Both startups and small companies will face various challenges when attempting to put a medical device on the market. As the industry is heavily regulated, the approval process can be expensive and complex for new or inexperienced business owners.
If you are developing life-changing technologies for the healthcare sector, you must familiarize yourself with the potential issues you may encounter and the solutions available. Here are five common challenges for medical device approval.
1. Poor Medical Device Manual Translations
All medical professionals must be able to read medical device installation or operation manuals. It’s for this reason that companies must provide various manual translations to ensure a device is safe and effective. The industry has many strict standards for medical device translations, which you must not underestimate. Enter the market with ease by hiring medical device translation services to adhere to the industry’s standards.
2. A Lack of Knowledge
Most inexperienced entrepreneurs often focus solely on developing their innovative medical devices. As a result, they often fail to consider the various regulatory requirements during the design and manufacturing process. Therefore, they may encounter approval issues after producing a prototype or multiple devices.
It is an intelligent idea for entrepreneurs to gain an in-depth understanding of the various approval demands to prevent issues down the road. For example, a lack of regulatory knowledge can result in production and market delays, project cancellation and substantial financial losses. If in doubt, it might be a wise move to hire a medical device consultant to avoid various pitfalls during development and production.
3. Inadequate Specifications
Medical companies must carefully pick a device’s materials to avoid regulatory issues. Before developing a device or prototype, you must consider the biocompatibility of the materials in a device. If you don’t, the specifications may need to be revised down the road, which can result in market delays and unnecessary additional costs.
4. The New EU Regulations
The EU’s Medical Device Regulation (MDR) will come into effect in May 2021 and change regulations for current and future medical devices used in the member states. Both new and experienced manufacturers must now gain a detailed understanding of their obligations to ensure a device meets MDR’s quality, performance, and safety standards.
Established and new companies have been forced to alter existing medical devices due to a lack of:
- EU guidance
- Notified body (NB)
- Expert panels
If you plan to seek medical device approval in the EU, you must perform extensive testing of its materials to adhere to the new stringent requirements.
5. A Failure to Understand Common FDA Failures
Many medical device companies struggle at the final stage due to technology deficiencies. Before applying for FDA or EMA approval, you must understand the common failures noted in various reports, such as:
- Poor procedures for preventive or corrective action
- The product doesn’t conform to specified requirements
- A lack of established procedures to control a product
- Poor investigation of device failures
- A failure to adhere to FDA or EMA documentation guidance
Don’t allow a lack of research or understanding to stand in the way of medical device approval. Bear in mind the above challenges to ensure it can hit the market without hassle.
