Welcome to our September newsletter in which we highlight the legal implications and support we can provide to your business across the full range of Life Sciences practice areas our legal teams cover.
This month's edition dips into the UK government's new Life Sciences Vision and its promise to unlock the potential of innovative UK life sciences companies while stripping away unnecessary bureaucracy. In the field of IVF, we also take a look at the legal and ethical implications of news that the current 10-year storage limit for egg freezing will be extended to 55 years.
Finally, we introduce you to one of our clients, Dan Blackman of DBC Medical, whose company has developed a suite of products for diabetics that merge the medical discipline of podiatry with technological advancements in material science and mechanical engineering. (If you would like your company to be featured in future Q&As please let us know.)
As always, we're happy to hear your feedback. Enjoy the read.
NEWS AND VIEWS - WHAT YOU NEED TO KNOW
New UK Life Sciences Vision – what it promises and legal implications
Earlier this summer the UK government launched a new and wide-ranging Life Sciences Vision with the aim of unlocking innovation and tackling some of the biggest healthcare challenges of our generation...read more
Gamete and embryo storage limits extended
This month, the government announced that restrictions on gamete and embryo storage would be relaxed. Under the current regulations, eggs, sperm and embryos may only be stored for a maximum of 10 years unless the patient is deemed 'prematurely infertile' by a doctor...read more
We're delighted to be sponsoring as well as speaking at this year's annual SEHTA conference (South East Health Technologies Alliance) on Friday 8 October. The event will take place as a hybrid virtual and in-person event focused on driving collaboration between healthcare SMEs, care and clinicians, and academics.
Life Sciences partners Jamie Foster and James Lawford Davies will both speak at the main conference as well as participating in the 'Fireside chat panel' discussion on: 'To what degree and pace will the transformation witnessed in the pandemic continue?' Register to attend
Q&A WITH DAN BLACKMAN OF DBC MEDICAL
This month, we chat with Daniel Blackman, COO of DBC Medical, developer of a suite of products for diabetics that merge the medical discipline of podiatry with technological advancements in material science and mechanical engineering.
MC: Hello Dan and thanks for agreeing to be the subject of this month's Q&A. DBC Medical's journey is typical of many startups and the challenges they encounter to bring an innovative product to market. Can you start by explaining what the company does?
DB: Hi Michael. It's a pleasure to join you today. DBC Medical is an Isle of Man-based business with a truly global focus. We have developed a suite of products that provide healthcare professionals with innovative medical devices to improve clinical outcomes of diabetics who develop foot ulcers as a complication of their chronic disease.
MC: Tell us about The PulseFlowDF and the impact you believe it could have in the healthcare market.
DB: PulseFlowDF is a prescription-only, class IIa wearable medical device suitable for almost all patients who have a diabetic foot ulcer. The product combines several treatment modalities within one mobile platform but its primary function is to promote rapid and sustained wound closure. PulseFlowDF achieves this by actively pumping oxygenated blood to the affected foot while redistributing harmful pressures away from the ulcer. The device allows patients to remain ambulatory while receiving continuous therapy and also monitors patient use to help ensure clinical compliance.
MC: The pace of technological innovation in the healthcare market is remarkable and competition is incredibly fierce. Why is PulseFlow different?
DB: PulseFlowDF is a first-in-class, multi-treatment platform in global healthcare.
It's different because, from a clinical perspective it works with rather than disrupts the market, which removes a significant barrier to entry. It's currently the case that a low percentage of foot ulcers in diabetic patients can be fully healed through clinical intervention and of those patients, nearly half will experience a reoccurrence of the problem within one year. Added to that is a lower extremity amputation rate of one every 30 seconds. It means our product has the potential to make a huge difference to the quality of patients' lives and to the health service that cares for them. The UK burden for direct healthcare alone currently adds up to a spend of more than £1 billion annually.
The device can be used alongside and enhances most current treatment approaches to promote healing and wound closure: it improves blood flow, reduces swelling and protects the wound from further biomechanical harm.
MC: The clinical trials stage can make or break new products. Have you been through that step yet and what did you learn from it?
DB: As you and your readers know, medical device development is a challenging path. The current iteration evolved as the team learned more about the characteristics and challenges of our unique patient population. For example, even when faced with dire consequences that could ultimately result in amputation, some patients with foot ulcers remain non-compliant with their prescribed treatment plan. This led to the development of an embedded patient wear-time monitor. This feature allows the clinician to correlate the progression of wound healing to the number of hours the patient dedicated to improving the flow of oxygenated blood to the ulcer.
MC: You say that DBC's products need to be prescribed to patients via the NHS/doctors' surgeries. What's the biggest challenge you anticipate in selling to one of the world's largest government-funded services and how will you approach it?
DB: The biggest challenge for the adoption of PulseFlowDF technology by the NHS is to convince clinicians to incorporate it into their standard of DFU care. For that to happen requires two things: an understanding at a clinical level of the dynamic between prescribers and an institution's purchasing department; and the ability to generate the required level of clinical evidence and health economic data.
You can never underestimate the power of grassroots relationships with treating physicians while at the same time trying to influence policy decisions at the highest possible level of the NHS. Failing to work both ends of the organisation is an error that can cost companies time and respect. In order to gain meaningful penetration in an organisation of that size, you need to rise to a level where cross-departmental budgets are decided; however, without the perceived clinical push to engage with your product, there is no incentive at the strategic level to even consider your innovation.
Both groups require scientifically sound evidence that the PulseFlowDF system improves patient outcomes and offers health economic benefits to the healthcare system.
MC: How has Hill Dickinson been able to assist you in this?
DB: Hill Dickinson has been a key partner for DBC Medical in our development as a business. The firm's ability to craft straightforward clinical trial and case series agreements has given DBC Medical credibility in working with various healthcare organisations in the UK and the EU. Having access to your subject matter experts has ensured that the commercial integrity of each study we undertake is maintained while at the same time respecting the institutional requirements of our clinical partners. Hill Dickinson's involvement has allowed our clinical research programme to move forward with pace, which is critical to our near- and long-term success as a business.
MC: Where do you see the business in the next two years?
DB: Building on the impressive results of our clinical research thus far, I see DBC Medical's commercial reach expanding throughout the UK, EU, North American and the Middle East in the next 24 months. The treatment of diabetic foot ulcers continues to challenge clinicians despite innovations in wound dressing, skin grafts and other adjuvant therapies. As a result, the market is primed for technologies like ours that are based on sound principles of wound healing that can help improve patient outcomes and healthcare budgets. We are fortunate that our early research has generated such positive outcomes and has fostered relationships with notable clinical leaders here in the UK and in the US. The data will help us to drive both our commercialisation as well as the next R&D phase of our product development as we strive to establish our technologies as first-in-class and DBC Medical as a leader in the wound-healing space.
In the longer term, we genuinely see the PulseFlowDF becoming the standard of care for the treatment of diabetic foot ulcers and DBC Medical being positioned as leaders in innovation in this sizable, complex and ultimately rewarding healthcare sector.
MC: Finally, tell us a little about you and what drives you.
DB: I am a podiatrist who has found the commercial aspects of healthcare as rewarding as working with patients. As a clinician with a love of biomechanics, I was driven to understand how and why people get injured with the goal of predicting and preventing trauma. This led to the development of products and innovative materials that ultimately led to my transition into commercial healthcare leadership.
At my core, I am motivated by the challenge of identifying a clinical need, assessing the market potential and developing innovative solutions that can make a difference in the daily lives of patients and their healthcare professionals. Understanding first-hand the pressures of managing healthcare during my tenure as a consultant podiatrist has further honed my commercial drive and desire to build a team that and can make a positive difference
MC: Getting a new business up and running can be very rewarding but also all-consuming. What's the last thing you think about before your head hits the pillow?
DB: I ensure that I'm acquiring knowledge on a daily basis. So every evening I try to consolidate the day's events into what I did well, what I could have done better, and what my team and I can achieve tomorrow for the benefit of patients, the healthcare professionals that treat them and ultimately our investors that support DBC Medical. So the last thing on my mind is pride.
MC: Where can I find out more/contact you?
DBC Medical IOM Limited
4th Floor, Viking House, Nelson Street
Douglas, Isle of Man IM1 2AH
Royal Wolverhampton Trust extends partnership with digital health provider Babylon Health
This month, Jamie Foster and Christiana Demetriou of our Health and Life Sciences team advised The Royal Wolverhampton NHS Trust on a five-year extension of its partnership with Babylon Health. The partnership's new digital healthcare service, Babylon 360, will be rolled out to over 55,000 people covered by trust's primary care network...read more
Yooma Wellness admitted to trading on Aquis Stock Exchange
Read how Sam Hudson, Cyprien Berlan and Vruksha Patel of our Corporate team advised CBD wellness company Yooma on its second stock market placing in just six months, marking the fourth largest fund raise and the largest ever capital raise for a cannabis company on Aquis...read more
Yooma acquires UK market leader Vitality CBD in £10.2m deal
Following its admission to trading on Aquis (see above), our London Corporate team also advised Canadian-listed wellness company Yooma Wellness on its purchase of Birmingham-based Vitality CBD Limited. Outlets for Vitality's products include Boots, Tesco, Asda and Lloyds Pharmacy...read more
Hill Dickinson advises former owners of Dora Wirth Languages on company disposal
Last month, London partner Shantanu Sinha advised the owners of life sciences specialist translation agency Dora Wirth Languages on its acquisition by US-based language service provider, BIG Language Solutions...read more
INDUSTRY NEWS IN BRIEF
New MHRA consultation on the future of UK medical device regulation
The Medicines and Healthcare products Regulatory Agency (MHRA) launched a consultation on 16 September 2021 inviting views on possible changes to the regulatory framework for medical devices in the UK...read more
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