Four tips for planning your product development
If you were purchasing a house for $1 million, you would selectively partner with a bank to receive a fair mortgage, a real estate agent to evaluate whether you are getting a good deal, and a surveyor to thoroughly check over the construction standards. These partnerships form a critical part of your decision-making strategy, in order to make your large purchase as cost-effective and time-efficient as possible. Product development in the life science industry can cost over $1 billion, and yet pharmaceutical and medical device companies of all sizes, from biotech startups to big pharma, often proceed without these critical partnerships and strategy in place. As a result, many companies end up wasting time and money addressing issues that should never have arisen with the right planning.
An integral part of product development is building your Target Product Profile (TPP) in the earliest stages. A TPP is a living document that outlines the strategy of product development, helping with the planning of clinical trials, liaisons with health authorities, and compliance with regulations. By choosing to partner with a CRO that has broad expertise including early development, your products can reach the market sooner, and with reduced risk and cost. There are four key factors to consider when outlining your early development strategy and considering a CRO partner:
Get the perspectives you need
One of the most important facets of early development is making sure that you have all of the expertise you need to make the right decisions. For instance, a medical doctor will have critical input on the indication or intended use of your product and will have a good understanding of the challenges you may face around planning your clinical study. On the other hand, a regulatory expert will provide insight into all the steps that must be taken to comply with relevant regulations. A statistician will ensure the best optional study design.Additionally, a health economist will be able to assess the market value of your product and support you with reimbursement planning. Using the TPP as a framework for discussion, experts from different specialties can work to develop a viable route to market. As if you were purchasing a house, you need a diverse team that provides input and a second opinion wherever there are knowledge gaps. It is important to bring all these experts together early in the process, forming a trustworthy team that can guide you at every stage of the process.
Know your market
What is your product’s market value? What is your product’s indication or intended use? Who is the payer for your product? The outcomes of this market assessment will outline the strategy associated with every stage of development – from which regulations you must consider, to how you design your clinical trials. It is therefore critical that your market is identified early in the development process: belief alone cannot carry a product to a market that doesn’t exist. An initial market assessment may find there is no viable market for a product with your intended pay structure or indication. In such a case, it is still possible at this early stage to make changes to your strategy at minimal cost, in order to fill that crucial gap in the market and make your product development a success.
Understand the regulatory landscape
It will come as no surprise that you can’t take a product directly the from the R&D bench and use it in clinical trials. Biotech and medtech companies in early stages of product development must carefully consider the regulatory pathway for their product, complying with legislation at all times to make sure the process from lab bench to clinical trial and then to market, is as smooth as possible. Regulatory landscapes are complex and fluid, with regular updates and changes as new information arises. This even applies to products already on the market, as changes in regulations can force companies to update aspects of their documentation in order to ensure continued compliance. It is therefore critically important to find regulatory affairs specialists that you can trust to give considered advice about the right steps to take at every stage.
Documentation, documentation, documentation
The intrinsic value of a product lies in rigorous, evidence-based documentation. Without the correct documentation, there is no product. Even with the most promising results from R&D work, if data are not published in the right way or experiments in critical stages are not carried out under GLP/GMP/GCPconditions, then those results are not usable. The necessary documentation must be thoroughly understood from the beginning, in order to successfully carry your product through to the market – and keep it there! This is often overlooked by smaller biotech and medtech startups that plan to license their product to a bigger company, but it is important to note that big pharma will not even look at a product that isn’t built on a solid foundation of documentation. Finding a team to track and maintain the required documentation is the single most cost-effective step you can take in product development, and helps to ensure compliance and market-relevance at every stage.
Planning for success
If companies lay down a clear strategy for navigating through regulatory and clinical development challenges, they ensure the best possibility that milestones on the road to market are delivered on time and on budget. The four considerations in early planning outlined above intersect to unlock this product development pathway. Partnering with a trusted company will enable you to assemble a diverse team of experienced specialists. This is essential to help you understand the market you are working towards, and build up the right documentation to comply with each and every regulation. This will not only help your product to reach the market, it will help your product to stay on the market and deliver a return on investment for years to come.
Ole Henrik Brekke – VP Early Development and Medical Device, LINK Medical
Ole Henrik Brekke has a PhD in Cell Biology and has developed a handful of successful Norwegian biotechs over the past 25 years. At LINK Medical, his role involves working with companies on the verge of starting their first clinical trials. Through strategic planning and advice, including TPP workshops, he guides a team of experts that help companies take the right first steps in their product development.