Critical considerations when launching a new medical device
Taking a new medical device to market is a big investment of time, human resources, and money. To successfully attract the right financial backers, you need to clearly define your process. It can help to call upon product development services providers to simplify the process. But when push comes to shove, you need a sound launch plan.
Define your product
Your device must solve a medical problem, but you also need to consider the design of your product from an end-user point of view.
- How user friendly is it?
- How is it packaged?
- What ancillaries, like power supply or add-on equipment, need to be considered?
- What is the name and label?
All these aspects of your product will define the user experience once it’s gone to market and contribute to its commercial success or failure.
Have a clear production strategy in place
For an investor to fund your device, production procedures need to be clearly defined. The acquisition or manufacturing process of raw materials and the production strategies and requirements are important, as they shape your medical device’s value proposition. If your production turnaround times are commercially unrealistic, you need to rethink your manufacturing cycle.
Identify infrastructure and logistical requirements
Optimal production processes are governed by automation, standardization, and the speed of manufacturing. Ideally, a great portion of the production process should be easy to outsource to product development services providers. Through standardization, production should be manageable using generic methodologies. If you do not achieve this level of standardization and automation, production time and costs will soon outweigh any medical benefit your product offers, which will deter potential backers from investing.
Training and documentation
Keeping a clear overview of your device’s production requirements is only a part of your launch plan. It is important to keep documentation up to date, create user manuals and courses, and ensure that these additional costs are factored in when taking your product to market. Don’t be too narrow in your definition of who your end-users are going to be, as you might develop a training program that doesn’t cover enough ground for those actually using your product. That is why it pays off to test your device’s real-world application from the early stages of development and prototyping.
Keep compliance in mind
Do not neglect regulatory compliance requirements when designing your medical device. In the US, these are defined by the FDA, which classifies medical devices in three tiers that must comply with increasingly stringent rules and regulations. Early on, you and your product development services provider need to ascertain which classification you will be pursuing and what requirements need to be met to be given clearance to go to market. Failing to do so can result in delays when you do submit your device, which can in turn lead to denied clearance.
Know your production overheads
An investor will not take unnecessary risks, which is why the points described above need to be properly fleshed out into a solid marketing and sales pitch. A novel idea that benefits the healthcare sector must have a clearly defined production strategy and quantifiable overheads. If you deliver a product with real-world applications that will generate a good return on investment, you will attract the right financial backer.
To keep track of the different aspects of a product launch, choosing to work with product development providers on a per-project basis can prove financially beneficial. Third parties will help ensure as short a time to market as possible. Technosoft is a product development services provider that specializes in in-house development, prototyping, pre-production, testing, and clinical trials. We are also well equipped to help you prepare for your compliance submissions.
To know more: download our guide
For any additional questions, a proposal request or to book a free consultation, contact us