It’s not just a question of biology, the strategy is equally important

5 reasons why SMEs need a team of experts for a greater chance of success. 

Written by: Peter Klar

Biotech and medtech companies are amazing innovators and experts in their field. However, the journey to put the miracle molecule that cures a complicated disease, into the market has just begun.

 In this article, you will read about 5 essential components biotech, and MedTech companies need to consider for a greater chance of success in getting their product into the market.

Do your research and start with a TPP

It’s important to have a solid understanding of the market being entered and what characterizes this market. A Target Product Profile (TPP) document outlines the strategy of product development, planning of clinical trials, liaisons with health authorities, and compliance with regulations. The pharma industry needs to prepare a business model to ensure that they reach the goals set out to reach. A lot of excellent ideas never materialise because they have not been prepared properly, or you keep running into errors that could have been prevented with suitable planning.

Utilize a good health economics (HE) team

A good HE expert can be invaluable during the early development as well as for post-marketing purposes. Having a solid case to show investors that your product has a future and well elaborated plan is one of the most important things SMEs need. Bringing a medical device to market, for example, requires that health economic models be prepared in order to compare the product to standard treatments and devices already on the market. Obtaining reimbursements for a new drug can be a time-consuming process and will depend on various terms and regulations, while the reimbursement application must adhere to all requirements and submission deadlines. It’s also important that life science companies target the right group of patients and get the right product into the right market. This requires a wide range of resources. In particular, the field of oncology is a minefield; more than 2,000 products are currently under active development. Only a small fraction of those products will reach the market, and those who put the most thought into a clear strategy will come the furthest.

Proper Regulatory guidance

Another common setback companies run into is that they design their protocol and study without a proper regulatory guidance. The regulatory department needs to be part of the team from the start. So many companies go through the process with regulatory as an afterthought and this always end up in extra time and money to adjust.

Your product is only as good as the quality of your data.

It’s all about collecting the right data and having the accurate protocol that can bring you to proof of concept. Without having the right framework and support to have a high quality not quantity of data collected is crucial for the success of your product. Having a top-notch biometrics team is something you do not want to underestimate.

Choose a strategic long-term partner

Product development is a long-term project and companies need to have the close collaboration with a trustworthy partner that knows how to guide them to make the best decisions based on evidence-based documentation.

A team of specific experts to carry the project through the whole product development lifecycle is required. The potential risks need to be limited and costs addressed thoroughly. These experts together, make a major time and money saving for customers. In addition, having a CRO that has an in-house team, will minimize the hassle of managing multiple vendors which more often than not, ends up being extremely difficult to manage.

Important to keep in mind is that the CRO’s role is to provide the data and the expert guidance for the clients to go for the optimal solutions.

Planning for success:

After all the scientific breakthroughs and hard research work has been done, it is important to find the CRO partner that shares the same enthusiasm and passion to bring your product to the market. A strong partner should have all the components to support a greater success outcome. It needs to be able show the best path for the greatest potential or show why the product has no future in the market. If the original idea does not work, having the scientific team that can find the greater possibilities for the product is even more important.  It’s not just a question of biology, the strategy is equally important.


Marianne Holst

Executive Vice President Regulatory

Marianne is a Registered Nurse from Copenhagen and has more than 30 years of experience within clinical research, joining LINK Medical in 2011. For more than 10 years she worked in the pharmaceutical industry as CRA, Project Manager and Line Manager within various indications. For the last 20 years she has worked in CROs where she held the positions as Head of Clinical Research, General Manager  and head of regulatory affairs.

More news

Don't miss out on the latest updates

Be the first to hear our breaking news at LINK Medical

Get in touch

How can we help you?

Contact us and we will tell you more