Med-Tech Innovation Engineering Award Winner 2020 - Biovation Orthopaedic Solutions

Med-Tech Innovation News spoke to Matthew Marsden, technical manager at Biovation Orthopaedic Solutions, after the company was crowned Med-Tech Innovation Engineering Award winner for 2020.

The company was recognised for its instrument kit used to perform cartilage replacement implant surgery for big toe arthritis, which was redesigned to reduce lead times, manufacturing costs and allow for more accurate surgery.

First of all, congratulations on winning the award, how do you feel?

I am elated to win the Med-Tech Innovation Engineering Award 2020. This is the first medical device that from a concept, I have brought to market through to continuous commercial supply. There were several challenges and obstacles that had to be overcome, so to be awarded this is an amazing accomplishment. I have a great team here at Biovation Orthopaedic Solutions Ltd (BOS), a testament to everyone’s hard work that we have been presented with this prestigious accolade. It means a lot to the whole team. On behalf of BOS, thank you.

Can you tell us what forms the instrument kit?

The sealed, sterilised instrument set tray contained four major components;

1. A stainless-steel metatarsal drill, which is used to cut an implantation cavity to a set depth to ensure accurate height of press-fit implant.
2. A stainless-steel guide pin, which is used to ensure stability during drilling of cavity.   
3. A polycarbonate placer, which had three functions; a sizing reference, depth check and guide for implant placement, a sheath for drilling the guide pin into the bone, and a syringe like pusher for implant delivery
4. A polycarbonate introducer, which is used to compress the implant and allow visualisation of implant during insertion and aid in implant delivery.

Sharp components were capped to ensure there was no damage to the instrument set during transit, maintaining the sterile barrier.

How does it reduce costs and lead times?

The single-use instrument set reduces costs for our customer due to:

• A lower cost to manufacture, due to material selection compared to the reusable instrument set. The cost savings in manufacture are passed onto our customer.
• Eradicating the ongoing cost of maintenance and refurbishment for the reusable set.
• Eliminating logistical time and resource required to manage the delivery and returns of the reusable instrument set, which were made worse if deliveries and returns were not successful first time. The single use set could be provided to hospitals and be held as stock, ready to use the off-the-shelf solution as and when required.
• The single-use instrument set being 78% smaller in footprint compared to the reusable set, therefore saving on storage space.
• Hospitals are not required to perform sterilisation and decontamination on the instruments, not just eliminating the risk of cross contamination but saving costs, time, and resource on each procedure.

It reduced lead times due to:

• Large batch production due to utilising automated processes during manufacture.

What aspect of this improves accuracy in surgery compared to other products in this field?

The Single Use Instrument set was developed exclusively for our customer to specifically deliver their big toe, cartilage replacement implant, and consequently does not have any comparable competitor products. Our customer previously provided hospitals a reusable instrument set, which had its limitations as discussed previously. For this reason, our single use instrument set had to improve upon our customers reusable approach.

The reusable instrument set was manufactured from stainless steel which obstructed the visibility during implantation. The single use introducer component (used to compress the implant for implantation) is manufactured from transparent polycarbonate to provide surgeons clear visibility throughout the procedure. The new introducer component was also redesigned to feature a nose that fit inside the drilled cavity. This provided anchorage and stability during implantation. The drilled cavity was created by a metatarsal drill that had a stop collar for precise depth of cavity. The improved surgical accuracy of delivering the implant helps provide patients with a successful outcome.

How did you go about engineering this product? What challenges did you face?

The biggest engineering challenges we faced were converting a conventional metal instrumentation set into plastic components, to reduce manufacturing costs whilst improving product functionality. With plastics being more malleable, having lower yield strength and being more brittle than metals, the newly proposed plastic components had to be engineered to be as strong and reliable as their metal predecessors. We also had to consider how were going to sterilise the instrument set. The reusable predecessor was steam sterilised, which was not a viable means of sterilising the single use instrument set due to the new plastic components having a lower melting point than metals. The solution to sterilising the single use instrument set presented new problems due to the process changing the plastics material characteristics. It meant plastic material selection was critical to the success of the product.

How much did your other products inform how you went about developing this solution?

BOS was specifically formed to design, research, develop, validate, manufacture, and supply this very Single Use Instrument Set, exclusively for our customer. At the time we did not have any other products to draw wisdom from and therefore had to  gain our knowledge through extensive research and understanding of the current reusable device procedure, we relied on quick learning, investigatory skills on top of a wealth of knowledge having worked in medical device design for 15 years. Apart from obviously taking this medical device to market and continuous commercial supply, this award is evidence that all pitfalls were learned from and now I have a trilled, tested, and proven pathway for future development.

I am on the lookout for new customers that are seeking design, research, development, validation, manufacture, quality & regulatory assurance, technical file creation, manufacture, and supply services (or anything in between). 

It’s used in cartilage replacement implant surgery for big toe arthritis, one could argue that’s pretty niche, do you feel there are opportunities to develop it further – both with the existing product and into other areas?

You are correct it is niche; we are in the process of developing a second-generation Single Use Instrument Set for our customer with further improvements to functionality and end user benefits. Our customer’s implant technology is not limited to the big toe, so wherever the implant can be applied, we can develop the instrumentation to allow for a smooth successful surgery.

Other than that, I can apply a single use or minimal invasive surgical approach to any idea/concept or currently established medical device.

Any medical device companies or inventors that have ideas/concepts, or if you have an established medical product that you are interested in reviewing for possible costs reductions whilst improving product functionality and end user/customer satisfaction, please do get in touch. You can visit our website www.BOS-UK.com or email inquiries to info@bos-uk.com and follow our company social media pages. We are on LinkedIn, Twitter and Facebook.   

Anything else you’d like to add? You can include a short victory speech here, too, if you’d like to!

I would firstly like to thank our hardworking, dedicated, loyal team. Your efforts do not go unnoticed. It has been a journey that we can always be proud of.

I would also like to mention our critical suppliers.

• Oracle Precision Ltd, who manufacture the metatarsal drill and guide pin. 
• Riverside Medical Packaging Company Ltd, who injection mould the introducer and placer components, perform cleaning, form the instrument tray and package, label & seal the instrument set. 

Without our supply chains manufacturing expertise and endless support from day one, we would not have been able to achieve this, on behalf of BOS, thank you. 

Lastly, I would like to thank John Everingham, BOS business owner, for investing and having the faith in the team and myself to come through and deliver a quality product that truly benefits many peoples lives.

Thank you.