Feb
7
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in Business, Regulatory | No comments

Recommended FDA report: “Understanding Barriers to Medical Device Quality”

Recently, I read an FDA report entitled “Understanding Barriers to Medical Device Quality”, which examines  the current quality status of medical devices. This informative report compiles the serious adverse events recorded in FDA’s Manufacturer and Used Facility Device Experience (MAUDE) databases, Recalls- CDRH (RECS) database and the Recall Enterprise System- ORA database (RES), as well as interviews with FDA officers,  industry leaders and other research experts. The report uncovers many interesting facts about the marketed medical device industry, including:

  1. This industry has experienced significant growth in both revenues and technical complexity.
  2. The increase in serious adverse events has outpaced industry growth by 8 % since 2001.
  3. Quality risk distribution is uneven. While the most frequently recalled products are radiology devices, 60% of adverse events are related to cardiovascular devices , in vitro diagnostic (IVD) and general hospital/surgical devices combined.

 

Graph 1: Top 20 Products with Most Recalls. 2003-2009

 Source: FDA report “Understanding Barriers to Medical Device Quality”

  1. Root cause analysis reveals that more than 50% of recalls are due to product design and manufacturing process control failures.  Hardware issues are significant contributor to product recalls.
  2. Based on their analysis, The FDA outlines the following opportunities for improvement:
    1. Improved design and reliability engineering (emphasis on validation, manufacturability and software robustness);
    2. More robust post postproduction monitoring and feedback;
    3. More stringent supplier management, focusing on  material and process change control;
    4. Strengthening quality metrics and measurement systems;
    5. A move towards cross- functional quality organizations. For example, design engineers should not be measured only on ‘time to market’ but also on the actual quality of the product and/or manufacturing processes;
    6. Accountability and performance management- key roles should be associated with quality outcomes;
    7. Stronger quality culture, with performance incentives for all levels based on fulfilling quality goals.

The report also features several industry recommendations to the FDA. These include featuring high-quality manufacturers as “case studies” as a learning tool for small medical device companies,  more quality review initiatives similar to the one conducted in response to sector-wide infusion pump quality failures, and improvements in enforcement consistency and transparency on behalf of the FDA.

Recommendation: This report was interesting and informative. I liked the emphasis and suggestions for establishing a strong quality culture. I strongly recommend this report to any small or large medical device manufacturing company.

Jan
30
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in Engineering, Industrial Design, Product Development | No comments

5 Effective Tools for Rapid Mechanical Engineering and Industrial Design Innovation

1.       Brainstorming – This is a tool that is most commonly leveraged among all disciplines, and Starfish encourages active participation with our innovative multi-disciplinary teams. The first and most important part of a brainstorm session is to ensure that we are asking the ‘right’ question. It is also useful to try on different approaches, and some may seem to be a little wacky at first. Most out-of-the-box solutions are failures, but sometimes when a problem is turned on its ear, the dollars will start flowing in!

2.       Leveraging Existing Technologies and Products – Sometimes a difficult problem to be solved, already is! By conducting investigations on the USPTO website, or FDA 510(k) databases related to broadly similar devices, solutions can be discovered. The application of an industry standard device in audio equipment to the medical field is quite often a patentable approach. In fact, many medical innovations are application of an existing medical device to a new Intended Use. The cost and time savings are well worth the effort!

3.       Low Fidelity Prototyping – The use of cardboard, urethane foam, 1:1 CAD drawings, and even around the office props provide a rapid and effective means to determine initial fit, form and functionality requirements. This is particularly useful for things that are difficult to model, such as cable management or hand grips in unusual orientations.

4.       Rapid Prototyping – Starfish is a leader in the medical device space in the use of Steriolithography (SLA) [http://en.wikipedia.org/wiki/Stereolithography], Selective Laser Sintering [http://en.wikipedia.org/wiki/Selective_laser_sintering] (SLS), and Rapid CNC machining. Advances in this area over the last decade have provided significant improvements in cost and material properties that have opened a variety of possibilities for designers. Many of these models are ‘looks-like’, and ‘works-like’ devices that investors seek in the early stages of a project. In a recent project, a toaster sized device went from a sparkle in an Industrial Designers eye to a full sized device, complete with touch screen, cabling, functional doors, and many other features in just two weeks – including the design! For simpler devices, turnaround times can be reduced to less than half of this; complete with paint and other cosmetic features incorporated.

5.       Optimization through Modeling – Exploiting the latest technological tools such as Finite Element Analysis (FEA), Mold Analysis, Optical Raytrace Analysis, Computational Fluid Dynamics (CFD), Simulated Fatigue Analysis,  and Simulated Drop Testing can all provide a quick answer or optimization to problems that would otherwise be difficult to resolve through first principles calculation/analysis. These tools are particularly useful prior to investing in tooling, expensive prototypes, or the like.

Jan
26
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in Business, Product Development, Project Management, Regulatory, Uncategorized | No comments

New FDA Draft Guidance on 510(k) Program

On Dec 27, 2011, the FDA released an important new draft guidance entitled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications”. Once issued, this guidance will replace “Guidance on the CDRH Premarket Notification Review Program, 510(k) Memorandum K86-3” from 1986 and “The New 510(k) Paradigm – Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notification” from 1998.

New FDA Draft:

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM284443.pdf

The intent of this guidance is to explain and clarify each of the FDA critical decision points in the determination of the substantial equivalence (SE). It should be noted that there are no significant changes in the current 510(k) policy; rather the FDA is providing more detail information on the regulatory framework.

This guidance is addressing several key 510(k) issues including:

  • The appropriate use of multiple predicates;
  • Whether a new device with new indications for use has a new intended use (if indication raises different safety and effectiveness questions and precludes meaningful comparison);
  • Whether different technological characteristics raise different questions on safety and effectiveness;
  • Resolving discrepancies between the 510(k) flowchart and the FD&C Act;
  • When performance data, including clinical performance data, may be necessary to support an SE determination;
  • How to develop 510(k) summaries to promote greater transparency in the 510(k) decision making process; and
  • Clarification on the Special and Abbreviated 510(k) submission options.

Some of the major points:

  • The FDA adopts a flexible approach to determining SE to accommodate evolving technologies.
  • The FDA will continue to allow the use of multiple predicates in certain circumstances to help demonstrate SE, however, the FDA recommends the use of primary predicate device to which an SE claim is being made.
  • The use of “reference devices” was introduced. Reference devices would be used to support SE claims by industry in some situations where “split predicates” were previously used. Scientific rationale has to justify the use of a reference device.
  • The FDA provides a detailed explanation of “intended use” and “indications for use” and the relationship of the two terms.
  • The guidance provides several illustrative examples on how to use multiple predicates, reference devices, indication for use, technological characteristics and when clinical data is needed.
  • The use of Abbreviated and Special 510(k)s continue to be acceptable as alternate approaches to a Traditional 510(k) to demonstrate substantial equivalence.
  • A decision-making flowchart that serves as a companion to guidance text has been retained and further simplified.

As before, if you are unsure what information to include within a 510(k) submission, you may submit a pre-IDE submission and seek additional feedback from the FDA to ensure your submission contains appropriate data elements.

If you would like to share your opinion regarding this draft document, you can submit comments and suggestions directly to the FDA by April 26, 2012 via mail or submit at http://www.regulations.gov.

Jan
23
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in Business, Product Development | No comments

Right Brains and Left Brains – Can They Work Together?

Each day when I come to work, I’m surrounded by a large group of very smart, extremely analytical engineers, physicists….and others of the same ilk.  You can easily spot them when you enter the office, because they carry the tell-tale signs of their brotherhood – they delight to gather in small groups and chat about OMAP’s, Androids and ultrasounds.  They enjoy sharing interesting snippets of news related to chips, bits and bites.  They love fleece.

Yes, there are others in the office as well.  Scattered among the ‘Lefties’ are a few ‘Right Brainers’.  Those who dare to dwell in the strange and foreign land of ‘Science’. Those who have attended design schools, marketing programs and other institutions of lower learning.  Those who love ambiguity and colour.

Some may find this disconcerting, but to me, the interesting and delightful part about working in a product development company is the variety and diversity of people you get to work with. The idea that people with very different backgrounds and ways of working can somehow align and do meaningful work is positively inspiring.  Each group looks at the same problem from different angles and the opportunities are greater when they do so.

The big question in all of this is: How do you bring these two groups together, inspire them, and encourage them to do great things?  From what I’ve seen, both right and left brained people need different types of fuel in order to inspire them to do their best work.

Left Brainers need well laid out analytical processes to help them identify problems and make decisions.  They cannot draw upon, nor do they trust, their intuition or ‘gut’.  Instead, they need ‘objective’ data gathered from complex processes, organized in sophisticated patterns in order to draw a conclusion and make a decision.

The Right Brainer on the other hand looks for verbal clues, emotions, nuances, inconsistencies, patterns, all in their search for an answer to a fuzzy question.  To this group, cold hard facts are just that – cold, hard and inhuman.  They have little place in a world of flesh and blood.  Instead of processing numbers like their brethren in the other hemisphere, they take the input they’ve absorbed and mix it into a complex soup of information, taste the flavour, and draw conclusions. Crazy stuff.

So the question is, how do you get these wonderful groups of very different, highly intelligent people to work together?  How does an organization encourage and harness the best of both methodologies and focus their collective efforts on solving the same challenge….all with the hope of gaining a holistic, comprehensive solution to a very real problem?

The answer seems to lie in defining early a shared understanding of the end goal, and the end goal needs to be decided at the beginning of a product development program.  The so called ‘fuzzy front end’ needs to have some order imposed upon it so that a well-defined end goal is identified early.  I hate to use the term ‘process’, but this is what is needed at the beginning of a program in order to harness and focus the collective creativity of a diverse team.  Good processes need not stifle the input and output of contributors, rather, they provide a positive framework that frees and enables both Left and Right Brainers to do their best work, and at the same time meet the very real demands of business partners who value innovation and profitability.

Jan
16
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in Regulatory | No comments

To cloud or not to cloud – FDA’s Part 11 implications

cloud computing or not?

These days you can read a lot about the advantages of cloud–based, shared infrastructure. Public virtual server providers are praised for scalable and flexible storage, affordable pay-per-use service or subscriptions, and convenient back up and disaster recovery.

Many providers are reputable companies based in the US. What does this mean for a Canadian company? Impacts of the US Patriot Act and the Canadian-based Personal Information Protection and Electronic Documents Act are well discussed in the Ottawa Business Journal.

The matter becomes even more complicated if your organization has to comply with the FDA’s guidance ”Part 11, Electronic Records; Electronic Signatures — Scope and Application”.

During an FDA inspection, you have to be prepared to answer many questions:

  • Is your provider Part 11 complaint- and if not, were you able to qualify them as an approved supplier?
  • How did you validate the use of the cloud service?
  • How did you document the system architecture that is not under your control?
  • How did you implement change control/configuration management?
  • Are you able to determine if revalidation is required and the extent of revalidation?
  • Are your electronic records trustworthy and reliable? Do they meet applicable record-keeping predicate requirements?
  • Do you know the exact location of where your data is stored?
  • Are you allowed to inspect the provider and would the provider allow FDA to conduct an inspection of their site?

For companies whose services or products fall under FDA regulations, it is mandatory to revisit user requirements before the final decision is made to move your data from your servers to the cloud.

Jan
10
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in Product Development | No comments

What’s your problem?

It’s easy to send a project sideways: all you need to do is identify a brilliant, expedient solution and unleash your brightest designers and engineers to implement it. You’ll reach your destination even faster if you add some schedule pressure or cost constraints to the mix. The outcome is invariably disastrous.

A project is far more likely to succeed if the underlying problems are clearly identified and understood before Engineering begins. It is also likely to cost less. Starfish brings a wealth of diverse skills, experience, and training to every new project opportunity, but resources are squandered if they aren’t focused on the fundamental problems facing the client. Medical industry challenges require much broader understandings than mere cutting-edge technologies can address. The first question we ask – and we ask it many different ways – is: “What’s your problem?”

By engaging in use studies, workflow analyses, and consulting with a range of equipment users and practitioners, we’ve often found that pre-conceptions of how a product ought to work or look like might be biased or misinformed, and from those misperceptions, ill-defined for development or for market. We are entrepreneurial in our development approach and highly attuned to regulatory requirements. We also manufacture devices in our ISO-13485 facility. From these foundations, we ask questions about sales channels and markets, about revenue streams, product life-cycles and field support. This approach maximizes the likelihood that we’ll identify and design-out obstacles well before they are encountered.

A core value at Starfish is to solve the right problem. An initial engagement proposal from Starfish will contain an outline of research activities, it will reflect and incorporate an understanding of the intended market, and will list a set of deliverables that includes (or at least leads to) a Product Requirements Document that identifies the core problems and how best to resolve them. Starfish develops for the Medical Industry – and only the Medical Industry – from concept to product.