Gaining market acceptance in biotechnology using a living lab: real case

How to know if a technology product will have market acceptance? What new innovations can customers and users create for the prototype? How can users and customers innovate so that technology is designed with them and not merely for them? These are some of the questions a living lab tries to solve. There are many living lab experiences in ICT technologies as well as in biotechnology, but as far as we know, the initiative described bellow is pioneering in applying living lab approaches to genomics.

genomicsThe reason is simple: products born out of the genetic research –and generally of biomedical research- seem not very adequate to be designed with users. They are developed after years of research in fields of nature that usually are no easy to be influenced by users. Most of the times they are created as an answer for a medical problem; they have to be primarily functional, not necessarily adapted. They also give answer to true and real (and often painful) needs of people, while technological products enter into saturated markets, where the need is not that clear and products compete either by added value or price. A drug does not need to get an added value: it has it already. Certainly, more easy application forms and differentiation aspects might be designed, but they are not the key point.

The product: a preconcepctional genetic test
Recombine is a genetic test that allows couples that want to have children to know the risk of inheriting a monogenic disease (caused by a single gene mutation) before the child is even conceived. The main innovation is not that more than 200 diseases can be identified with a simple saliva sample, but that a couple can know before having children, the risks they have. In case that both are carriers of homozygote mutations, the child will have a high chance to be born with a genetic disease. A chance that can be avoided by making an artificial fertility treatment and choosing the healthy embryo using the preimplantacional genetic diagnosis, a technique that is 20 years old and allows to detect if an embryo has genetic diseases and if not to implant it into the mother for further development.

Preconceptional genetic testing is important: there are over 1.000 recessive monogenic diseases. We all carry 14 to 18 recessive mutations. One in 300 children has a rare disease. Mutations are transmitted silently over many generation; they often do not show symptoms and most people do not know familiar antecedents.

There are many ways to know if an embryo has a genetic disease: amniocentesis, ultrasound, blood analysis, corial biopsy, premiplantation genetic testing, etc. But when they are done it is too late! If the result is positive, parents are confronted with the terrible decision of carrying out a child and take care of a baby and –if it survives- an adult person that will suffer its entire life or to abort, also a very hard decision.

Therefore Recombine is a blessing for couples. It identifies in a sole test and before pregnancy over 200 monogenic diseases, among them the most frequent such cystic fibrosis, muscular dystrophy, fragile X, thalasemias, etc. For the health system Recombine should be a blessing too, since a test for 12 diseases would cover the treatment for babies born with these diseases during 3 years, avoiding thus suffering and costs.

Los tests genéticos se basan en la identificación de SNPs

Los tests genéticos se basan en la identificación de SNPs

Why a living lab for Recombine?
If the product was so good, why don’t launch it directly to the market, why use a living lab? The reality of the biotechnology market is that it is full of great patents that had little commercial success. According to an interesting article by Paul Nightingale and Paul Martin (“The myth of the biotech revolution”) there has certainly been a boom of studies and publications in the sector, followed by a great number of patents that have not evolved to significant economic impact because they followed the research and business model of the pharma industry, which is slow and expensive (and secure, I would add). More recent data by Price Waterhouse Coopers confirm the trend identified by Nightingale and Martin: despite good clinical results, pharma models prevent the development of biotech companies. In fact, “from 1.606 investments done in biotechnology between 1986 and 2008, 704 investments produced total or partial losses, while only 16 covered costs”.

With this precedent, Recombine decided to apply the principles of lean start up recommended by Blank: get out to talk with your customers, even if your product or company is not ready, test with them and listen to them.

Business models based on patients and users
A living lab is a way to apply Blanks advices: it is experimentation and testing in a real environment with real users and customers that can co-create within an open and trusted ecosystem and that is able to produce technological, business or social innovation. Many still believe a living lab is a specific place, but it is a methodology. This is why we used a real customer to set up our genomic living lab.

What is Recombine’s natural market? Gynecologists and fertility clinics. For this reason and others of very practical nature we chose IVF-SPAIN. The first one, was a pre-existing relationship between Recombine and thee clinic. Second, over 80% of patients come from Europe, so that patient reactions from all Europe could be tested. Third, it has worked since its foundation with co-creation methodologies driven by employees and/or patients (due to its very patient centered approach and –here I am going to talk nicely about me- to its work with ValueCreation), so that whether management nor staff had to be trained. It is also a clinic that invests heavily in R&D, what is more valuable, since it is a medium clinic. Currently it works in 8 research projects: 3 of them are ruptural. Last, but not least it has created an innovation and co-operation ecosystems with research centres, Alicante University and over 17 clinics in all Europe, also with pharma and biotech companies. This means, that Recombine would not only be tested within the clinic’s four walls, but a much broader ecosystem was involved.

Creating a living lab for Recombine within IVF-SPAIN had as a goal testing and innovating in:

  • Technical working in real environment
  • Logistic and administrative processes
  • Use of Recombine with egg donors
  • Patient acceptance
  • Patient reactions

The living lab methodology was not applied only to testing and improvement, but also to scientific research, product innovation and anew applications.

Sequencing-Money Propiedad de genomesunzipped.orgMarket risks
Recombine is a very useful product for couples wishing a child. But how to test without risk a product that had not concluded its final scientific validation yet (though the chip worked, was tested, CE approved and was designed according to CLIA) and that had processes that were described on paper, but not implemented? Going to market in these conditions would have been very risky. For a final customer and –more important- for a patient, a mistake in a report could have had very serious consequences, that would have an impact on the physician recommending the test and on the Recombine brand.

Also, delays in delivery or unclear reports, to quote some factors that might not work properly, meant that a couple waiting for results during a fertility treatment might lose its window and start a cycle again. This is why Recombine opted to test itself in a real clinic, with real patients, but in a controlled and secure environment.

Goals of the living lab
The goals of the Recombine living lab were:

  •  Analyze the tests’ scientific viability in a clinical environment
  • Identify and understand patient’s reactions to the product and also its acceptance
  • Test the Recombine processes
  • Innovate in the product or the treatment

Set up
The Project design was very simple in order to interfere in a minimal way in the clinic’s daily business. The medical director was in charge of the scientific analysis. The conversations with patients to “sell” Recombine and get to know patient insights were responsibility of the clinic director. The director was given a field diary and a training in participant observation and active listening in order to get as many insights as possible, but without using focus groups and interviews so that observation happened in the most natural manner and the less degree of biasing.

Technical process testing was done by lab biologists. Both registered incidences, problems as well as customer and patients “life” reactions (calls, mails).

Product and treatment innovation was responsibility of the clinic director.

All the process was ethnographically recorded with following methods:

  • Scientific validation: protocols and results
  • Patients: field diaries
  • Process incidences: control documentation, mail and call records and analysis
  • Innovation: project documentation

Documented material was the basis for interviews with each responsible with the goal of data unification and triangulation.

Patient reactions
Patient interest for Recombine has been parallel to cycle evolution of the clinic (attention, real figures have been altered for confidentiality reasons, but proportion has been kept). The novelty was very well accepted at the beginning (27%) and then interest dropped; probably due to accumulation of incidences in the processes. The annual peak of cycles in may pushed demand up to 33% and by then sales arguments and claims were identified and develop, which helped demand to rocket up to 77% in august and remain stable around 60% to 70% from September on.


Aceptación de pacientes

Aceptación de pacientes

IVF-SPAIN found a new use for Recombine, which was the testing of oocyte donors. The clinic noticed that the patients were concerned about egg donor’s genetic health and started to test them systematically in order to ensure couples in egg donation treatments that their children would nUserJourneys-e1299060882146ot inherit a donor monogenic disease.

The qualitative analysis based on the conversations the clinic director had with the patients and documented in the field diary shows that patients value Recombine mainly for the security it offers regarding donors. Main complaints came from genetic testing reports that seemed often obscure and difficult to understand to patients.

Active listening provided another interesting insight: egg donation patients are worried about the phenotypical, cultural and intellectual similarity with the donor: “how does she look like? does she resemble me and my partner, has she a degree?” are frequent questions. But the appearance of Recombine raised other questions: “can we know if here genes and mine are similar, can we find out if we are related?” These questions were the origin of genetic matching, an innovative service that will be described later on.

Process incidences
At the activity’s beginning many mistakes happened when setting up process, but three error categories could be luckily be discarded:

  • Tracking of samples
  • Patient data protection
  • Report results accuracy

Nevertheless, Recombine’s first months were full of logistical errors, half of them due to process execution mistakes. The test showed that processes were mainly well designed, but wrong communication between Recombine US (were the screened DNA is interpreted by a bioinformatic algorithm) and Recombine Europe created confusion and misunderstandings.

As can be seen in the chart bellow, the other half of mistakes was born out of inexperience, for instance in the writing of informed consents and contracts..

Kind of   incidence


Process   error


Reports with   lack of concordance




Not enough DNA quantity




Errors in consents




Delays in   reports for patients and donors




Delays in promotional reports




Reports out of date




Marketing materials errors




Contract errors




Expired arrays








As can be seen, a very high number of errors happened at the beginning of the activity, that reached their peak in March and April 2013 (see chart below) and that were descending until their practical disappearance.incidencias

Testing real customers: identifying market resistances
The living lab allowed, as we have seen, to identify and solve many internal problems, but what would be the customer’s perspective? In order to adapt Recombine’s service to customer needs, the company worked with a distribution lab in Barcelona the improvement of Recombine’s processes and promotional materials. The lab’s customers are gynecological clinics and medical centers in Spain and European countries.

Going through the whole process with the distribution lab, from petition to delivery of reports with several real cases. The customer helped to:

  • Produce an instruction manual for new customers
  • Improve usability and understanding of results reports
  • Improve their design too

experience-map 2 Fuente nrlBut more important than these improvements were the resistances of clinics and physicians the Barcelona center identified. Many doctors did not want to sell a product that –although safer than postconceptional tests- had less margin for them; even at the cost to harm the child’s and mother’s health. The other big resistance was against testing oocyte donors: 40% could carry one or other disease and this would mean to increase donor pool maintenance costs dramatically.

In order to solve these resistances, three measures were taken in concordance with the customer and in dialogue withlivinglab other physicians: first, broad and easy information on the legal and criminal consequences of not recommending the best available medical solution. Second, developing an easy bluebox IT system to select only those donors with severe diseases, which are only 1% to 5%.

And third, rethink the market niche. While it may take time until European couples are aware of the benefits of a genetic screening, in societies with high inbreed there is very high prevalence of specific severe monogenic diseases, like muscular dystrophy in the Basque Country, Thalasemias in Mediterranean regions or the case of Arab countries, where marriages among relatives (54%) have produced 5% of mortality by monogenic diseases and 90% of youth deaths.

Working with a living lab has meant for Recombine Europe, if not its salvation, at least avoid losing lots of money tapping in a new market:

  • Processes that were different in reality than in design and that would have caused complains and lack of trust.
  • Customers with high resistances
  • Claims and commercial arguments for European clinics

Additionally, IVF SPAIN has developed a genetic matching algorithm for donors using Recombine’s chip ancestral genes and Recombine has found the market niche of endogamy societies. Now Recombine is sold in mass market with specific distribution companies that have all the commercial and legal arguments and in the niche markets by partnering public authorities that want to increase genetic health of the population.


Written by Carlos Bezos Daleske
Director IEXP