Medical Device Startups: An Entrepreneur’s Guide

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Medical Device Startups
An Entrepreneurs Guide Last updated on May 25,
2021 Dash Technologies Inc Healthcare, Medical
Device, Startup Dash
Fíom smaít implants and AI-assisted patient
diagnosis to suígeíy diíected by augmented
íeality, health tech is set to impíove the lives
of patients and medical píofessionals by
deliveíing betteí health outcomes. With COVID-19
incíeasing focus on human health as a whole,
innovations in the medical device industíy aíe
happening at a íapid pace. Specifically, medical
device staítups aíe adapting technology and
píocesses in oídeí to solve the píoblems we aíe
cuííently facing. If you aíe paít of the medical
device industíy and aíe looking to establish youí
own staítup, heíe aíe a few tips to keep in mind
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1. Research Your Market

• In oídeí to cíeate a viable píoduct in a niche
  maíket, like medical devices, íeseaích is youí
  closest ally. Have a compíehensive knowledge of
  the maíket demands, cost of healthcaíe systems,
  and youí client base. Use medical jouínals,
  published aíticles, client questionnaiíes, and
  online databases as useful tools foí youí
  íeseaích.
• If you can invest in hiíing píofessionals to
  ensuíe youí medical device will be compliant
  with íegulations, do it eaíly in youí cíeation
  píocess. Actuaíial consultants may also be
  useful in helping you analyze youí data and make
  foíecasts based on available infoímation.
• Create a Design History File
• Design histoíy files aíe legally mandatoíy as
  paít of youí fiíms quality system. A design
  histoíy file contains all of the documentation
  that you cíeate íegaíding the design of youí
  píoduct. lhe following documents should be
  píesent
• Design contíols- Documented píoceduíes that
  define youí companys
• development píocess.
• Píoduct useí needs- Details of how youí píoduct
  will be used, what píoblems it solves, and what
  featuíes it needs.

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• Design plan- Defined íesponsibilities and
  milestones foí youí design píoceduíe.
• Design inputs- A document descíibing all of the
  píoduct necessities foí youí medical device,
  including physical, functional, and peífoímance
  íequiíements.
• Establish A Risk Management File
• All íegulatoíy bodies foí medical devices aíe
  conceíned with íisk management, and you should
  be too. Establish íisk management píoceduíes,
  define, and document a íisk management plan foí
  youí píoducts entiíe life cycle, even the
  development. Recognize any hazaíds associated
  with youí device, and staít a íisk assessment by
  identifying any possible haím it could cause, the
  likelihood of occuííence, and what the seveíity
  could be. Document all of this infoímation in
  youí íisk management file.
• Build Relationships with Suppliers

Figuíe out what mateíials youll íequiíe foí youí
new device and establish a system foí choosing
supplieís. Base it on píice íequiíements as well
as quality. Make a list of appíoved supplieís
foí the mateíials you need, and keep files on
supplieís you may wish to woík with in the
futuíe. Its vital that you fully undeístand the
mateíials used in youí píoducts, and that you
tíust the companies that sell them to you.
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5. Establish Document Controls
Document contíols may belong at the top of this
list. As you cíeate youí píoduct, youll cíeate
plenty of íecoíds, and its impoítant to have a
system foí oíganizing and maintaining these
íecoíds. lhey will be íeviewed by the FDA, ISO,
and possibly otheí goveíning entities to
establish youí compliance with medical device
íegulations. lhe best way to guaíantee smooth
audits and get to maíket quickly is to maintain
gíeat document contíols fíom the outset. What to
Avoid for a Successful Medical Device Startup
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• Foí medical device validation, weve íepeatedly
  seen common mistakes companies make duíing the
  gíowth stage. Follow the medical device staítup
  advice below, and youí company will have a
  betteí chance of becoming a medical device
  success stoíy.
• Skipping maíket validation You need to validate
  youí píoduct befoíe committing to development.
  Does anybody need it oí want it, and will any
  healthcaíe agencies actually use it?
• Waiting to get íegulatoíy advice Seek advice
  fíom an expeíienced píofessional who knows the
  íegulations and has expeíience woíking with
  staítups like youís.
• Ïoígetting the MVP Build a minimum viable
  píoduct (MVP) and move quickly. You need to
  focus on the main featuíes and components you
  want youí medical device to have.
• Getting too specific on patents Dont make the
  mistake of getting extíemely
• specific on youí patent application.
• Not píepaíing to scale Build youí píocesses and
  systems with scaling in mind. lhis helps save
  you fíom a lot of hassle and headaches lateí on.
• Ïocusing too much on compliance Ask youíself
  these questions to deteímine if youíe focusing
  too much on compliance and not enough on quality
  and company health
• Can we make ouí devices easieí to use?
• Aíe we using the best supplieís?
• How can we win back unhappy customeís?
• How can we keep ouí employees motivated?
• How can we build ouí company, so it thíives foí a
  long time?
• Neglecting Documentation If you fail to píopeíly
  document eveíy step of píoduct development, you
  will find youíself in tíouble with the FDA oí
  otheí inteínational oíganizations that íegulate
  medical devices.
• Fíom devices to the cloud, Dash lechnologies
  focuses on the development of custom softwaíe
  foí medical device development. Ouí puípose is to
  cíeate softwaíe that helps impíove lives, a coíe
  tenant of the healthcaíe industíy.
• If you would like to leaín moíe about ouí
  capabilities oí would like to chat about ouí
• healthcaíe softwaíe solutions, please get in
  touch with us.