The MPO Summit concluded yesterday and it was one for the books. It was a wonderful conference event set in the breathtaking mountains of Park City, UT at the luxurious Stein Eriksen Lodge. The conference was well-organized, well-attended, and there was a fantastic roster of speakers that discussed the most pressing topics in today’s medical device industry. Kudos to Medical Product Outsourcing for producing a fantastic atmosphere for key members of the medical device industry to connect, network, and say hello to old friends.
DAY 1 Highlights:
Keynote Address–Giving a Voice to Those at the Forefront of Healthcare
Robert Grajewski, of Edison Nation Medical, discussed the process of getting new “eureka” healthcare products to the market.
M&A Market and its Impact on Contract Manufacturing
A popular acquisition strategy is: Accelerate growth, provide global footprint. The top 25 medical device companies control 60% of the market. The impact of M&A on contract manufacturing is companies pursuing widespread supplier consolidation. It begs the question: Are suppliers positioned to be a beneficiary of these mergers and acquisitions? As markets evolve, are suppliers positioned to meet their objectives?
Panel discussion: Women in Medtech – What Glass Ceiling?
Maria Shepherd discussed how women in Medtech are underrepresented, unlike its sister industry: Pharma. When the panel was asked about mentors, the leading response was that the best mentors are sponsors, where value is measured in opportunities given instead of imparting wisdom.
Gender diversity promotes better performance. Our work as innovators is for the community and the community is very diverse. Be the change you want to see in the world. To quote a member of the audience, “Diversity drives innovation and we are innovating for life”.
When asked how they have dealt with glass ceilings, a woman on the panel described a time where she experienced gender equality at review time:
“I was told, “You are the best we have but I cannot give you the top raise. I have men who need to support their families who I need to give the top raises to.” I dealt with that by leaving the company.”
Engaging Universities and Medical Device Companies in New Product Creation
University of Utah stated that a new life sciences MBA education path will be offered this year to make better leaders for medical device companies in this market.
Getting Medical Devices to Market Faster
For the manufacturing process validation, medical device companies must validate everything that cannot be 100% verified. What’s critical? That is not contract manufacturer’s choice. The better your partner, the lower your risk.
What’s critical for speed to market? Strong technological support – outsource if needed. Make sure your quality system is there and meets the business needs. Don’t recreate the regulatory wheel, invest in experienced project management, and start with the end in mind.
MedAccred Accreditation Process: Driving Supplier Quality
MedAccred certification is a Process Capability assessment audit that reduces onsite customer audits, enhances compliance status, sets suppliers apart from competitors, helps position companies for new business, and highlights companies by media as a leader in marketplace.
The Long-Term Impact of Supplier Consolidation:
Takeaway: Find the key partners who we like and move volume to them. Place our bets with our key suppliers.
Identify the true cost and value of your suppliers. What is the true cost of doing business with your suppliers?
Validation: “Let’s do it once and let’s do it right the first time.”
What about year-over-year price reductions? The Fairness Model – it has to be a win:win or else it won’t work. It is much harder for suppliers to pick up margins like OEMs can. If OEMs can double volume, we can pursue price reductions.
Medicine is a business. But there are some places where it makes sense to shave costs, other places not so much. We have a moral responsibility to patients’ well-being.
DAY 2 Highlights:
Nelson Labs Tour
Real time aging and accelerated aging testing is required for medical device companies. Accelerated age testing does not take the place of real time aging.
The amazing takeaway I took away from that lab was that American medical device testing labs are in a rapid transition away from animal testing with microbiology testing proving it completely unnecessary. Europe is already there – no animal testing and relying on microbiology only.
Unique Device Identification: An FDA Imperative
The purpose is for post marketing reporting, recalls, and tracking. Who is responsible to do this? “Labelers, manufacturers, reprocessors” – not necessarily manufacturers sole responsibility.
Every medical device must comply with UDI requirements if sold in the USA. Who is exempt? Individual single use devices, not intended for individual distribution.
Direct Marking Exception: not technically feasible, would interfere with safety of effectiveness of product.