Last month, the Brandwood Biomedical team had the privilege of presenting at the ARCS conference here in Sydney. This gave me an opportunity to speak about one of my dearest subjects – marketing in a regulated market – in front of Australian companies and Innovators in the Medical Device sector. The feedback has been overwhelmingly positive and certainly worth a few lines in this month’s update.
A journey to the Regulator
Once upon a time, an innovator came up with a great new concept, he engaged a team of engineers and built a prototype device, the team carried out some form of bench testing, light evaluations on human subjects (employees of that company) were also completed. By that stage, months have passed, bank reserves have been consumed, the device appears to be fully functional and the initial concept validated, it was time to package an application for regulatory approval within the next couple weeks.
In god they trust, for anyone else, they need data
An application was sent to the Regulatory agency for review. It was pointed out that the data presented was insufficient, the device did not meet local requirements, additional testing would be required and approval may not be granted at that stage. The company will also require prior auditing by the regulatory agency. The whole process will cost tens of thousands of dollars more and take approximately 9 months to completion. Competition is not waiting for you As the company kicks off additional testing, a major competitor comes to market and takes a substantial portion of the market share. Our innovator’s dream falls from what seems to look like a high-flying future… So what could have possibly gone wrong along the way?
Do it once, do it right
Pretty much everything! Here is why:
1. Marketing in a Regulated Environment is as much about the process as the product itself
– No matter how good you think your product is, if you can’t demonstrate it, it is just not going to happen.
2. Take a Global View
– Define clearly where you want to market your device – each market/jurisdiction may attract special requirements. Although there is a global effort to harmonise, it is important to understand that each Regulatory body may still have defined a set of local requirements and regulatory routes to market may also differ from market to market.
3. Defining (i.e. documenting) your Regulatory Strategy early (and sticking to it) is absolutely essential:
– Identify the process, time constraints and requirements associated with your commercial strategy as early as possible. In regulatory terms, this means identifying your intended uses and claims from which Medical Device classifications and Regulatory process will depend.
– The strategy shall also define the specific Regulatory requirements that will require implementation through the Design and Development process (e.g. Essential principles that are applicable to the specific device, harmonised standards, predicate characteristics that require comparison testing, compliance requirements with regulatory guidelines).
4. Driving Product Development as a process (yes, again) is fundamental
– A process is a set of inter-related activities that are managed to achieve a particular endpoint. Every word counts in this definition. The end results are multiple but include in this case, your regulatory approval. Regulatory approvals heavily rely on the design data that is produced as part of the design process (e.g. design descriptions and specifications, test data and clinical evidence are critical parts of the regulatory application). As such, identifying what is required to meet this marketing approval is key to the success of your application.
– Lastly, make sure your Regulatory partner is involved in this process, throughout. If possible, continuous involvement of your Regulatory partner from concept initiation, strategy elaboration, through to verification and validation and (obviously) ahead of the Regulatory application will ensure such application contains the correct data and in the correct format!
Our team is specialised in defining regulatory strategies and requirements that will maximise your chances of obtaining marketing approval and successful implementation of your business objectives. We support design and development in a global market context from concept initiation through to product release and obsolescence. We are here to help.
Don’t delay, contact us for a free, no obligation discussion.
Our team is specialised in defining regulatory strategies and requirements that will maximise your chances of obtaining marketing approval and successful implementation of your business objectives. We support design and development in a global market context from concept initiation through to product release and obsolescence. Contact us to discuss your needs and how we can help. You can drop us an Email email@example.com or call 1 888-271-5063 (US toll free) ♦ 400-842 7017 (Beijing – toll free) ♦ +61 2 9906 2984 (Sydney)