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Quality and Innovation Can Coexist


Posted in Quality Assurance by Jamie Hartford on February 8, 2013

St. Jude Medical design quality engineer David Amor discusses R&D mistakes, how a postgrad degree can help medtech engineers, and what every student should learn about quality engineering. 


Last year MD+DI's editors recognized David Amor as one of our 40 medtech innovators under 40. At just 25, the medical device R&D and quality control consultant had already helped found the start-up MEDgineering, which pairs physicians who have engineering backgrounds with medical device companies, and was serving as a senior innovation fellow at the University of Minnesota’s Medical Device Center. He's since taken a position as a design quality engineer at St. Jude Medical, where he focuses on implantable electronic systems, including leads and lead-delivery tools. 

Amor will speak at MD&M West.

MD+DI caught up with Amor in advance of his MD&M West presentation to talk about innovation, R&D mistakes, and what every biomedical engineering student should learn about quality engineering.  

 

MD+DI: What does it mean to innovate with quality in mind?

Amor: Innovating with quality in mind is the discipline and science of ensuring that all product development activities are compliant with quality and regulatory standards – both internal and external. It means not working en vacuo while inventing new technologies but understanding the industry environment, regulatory climate and applicable risk management and testing standards that will ultimately govern whether your product makes it into a healthcare provider’s hands or not. The FDA approves products, not innovations.

MD+DI: The title of your MD&M West session asserts that innovating with quality in mind is a new theme in medical device development. Why is this just now coming to the forefront?

Amor: The reality of product development programs is that oftentimes, quality and regulatory requirements are considered “after the fact.” Engineers excel at brainstorming and creating novel solutions to complex problems. Unfortunately, within the context of the medical device industry, free thought and creativity does not necessarily translate into an approved product submission. What good are your paper drawings if they can’t ultimately help a patient in need? I think making sure that R&D and quality engineers understand external guidelines while designing prototypes, test plans and submission strategies is crucial to having a streamlined product development cycle (PDC). I have the distinct advantage and honor of having gone through the Innovation Fellowship program at the University of Minnesota, one of only two programs in the United States dedicated to pure innovation of medical technology. I’ve been able to combine that experience with my medical device industry background in quality to develop creative product development frameworks that get products from the brain to the bedside.

MD+DI: What are some of the biggest mistakes medical device engineers make with regard to quality in R&D projects?

Amor: Thinking of the quality function as a barrier or obstacle to innovation is a huge mistake that plagues med-tech companies, on a very alarming and consistent basis. A big part of my talk is on incorporating the quality engineer into PDC activities. A QE bring a unique skill set to core teams that should be leveraged, not cast aside. I’m a big proponent of R&D / Quality synergy; it is the most effective way of ensuring time efficiency, and a team dynamic likely to excel. The model at St. Jude Medical- where quality engineers are integral contributors to innovation decisions and not just approvers of documentation- should be adopted and exploited by every other company in the medical device space.

MD+DI: You have guest-lectured at the University of Miami Department of Biomedical Engineering. What’s the most important lesson you tried to get students to learn about quality engineering?

Amor: One of the things I like to convey to student engineers is that quality gives you a perspective within a medical device company that is unmatched by any other job function. You have to be attentive, knowledgeable about every aspect of the company and above all, you must be versatile. No other role requires you to be an R&D engineer, Manufacturing engineer and Process Development engineer- all at the same time. It is both challenging and rewarding!

MD+DI: You helped found MEDgineering, a consulting firm that pairs physicians with engineering backgrounds with medical device companies. What made you see a need for that business niche?

Amor: One of the recurring themes that I noticed while I was a med device consultant was the inability for both larger companies and start-ups alike to obtain clinical input during all facets of their PDC. The options were limited: hiring high priced consultants, waiting months for key opinion leaders to return phone calls or having to wade through personal contacts to find a physician. MEDgineering provided a one-stop shop for physician consulting services and offered flexible price points, on-demand service options and even remote clinical consulting opportunities. It was a hit with both companies and physicians who wanted to get involved with the med-tech world.

MD+DI: You hold a master’s degree in biomedical engineering, and you’re currently a doctoral candidate at the University of Minnesota, Twin Cities. Medical device professionals surveyed in our annual salary survey who have earned postgraduate degrees increased by 7 percentage points last year. Are postgraduate degrees becoming more important to medtech employers?

Amor: I think postgraduate degrees are important in that they provoke a paradigm shift in how you approach both your job and your engineering tasks. Although your technical competence is ultimately enhanced by the postgraduate experience through coursework, thesis work, etc., graduate school also teaches you more practical things like time management, leadership skills and networking. This creates a more confident, goal-oriented engineer and not surprisingly, one who strives to achieve results within their companies.

MD+DI: What presentations (besides your own) are you excited about at MD&M West and why?

Amor: I’m looking forward to the keynote speech by Mr. Rowe on whether innovation is possible within today’s regulatory and quality climate, as it mirrors some of the points that I discuss as well. I’d also like to check in on the RoHs requirements presentation, as this is a “hot” topic within the industry right now. Overall, all of the conference tracks seem phenomenal and I’m looking forward to speaking at MD&M West.

David Amor's conference session, "Innovating with quality in mind—a new theme in medical device development" will take place Wednesday, February 13, 2013, at 3 p.m. PST, at MD&M West

Jamie Hartford is the managing editor of MD+DI.   


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