Post-market clinical follow-up (PMCF) activity isn't the sexiest topic, but it is essential that medtech manufacturers choose and design the appropriate PMCF activity for each medical device they put on the market.
According to Jon I. Bergsteinsson, there are three primary factors that should influence the choice and design of PMCF activity for medical devices: existing clinical evidence; clinical outcome measures; and clinical marketing claims.
Bergsteinsson is among the 25 industry influencers recently recognized as a leading medtech voice on LinkedIn. He founded Smart-Trial, a firm that provides regulatory services to the industry and was acquired by Greenlight Guru last year.
PMCF factor: existing clinical evidence
Depending on the existing clinical evaluation report, Bergsteinsson writes, you may or may not have to gather more clinical data to proclaim "sufficient" clinical evidence.
"A gap analysis of your clinical evidence will provide details on what is needed, and based on what is needed, different activities should be included in a PMCF plan," he wrote.
PMCF factor: clinical outcome measures
What data you need to collect will have a huge impact on the type of PMCF activity, Bergsteinsson wrote.
"For example, if 'time to heal' is your primary clinical parameter, you cannot suffice by asking 100 physicians, 'what was the average time to heal for your patients...' in a simple survey. That would be too subjective," he wrote. "You would probably have to collect individual dates, on individual cases – which most likely is not done by sending out a single survey."
PMCF factor: clinical marketing claims
According to Bergsteinsson, your marketing claims must match your clinical evidence, especially if your claims relate to long-term outcomes.
"If you want to claim X benefits over a longer period of time, you need to collect the data to back it up," he wrote.
Most of the time, marketing claims and clinical claims (documented in a CER) will mirror each other, Bergsteinsson said. But he warns that if marketing claims are made on long-term effects, there must be long-term data to justify it. That likely means a long-term follow-up approach such as a post-market study.
Rianne Tooten, a medical device clinical research consultant, agreed.
"Make sure there is a good collaboration between clinical and marketing," she wrote in a comment on Bergsteinsson's post. "A marketing claim that is not backed up by clinical evidence can cost the company a lot of money that might not be needed."