Everything You Know About Medical Design Is Wrong - 0

arenasolutions.
com
Whitepaper
Warning: Everything You Know

About Medical Design Is Wrong
Achieve PLM product design utopia in Medical Device
GET DEMO
arenasolutions.com
An Industry Defined By High Hurdles and High Margins

Developing a medical device has always been a complex process.
Manufacturers must continue to drive innovation while

facing ever-intensifying business challenges, including the
onslaught of fierce competition, the difficulty of managing
globally dispersed teams, and an increasing need to
address quality and risk. On top of this already challenging
state of affairs, OEMs must also comply with strict and ever-
changing regulatory requirements imposed by governing
agencies around the globe.
So how does a medical device manufacturer navigate this

balance beam at high speed?
It’s a tall order because so much is involved in developing

a medical device. Medical device manufacturers face
complications with component changes when developing a product. They have to meet compliance regulations
and face risks more dangerous than other industries. After all, human lives are at stake. And every time a medical
device company makes a single change to a product design, the government needs to know — and it doesn’t
matter whether it’s just a labeling issue or single component change.
And here’s where things get really crazy: the medical device industry has such extended regulatory approval
cycles that by the time a part is approved — it can be deemed obsolete. Replacing the part means the submission
process starts all over again.
Gasp.
The medical device industry is defined by a number of high hurdles that stand in the way of an OEM’s success. But
for those who can overcome these challenges there is the promise of high margins…and vast riches.
The only way to manage the entire medical device product lifecycle – from regulatory compliance, to global
monitoring, quality assurance, risk management and part nonconformance – is through a holistic approach that
brings all of these moving parts together into a single, integrated view. When quality, design control processes,
and risk management are embedded as an integral part of the day-to-day product design and development cycle,
OEMs can dramatically reduce supply chain oversights, employee missteps and product design errors.
Misleading reports that extol the virtues of “best of breed” solutions, so-called “linked” systems, and even the
traditional model of isolated systems claim to be able to deliver the holistic solution described above; however,
recent evidence points to the contrary. Medical device executives, whose use of siloed systems has led to product
delays, scrap, rework and risk exposure, can attest to the painful truth that everything they had been told about
medical design control was…wrong.
According to an Aberdeen Group report, embedding quality and design control processes within a product
lifecycle management (PLM) solution can reduce internal and external failure costs by more than 50 percent and
the total cost of quality by 8 percent.1
©2015 Arena Solutions, Inc. Arena and Arena Solutions are trademarks of Arena Solutions, Inc., Reg. U.S. Pat. & Tm. Off.
All rights reserved. Other product and company names are the property of their respective holders.
1
GET DEMO
arenasolutions.com
For medical device companies, the ideal design environment to avoid risk and ensure quality is a three layer
stack: the foundation is a modern cloud-based PLM solution with an extensible architecture to support a range of
current and future integrations; next is an embedded quality module with corrective and preventive action (CAPA)
capabilities; the final layer are next generation design solution integrations, add-ons — and even component
databases — all woven into the PLM-driven design environment.
In this medical device-focused whitepaper, we look at strategies and modern solutions that when integrated
together can improve quality, streamline design control processes, reduce risk, control design and accelerate
innovation. As we search for a utopian medical device design environment, we cover the following topics:
• Why PLM?
• Advantages of Integrating Quality with PLM
• Strategies for Managing REACH and RoHS Risks Collaborative Quality
• How to Reduce Obsolescence and Counterfeit Parts
Management Life Cycle
• Extending Your PLM Solution Requirements definition
and management
Why PLM?
Build and release Analysis and
Before we begin to delve into buzzwords, such as “holistic management Dynamic design
planning
solutions,” “complete quality pictures” and “enterprise-wide
visibility”, let’s investigate why PLM is the first step in a Risk
Analytics
medical device company’s plan to reduce risk and ensure Collaborative
management
quality in their design processes. quality

management
Defect
life cycle Test
To start with, PLM was created to allow all product resolution management
companies — not just medical device OEMs — to better
manage documents to streamline their extended supply Coverage
analysis
chain efficiencies, improve cross-functional collaboration Testing Construction
and increase enterprise-wide visibility into the design process.
By this very function alone — coupled with configurable
routing and electronic signatures — companies can reduce
costly risks and significantly improve compliance processes.
PLM specifically helps medical device OEMs by empowering them with greater management control over their
quality documents. This expansive list of quality-related documents includes bill of material (BOM), change orders,
design history files (DHF), device master records (DMR), validation and verification certifications, risk management
reports and product records. And let’s not forget the need for a well-documented paper trail for 21 CFR Part 11, 21
CFR Part 820 and CAPA.
PLM offers greater document control for med device companies by consolidating all design information in one
centralized system, enabling OEMs to easily share BOMs with globally dispersed suppliers. Because quality-
related documents can be complicated (a DMR is an enormous compilation of records containing the procedures
and specifications for a finished medical device), a solution like PLM is necessary to avoid misplacing documents
and keeping a tight rein on version control.
2
GET DEMO
arenasolutions.com
When quality processes (CAPAs, supplier corrective action requests (SCARs), corrective action requests (CARs),
NCMRs, 8D, etc.) are integrated into the PLM system, supply chain teams have access to the quality product
records, enabling them to be proactive rather than re-active in managing quality. And because this information is
tracked and visible throughout the organization, auditors can quickly and easily verify compliance.
Advantages of Integrating Quality with PLM

In today’s hyper-competitive medical device market, medical device companies must balance the need to meet
increasingly stringent regulations while continuing to innovate quickly and be first to market. To succeed, medical
device companies should ensure these quality best practices:
• Processes complement one another: Manufacturing, engineering, quality control and compliance
management must all work together to control costs and shorten development cycles and retain a ‘First
Mover’ advantage.
• Compliance becomes part of the culture: Medical device developers must embed compliance into
the day-to-day work life of all global teams; otherwise employees will never be able to keep up with,
much less meet, the ever changing array of local regulatory requirements.
• Ongoing, global monitoring of risks: Again, organizations need to take a holistic monitoring
approach to account for the diversity of risks a medical device OEM faces, including lifecycle,
compliance, multi-sourcing and inventory risks.
• Ensure everyone participates: If the quality process is relegated to an isolated team using an
isolated system, it is almost a guarantee that the product will face quality issues. Quality processes
must be integrated into the day-to-day product record so that everyone, including members of the
extended supply chain, can contribute to producing the highest quality product.
LNS Research recently released the results of a quality management survey that showed medical device
executives ranked the ability to “better manage operational risk” and “ensuring compliance” as the top two quality
management objectives. The roadblocks that executives felt kept them from achieving those goals were “effectively
measuring quality metrics” and “disparate quality systems and data sources.”
Top Quality Management Challenges

Quality metrics are not effectively
measured
Quality is considered a “department”

not a “responsibility”
Disparate quality systems and

Challenges
data sources
Lack of visibility into supplier quality
No formal process for continuous

improvement
Engineering lacks feedback

on quality
0 10% 20% 30% 40% 50%
Percentage of Respondents Source: LNS Research
3
GET DEMO
arenasolutions.com
Fortunately, with a PLM-based quality solution, processes are embedded into

How Arena Helped Swan enterprise business systems and other external data sources, producing – as
Medical Take Flight documented by this research — the following business benefits:
Swan Medical’s COO Larry Sampson • Reduction of the cost of quality by up to 3X 2

was frustrated with his company’s CAPA • A 25 percent increase in operating margin and a 29 percent reduction in failure costs.3
processes. Unreliable and unpredictable
design controls were keeping him awake • A reduction of the cost of poor quality (COPQ), which increased earnings 10 to 15%4
at night. “We suffered from poor internal
understanding of process flow and inability When organizations employ disparate systems to manage quality, risk and other
to produce corrective evidence,” said
key processes, in large part they fail to perform because there is no effective way to
Sampson. “Simply put: we had improper
information in the specified locations.” retrieve recorded notes, making prior corrective actions difficult to adjudicate and
true up. Quality Digest discovered that up to “80 percent of quality issues are repeat
Sampson realized he could not depend issues for which a corrective action has already been identified but does not persist.”5
upon divergent systems to ensure quality.
Redundancy and version control issues
were creating havoc. “With siloed systems,
Because of existing investments in engineering, many companies are implementing
it was hard enough to get the input correct quality management systems (QMS) and associated functionalities, such as
once, let alone twice in exactly the same CAPA, as an extension of PLM. For engineering-intensive organizations, this helps
way,” said Sampson. The COO knew a to incorporate quality processes not only into the design phase, but also into
holistic PLM-driven approach to quality
manufacturing, sourcing and business operations.
control was the key to his medical device
company’s success.
Extending CAPA and other QMS functionalities with PLM strengthens the feedback
Sampson turned to Arena PLM to streamline loop, because it enables stakeholders to take advantage of critical information
his company’s design processes. According
earlier in the value chain. This rapid iterative process in new product introduction
to Sampson, Arena PLM’s change
management capabilities and document (NPI) results in better-formalized first versions.
control enabled him to improve processes
for creating, reviewing and gaining formal With a modern PLM solution, medical device manufacturers can develop a unified
approval for engineering change requests,
information management system for engineering and quality, which creates a
change orders and change notifications. He
also integrated Arena Quality into Arena PLM. single point of entry for all product and quality information irrespective of function.
Streamlining independent data sources into a centralized system delivers more
“I use all of Arena’s tools together to establish accurate product information, improves knowledge sharing, supports better design
a regulatory compliant standard work flow
processes, and provides improved visibility into quality information for all stakeholders.
for predictable outcomes,” said Sampson.
“The quality process integration is great, the It also eliminates the duplication of data in various disconnected systems.
ECO management capabilities are awesome.
Arena allowed me to establish a complete The benefit of integrating quality within PLM is clear, but what other tools and
quality and risk management solution that
strategies can help reduce an increasingly broader array of risks and pains that
streamlined processes to ensure quality for
better business results.”
afflict and ail the medical device industry?
In addition to Arena Quality, Sampson Strategies for Managing REACH and RoHS Risks
also integrated Arena Projects into the
design mix to flexibly track CAPA project When introducing a new medical device onto the market, organizations should
progress through customizable phases with initiate a number of well-defined risk analysis and evaluation phases. Risk
assignable milestones and tasks. “When an management and the performance of risk assessments are key parts of the design,
auditor comes in, it’s useful to have quality
development and control process, because they help ensure that manufacturers
processes tied directly with project tasks,”
said Sampson. “You can click and show fully understand the product and that that designers have fully considered user
them exactly where you’re at in the project requirements, the patient and the operator.
and how much time you expect to complete
the CAPA and which aspects of the system
you’re touching upon.”
4
GET DEMO
arenasolutions.com
At a high level, ISO 14971 defines risk as the “combination of the probability of occurrence of harm and the severity
of that harm.” Risk management for medical devices is “the systematic application of management policies,
procedures and practices, to the tasks of analyzing, evaluating, monitoring and controlling risk.”
The first step in the risk assessment path is to identify the device’s potential hazards and their severity. What does
“severity” mean? One person out of a million dying due to a faulty pacemaker is a more severe “risk” than one in ten
may suffer minor burns due to poor design of an electrical component.
A single death out of a million trumps 10 small injuries in a hundred. Just ask a lawyer.
Problems in the design, development and use of the device can often be eliminated with the review of a medical
device company’s multidisciplinary team; however, the design, quality, production and operational risk assessment
can break down as the experts required for the overarching evaluation process tend to focus on only their specific
area, losing insight into how other elements beyond their vision can impact design.
Providing these different teams with greater enterprise-wide visibility to all processes, while also enabling them to
share knowledge with peers outside of their area is one of the key benefits of a modern PLM solution. At a high
level, Emergo Group Research recommends that teams participating in the risk assessment and management
evaluation process ask these questions:
• What is the intended use of the product?

• Is energy or a substance delivered to or extracted from the patient?
• Is the device to be routinely cleaned or disinfected by the user?
• Are measurements taken? Is maintenance or calibration necessary?
• Is the medical device susceptible to environmental influences?
• Does the medical device have software?
• Does the product have a shelf life, and what determines its useful life?
• Does product installation or use require special training?
Once the risk elements and hazards

of the product design are identified, Table 1: Substances banned by the RoHS Directive
an analysis of each element can be
performed. Various types of hazards can Banned Substance RoHS Limit Typical Use
include energy, biological, environmental,
Lead (Pb) 1000 ppm Solder, batteries, ceramic components
software, user error, labeling, complexity
of use and functional failure. In addition Cadmium (Cd) 100 ppm II-VI compounds, batteries, pigments
to the Chemicals Regulation REACH
(Regulation concerning the Registration, Mercury (Hg) 1000 ppm II-VI compounds, lighting, switches
Evaluation, Authorization and Restriction
Coatings for metal housings
of Chemical substances), medical device Hexavalent Chromium (Hex-Cr) 1000 ppm
and chassis
companies who want to sell their products
Polybrominated Biphenyls (PBB)
globally must now report frequently on
Polybrominated Diphenyl 1000 ppm Flame retardants for plastics
use of certain hazardous substances Ether (PDBE)
with RoHS (Restriction of Hazardous
Substances) Directives.
5
GET DEMO
arenasolutions.com
Until recently, the original RoHS compliance exempted medical devices, allowing them to contain an unlimited
amount of toxic metals and plastics. Not anymore. RoHS now targets a wide array of medical devices, and will
expand to include in-vitro diagnostic devices in 2016. The current list of devices RoHS targets include:
• Radiotherapy equipment
• Cardiology
• Dialysis
• Pulmonary ventilators
• Nuclear medicine
• Laboratory equipment
• Other appliances for detecting, preventing, monitoring, treating or alleviating illness, injury or disability
Today, environmental regulations are now an integral part of medical device product design. Because of this,
OEMs, distributors and contract manufacturers are now using modern component database solutions to manage
substance declarations from their supply chains. A component database is the only realistic way to comply with
ever-changing compliance mandates and frequent adds to both the REACH and RoHS hit lists.
A component database dramatically improves BOM risk management. It provides instant access to component
documentation, accurately forecasts components at existing risk, and offers an in-depth look into electronic
component lifecycle statuses, multi-sourcing, available inventory, and environmental compliance data. When
integrated into a PLM system, a component search engine can help medical device OEMs dramatically reduce
risks across the supply chain.
How to Reduce Obsolescence and Counterfeit Parts

Choosing the right part at the right time is one of the most important aspects of product design. Unfortunately,
many medical device companies don’t utilize a standardized method for selecting electronic parts. And relying
on archaic management tools like Microsoft Excel to manually manage product data can cause medical device
companies to make incorrect selections, as well as waste time.
“Manually searching for and selecting components is time consuming and error prone. It can result in incorrect
or incomplete part numbers, missing information on various attributes, and a host of other inconveniences and
errors,” said Amanda Martin, marketing manager of SiliconExpert, a leading electronic component database.
In addition to enabling medical device companies to better manage compliance, a modern database solution can
forecast a component’s EOL (end of life) using advanced lifecycle algorithms. With this information, OEMs can
make better component selection decisions.
Part obsolescence is an ever-present risk to medical device companies. Even parts have to die someday — bless
their hearts. Managing part data in-house makes it difficult to plan for obsolescence issues, as forecasts are often
based on data that is inaccurate or incomplete. Being caught unaware on a part going EOL can be catastrophic,
causing costs to skyrocket and shipment delays. Additionally, faulty manual risk management processes caused
by a bad part can lead to several medical device nightmare scenarios.
6
GET DEMO
arenasolutions.com
“Imagine you have a device that you’re expecting to

1%
last for ten years — it’s working well in the market, its Documents on a shared network
components are readily available, and all of a sudden (Word, Excel, SharePoint, etc.)
12%
one part goes obsolete. Because of one component, Documents under document
your entire product is now at risk,” said Martin. “In an control (EDCM, QMS, etc.)
absolute worst case, your company might need to
34% 53% Commercial software product
spend millions of dollars to redesign because of one (IBM Rational Doors/Requisite Pro,
component. Our software and tools aim to mitigate Seapine’s TestTrack RM, etc.)
and avoid this type of risk.” By subscribing to an Other
electronic component database and proactively
How do you typically manage
assessing components with complete data risk identification, analysis,
knowledge, the service ‘cleanses’ components and and mitigation?
provides visibility into their potential risk.
Another issue medical device companies face is a growing plague of counterfeit parts, which if included in the
design, can sabotage a device. No company wants to hear that its medical device failed during the course of
performing surgery or that its medical scanner failed to detect cancer. To battle counterfeit risks, some database
providers have developed algorithms — similar to the formulas devised to forecast EOL components — that
examine how long a suspect part has been in the market. The system can also detect whether any counterfeit
reports have been made on the component in the past, and verify how many distributors still carry inventory on
this product.
“Usually counterfeiters will go after parts that are on the gray market — parts no longer being carried by authorized
distributors,” explained Martin. “Counterfeiters know companies are in a panic to get a hold of these parts. Yes, there
are tests and measurements and methods in the market today, but you are not going to be able to test every single
component, so there is always a risk.”
When the electronic component database is integrated into a PLM system to manage the BOM and associated
engineering change orders, medical device engineers have the ability to validate and assess all parts with cross
references, lifecycle, parametric, obsolescence
Risk controls User needs forecasts, regulation compliance and inventory data.
Project status Related issues
Gap analysis Related documents “From a medical device perspective — in the case of
Impact analysis Trace structure having components and products you can trust — we
Related requirments Other are literally talking about saving lives here,” Martin said.
Extending Your PLM Solution

For medical device companies, a highly integrated,
robust and complete design system is needed to
address hurdles, such as obsolescence, single-
sourced components, regulation compliance, and
43% 38% 35% 34% 30% 24% 23% 20% 19% 3% market availability of electronic components. Today,
What types of information do you need better holistic quality system needs to be more whole
visibility into during product development? than ever before.
7
GET DEMO
arenasolutions.com
Laurence Sampson, chief operating officer of Swan Valley Medical, can attest to the value of a PLM solution that
embeds quality and also supports all future integrations and add-ons. “All the systems that we have had in the past
— CAPA systems, Non-conforming Medical Reports (NCMRs), complaint logs — had been paper systems,” said
Sampson. “The interlinking of the different systems had been difficult to follow and understand.”
Sampson relies upon Arena BOMControl and a suite of complementary solutions to meet his product design goals
(see sidebar) “Each one of these different processes (Arena BOMControl, Arena Quality, Arena Projects, Document
Control) can be linked together, so that when you get an audit you have a tightly integrated cross linked evidence
chain for whatever problem you’re dealing with,” said Sampson.
Carl Dupper, director of technical operations at Yukon Medical, agrees with Sampson that Arena Quality, which
is linked to Arena PLM with integrated corrective action preventive action (CAPA) capabilities, provides a superior
industry-wide approach to managing quality compared to using disparate systems.
“The big win with Arena is the visibility of knowing where things are along in the design development and
commercialization process and who is involved,” said Dupper.
In addition to Arena’s suite of complementary PLM design management solutions, BOMControl integrates with
component databases, such as SiliconExpert, and external systems, including ERP, MCAD, and OrCAD, to fortify a
truly end-to-end design environment.
According to Manny Marcano, president and CEO of EMA, the integration between OrCAD and Arena provides
a number of special benefits for medical device companies using both systems; for example, components from
an OEM’s PLM system are available directly within the OrCAD design environment making search, selection, and
placement very simple. Parts listed as obsolete or compliance risks in the PLM environment can be easily identified
and swapped out in an OrCAD design.
Top Quality Management Objectives

0.38
Reduce the total 0.49
0.46
cost of quality 0.28
Top Quality Management Objective
0.24
0.23
Reduce non- 0.27
conformances in 0.23
0.35
manufacturing 0.28
0.15
Improve customer 0.13
0.23
experience 0.33
0.17
0.10 Color by Industry

Better manage 0.11
0.08 Aerospace and Defense
operational risks 0.08
0.21 Automotive
0.10
Electronics
0.02 Industrial Equipment Man.
Ensure compliance 0.03
Medical Devices
0.10
0 0.05 0.1 0.15 0.2 0.25 0.3 0.35 0.4 0.45
Percentage of Respondents Source: LNS Research
8
GET DEMO
arenasolutions.com
“If business and parts information live in two different systems, you’ve got an engineer jumping back and forth
between systems trying to figure out if they can use this part — and that usually leads to a huge opportunity for
error,” said Marcano.
Because of this integration, all parts added to a medical product design are assured to be approved and preferred
components. With a complete design containing accurate component information, OrCAD users can create zero
touch BOMs because all required component information comes directly from their enterprise PLM system.
“This integration helps companies, especially medical device OEMs, consolidate the number of data sources they
need to reference when they’re working on a design,” said Marcano. “We often hear of eCAD/mCAD co-designs
but I suggest, you’ve never heard of eCAD/PLM co-design. And medical device companies today can benefit
from this integration in several ways: quicker time to market, better efficiency, and tamping down risk. For medical
device engineers, an eCAD/PLM co-design is a game changer.”
Conclusion
Many executives in the medical device industry — from the founders of startups to the heads of billion dollar
public companies — have long felt overly burdened by what they consider unduly complex approval processes.
Frustrated executives bemoan how these directives impede innovation and delay the availability of better health
care. Impediments to medical device development cycles can, axiomatically, cost lives. Even the FDA recognizes
the validity of the criticism, announcing last year a new Medical Device Innovation Consortium (MDIC) that will be
charged with simplifying the process of designing and testing new technologies.
Against the backdrop of health care reform and a controversial medical device tax, modern medical technology
companies are focusing more than ever on the power of complete design solutions that deliver cheaper, faster,
more efficient patient care.
A PLM solution that supports interoperability among complementary solutions coupled with an extensible
architecture to support integrations with current and future systems is now possible. This new and improved
embedded holistic environment is an important key to ensure medical device makers succeed by reducing risk,
improving quality and accelerating time to market.
And that’s why three of the top five medical device companies rely on Arena.
Bibliography:
1) http://aberdeen.com
2) International Journal of Management
3) http://aberdeen.com
4) http://www.mckinsey.com
5) Quality Digest
9
GET DEMO
arenasolutions.com
About Arena
Arena pioneered cloud PLM applications. The company’s products Contact
enable engineering, manufacturing teams and their extended Arena Solutions
Foster City, CA 94404
supply chains to speed prototyping, reduce scrap, lower cost and
P. 650.513.3500
shrink time to market. Arena cloud PLM applications simplify bill F. 650.513.3511
of materials and change management for companies of all sizes,
and offers the right balance of flexibility and control at every point
in the product lifecycle—from prototype to production. Based in
Foster City, Calif., Arena has been ranked as a Top 10 PLM solution
and also holds a spot on the San Francisco Business Times’ Best
Places to Work List for 2013.
Author
John Papageorge, the author of “Warning: Everything
You Know About Medical Design is Wrong,” has worked
with some of the biggest names in technology, including
Oracle, IBM, Hewlett Packard, Cisco and Silicon Valley
Bank, to analyze and communicate emerging business
and technology trends.
Cloud. Connected. Content. Makes Making Easier.
2013.06.27.cleantech.wp
10

Everything You Know About Medical Design Is Wrong - 0

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Everything You Know About Medical Design Is Wrong - 0

Uploaded by

Copyright:

Available Formats

arenasolutions.

Warning: Everything You Know

An Industry Defined By High Hurdles and High Margins

Manufacturers must continue to drive innovation while

So how does a medical device manufacturer navigate this

It’s a tall order because so much is involved in developing

quality in their design processes. quality

Advantages of Integrating Quality with PLM

Top Quality Management Challenges

Quality is considered a “department”

Disparate quality systems and

Lack of visibility into supplier quality

No formal process for continuous

Engineering lacks feedback

0 10% 20% 30% 40% 50%

Percentage of Respondents Source: LNS Research

Fortunately, with a PLM-based quality solution, processes are embedded into

Swan Medical’s COO Larry Sampson • Reduction of the cost of quality by up to 3X 2

• What is the intended use of the product?

Once the risk elements and hazards

How to Reduce Obsolescence and Counterfeit Parts

“Imagine you have a device that you’re expecting to

Extending Your PLM Solution

Top Quality Management Objectives

0.10 Color by Industry

0 0.05 0.1 0.15 0.2 0.25 0.3 0.35 0.4 0.45

Percentage of Respondents Source: LNS Research

2) International Journal of Management

Cloud. Connected. Content. Makes Making Easier.

You might also like