative ventures or provide the missing connections, personnel and skills

Key Lessons Learned

1. Things usually start small, and have modest or no success, but continued and regular interaction can lead to more productive collaborations.
   Measurable: key participant interaction time before filing a patent which is the basis for a commercial product. This is not often discussed, but may be the most significant factor. Trust is essential, and can be built through experience working together or through formal written contracts. Early contract construction can delay things from getting started, and can even engender distrust, but they are helpful once things are moving along. “Boiler plate” agreements make the process much easier, as well as experienced negotiators. CTSA’s can provide both, if only through a list of reliable contacts.  As seen in Table 1, it took more than five years of experience working together to establish the relationships that led to the progress in these cases.
2. Understand the regulatory environment as early as possible, and talk to the FDA (they can be very helpful). Consultants were less helpful initially, than talking directly, as one excellent consultant did advise.
   Measurable: has a discussion been made with the FDA, and a contact person identified there? Perhaps finding the “right” consultants would make things move better, but we found that going to the potential licensee/customer, or to the agency directly was the most efficient way to get started…and by far the least expensive in terms of time and money.
3. Look for really different approaches to problems since they have the best patent protection. Each of these three examples discussed here is (in the author’s opinion) the technical leader in what it does.
   Measureable: eventual real-world adoption of use, licensed patents, de novo FDA clearance (rather than 510(k)). There are volumes written on how to direct research to achieve commercial success, but most researchers in a university setting do not read them. Industrial experience helps quite a bit to make researchers “market-sensitive” as does consulting with business entities. It is important to balance such activities with academic responsibilities. One of the important elements to recognize is to work in an area where there are limited market leaders. Another factor (harder to determine) is whether there is limited small area variation in product use. Both of these factors indicate that the field has the capability to evaluate technical merit, rather than be swayed primarily by authoritative opinion or marketing. This means that “all one has to do” is find a way to produce a product with the best technical merit to be successful (using the word “technical” in a very broad sense).
4. Facilitate integration and understanding of the different cultures that exist in respective colleges, especially for communication and funding.
   Measurable: interdisciplinary funding, publications and other joint activities. Few academics become rich, but many find their work fun and fulfilling. Often this is because such jobs evolve with new collaborative opportunities. Physicians will forgo some clinical income to participate in a risky research opportunity because it is often a change, a new challenge, and has the opportunity to improve care for a large number of patients. Scientists and engineering faculty often enjoy such collaborations for the same reasons, and this includes a chance to get away from the “ivory tower” routine. However, the financial, promotion, and cultural reward systems of the academic units mitigate against this in many cases. For instance, scientists are sometimes criticized for being “too practical” or engineering faculty for working on problems that are too “low tech” even though they are often the real barriers to improving health care. Community engagement is also only marginally supported, although the biggest chance for impact is often by taking such considerations into account. The CTSA’s have the opportunity to change such limitations

How the CTSA can help the process

• Connect investigators , advise patience and persistence.
• Provide regulatory advice and contact with industry.
• Promote real novelty in problem solving.
• Encourage discussions between disciplines.

(Note: some of the CTSA’s are doing most of the above already! We just need to keep at it: with patience and persistence. I think that forming small focus groups that meet regularly will have the best long-term impact.)

Examples of ideas being developed into commercial products

• NanoTherics (magnetic gene delivery)
• Bioguard Dressings (contact microbicide)
• HyGreen (hand-washing monitor)