In this week’s instalment of the MBE forum Paul Dyson, medical device guru, was invited along to discuss medical devices/ technologies and NZ’s potential to develop a strong industry in this area. Below is a few of the notes that I made throughout the session.
‘How many people can name NZ’s top 5 medical device companies?’ No one, including Paul knew. Of course everyone knows #1 i.e. F&P Healthcare who have pioneered the humidified air technology. But other than that the field of medical devices (MD) / technologies (MT) in NZ is pretty much unknown territory. This is despite it posing as major growth industry for our economy. It is a very broad industry ranging from band aids to cochlear implants, surgical instruments to pacemakers
Why is the MD industry important to NZ?
- it is knowledge intensive, recession proof, large market, low volume ( & small objects typically), high margin and a number of diverse niches to enter.
In the US there are thousands of companies in this space each with a share of the estimated US $200billion global and US$ 80billion US markets. Other leading MD/MT exporting countries include Germany, Ireland, Denmark, Finland. Leading markets include #1 US #2 Europe and #3 Japan.
There are 301 US publically listed companies: 57% are therapeutic based, 11% imaging, 9% in vitro diagnostics ( you’ll need to ask Paul for the rest of the stats). Together they soaked up US$3.25 billion of California based life science investment in 2006 (CA is significantly more active in this area compared to other states).
In Israel MD/MT accounts for 55% of the life science industry with approx 500 companies. Australia has 200 and NZ has 50 (we actually have more in the region of 70+). Israel is also #1 in the world for # of MD/MT patents /capita.
Ingredients for a successful local MD/MT industry:
- spirit of research and innovation, entrepreneurship, government policy (clusters, innovation centres), world class education, capital, ecology of support, experienced people.
Focusing on the ecology Paul refers to:
- contract manufactures/ prototype developers in the MD/MT
- contract sterilisation services
- quality control MD/MT standards
- MD/MT regulatory specialists
- MD/MT savvy investors
- MD/MT marketing experience
- Experienced managers.
i.e. bring in people with experience not only in their field but those who also have experience doing this within the MD/MT industry.
Pathway to Market:
5 sections: product development, validation, regulatory submission, approval, market acceptance
Several key aspects in this pathway were highlighted:
- Engage with regulatory bodies early – ensure you have quality systems integral to product development, ensure the design meets strict regulations, get practitioners testing your product through clinical trials as early as possible
- Communication with doctors through conference attendance or publications is essential.
Gate keepers of the industry:
Europe–MDD, US-FDA, Canada-TPD, Japan-MNLW, Australia-TGA, China- SFDA and NZ has nothing, no regulation.
Why do we need to do clinical trials ?
- convince you and your investors your product works
- convince regulatory bodies that it is safe and works
- convince your customers to buy it
Regulatory approvals are necessary but not sufficient. The key opinion leader network is essential to product success. You need advocates/ enthusiasts, publications, conference attendances and excellent marketing partners that are already tapped into the local market. Develop the strategy for these components early in the product’s development.
It is hard to change medical practice because there are strict guidelines that practitioners must abide by while practicing medicine. Deviating from these can have serious consequences for them.
If product doesn’t make money for everyone one in the value chain then it won’t work.
In the Q&A to follow Simon Malpas, CEO of Telemetry Research (a medical device company, spun out of the Spark Challenge and the UoA) mentioned that rather than bringing in specialists with MD/MT experience we can leverage off strong existing industry experts. e.g. PCB manufacturers, software, plastic fabricators/ moulders.
Dick Bellamy, ex Dean of Science UoA, asked whether their are any niche areas we (NZ) can focus on for medical devices. Paul said it is an open slate , too broad. Looking into this further he is probably right as we are currently championing in a broad range of areas (in both MD/MT areas and those that are applicable to the field).
– Health IT – Orion
– Materials Research – PERC, CACM and even UoA CHEMMAT ( in fact one of Spark’s Unpolished GEMs this year is technology to convert seashells into hydroxyapatite, a compound use to make certain MDs)
– Nanotech – MacDiarmid Institute
– Neonatal/Paediatric care – BRAINZ Ltd and the Liggins Institute
– Physiological signal monitoring and inductive power transfer – Telemetry Research
– MRI/NMR – Magritek
– Wound care – Comvita
– Nexus6, Pulsecor, Auximedic, Adept Medical, Bioengineering Institute
The Dean of Engineering, UoA, Michael Davies, announced a new masters degree in medical technologies which is a joint between UniServices (i think), Faculty of Engineering and Faculty of Medical and Health Sciences. Sounds very cool and perfect for this new emerging industry. I will be interested to know how the bioengineering program flows into or runs parallel to this?
Overall this was a great session that I believe proved quite an inspiring eye opener for those in audience. Looking forward to the next forum.
Additional Link :http://nzmedtech.nzte.govt.nz/. NZTE have been busy putting together some good resources on there. Also in combination with NZBio there is http://www.nzbio.org/MedTechs which includes a director of the MD/MTs in NZ.
Recent media release about NZ med tech sector performance from Feb 09.
Graeme @ graemefielder.com