The world’s estimated two million different types of medical devices range from artificial hips to heart pacemakers and from blood pressure monitors to nifty gadgets that split pills in two.
Regulating quality and safety in this $515bn (£385bn) global market is a huge challenge for authorities like the US Food and Drugs Administration and the UK Medicines and Healthcare Regulatory Agency.
Medical devices do not have to be of the highest quality to meet the ‘compliance standards’ required to bring them to market. Some manufacturers have expressed concerns that increasing regulatory requirements for quality and safety standards would result in increasing costs and wait times for patients.
But a novel FDA initiative, the Voluntary Improvement Program (VIP), has shown that ‘going above and beyond compliance’ towards excellence has the opposite effect. VIP appraisals within companies have been shown to increase manufacturing efficiency and product availability by helping device-makers better understand, measure and improve everything they do.
Manufacturers can decide whether or not to apply for the VIP - more are expected to do so in the light of the programme’s early, astounding successes. ISACA reports that one VIP company has increased production capacity by 11%, resulting in an additional $15m (£11m) in sales. Another participating company has generated $286,000 (£222,000) in annual savings.
From a patient perspective, the appraisals have enabled a VIP company to provide 882 more patients with faster life-saving treatment. Production at yet another VIP company has been increased by 62%, staff turnover has decreased by 70% and customer complaints have reduced by 95%.
Results from the VIP demonstrate that prioritising quality and collaboration benefits both patients and manufacturers
Kim Kaplan, senior product manager at the Information Systems Audit and Control Association (ISACA), explained that the programme followed an FDA study in 2011 into how to improve device quality and safety.
This prompted the launch of the Medical Device Innovation Consortium (MDIC), the only US public-private partnership to work with government and industry to promote innovation in medical devices. “The MDIC provides a safe space where the industry and the FDA can collaborate on solutions together,” says Kaplan. The MDIC launched VIP in 2021 following a pilot version in 2018.
The New Zealand company Fisher and Paykel Healthcare (FPH), was among the first 120 manufacturers - including UK companies - in the ‘Case for Quality’ VIP programme. FPH makes devices for respiratory care and treating obstructive sleep apnea, a condition which restricts breathing.
Brian Schultz, FPH VP of quality, safety and regulatory affairs, said that the VIP had enabled the company to achieve improvements in its quality system processes by ensuring staff understood the rationale for them.
“We really worked to communicate the purpose and efficiencies of each process. The appraisals have changed mindsets and helped us get better at what we do,” says Schultz.
Other benefits included better resource planning and project management, improved data use and better control of performance objectives and targets.
A major plus for VIP enrollees is that they receive select regulatory relief from FDA to modify an existing product or launch a new one. This decreases the usual ‘review and inspection time’ and reduces the costly regulatory burden.
Asked what was the VIP’s major benefit, Kaplan replied: “This may sound strange, but I think it’s the relationships the industry develops, both with the FDA and with each other. The VIP facilitates cross-industry conversations. We have working groups and industry representatives on the programme’s governing committee.”
Fostering these kinds of relationships is especially beneficial when there is significant regulatory flux. “Look at the UK’s MHRA, it is in the process of developing a new MedTech regulatory framework. This is a perfect example of when companies need to be working hand in hand with regulators,” says Kaplan.
“VIP is a wonderful opportunity for them to get connected with their peers and identify solutions to challenges they’re all facing. To learn from each other, as well as to be more collaborative with the agency. It’s a win-win for everyone.”
Results from the VIP demonstrate that prioritising quality and collaboration benefits both patients and manufacturers. With increased efficiency, reduced costs and improved patient outcomes, the initiative paves the way for a stronger, safer medical device industry. As more companies join, VIP has the potential to redefine global healthcare standards.
For more information please visit www.isaca.org/vip
