The idea of developing health care products is very intimidating. While it is true that there are tons of things to consider, it is also a very rewarding process that is well worth pursuing. This is a step-by-step guide that will clear all your doubts on important health care products manufacturers must consider in the early stage of bringing products to market. Our aim is to provide readers with a go-to guide that points you in the right direction and prepares you for a successful product launch. So, let’s get started…
Early-Stage Considerations for healthcare product manufacturers:
Secure funding and team building:
Like any business, you will require a team and capital to make your idea real. People oversee huge costs in the early stage of the process. To bring your product to the market positively, you will have to consider expenses related to clinical trial management, manufacturing equipment, testing, documentation with informed bodies, product registrations, and many other items.
Make a Regulatory Plan:
By this point, you are probably thrilled and prepared to work on a project with full force. Regulatory plans are the most challenging aspects that every health care product manufacturer faces during the launch of a new product. It is significant to remember that every product is different, and every item involves its regulatory plans. You are free to develop your own story and do not require to follow a set plan. The best strategies include active planning with documented and sound validation for the choices that are eventually made.
Choosing markets of interest:
Stick to the regulatory plan and don’t waste time understanding the rules of markets that won’t give a good return on your investment. For any market where you choose to launch your healthcare product, it is significant for you to define, understand and document the usage. This helps to create the scope of the product and will be helpful when determining user needs, designing inputs, and other development activities.
Determining US classification:
The classification determines the type of proposal required for clearance, so it is crucial to have a clear goal of what class your health care product will come on early stage in the launch. This has a major impact on your project cost and timeline.
Determining EU classification:
If you’re planning to step into the EU market, your classification will help you decide what is required to get approval for the device.
Preparing for Other Markets:
Some important things to consider while determining the requirements of numerous regions:
- Classification categories vary from country to country.
- Some countries require licensing or specific registrations.
- Clinical data is expected in some regions.
- The physical representation of a local agent is important in certain countries.
- Getting approval or clearance in one region does not mean you get an easier way to other regions.
By this point, you will get the idea that you will have to work under a Quality Management System (QMS) while bringing any healthcare product to market.
Identify your short-term goals to decide what you are focusing on first. Usually, the main aim of health care product manufacturers in the initial stage is to take their product through the supervisory submission process.
In that situation, some vital QMS processes have to be implemented from the beginning:
- Records management and document control
- Design controls
- Supplier management
- Risk management
It’s not easy to introduce healthcare products in the market. The process is surprisingly complex and multifaceted for new device developers. However, with the help of a strategic plan from the beginning. You can remove a lot of uncertainty and stress from the process while rising the chances for success in introducing your medical product to market.