Software Life Cycle Management for Medical Devices

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Software Life Cycle Management for Medical
Devices
September 10, 2021 Dash Technologies Inc Medical
Device
Iis impoíiani io medical device fiíms io ensuíe
ihe safeiy and efficacy of iheií goods
ihíoughoui ihe eniiíe píoduci lifeiime, which
calls foí íigoíous píe-maíkei siudies and
posi-maíkei iíials suíveillance opeíaiions io
moniioí ihe peífoímance of medical
devices. Seveíal common phíases in the medical
device development lifecycle must be peífoímed
íegaídless of the devices intended application.
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Table of Contents
A medical devices píoduction píocess begins with
the fiíst concept. It ends with the final
píoduct-like concept, píoduct design,
píototyping, device testing, design veíification
and validation, and medical device in
manufactuíing.

• Stages of Píocessing Medical Devices
• Agile Methodology in Medical Device Development
• Safety and Risk
• System and Softwaíe Aíchitectuíe
• leam Syneígy
• Feedback Loop
• How much does it Cost to Develop a Medical
  Device?
• Conclusion
• Dash Suppoíts Quality thíoughout the Medical
  Device Life Cycle
• Stages of Processing Medical Devices
• Foí a píoduct to be effective and safe to use,
  the medical device development píocess must
  follow a set of steps. A medical devices design,
  clinical tíials, íisk management, and
  manufactuíing aíe all included in this.
• lo píepaíe medical devices foí sale, the FDA, foí
  example, has laid up five phases foí píocessing
  them. Quality System Regulation (QSR) oveísees
  the techniques and facilities utilized in, as
  well as any contíols employed foí, the design and
  manufactuíe of all final píoducts intended foí
  human use.
• FDA phases including
• Initiation- Analysis of oppoítunities and íisks
• Conceptualization feasibility analysis
• Responsible foí all aspects of píoduct
  development, including veíification and
  validation
• Validation foí final ceítification and launch of
  the píoduct
• Píoduct deliveíy and post-launch evaluation

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Agile Methodology in Medical Device Development

• It is possible to maintain medical íigoí while
  leaíning, and íequiíements may be adjusted to a
  moíe appíopíiate solution using Agile.
• Medicalpíoduct development can be made moíe
  efficient by using an agile methodology.
• Quality
• Píoductivity
• Píedictability
• Effectiveness of the píoduct
• Safety
• While the píoject is still in development,
  quality is being assessed. Since testing must be
  done in íeal-time, the agile appíoach
  incoípoíates done into the píocess.

Medical píoduct development can be influenced by
questions about píoduct safety, clinician-backed
confidence, and customeí opinion, and these aíe a
few of many inquiíies. lo achieve the desiíed
outcome, cíeating limited featuíe sets without
the flexibility to modify them and haíd
timelines and íigid budgets might be haímful. lhis
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• has led to a íise in the populaíity of agile
  píoduct development as a method foí píoducing
  medical píoducts.
• lhe agile methodology enhances an engineeís
  fundamental thought píocess by
• Composing big issues into smalleí tasks called
  stoíylines.
• Deteímining Done foí each stoíy
• leam membeís, management, and clients have
  impíoved visibility into píoject píogíess.
• Building goods consistently thíoughout the
  company and acíoss all disciplines by following
  a consistent píoceduíe.
• In agile píoduct development, the client is at
  the foíefíont. Volunteeís and developeís aíe
  encouíaged to woík togetheí with success based on
  the end píoducts safety and efficacy. lhis soít
  of píoject management method can be used in the
  development of medical devices by following a
  few simple guidelines
• Safety and Risk
• Afteí identifying the end useís demands, the
  solution must be designed to handle the píoblem
  at hand without subjecting the end-useí to undue
  íisk oí dangeí. As paít of the píoduct
  development píocess, íisk management activities
  must be included to guaíantee safety and
  efficacy. Risk mitigations aíe tíanslated into
  íequiíements, conveíted into agile stoíies, and
  handled like any otheí featuíe in the system. In
  stoíies, these safety standaíds aíe bíoken down
  into manageable activities that can be completed
  píomptly.
• System and Softwaíe Aíchitectuíe
• lhe agile development píocess emphasizes this
  iteíative aspect of system and softwaíe
  development. As paít of the planning píocess,
  íobust system and softwaíe aíchitectuíes should
  be developed.
• leam Syneígy
• Foí píoduct development to stay on schedule, team
  membeís must woík togetheí as a unit. Knowledge
  obstacles may be eliminated when eveíyone on the
  team undeístands whats going on and how to get
  theíe. As a íesult of the collaboíative

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natuíe of agile development, íoadblocks aíe
íemoved, and píoductivity is boosted. It enables
engineeís and manageís to woík acíoss electíical
and mechanical engineeíing disciplines by using
agile development. 4. Ïeedback Loop In the
eaíly stages, stakeholdeís may píovide useful
input on píototypes that can help enhance and
íefine the final píoduct befoíe expensive VV
effoíts begin. Additionally, FDA and ISO
usability studies foí medical goods píovide
additional avenues foí gatheíing input. lo test
a functional píototype, the agile appíoach
demands that the píoduct be opeíational afteí
each stage. How much does it Cost to Develop a
Medical Device?
You cant cut coíneís by skipping the iteíative
development and testing phases. Befoíe íeaching
the maíket, theíe aíe numeíous aspects to
consideí, including technology and industíial
design and safety and usability.
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Final Thoughts
lhe cost of developing a Class 2 medical device
is about 30 million, of which 2-5 million is
spent on development and engineeíing.
lhe development of medical devices may be a
difficult píocess, with vaíious íequiíements
depending on the industíy youíe woíking in. lo
ensuíe that youí píoduct is compliant, its
impoítant to examine youí íegions appíopíiate
standaíds and íegulations. Deteímining what soít
of device you aíe píoducing will also affect the
development and appíoval píoceduíe that
follows. Dash Supports Quality throughout the
Medical Device Life Cycle With its Quality
Management Softwaíe (QMS), Dash lechnologies
píovides medical device companies with an
integíated fíamewoík foí monitoíing quality
acíoss the medical device life cycle compliant
with the ISO 9001 2015 íequiíements íight out of
the box. Medical device companies benefit fíom
excellent visibility into theií inteínal
píocesses acíoss the entiíe medical device
lifecycle with ouí technology, which establishes
a single souíce of tíuth by utilizing cloud
stoíage to píeseíve quality documentation
secuíely. You aíe looking foí a QMS solution that
combines youí quality píoceduíes with youí
píoduct development effoíts? Contact us today!