Too often we sit in meetings assuming we know what our customers want and how they will react to our products in development. Think about the meetings you attend where you discuss clinical planning, brand strategy, positioning, or messaging for new products in development. In these meetings, how often have we all heard statements that begin with the phrases, “I think”, “This will be an improvement”, “In my opinion”, or the most famous of all – “We know our customers” without having the benefit of customer feedback and insights on hand. It’s easy for meetings to turn into waxing philosophical dissertations given by the most vocal members in the room and group conjecture as to the future licensing royalties and product sales we’ll generate as a result of our new formulation or phase II clinical trial results. 

 

For new product planning, not being tuned in to your target customers can lead to commercial development disasters. When I was in strategic planning for a large biotech company, we evaluated a number of in-licensing opportunities and observed the effects of “Tuned Out” product development on numerous occasions. Needless to say, we passed on all of these as they appeared to create more problems than they solved.

 

On one occasion, we evaluated a human plasma derived fibrin glue product that provided a natural “sealant” that surgeons could use during surgery to control bleeding and act as a natural suture. Fibrin glue consists mainly of thrombin and fibrinogen which, when mixed together, create a “biological glue”. The components come in different vials and are applied with a double syringe injection device that combines the two main ingredients with a “Y” applicator just before injecting or spraying into the surgical field. 

 

A non-US biopharma company, which I’ll refer to as “Biopharma”, approached us with a “great opportunity” to in license their fibrin glue candidate that they had recently completed phase III clinical trials on and were gearing up for their FDA BLA submission for licensure in the US. They indicated that their greatest value proposition was that they used human sourced thrombin as opposed to the leading competitor who used bovine derived thrombin, and that avoiding the risk of CJD “mad cow disease” was more than compelling enough to steal share away from the market leader. (Note: this was in 2002 when mad cow disease was on everyone’s mind. No pun intended!)

 

They further indicated that the leading competitor included a bovine derived protein stabilizer in their formulation and that Biopharma’s product included a non-animal component stabilizer called tranexamic acid. As a side note they informed us that tranexamic acid could cause cerebral edema and seizures if it came in contact with the CSF during neurosurgical procedures, and that the FDA would likely require a Black Box Warning as a result! No worries, however – just the small price you have to pay to get rid of the cow proteins!! 

 

Our management was interested in entering the fibrin sealant market and asked my group to conduct some due diligence market research with surgeons. We had an interesting time when we tested this concept in focus groups. Early into the first focus group, we realized that bovine products were the least of surgeons’ concerns, and the only real value proposition we saw was for Biopharma who was looking to generate revenues from another plasma therapeutic product.

 

Surgeons could not care less where the product came from. They assumed that if the FDA approved it, the risk of viral transmission was too low to worry about. As one surgeon succinctly stated, “we don’t care if the thrombin is bovine derived because they keep all the sheep isolated in a pen”! Tranexamic acid on the other hand caused a great deal of concern. Although my opinion is irrelevant, I think this company spent too much time speculating in their boardroom than talking with potential customers when designing and developing their product.

 

Interestingly, during the focus groups, we heard an earful of frustrations about existing fibrin glue products and very clear direction on what a solution would need to look like to solve their problems. The competitor’s product had to be warmed, reconstituted, and stirred prior to administration. In many surgeries, the surgeon couldn’t predict whether they would need to use fibrin glue, and if they needed it, they had to halt surgical procedures to prepare the fibrin sealant prior to use. This lead to countless delays and frustrations.

 

1.            Surgeon calls the blood bank or pharmacy to order fibrin glue. If he/she is lucky, it’s already stored in the OR and this step can be avoided.

2.            15 minutes later it arrives in the OR suite.

3.            Components arrive as a kit in 4 different vials in a lyophilized freeze dried state.

4.            Place all 4 vials into a warming and stirring device for 5 minutes to warm the vials. Some physicians affectionately referred to this device as “that damn Easy Bake Oven(note: click on this link for a bit of American pop culture nostalgia!)”

5.            Transfer components from vial #1 into vial #2

6.            Place vial #2 back into the “EZ Bake Oven” for upwards of 20 minutes for warming and stirring to dissolve components.

7.            If after 20 minutes components are not fully dissolved, discard vial and prepare a fresh kit. – It actually says this in the package insert!!

8.            Once vials #1 and #2 are successfully mixed, add the components from vial #3 to vial #4

9.            Swirl to dissolve. – Phew! No more EZ Bake Oven needed.

10.       Load vials 2 and 4 on to the applicator, which is then ready for use.

11.       40 minutes after ordering, apply sealant to surgical site. 

12.       If laid flat, applicator gums up after a few minutes and needs to be reamed out to continue use, or another order placed to blood bank or pharmacy for new fibrin sealant kit.

13.       Arrrrrrrrrrgh! plus other expletives from surgeon, nurses and OR staff.

14.       Surgeon late again for office patients. 

15.       Hospital administrator calls and asks why OR schedule is delayed again.

16.       Surgeon comes home late. Spouse mad again. Dog gets kicked.

 

Fortunately, Biopharma did think of some of these problems when formulating their product. They had a premixed solution to address these issues. The only problem was that this solution had to be stored at -18C or colder in special freezers that many pharmacies did not have and had too short a shelf life to keep on hand in OR or pharmacy refrigerators if thawed out! So here’s the tradeoff – EZ Bake Oven versus very cold frozen brick vials that need to be gradually thawed prior to use!

 

 

 

 

·        What are their greatest patient care challenges related to your target product concept application?

·        What are their greatest FFUDs?

·        What do they do now to minimize or avoid FFUDs? Why?

·        What, if at all, are they looking forward to doing differently when new products in development come out? Why?

·        Develop descriptions or personas of customers based on differing FFUD factors.

 

  

 

 

For starters, Biopharma should have conducted focus groups instead of us, the potential licensee, to understand unmet needs and behavioral drivers for surgeons as they address the need for surgical sealants during different surgical procedures. 

 

 

Armed with FFUD factors early on and current/pipeline product limitations, Biopharma would have a clear indication of surgical procedures where fibrin glue is most needed, and an understanding that any solution would not only need to satisfy safety and clotting needs, but would also need to be more convenient and easy to use than existing alternatives in order to garner significant use and market share.

 

 

Biopharma could have directed resources towards development of a stable, room temperature liquid formulation, which was not out of the realm of feasibility if they utilized alternative formulations. The ability to stabilize as a liquid at room temperature could have been go/no go criterion for continued commercialization of fibrin sealants Biopharma was developing internally, and/or a key criterion when evaluating potential in-licensing opportunities. 

 

Biopharma could also have explored partnering with medical device manufacturers to improve the design of applicators and co-develop or license unique applicators that don’t easily clog. As there was no real IP on the biological components, a differentiating IP estate could have been developed around applicators to create a sustainable advantage for any future Biopharma fibrin glue product.  

 

 

 

 

Interestingly, this product was licensed to a US company, but was never a big seller and the original licensor has since dropped the product line. Maybe things could have been different if Biopharma took a Tuned In approach to new product planning!

 

Fortunately for Biopharma, the product was reformulated and is now licensed to a major medical device manufacturer with expertise in surgical devices and the product is delivered via a novel spray tip applicator. All is well that ends well!