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These are exciting times to work in healthcare. With advancements in research and innovation, the medical device industry continues to push the envelope, saving lives and improving the quality of living for people across the globe.
But even with all of the game-changing products that have been recently introduced such as LifeWatch's Mobile Cardiac Telemetry (MCT) patch, or Medtronic's new superDimension lung navigation software, there are still many barriers and process inefficiencies that are detrimental to innovation.
As Director of Regulatory & Quality for Creation Design Services, I see both the technical and business challenges of taking new medical products to market every day. As we begin the new year, I’d like to share my view of three ways we can do better.
1. Address the high cost of regulatory requirements
Whether we’re talking about medical devices, pharmaceuticals, or veterinary medicine, medical companies are constantly challenged to keep up with the never-ending changes to regulatory requirements. As a quality and regulatory professional, I am constantly thinking about these changes and their impact.
For example, there are costs associated with allocating resources and time to understand any new legislation and standards.
There are costs associated with acquiring new certifications themselves, not to mention all of the preparation, due diligence and training that must come first.
There are costs associated with providing ongoing training for your people.
Depending on the number and type of products produced, and the number of people you employ, these costs are not trivial and can run into the millions.
And passing these costs onto the consumer, or worse, the costs of non-compliance, may take you right out of competition.
How would costs of compliance be altered if softcopy standards were public domain? Or if “eLearning” were entirely non-profit?
2. Reduce lengthy delays in FDA Premarket Notification/Premarket Approval
There are substantial delays in the process of marketing a medical product in the United States from FDA submission to approval. A device with a predicate, for instance, can take 180 days for the FDA to grant clearance to market. Class 3 devices requiring premarket approval can take even longer.
These delays can result in loss of potential revenue, leading to increased unit costs because of amortization.
And what about the loss of potential benefit to society?
Because of these costs and delays, some innovative products never get to market. Both startups and Fortune 500s alike elect not to pursue some concepts because of this barrier to market entry.
What would happen if the FDA hired more submission reviewers? Or if the FDA addressed existing internal administrative hurdles?
3. Simplify complex and fragmented global legislation
There are many quality and regulatory legislative requirements around the globe. Some of these are region-specific. Some are industry- or product-specific.
As much as the International Organization for Standardization (ISO) advocates a homogeneous approach to regulatory requirements, this harmonization is not yet a reality.
For example, the FDA 21CFR820 regulation versus the ISO 13485 standard. These two requirements are very similar, however will most likely never merge. For those wishing to market in Japan on the other hand, the requirements of the Pharmaceutical and Medical Device Law (PMDL) must be independently met.
Comprehending, executing and sustaining the in-depth requirements of multiple standards is a constant burden.
If a globally harmonized standard existed, how else could these time and resources be spent?
Looking forward in 2016
In conclusion, can the industry be more Lean, while still maintaining public safety and integrity?
How can we apply the Theory of Constraints to the industry as a whole?
Without a doubt, the medical device industry matures each year and while I look forward to the advancements in 2016, there is always room for improvement. Imagine if companies did not have to worry so much about barriers, but rather, focus more time into innovation and collaboration. The possibilities could be limitless.
Based in Denver, Tim Holzschuh is the Regulatory & Quality Director for Creation Design Services at Creation Technologies LP.
