New week, new post on our blog Dispotech! The source of our article today is the website medicaldesignandoutsourcing.com.
After-sales surveillance is a very important process for medical device manufacturers, with regulatory bodies that (supposedly) assist users in carrying out their operational functions correctly.
Post-marketing surveillance often represents a breach, where many companies fall when inspected or audited. In both this article and the next, we will try to give you a few tips on how to keep up and not be taken by surprise, by controls - which are often a source of secondary problems and/or unpleasant situations.
The manufacturer's work does not end after having launched his medical device on the market: what does it take, then, to be compliant in the after-sales world?
- Keep up with new regulations.
Be honest: who, among you readers, can be certain to have a perfect knowledge about any change of law or regulation, that could even remotely affect your company's operations? Many are aware of the legal requirements or the basic characteristics, but actually you have to pay attention even to the slightest correction of a law.
Information is your friend, and it is essential in the after-sales world of a medical device. It's important to be proactive and constantly inquire about the workings of your "creature" and prepare for sudden changes in the industry. Any advice to facilitate a proactive approach? Attend industry conferences, trade fairs, meetings with the public or with competitors, specific training. Monitor websites and forums that talk (also) about you, read plenty of trade magazines to keep up with the changes. Making time for these activities is crucial.
- Monitor users' feedback.
Keeping up to date with users' feedback is another major challenge for medical device companies. The point is that comments may come from multiple channels. The customer can sue you (at worst!) or use other means - email, forms on the website, through comments on social media, with a phone call ...
But feedback can also come from healthcare professionals, who support users to operate their medical device. Comments may also come from technicians, study groups or scholars. I mean, the list could get even longer.
It is therefore necessary to have a system in place to keep up with all the channels where an opinion can be given on your product: nothing must be overlooked. Some companies, for not taking into account the opinions of their customers, have been extremely burned.
- Get a reliable system.
What means do you have in place, to ensure that all feedback is properly scrutinised and that nothing is overlooked? It has been proven that companies with the most problems are those that have adopted an inappropriate approach to reviewing customer opinions.
You can find a system that focuses on this issue: try using dedicated software to help you keep up with everything.
Read the next article for the final part of the list of after-sales tips for medical devices! What do you think so far? Have your say, by contacting Dispotech!