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medical device questions Flashcards

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1
Q

what are business incubators?

A

A business incubator is a company that helps new and startup companies to develop by providing services such as management training or office space.

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2
Q

what can incubators claim they can do?

A 
business basics
networking
internet
access to bank loans
presentation skills, etiquette
work like enviroment...
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3
Q

how do incubators earn money?

A

by rent
subsidies
Grants
Equity in clients

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4
Q

who owns incubators?

A

goverment to hire new startups, increase employment.
university.
Private- feel good arent reliable, VC like

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5
Q

what can incubators do to help medical device startup?

A

networking, internet, presentation and etiquete skills, access to investors, work like enviroment, regulatory compliance, intellectual property management.

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6
Q

what are reasons to have a clinical trial?

A

see if invention works and its safe

proof for doctors, regulators, employees, NICE, and convince investors of reduce risk

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7
Q

what are the phases in pharma clincal trial?

A

preclinical,
phase 1-3 increase in number
phase 4- post marketing data collection

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8
Q

what are the goals of device trials?

A

safety
performance- does the device work as intended.
efficacy

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9
Q

what problems arise when conducting device trials?

A

how to negate placebo effect,

how to ensure blinding

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10
Q

What to think about in clinical protocols(recipe of clincal trial)?

A 
patient selection(age, chronic vs acute, gender)
procedure to do
endpoints- measurement made to ensure device has worked. How long to follow up the patient ?
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11
Q

Clinical trial checklist?

A

Protocol.
Investigators’ brochure- leaflet for doctors to be able to explain the device to patients.
Technical file- preclinical data of the device
The clinical trial application
Ethics committee submission

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12
Q

where can you get help to design medical device trial?

A

quality, regulatory, manufacturig bodies.

Individual consultants. Clinical/contract research organisation.

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13
Q

Case study- ardian summary.

A

hypertension drug resistant patient = market. Solution = kill renal nerve cells. device reduced pressure by 33mmHg. Aquired by medtronic for $800 million. When large case study- safe but no efficacy. Patient not adherent to drugs in real life. when in control group of study, adherence increased. drug actually works.

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14
Q

what factor can increase value of medical device company the most?

A

positive clinical trial evidence. inverse corelation between risk and value of company.

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15
Q

pathfinder summary.

A

catheter technology- postion and connect blood vessels without open surgery. Approved for CTO re-entry. Can be used for vascular access creation- eg anastomoses dialysis- 3bill market.

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16
Q

pathfinder class?

A

class 2, can be used to access blood vessels in all organs except brain and heart.

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17
Q

clincal need of pathfinder?

A

Surgical Fistula creation fail- costs 5billion in usa, low success rate. shunt with pathfinder better efficacy 86% saving.

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18
Q

competitors of pathfinder?

A

tva/ avenu edge is the guidance technology with the catheter

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19
Q

exit of pathfinder?

A

sold to larger company- either peripheral vascular access or fistula created

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20
Q 
terminology:
equity
capitalization table
dilutive funding
non dilutive funding
SEIS/EIS (seed)
burn rate and runway
A

equity- part of company(share) traded for capital.
capitalization table- list of all individuals holding equity.
dilutive funding- capital raised in exchange for equity.
non dilutive funding- capital raised without giving up equity.
SEIS/EIS (seed)- early stage start up investment. Tax incentives private investors
Burn rate and runway- money spent/time. runway is how long till money finishes.

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21
Q

examples of non dilutive funding.

A

grants- typically form goverment
prizes/awards- private sponsors part of accelerator or incubator support
Rand D tax credts- tax relief based on eligible costs, can come in the form of cash credit.
Loans- repayable funding with interest

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22
Q

Grant funding info

A

apply to funding bodies. European funding is still available after brexit and long as working with european company. Funding between 50k to 2 mill over 6 to 36 months. Typically match funded, so have to match with private funds. 30-100%
Funding is awarded in rears- spend first, reimburshed later. Competitive

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23
Q

grant application advice

A

full time job. post grant management time consuming. grant writers not needed if you have written academic grants. Some grants reduce grant funding able to be raised by RnD tax credit.

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24
Q

prizes info

A

SME or founder apply, funding between 10k to 100k between 6-12 months. Additional netwroking and business mentoring support available.

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25
Q

why won’t banks give medtech loans? what else is possible?

A

lack of collateral. goverment loans is a possibility.

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26
Q

Dilutive funding

A

crowd funding, angels and high networth, SEIS(seed enterprise investment) by VC or investment manager

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27
Q

crowd funding pros and cons

A

pros- easy for friends and family to invest, simple online pitch, no need to manage investors, can validate market potential.
Cons- messy cap table, short term expected returns, higher success fees, limited ability to negotiate

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28
Q

Angel investors info

A

high net work individual- invest 10k-50k. Must hold investment for a minimum of 3 years. Can invest as individuals or as a syndicate with corner stone investor leading.

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29
Q

what is SEIS/EIS

A

HMRC scheme to encourage investment in SMEs.
SIES-50% tax credit. 27.5% risk capital- 150k max investment
EIS- 30% tax credit relief. 38.5% risk capital- 5mill per year and 12mill over company lifetime max

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30
Q

Angel syndicates info

A

competitive + SEIS/EIS preassurance required. 5% success fee can be taken. angel = boardmember. typical timeline from pitch to close is 6-12 months.
Fundmanager pros dont need to deal with investors directly. Higher level of due diligence and higher cost. Apply a couple of months before the end of tax year.

31
Q

how long do most medtech companies take from start to exit?

A

6-8 years

32
Q

academic collab pros and cons

A

pros: student project reduce cost, simpler clinical trial management, academic resouce, business development support
cons: lack of early stage funding, grant funding is time consuming, administrative burden high.

33
Q

what is imperial founders choice?

A

if IP created in Uni two route taken:
founder driven- uni holds 5-10% non dilutive equity.(3-15mill cap)
jointly driven- 50/50 dilutive equity split.
fee paying students cannot claim IP

34
Q

what is the main current usage of da vinci?

A

prostectomy

35
Q

what did the anaesthetic design?

A

CPAP mask self wearable with one hand

36
Q

is design important?

A

design focused companies have better stock market value. There are standards associated with desgin processes. FDA regulates design. Also effects patients compliance.

37
Q

Example of bad design?

A

Syringes looking the same, causes clinicans to make mistake.

38
Q

what three criteria does good design meet?

A

Desirability, viability (business), feasibility (technical)

39
Q

Give a overview of HCD process- design council.

A

Discover problem and define.
develop a solution and deliever. Cognitive diveristy captures all of important aspect of defining problem and coming up with solution.

40
Q

HCD (human centered design) process- standford design school.

A

emphathize, define, ideate, prototype, test

41
Q

HCD process- Norman Nielsen group

A

same as stanford but keep looking back for verification of criteria met.

42
Q

Design toolkit- LUMA institute overview and example

A

looking, understand, making
Electronic autoinjector AVA. Automatic retraction of needle. Control needle speed, to give sense of control and reduce senstation of pain.

43
Q

how did seattle children’s bellevue clinic improve hospital design?

A

looked at flow of people within the hospital and observed oppurtunities to reduce downtime and retracing of steps.

44
Q

which map can help to identify design problem?

A

stakeholder map

45
Q

how does ebola spread?

A

spread by fluid. often through direct contact with severly ill. Poor infrastructure in poor contries promotes spread. Solution = sanitation, isolation, information

46
Q

questions to ask about ethnographic research?

A

lifestyle, diet, housing and sanitaion, education, journaling and video observation, access to technology

47
Q

what were the purpose of guild?

A

store valuables, paper given as proof- medium of exchange. first traded in china

48
Q

how was errors minimised in accountancy by luca pocioli?

A

double entry book keeping

49
Q

What is meant by a note being legal tender?

A

Has to be accepted during repayment of a debt

50
Q

what two properties do investors consider before investing and give examples.

A 
Risk and return
Cash- low risk
fixed interest
property
Shares- high risk, high return
51
Q

what is the least riskiest currency and why is this?

A

Swiss francs- political stability, historical performance shown by the negative interest rate

52
Q

what risk might a medical device company face?

A

clinical, technology, people, regulatory

53
Q

what is meant by a share?

A

piece of a company

54
Q

what is meant by junk bond?

A

junk bond = high yeild bond often lent to struggling company.

55
Q

why is alternative investment the riskiest?

A

is not liquid, hard to resell. E.g. investment in small company, paintings

56
Q

who owns majority of shares?

A

Institutions- insurance, pension funds. Percentage of shares in large companies owned by rich individuals has decreased.

57
Q

who are venture capital investors?

A

specialised in certain geography or industry. Looking for high risk, high reward. Money from pension fund often.

58
Q

How are family officies different from tradition VC?

A

often VC like however with just one families money. no time restriction unlike traditional VC whom want a return within 10 years.

59
Q

what is the annual interest rate to double money in 10 years?

A

7% compound interest

60
Q

what is a derivative?

A

Promise related to specialist exchanges.

61
Q

what are problems associated with stenting?

A

metal contact with blood- clot ( anti- coagulant), long term reaction- structure to artery disrupted leading to scar formation and further restenosis of artery- 33% rate.

62
Q

what causes complex flow patterns in a stented artery?

A

Mismatch between the naturaly compliant of artery and stented region with abrupt change at boundary.

63
Q

What could be a potential problem in the complianting stent?

A

it has sharp corners, postion of high stress.

64
Q

who was the main competitor and what was the restenosis rate and what effected it?

A

Guidant multi link 20%- all competitors used stainless steel but design different. Then after the competitor was drug eluding stent, which was coated with anti cancer drug, slowing down cell proliferation.

65
Q

what was the funding history of compliant stent?

A

Option agreement- 1999 to 2001 where company funded research and waited to see development of stent. NIH funding 2003 to 2007.

66
Q

what could happen if you wait for a patent?

A

someone else could patent something similar which

limits boundary of the patent.

67
Q

what are self expanding stents for aorta made out of?

A

Nickel titanium alloy

68
Q

Define entrepreneur?

A

Entrepreneur – a person who organises and manages an enterprise, esp a business, usually with a considerable initiative and risk. (Webster’s)

69
Q

Why is IP important?

A

gives exclusive rights, therefore attracts investors. Return from monopoly, lasts 20 years.

70
Q

who invented the first commercially viable balloon expandable coronary stent?

A

Julio Palmaz

71
Q 
Overview of Bioceramic theraputics
IP
Funding
Management
Technology
A

IP-ICL
Funding-innovations+ network
Management- Entreperneur in residence
Technology- bioactive orthapedic + dental material made from bioactive glass strontium replaces some calcium making material stronger.

72
Q

Brief overview of graphene

A

Discovered 2010 UoM. 213 companies 7 in manchester

73
Q 
Overview of Phagenesis
IP
Funding
Management
Technology
A

IP-UoM
Funding- angloscientific angel network
Management-UoM, angloscientific angel network + daniel green
Technology-neurostimulation for stroke rehab

74
Q 
Overview of Yaqrit
IP
Funding
Management
Technology
A

IP-UCL
Funding- UCLB + superangels
Management- DG
Technology- liver disease treatment

biomedical science (3 decks)

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